title: A Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-Experienced Adults 50 Years of Age or Older

summary: This a study of V116 in adults ≥50 years of age who previously received a pneumococcal vaccination ≥1 year before enrollment. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116.

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Taiwan
Spain
Italy
Canada
Korea, Republic of
United States
Israel
France
Japan

location_facility: Central Research Associates ( Site 0024)

location_facility: Southland Clinical Research Center ( Site 0026)

location_facility: The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 0752)

location_facility: A.O.U. Policlinico Paolo Giaccone ( Site 0402)

location_facility: Alliance for Multispecialty Research, LLC ( Site 0020)

location_facility: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-Respiratory ( Site 0508)

location_facility: Korea University Ansan Hospital ( Site 0751)

location_facility: The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 0753)

location_facility: Advanced Medical Research Institute ( Site 0018)

location_facility: Diex Recherche Sherbrooke Inc. ( Site 0101)

location_facility: Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 0302)

location_facility: Lenzmeier Family Medicine/CCT Research ( Site 0008)

location_facility: Fiel Family and Sports Medicine, PC/CCT Research ( Site 0006)

location_facility: Maccabi Health Services - Holon ( Site 0305)

location_facility: Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0016)

location_facility: Sheba Medical Center-Early Phase Clinical Trials Unit ( Site 0304)

location_facility: Hamilton Medical Research Group ( Site 0114)

location_facility: National Cheng Kung University Hospital ( Site 0801)

location_facility: University of Texas Medical Branch-Sealy Institute for Vaccine Sciences Clinical Trials Program ( Si

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0400)

location_facility: Hadassah Medical Center-Clinical Reaserch Unit ( Site 0300)

location_facility: Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia ( Site 0405)

location_facility: HOSPITAL CLÍNIC DE BARCELONA-Medicina Preventiva i Epidemiologia ( Site 0503)

location_facility: Maccabi Healthcare Services ( Site 0306)

location_facility: National Taiwan University Hospital ( Site 0800)

location_facility: Hallym University Kangnam Sacred Heart Hospital-Internal Medicine ( Site 0754)

location_facility: Hospital Internacional Xanit ( Site 0520)

location_facility: Health Research of Hampton Roads, Inc. ( Site 0003)

location_facility: Diablo Clinical Research, Inc. ( Site 0019)

location_facility: Korea University Guro Hospital ( Site 0750)

location_facility: CHU de Québec-Université Laval-Équipe de recherche en vaccination ( Site 0120)

location_facility: Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0203)

location_facility: Indago Research & Health Center, Inc ( Site 0005)

location_facility: Meridian Clinical Research, LLC ( Site 0009)

location_facility: Hospital Universitari de Bellvitge ( Site 0505)

location_facility: Gachon University Gil Medical Center ( Site 0755)

location_facility: centre hospitalier lyon sud ( Site 0204)


title: Efficacy and Safety of the Omnipod 5 System Compared to Pump Therapy in the Treatment of Type 1 Diabetes: a Randomized, Parallel-group Clinical Trial

summary: Subject will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 90-day outpatient phase where subjects will either use the Omnipod 5 system or continue to use their personal insulin pump with the study provided continuous glucose monitoring system.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Insulet Corporation

location_country:
United States
France

location_facility: Hospices Civils de Lyon - Centre du diabete Diab-eCare

location_facility: Hopital Lariboisiere - Centre Universitaire du Diabete et de ses Complications

location_facility: Diabetes & Glandular Disease Clinic, P.A. (DGD Clinic)

location_facility: CHRU de Montpellier, Hopital Lapeyronie - Departement d'endocrinologie, Diabete, Nutrition

location_facility: State University of New York, Upstate Medical University

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Disease Registry on Patients With Advanced NSCLC Harboring METex14 Skipping Alterations (MOMENT)

summary:
The purpose of this multi-national disease registry is to collect prospectively (with longitudinal follow-up) high-quality, standardized, and contemporaneous data to capture changes in the non-small cell lung cancer (NSCLC) treatment landscape and outcomes over time.

The registry will capture data on participants; demographic, clinical characteristics (including biomarker data), treatment patterns, and effectiveness and safety outcomes for advanced NSCLC with mesenchymal-epithelial transition exon 14 (METex14) participants treated with systemic therapy.

study_type: Observational

time_perspective: Prospective

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Portugal
Spain
Italy
Austria
Netherlands
United Kingdom
Finland
Canada
Sweden
United States
France
Israel
Belgium
Germany

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS

location_facility: Complejo Hospitalario Universitario Insular-Materno Infantil

location_facility: Hospital Regional Universitario de Malaga - Hospital General

location_facility: Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria

location_facility: Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.

location_facility: Institutional Helsinki Committee, The Lady Davis Carmel Medical Center

location_facility: Assuta Ashdod Institutional Review Board


type: EudraCT Number

title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase IIIb Study Evaluating the Effect of Inclisiran on Atherosclerotic Plaque Progression Assessed by Coronary Computed Tomography Angiography (CCTA) in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events (VICTORION-PLAQUE)

acronym: V-PLAQUE

summary: CKJX839D12303 is a research study to determine if the study treatment, called inclisiran, in comparison to placebo taken in addition to statin medication can effectively reduce the total amount of plaque formed in the heart's vessels as measured by coronary computed tomography angiography (CCTA) from baseline to month 24. This study is being conducted in eligible participants with a diagnosis of non-obstructive coronary artery disease (NOCAD), where the coronary arteries are blocked less than 50%, and with no previous cardiovascular events.

ipd_sharing: Yes

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

lead_sponsor: Novartis Pharmaceuticals

location_country:
Brazil
Spain
Ireland
Italy
Australia
United Kingdom
Switzerland
Hungary
United States
Chile
China
France
Belgium

intervention_type: Drug


type: Other Identifier

title: A Phase 2a Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Oral Tablet Formulation of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis

acronym: SUMMIT

summary: The purpose of the study is to evaluate the efficacy of an oral tablet formulation of JNJ-77242113 compared with placebo in participants with moderate-to-severe plaque psoriasis.

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
Poland
Spain
Canada
United States
France
Germany

location_facility: The Guenther Dermatology Research Centre

location_facility: Universitätsklinikum Schleswig Holstein Campus Lübeck

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: The Pennsylvania Centre for Dermatology, LLC

location_facility: Specjalistyczny gabinet dermatologiczny Aplikacyjno-Badawczy Marek Brzewski, Pawel Brzewski Spolka Cywilna

location_facility: Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna


title: A Multicenter, Randomized, Dose-Blind, Phase 3 Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus

summary:
The primary objective of this study is to evaluate the long-term safety and tolerability of BIIB059 in participants with active systemic lupus erythematosus (SLE).

The secondary objectives of this study are to evaluate the long-term effect of BIIB059 on disease activity in participants with SLE, to evaluate the long-term effect of BIIB059 in participants with SLE in maintaining low disease activity, to evaluate the effect of BIIB059 in participants with active SLE in preventing irreversible organ damage, to assess long-term use of oral corticosteroid (OCS) with participants receiving BIIB059 treatment, to assess the impact of BIIB059 on participant-reported Health-Related Quality-of-Life Questionnaire (HRQoL), symptoms, and impacts of SLE, to evaluate long-term effect of BIIB059 on laboratory parameters, and to evaluate immunogenicity of BIIB059.

ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/

lead_sponsor: Biogen

location_country:
Serbia
Spain
Italy
United Kingdom
United States
Peru
Belgium
Japan
Philippines
Romania
Czechia
Poland
Russian Federation
Australia
Argentina
Puerto Rico
Israel
Mexico
Sweden
Brazil
Canada
Hungary
China
Germany
Bulgaria
Taiwan
Greece
Korea, Republic of
France
Chile
Colombia
Netherlands


title: A Phase 1b Study of Bispecific T Cell Redirection Antibodies in Combination With Checkpoint Inhibition for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma

summary: The purpose of the study is to identify the safe dose(s) of a PD-1 inhibitor in combination with talquetamab or teclistamab, and to characterize the safety and tolerability of talquetamab or teclistamab when administered in combination with a PD-1 inhibitor.

design_allocation: Non-Randomized

location_country:
Germany
United States
Spain
France

location_facility: Institut Universitaire du Cancer Toulouse Oncopole


title: A Randomized, Double-blind, Placebo-controlled, Multi-center, 2-part, Phase 2 Study to Evaluate Efficacy, Safety, and Tolerability of RGH-706 in Prader-Willi Syndrome

summary:
RGH-706 is a novel, potent, and orally active MCHR1 antagonist drug candidate discovered and being developed by Gedeon Richter Plc. for weight management.

This will be the first Phase 2, proof-of-concept study using RGH-706 and is the third study in the clinical development program for RGH-706. The aim of this study is to evaluate the efficacy, safety, and tolerability of RGH-706 in patients with Prader-Willi Syndrome (PWS).

ipd_sharing: No

lead_sponsor: Gedeon Richter Plc.

location_country:
Spain
Italy
United States
France
Czechia

location_facility: Azienda Ospedaliera Universitaria "Federico II"

location_facility: Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez

location_facility: Hospital Regional Universitario de Málaga - Hospital General

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: University Hospitals Cleveland Medical Center

location_facility: Parc Taulí Sabadell Hospital Universitari

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Hospital General Universitario Gregorio Maranon-Instituto Provincial de Psiquiatria y Salud Mental

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

location_facility: Morgan Stanley Children's Hospital of NewYork-Presbyterian


type: Registry Identifier

title: A Phase 3, Open Label, Randomized, Non-Inferiority Pharmacokinetic Study of Nivolumab Administered Subcutaneously (Nivo SC) Versus Intravenous Administration of Nivolumab in Participants With Stage IIIA/B/C/D or Stage IV Adjuvant Melanoma Following Complete Resection

summary: The purpose of this study is to compare the drug levels of nivolumab administered subcutaneously versus intravenous administration in participants with melanoma following complete resection.

lead_sponsor: Bristol-Myers Squibb

location_country:
Poland
Spain
Italy
United Kingdom
Australia
Canada
United States
France
Belgium
Germany

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: Ft. Wayne Medical Oncology and Hematology

intervention_type: Biological


title: A Randomized, Double-Blind, Multicenter, Phase 2 Study of Retifanlimab in Combination With INCAGN02385 (Anti-LAG-3) and INCAGN02390 (Anti-TIM-3) as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

summary: The purpose of this study is to evaluate the safety and efficacy of the combination of retifanlimab plus INCAGN02385 and retifanlimab plus INCAGN02385 and INCAGN02390 compared with retifanlimab alone as first-line treatment in PD-L1-positive and systemic therapy-naive recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN).

ipd_sharing_description: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

lead_sponsor: Incyte Biosciences International Sàrl

location_country:
Poland
Taiwan
Portugal
Spain
Greece
Georgia
Italy
Netherlands
Canada
Korea, Republic of
United States
France
Belgium
Germany

location_facility: Istituto Nazionale Tumori Irccs Fondazione Pascale

location_facility: Ico Girona Hospital Universitari de Girona Dr Josep Trueta

location_facility: University Hospital of West Attica - Attikon

location_facility: Centrum Onkologii Im. Prof. Franciszka Lukaszczyka

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E.

location_facility: Hospital General Universitario de Valencia

location_facility: Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau

location_facility: Chonnam National University Hwasun Hospital

location_facility: Fondazione Del Piemonte Per L Oncologia Ircc Candiolo

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Hospital Universitari I Politecnic La Fe

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Fondazione Irccs Istituto Nazionale Del Tumori Di Milano

location_facility: Przychodnia Lekarska Komed Roman Karaszewski

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, Epe-Unidade L

location_facility: Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

location_facility: University of Maryland - Greenebaum Cancer Center

location_facility: Chang Gung Medical Foundation. Kaohsiung Branch

location_facility: Catalans Institute of Oncology Barcelona

location_facility: Fundacion Jimenez Diaz University Hospital

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: Pusan National University Yangsan Hospital

location_facility: University of Virginia - Emily Couric Clinical Cancer Center

location_facility: McGill University Health Centre/Glen Site/Cedars Cancer Centre

location_facility: University of California San Diego Medical Center, Moores Cancer Center

location_facility: University of California San Francisco Comprehensive Cancer Center

location_facility: McGill University Jewish General Hospital

location_facility: Huntsman Cancer Institute At University of Utah

location_facility: Centrum Onkologii Ziemi Lubelskiej Im. SW. Jana Z Dukli

location_facility: Centro Hospitalar de Lisboa Norte E.P.E. - Hospital de Santa Maria

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Taipei Veterans General Hospital Institutional Review Board

location_facility: Leids Universitair Medisch Centrum (Lumc) (Leiden University Medical Center)

location_facility: Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie


title: A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations (FIGHT-209)

summary: This is an open-label, monotherapy study of pemigatinib in participants with recurrent glioblatoma (GBM) or other primary CNS tumors with an activating FGFR1-3 mutation or fusion/rearrangement. This study consists of 3 cohorts, Cohorts A, B, and C, and will enroll approximately 82, 82, and 25 participants into each cohort, respectively. Participants will receive pemigatinib 13.5 mg QD on a 2-week on-therapy and 1-week off-therapy schedule as long as they are receiving benefit and have not met any criteria for study withdrawal.

lead_sponsor: Incyte Corporation

location_country:
Denmark
Spain
Italy
United Kingdom
Netherlands
United States
France
Japan
Germany

location_facility: Ico Girona Hospital Universitari de Girona Dr Josep Trueta

location_facility: Klinikum Der Johann Wolfgang Goethe University

location_facility: Comprehensive Cancer Center of Wake Forest University

location_facility: Hospital General Universitario de Valencia

location_facility: H. Lee Moffitt Cancer Center and Research Institute Hospital

location_facility: The Royal Marsden Nhs Foundation Trust - Sutton

location_facility: Rush University Medical Center - Consultants in Hematology

location_facility: Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele

location_facility: Hospital General Universitario Vall D Hebron

location_facility: Netherlands Cancer Institute Antoni Van Leeuwenhoek Ziekenhuis

location_facility: Lynn Cancer Institute Marcus Neuroscience Institute

location_facility: Baylor Scott and White Research Institute

location_facility: Providence St Joseph Hospital Orange Center For Cancer Prevention and Treatment

location_facility: Orlando Health Cancer Institute Downtown Orlando

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: University of Pittsburgh Medical Center Health System

location_facility: Rigshospitalet Uni of Hospital of Copenhagen

location_facility: Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza

location_facility: University of Minnesota Health Clinics and Surgery Center

location_facility: UC Health At Cincinnati Va Medical Center

location_facility: A.S.L. Napoli 1 Centro Ospedale Del Mare

location_facility: The Royal Marsden Nhs Foundation Trust - Chelsea

location_facility: Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole

location_facility: Rhodes Center For Glioblastoma At Newyork - Presbyterian Hospital


title: A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Advanced Non-Small Cell Lung Cancer With an FGFR Alteration Who Progressed on Previous Therapy (FIGHT 210)

summary: This is an open-label, single arm study to study the safety, efficacy and tolerability of Pemigatinib when used on participants with squamous or nonsquamous NSCLC with a documented FGFR1-3 mutations or fusions/rearrangement who have progressed on prior therapies and have no available standard treatment options

location_country:
Spain
Italy
United States
France
Germany

location_facility: Ico Girona Hospital Universitari de Girona Dr Josep Trueta

location_facility: Hospital Regional Universitario de Malaga

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Rush University Medical Center - Consultants in Hematology

location_facility: Florida Cancer Specialists & Research Institute

location_facility: Chu de Toulouse Hopital Larrey Centre de Reference Des Maladies Rares de La Peau Service de Dermatol

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Azienda Ospedaliera Di Perugia - Ospedale Santa Maria Della Misericordia

location_facility: Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari

location_facility: Istituto Nazionale Tumori Regina Elena Irccs

location_facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano

location_facility: Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori


acronym: HUDSON GI

title: A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled 3-Part Phase 3 Study to Demonstrate the Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)

lead_sponsor: AstraZeneca

source: euctr

ipd_sharing_description: Qualified researchers can request access to anonymised individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Poland
Brazil
Spain
Italy
Australia
Netherlands
Canada
Vietnam
Ukraine
United States
France
China
Japan
Germany

summary: This is a 3-part study. Part A and B have identical designs and are randomized, double-blinded, placebo-controlled studies, which will include patients with eosinophilic gastritis and/or duodenal-only disease. Part A will be enrolled first, followed by Part B. After completing Part A or Part B, participants will continue to Part C - open-label benralizumab treatment period.


title: A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis

acronym: AQUARIUS

summary: The purpose of this study is to characterize cardiac safety of Daratumumab, Cyclophosphamide, Bortezomib, and Dexamethasone (D-VCd) treatment regimens (Arm A: immediate daratumumab + VCd treatment and Arm B: daratumumab + deferred VCd) in newly diagnosed systemic amyloid light chain (AL) amyloidosis with cardiac involvement and to identify potential mitigation strategies for cardiac toxicity (cohort 1); to characterize the pharmacokinetics of subcutaneous (SC) daratumumab, among racial and ethnic minorities, including Black or African American, with newly diagnosed AL amyloidosis treated with D-VCd (cohort 2).

location_country:
Spain
Greece
Italy
Netherlands
United Kingdom
Canada
United States
France
China
Germany

location_facility: Hospital Maastricht University Medical Center

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: DIPARTIMENTO DI BIOTECNOLOGIE CELLULARI ED EMATOLOGIA - UNIVERSITà ''LA SAPIENZA''

location_facility: A.O.Citta della Salute e della Scienza di Torino

location_facility: University Health Network (UHN) Princess Margaret Cancer Centre

location_facility: Universitaetsklinikum Heidelberg Medizinische Klinik V

location_facility: Ruijin Hospital, Shanghai Jiao Tong University

location_facility: Johns Hopkins University School of Medicine (JHUSOM)

location_facility: West China Hospital, Si Chuan University

location_facility: Università Degli Studi Di Napoli Federico Ii

location_facility: First affiliated Hospital of Zhejiang University


title: A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy

acronym: ARDA

summary: This is a phase 2, randomized, double-blinded, placebo-controlled, parallel-group, multicenter trial to evaluate the safety and efficacy of 2 dose regimens of ARGX-117 versus placebo, in participants with MMN previously stabilized with IVIg (intravenous immunoglobulin).

lead_sponsor: argenx

location_country:
Poland
Spain
Italy
Austria
Netherlands
United Kingdom
United States
France
Belgium
Germany

location_facility:
Investigator site 1 - US0010068
Investigator site 25 - NL0310010
Investigator site 28 - PL0480045
Investigator site 2 - US0010066
Investigator Site 9 - US0010019
Investigator site 13-FR0330042
Investigator site 23 - IT0390058
Investigator site 11-AT0430012
Investigator site 12-FR0330037
Investigator site 29 - DE0490040
Investigator Site 6 - SP0340043
Investigator Site 4 - BE0320027
Investigator Site 8 - US0010071
Investigator site 17-ES0340056
Investigator site 20-US0010126
Investigator site 26 - UK0440034
Investigator site 18-UK0440033
Investigator site 19-US0010013
Investigator site 3 - PL0480043
Investigator Site 5 - SP0340044
Investigator site 30 - US0010173
Investigator site 27 - UK0440026
Investigator site 15-FR0330038
Investigator site 24 - IT0390056
Investigator site 16-IT0390057
Investigator site 22 - US0010121
Investigator site 14-FR0330039
Investigator Site 7 - US0010143
Investigator site 10-NL0310013
Investigator site 21-US0010135


title: A Phase 1b/2, Open-Label, Multicenter Study to Evaluate the Safety and Pharmacokinetics of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

acronym: MINDway

summary: This is an open-label, multicentre study too Evaluate the Safety and Pharmacokinetics of a Modified Tafasitamab IV Dosing Regimen Combined with Lenalidomide (LEN) in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) who have had at least one, but no more than three prior systemic regimens and who are not eligible for high dose chemotherapy (HDC) with autologous stem-cell transplantation (ASCT) at the time of study entry.

lead_sponsor: MorphoSys AG

location_country:
Spain
Austria
United States
France
Czechia

location_facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center - USOR

location_facility: Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon

location_facility: Complejo Asistencial Universitario de Salamanca - H. Clinico

location_facility: Hospital Universitario Fundacion Jimenez Diaz


title: A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients With Polycythemia Vera

acronym: VERIFY

summary: The study is designed to evaluate the safety and efficacy of rusfertide in subjects with polycythemia vera (PV) in maintaining hematocrit control and in improving symptoms of PV.

ReferenceType: derived

ReferenceCitation: Pemmaraju N, Kuykendall A, Kremyanskaya M, Ginzburg Y, Ritchie E, Gotlib J, Gerds A, Palmer J, Valone F, O'Connor P, Modi N, Gupta S, Hoffman R, Verstovsek S. MPN-469 Rusfertide (PTG-300) Treatment Interruption Reverses Hematological Gains and Upon Reinitiation, Restoration of Clinical Benefit Observed in Patients With Polycythemia Vera. Clin Lymphoma Myeloma Leuk. 2022 Oct;22 Suppl 2:S338-S339. doi: 10.1016/S2152-2650(22)01462-8.

lead_sponsor: Protagonist Therapeutics, Inc.

location_country:
Hong Kong
Spain
Italy
United Kingdom
Australia
Canada
Hungary
United States
France
Israel
Germany
Czechia

location_facility: University of California, San Diego (UCSD) - Moores Cancer Center

location_facility: University of Colorado - Aurora Cancer Center

location_facility: New York Presbyterian Hospital/Weill Cornell Medical Center

location_facility: Uniklinik RWTH Aachen - Klinik fuer Haematologie, Onkologie, Haemostaseologie und Stammzelltransplantation (Med. Klinik IV)

location_facility: California Cancer Associates for Research and Excellence - Fresno

location_facility: University of California, Los Angeles (UCLA) - Medical Center

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: American Oncology Partners of Maryland PA (Center for Cancer & Blood Disorders)


title: A Single Arm, Open-Label, Phase 1b Trial of Epcoritamab in Pediatric Patients With Relapsed/Refractory Aggressive Mature B-cell Neoplasms

summary:
The most common types of mature B-cell lymphomas (MBLs) in children are Burkitt lymphoma (BL) and diffuse large B-cell lymphoma (DLBCL). Initial treatment cures 90% - 95% of children with these malignancies, leaving a very small population of relapsed/refractory disease with a poor prognosis. The purpose of this study is to assess the safety and tolerability of epcoritamab in pediatric participants with relapsed/refractory aggressive mature B-cell neoplasms and young adult participants with Burkitt's or Burkitt-like lymphoma/leukemia. Adverse events and change in disease activity will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of relapsed/refractory aggressive mature B-cell neoplasms. Participants will receive subcutaneous (SC) of epcoritamab. Approximately 15 pediatric participants with a diagnosis of relapsed/refractory aggressive mature B-cell neoplasms and and young adult participants, ages of 18-25, with a diagnosis of Burkitt's or Burkitt-like lymphoma/leukemia will be enrolled at 50 sites globally.

Participants will receive subcutaneous epcoritamab in 28-day cycles. Participants will be followed for a minimum of 3 years after enrollment.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

lead_sponsor: AbbVie

location_country:
Taiwan
Spain
Italy
Australia
Netherlands
Canada
Korea, Republic of
United States
France
Israel
Turkey
Belgium
Japan
Germany
Czechia

location_facility: Comitato Maria Letizia Verga /ID# 245592

location_facility: National Cancer Center Hospital /ID# 246722

location_facility: St Jude Children's Research Hospital /ID# 239184

location_facility: CHU Bordeaux - Hopital Pellegrin /ID# 240832

location_facility: National Taiwan University Hospital /ID# 242890

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 240831

location_facility: Koc Universitesi Hastanesi Translasyonel Tip Arastirma Merkezi /ID# 240026

location_facility: Universitaetsklinikum Erlangen /ID# 240861

location_facility: Children's Hospital of Philadelphia - Main /ID# 239294

location_facility: Medical College of Wisconsin - Plank Rd /ID# 239782

location_facility: Dokuz Eylul University Medical Faculty /ID# 239954

location_facility: Cincinnati Childrens Hospital Medical Center /ID# 239823

location_facility: The Chaim Sheba Medical Center /ID# 240670

location_facility: Universitaetsklinikum Giessen und Marburg /ID# 240787

location_facility: Azienda Ospedaliero Universitaria Meyer /ID# 240049

location_facility: National Center for Child Health and Development /ID# 246658

location_facility: Hospital Universitario Vall d'Hebron /ID# 240715

location_facility: University of Texas Southwestern Medical Center /ID# 240892

location_facility: Universitair Ziekenhuis Leuven /ID# 242384

location_facility: Seoul National University Hospital /ID# 239894

location_facility: Universitaetsmedizin Rostock /ID# 240891

location_facility: Nicklaus Children's Hospital /ID# 241174

location_facility: Universitaetsklinikum Muenster /ID# 239970

location_facility: Lucile Packard Children's Hospitals - Stanford /ID# 240854

location_facility: Schneider Children's Medical Center /ID# 240171

location_facility: Hospital Infantil Universitario Nino Jesus /ID# 240717

location_facility: Children's Hospital of Westmead /ID# 240091

location_facility: Oregon Health & Science University /ID# 240090

location_facility: IRCCS Ospedale Pediatrico Bambino Gesu /ID# 240039


title: A Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib and Panitumumab Versus Investigator's Choice (Trifluridine and Tipiracil, or Regorafenib) for the Treatment of Previously Treated Metastatic Colorectal Cancer Subjects With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation

acronym: CodeBreak 300

summary: The aim of the study is to compare progression-free survival (PFS) in previously treated participants with Kirsten rat sarcoma (KRAS) p.G12C mutated colorectal cancer (CRC) receiving sotorasib 240 mg once daily (QD) and panitumumab vs investigator's choice (trifluridine and tipiracil, or regorafenib), and sotorasib 960 mg once daily (QD) and panitumumab vs investigator's choice (trifluridine and tipiracil, or regorafenib).

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

lead_sponsor: Amgen

location_country:
Taiwan
Spain
Greece
Italy
Australia
United Kingdom
Korea, Republic of
United States
France
Mexico
Japan
Germany

location_facility: Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

location_facility: Centre Hospitalier Universitaire de Lyon - Hopital Edouard Herriot

location_facility: University of California at Irvine Medical Center

location_facility: Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II

location_facility: The Cancer Institute Hospital of Japanese Foundation for Cancer Research

location_facility: Johns Hopkins University School of Medicine

location_facility: Hospital General Universitario de Valencia

location_facility: Azienda Unita Locale Socio Sanitaria Berica 8

location_facility: Azienda Ospedaliera San Giovanni Addolorata

location_facility: Complexo Hospitalario Universitario de Ourense

location_facility: Azienda Sanitaria Locale 5 Spezzino Ospedale S Andrea

location_facility: Azienda Ospedaliera Cardinale Giovanni Panico

location_facility: Klinikum der Universität München Campus Grosshadern

location_facility: Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation

location_facility: Charite Universitätsmedizin Berlin, Charité Campus Virchow-Klinikum

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Health Pharma Professional Research SA de CV

location_facility: Universitätsmedizin Göttingen - Georg-August-Universität

location_facility: Azienda Ospedaliera Rilievo Nazionale e Alta Specializzazione Garibaldi Nesima

location_facility: Azienda Ospedaliero Universitaria Maggiore della Carita

location_facility: White Plains Hospital Center for Cancer Care

location_facility: Istituto Ospedaliero Fondazione Poliambulanza

location_facility: Azienda Ospedaliera Universitaria Pisana Ospedale Santa Chiara

location_facility: Azienda Ospedaliero Universitaria di Cagliari Policlinico Duilio Casula

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Universitaetsklinikum der Eberhard Karls Universitaet Tuebingen

location_facility: Azienda Unita Sanitaria Locale di Reggio Emilia Arcispedale Santa Maria Nuova

location_facility: Azienda Ospedaliero Universitaria Luigi Vanvitelli

location_facility: Lancaster General Hospital Ann B Barshinger Cancer Institute

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Severance Hospital Yonsei University Health System

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione Giovanni Pascale

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda


title: A Phase 1/2 Dose-Escalation and Dose-Expansion Study of ZN-c3 in Combination With Niraparib in Subjects With Platinum-Resistant Ovarian Cancer

summary: This is a Phase 1/2 study to evaluate the safety, clinical activity, pharmacokinetics (PK), and pharmacodynamics (PD) of ZN-c3 in combination with niraparib in subjects with platinum-resistant ovarian cancer.

lead_sponsor: K-Group Beta

location_country:
United States
France

location_facility:
Site 0228
Site 0130
Site 3608
Site 0191
Site 0135
Site 0136
Site 0264
Site 3611
Site 3604
Site 0194
Site 3603
Site 0152
Site 0201
Site 0273


title: postMONARCH: A Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy of Abemaciclib Plus Fulvestrant to Placebo Plus Fulvestrant in Participants With HR+, HER2-, Advanced or Metastatic Breast Cancer Following Progression on a CDK4 & 6 Inhibitor and Endocrine Therapy

acronym: postMONARCH

summary: This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that progressed or recurred after previous treatment with a type of drug known as a CDK4/6 inhibitor and endocrine therapy. Participation could last up to 5 years, depending on how you and your tumor respond.

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

lead_sponsor: Eli Lilly and Company

location_country:
Denmark
Poland
Taiwan
Spain
Greece
Italy
Mexico
Argentina
Hungary
Korea, Republic of
United States
France
Israel
Turkey
Belgium
Sweden
Czechia

location_facility: Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan

location_facility: Chang Gung Medical Foundation-Linkou Branch

location_facility: University of New Mexico Comprehensive Cancer Center

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

location_facility: Torrance Memorial Physician Network / Cancer Care

location_facility: COI Tijuana - Centro Oncológico Internacional

location_facility: Centro de Investigacion en Artritis y Osteoporosis SC

location_facility: Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

location_facility: The University of Vermont Medical Center Inc.

location_facility: Europejskie Centrum Zdrowia - Oddzial Onkologii

location_facility: Vernon Cancer Center Pharmacy, Massachusetts General Cancer Center at Newton-Wellesley

location_facility: Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan

location_facility: Hospital Clínico Universitario Virgen de la Arrixaca

location_facility: Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego

location_facility: Inonu Universitesi Turgut Ozal Tıp Merkezi

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Euromedica General Clinic of Thessaloniki

location_facility: University of Texas MD Anderson Cancer Center

location_facility: University of Miami Hospital and Clinics, Sylvester Cancer Center

location_facility: Fundación Cenit Para La Investigación En Neurociencias

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Winship Cancer Institute, Emory University

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

location_facility: TRIO-US (Translational Research in Oncology-US)

location_facility: Seoul National University Bundang Hospital

location_facility: H.R.U Málaga - Hospital Materno-infantil

location_facility: Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii

location_facility: Ankara Gülhane Eitim ve Aratrma Hastanesi

location_facility: University General Hospital of Heraklion

location_facility: St. Joseph's Hospital and Medical Center

location_facility: P.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale

location_facility: Kapiolani Medical Center for Women and Children


title: A Physician-initiated, International, Multi-center, Retrospective and Prospective, Observational Registry of Patients Treated by Preloaded Fenestrated Stent-graft Designs for Complex Endovascular Aortic Procedures

summary:
The aim of the study is to evaluate the outcomes of the preloaded stent-graft design (PLD) in the routine treatment of para-renal and thoraco-abdominal aneurysms. Results and postoperative events are reported in accordance with the current reporting standards for endovascular aortic repair prepared and revised by the Ad Hoc Committee for Standardized Reporting Practices in Vascular Surgery of The Society for Vascular Surgery/American Association for Vascular Surgery.

The Registry will include approximately 300 patients treated from January 2015 to May 2021 (retrospective arm) and June 2021 to June 2023 (perspective arm) for the routine treatment of para-renal and thoraco-abdominal aneurysms. To reach 300 patients, the enrollments can be extended until June 2026.

study_start_date_type: Anticipated

time_perspective: Other

ReferenceType: background

ReferenceCitation: Greenberg RK, West K, Pfaff K, Foster J, Skender D, Haulon S, Sereika J, Geiger L, Lyden SP, Clair D, Svensson L, Lytle B. Beyond the aortic bifurcation: branched endovascular grafts for thoracoabdominal and aortoiliac aneurysms. J Vasc Surg. 2006 May;43(5):879-86; discussion 886-7.

ReferenceCitation: Mohabbat W, Greenberg RK, Mastracci TM, Cury M, Morales JP, Hernandez AV. Revised duplex criteria and outcomes for renal stents and stent grafts following endovascular repair of juxtarenal and thoracoabdominal aneurysms. J Vasc Surg. 2009 Apr;49(4):827-37; discussion 837. doi: 10.1016/j.jvs.2008.11.024. Epub 2009 Feb 23.

ReferenceCitation: Manning BJ, Harris PL, Hartley DE, Ivancev K. Preloaded fenestrated stent-grafts for the treatment of juxtarenal aortic aneurysms. J Endovasc Ther. 2010 Aug;17(4):449-55. doi: 10.1583/10-3024.1.

ReferenceCitation: Kitagawa A, Greenberg RK, Eagleton MJ, Mastracci TM. Zenith p-branch standard fenestrated endovascular graft for juxtarenal abdominal aortic aneurysms. J Vasc Surg. 2013 Aug;58(2):291-300. doi: 10.1016/j.jvs.2012.12.087. Epub 2013 Apr 20.

ReferenceCitation: Bisdas T, Donas KP, Torsello G, Austermann M. Technical assessment of the preloaded fenestrated stent-graft in the management of pararenal aortic aneurysms. J Endovasc Ther. 2013 Aug;20(4):461-8. doi: 10.1583/13-4310.1.

lead_sponsor: IRCCS San Raffaele

location_country:
Denmark
Spain
Italy
United Kingdom
Sweden
United States
France
Germany

location_facility: UMass Memorial Center for Complex Aortic Disease

location_facility: Aortic Centre Marie Lannelongue, Groupe Hospitalier Paris Saint Joseph, Université Paris Saclay

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Vascular Center Malmö, Skåne University Hospital

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Department of Surgical Sciences, Vascular Surgery, Uppsala University

intervention_type: Procedure


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Two-Arm, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of LY3361237 as a Treatment for Adults With At Least Moderately Active Systemic Lupus Erythematosus

summary: The main purpose of this study is to assess the efficacy and safety of LY3361237 in participants with at least moderately active systemic lupus erythematosus (SLE). Study will last up to 34 weeks and may include up to 15 visits.

location_country:
Poland
Taiwan
Argentina
Puerto Rico
United States
France
Mexico
Czechia

location_facility: Chang Gung Memorial Hospital at Kaohsiung

location_facility: Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy

location_facility: Atlanta Research Center for Rheumatology

location_facility: Instituto de Investigaciones Clinicas Zarate

location_facility: Investigacion Biomedica para el Desarrollo de Fármacos S.A. de C.V.

location_facility: Arizona Arthritis & Rheumatology Associates, P. C.

location_facility: Clinical Research of West Florida, Inc. (Clearwater)

location_facility: Chang Gung Medical Foundation-Linkou Branch

location_facility: University of Florida College of Medicine

location_facility: Twoja Przychodnia Poznanskie Centrum Medyczne

location_facility: Twoja Przychodnia Centrum Medyczne Nowa Sol

location_facility: Houston Rheumatology & Arthritis Specialists

location_facility: CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas

location_facility: Centro de Investigaciones Médicas Tucuman

location_facility: Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan

location_facility: Arizona Arthritis & Rheumatology Research - Sun City

location_facility: Clinica de Investigacion en Reumatologia y Obesidad S. C.

location_facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu


title: A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Melanoma (Morpheus-Melanoma)

summary: This study will evaluate the efficacy, safety, and pharmacokinetics of treatment combinations in cancer immunotherapy (CIT)-naive participants with resectable Stage III melanoma (Cohort 1) and in participants with Stage IV melanoma (Cohort 2). The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, and modify the participant population.

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here ( https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

lead_sponsor: Hoffmann-La Roche

location_country:
Spain
Italy
Australia
United States
France
Netherlands

location_facility: The Angeles Clinic and Research Institute - W LA Office

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Institut Universitaire du Cancer de Toulouse-Oncopole

location_facility: Hospital Universitario HM Sanchinarro-CIOCC

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Clinica Universidad de Navarra ; Servicio de Farmacia


title: A Phase 3 Multicenter, Open-label Study to Evaluate the Efficacy, Pharmacokinetics, Safety, and Immunogenicity of Subcutaneously Administered Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis (PSUMMIT-Jr)

acronym: PSUMMIT-Jr

summary: The purpose of this study is to evaluate the pharmacokinetics (PK) and efficacy of ustekinumab and guselkumab in juvenile psoriatic arthritis (jPsA).

location_country:
Poland
Spain
Italy
United Kingdom
Argentina
United States
France
Turkey
Germany

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Harvard Medical School - Boston Children's Hospital

location_facility: Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum

location_facility: CSK, Uniwersyteckie Centrum Pediatrii im.M.Konopnickiej

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico


title: Phase 3, Randomized, Open-Label, Parallel Arm Study to Evaluate the Efficacy and Safety of 180 mcg Peginterferon Lambda-1a (Lambda) Subcutaneous Injection for 48 Weeks in Patients With Chronic Hepatitis Delta Virus (HDV) Infection (LIMT-2)

summary: The Phase 3 LIMT-2 study will evaluate the safety and efficacy of Peginterferon Lambda treatment for 48 weeks with 24 weeks follow-up compared to no treatment for 12 weeks in patients chronically infected with HDV. The primary analysis will compare the proportion of patients with HDV RNA < LLOQ at the 24-week post-treatment visit in the Peginterferon Lambda treatment group vs the proportion of patients with HDV RNA < LLOQ at the Week 12 visit in the no-treatment comparator group.

lead_sponsor: Eiger BioPharmaceuticals

location_country:
Romania
Spain
Italy
Russian Federation
Ukraine
United States
France
Israel
Turkey
Belgium
Germany
Bulgaria
Moldova, Republic of

location_facility: Icahn School of Medicine - Mount Sinai Hospital

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Medical Center "Nov Rehabilitatsionen Tsentar", EOOD

location_facility: Acibadem City Clinic Tokuda Hospital Ead

location_facility: Spitalul Clinic de Boli Infectioase Constanta

location_facility: Istanbul Universitry-Cerrahapasa, Cerrahpasa School of Medicine

location_facility: State budgetary institution of health care "Specialized clinical infectious diseases hospital" of the Ministry of health of Krasnodar region

location_facility: The Liver Diseases Center, Sheba Medical Center

location_facility: Asian Pacific Liver Center at Coalition of Inclusive Medicine

location_facility: Universitätsmedizin Mainz, I. Med. Klinik

location_facility: Communal Noncommercial Enterprise Vinnytsia City Clinical Hospital #l, Infectious Department, National Pirogov Memorial Medical University, Vinnytsya , Chair of Infectious Diseases with Course in Epidemiolog

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: National Institute for Infectious Diseases "Matei Bals"

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia

location_facility: ZIM 1, Gastroenterologie, University Hospital Frankfurt

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Cliniques Universitaires de Bruxelles Hôpital Erasme

location_facility: Medical Center 'Ok!Clinic+' of International Institute of Clinical Studies LLC

location_facility: NYU Langone Health / NYU School of Medicine

location_facility: Municipal Non-Profit Enterprise "Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital" of Ivano-Frankivsk Regional Council

location_facility: Hospital Universitario Fundación Alcorcón


title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Moderately to Severely Active Crohn's Disease (CD): AIM-CD

acronym: AIM-CD

summary:
Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. CD may cause tiredness, loose stools with or without bleeding, abdominal pain, weight loss, and fever. This study evaluates how safe and effective ABBV-154 is in participants treated for moderately to severely active CD. Adverse events and change in the disease activity will be assessed.

ABBV-154 is an investigational drug being evaluated for the treatment of CD. In the induction period, there is a 1 in 5 chance that participants will be assigned to placebo. Depending on the dose received in the induction period, there is a 1 in 2 or 1 in 3 chance that participants will be assigned to placebo in the maintenance period. Around 265 participants 18-75 years of age with moderately to severely active CD will be enrolled in the study at approximately 200 sites worldwide.

The study is compromised of a 12-week double-blind, placebo-controlled induction period, followed by either a 12-week double-blind re-induction period for non-responders or a 40-week double-blind placebo-controlled maintenance period for responders. In the maintenance period, responders will be randomized to receive subcutaneous placebo or ABBV-154 in 2 different doses every other week. Participants in the placebo group who are initial responders will receive ABBV-154 in the maintenance period. Participants with inadequate response at/after Week 4 of the maintenance period will be eligible to receive ABBV-154 rescue therapy.

There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Puerto Rico
Israel
Turkey
Mexico
Slovakia
Canada
Hungary
Germany
Bulgaria
Taiwan
Greece
New Zealand
Korea, Republic of
France
Netherlands

location_facility: Gastroenterology Consultants PC - Roswell /ID# 233552

location_facility: Atlantic Medical Research Group /ID# 233506

location_facility: Tyler Research Institute, LLC /ID# 233730

location_facility: Hoag Memorial Hosp Presbyterian /ID# 233555

location_facility: Hunter Holmes McGuire VA Medical Center /ID# 233759

location_facility: Universitaetsklinikum Freiburg /ID# 233719

location_facility: Aichi Medical University Hospital /ID# 238528

location_facility: Toronto Digestive Disease Asso /ID# 234143

location_facility: The Chaim Sheba Medical Center /ID# 233457

location_facility: Digestive Disease Consultants - Orange Park /ID# 241015

location_facility: Tel Aviv Sourasky Medical Center /ID# 238525

location_facility: China Medical University Hospital /ID# 234132

location_facility: Nagoya City University Hospital /ID# 238368

location_facility: London Health Sciences Center /ID# 234058

location_facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 234225

location_facility: Fukushima Medical University Hospital /ID# 239314

location_facility: Digestive Disease Specialists /ID# 233825

location_facility: CHU Montpellier - Hôpital Saint Eloi /ID# 241136

location_facility: Tokyo Medical And Dental University Hospital /ID# 238950

location_facility: Hamamatsu University Hospital /ID# 238527

location_facility: Tsujinaka Hospital Kashiwanoha /ID# 239012

location_facility: Clinical Research Institute SC /ID# 251033

location_facility: St. Marianna University Hospital /ID# 239167

location_facility: Universitatsklinikum Mannheim /ID# 233716

location_facility: Agile Clinical Research Trials /ID# 233739

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 238653

location_facility: National Taiwan University Hospital /ID# 234134

location_facility: Universitatsklinik Regensburg /ID# 238702

location_facility: Yamagata University Hospital /ID# 239572

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 231657

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 233527

location_facility: University of Utah Hospitals and Clinics /ID# 239264

location_facility: Guys and St Thomas NHS Foundation Trust /ID# 234191

location_facility: Gastroenterology Associates of Central Georgia, LLC /ID# 245604

location_facility: WIP Warsaw IBD Point Profesor Kierkus /ID# 233533

location_facility: Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 233387

location_facility: Perm Clinical Center of the Federal Medical and Biological Agency /ID# 234166

location_facility: Allegheny Health Network Research Institute /ID# 239334

location_facility: Louisana Research Center, LLC /ID# 245370

location_facility: Medizinische Universitaet Innsbruck /ID# 234217

location_facility: Universitaetsklinikum Frankfurt /ID# 246350

location_facility: Istanbul University Istanbul Medical Faculty /ID# 233785

location_facility: Northshore Gastroentrology Research LLC /ID# 239307

location_facility: General Hospital of Athens Ippokratio /ID# 231655

location_facility: Hyogo Medical University Hospital /ID# 239049

location_facility: University Hospital Kyoto Prefectural University of Medicine /ID# 239918

location_facility: Center Hospital of the National Center for Global Health and Medicine /ID# 239792

location_facility: Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 239554

location_facility: Osaka Metropolitan University Hospital /ID# 238638

location_facility: The Queen Elizabeth Hospital /ID# 234242

location_facility: Gastro Health & Nutrition - Victoria /ID# 240158

location_facility: General Hospital of Nikaia-Piraeus "Agios Panteleimon"- general hospital dytikis /ID# 231659

location_facility: Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 249046

location_facility: New York Gastroenterology Associates /ID# 241967

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 232373

location_facility: University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 233765

location_facility: Hadassah Medical Center-Hebrew University /ID# 233518

location_facility: Hospital Santa Creu i Sant Pau /ID# 232301

location_facility: Gastroenterology Group Naples /ID# 233829

location_facility: University of Colorado Hospital /ID# 239361

location_facility: Sapporo Medical University Hospital /ID# 239201

location_facility: Medizinische Universitaet Wien /ID# 234218

location_facility: Policlinico Agostino Gemelli /ID# 233380

location_facility: Soroka University Medical Center /ID# 233458

location_facility: Hospital Universitario La Paz /ID# 232300

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 233382

location_facility: Toronto Immune and Digestive Health Institute Inc /ID# 234142

location_facility: Kanazawa University Hospital /ID# 239670

location_facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 231660

location_facility: Hospital Clinico Universitario de Valencia /ID# 234103

location_facility: School of Medicine University of Puerto Rico-Medical Science Campus /ID# 249610

location_facility: NHS Greater Glasgow and Clyde /ID# 234186

location_facility: Azienda Ospedaliera di Padova /ID# 233389

location_facility: East View Medical Research, LLC /ID# 240030

location_facility: Scott Shulman Medicine Professional Corporation /ID# 239567

location_facility: University Multiprofile Hospit /ID# 232468

location_facility: CHRU Nancy - Hopitaux de Brabois /ID# 234224

location_facility: Hiroshima University Hospital /ID# 238947

location_facility: Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 249047

location_facility: Radboud Universitair Medisch Centrum /ID# 241292

location_facility: Taichung Veterans General Hospital /ID# 234131

location_facility: QE II Health Sciences Centre /ID# 233839

location_facility: Second Multiprofile Hospital f /ID# 250706

location_facility: Immanuel Kant Baltic Federal University /ID# 234165

location_facility: First Moscow State Medical University n.a I.M. Sechenov /ID# 238773

location_facility: Allen Whey Khye Lim Professional Corporation /ID# 233831

location_facility: Nemocnice Horovice - NH Hospital a.s /ID# 233915

location_facility: ASST Rhodense/Presidio Ospedaliero di Rho /ID# 233386

location_facility: Tokyo Women's Medical University Hospital /ID# 239760

location_facility: Southern California Res. Ctr. /ID# 233512

location_facility: The Edith Wolfson Medical Center /ID# 234042

location_facility: Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 232299

location_facility: Ustredni Vojenska Nemocnice - Vojenska fakultni nemocnice Praha /ID# 238486

location_facility: Endocrinologia y Nutriologia /ID# 251618

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 238791

location_facility: Medical Research Center of CT /ID# 233542

location_facility: Iwate Medical University Uchimaru Medical Center /ID# 238953

location_facility: Concord Repatriation General /ID# 233467

location_facility: Kocaeli University Research and Application Hospital /ID# 249136

location_facility: Gazi Universitesi Tip Fakultes /ID# 233786

location_facility: The University of Chicago DCAM /ID# 233824

location_facility: The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 233700

location_facility: Medizinische Hochschule Hannover /ID# 238804

location_facility: Gastroenterology Group of Northern NJ - Englewood Division /ID# 241935

location_facility: CCA Braga - Hospital de Braga /ID# 249049

location_facility: Unidade Local de Saude do Alto Minho, EPE - Hospital de Santa Luzia /ID# 249087

location_facility: Universitaetsklinikum Erlangen /ID# 233529

location_facility: Royal Devon and Exeter NHS Trust Hospital /ID# 234194

location_facility: Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 233763

location_facility: Acibadem City Clinic University Hospital EOOD /ID# 240003

location_facility: St George's University Hospitals NHS Foundation Trust /ID# 234193

location_facility: Antalya Training Research Hosp /ID# 249138

location_facility: Gastroenterology Associates, P.A. of Greenville /ID# 233544

location_facility: Wellington Regional Hospital /ID# 238326

location_facility: Digestive Health Specialists of the Southeast /ID# 239599

location_facility: Southern Star Research Institute, LLC /ID# 240132

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 234187

location_facility: UMHAT Tsaritsa Joanna - ISUL /ID# 234135

location_facility: Tokyo Medical University Hospital /ID# 239668

location_facility: Hepato-Gastroenterologie HK, s.r.o. /ID# 239965

location_facility: Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 234069

location_facility: University Hospital Southampton NHS Foundation Trust /ID# 238960


title: A Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis

acronym: VALIANT

summary: This is a Phase 3 study to assess the efficacy and safety of twice-weekly subcutaneous (SC) doses of pegcetacoplan compared to placebo in patients with C3 glomerulopathy (C3G) or immune-complex membranoproliferative glomerulonephritis (IC-MPGN) on the basis of a reduction in proteinuria.

lead_sponsor: Apellis Pharmaceuticals, Inc.

location_country:
Poland
Spain
Italy
Australia
Switzerland
United States
France
Belgium
Netherlands

location_facility: SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

location_facility: Hospital Edouard Herriot, Hospices Civils de Lyon

location_facility: Hospital Universitario Materno-Infantil Vall d' Hebron, Nefrologia Pediatrica

location_facility: Rangueil Hospital-University Hospital Center (CHU) of Toulouse

location_facility: Hospital Materno Infantil Sant Joan de Deu

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

location_facility: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

location_facility: Hospital Universitario 12 de Octubre, Nephrology Department

location_facility: Renal and Transplant Associates of New England, PC

intervention_type: Other


title: A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With FGFR2b Overexpression

summary: The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS).

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

location_country:
Spain
Italy
Lithuania
United States
Belgium
Japan
Romania
Czechia
Poland
Portugal
Australia
Argentina
Turkey
Mexico
Singapore
Sweden
Brazil
Canada
Hungary
Bulgaria
Denmark
Taiwan
Greece
Latvia
Estonia
Thailand
Korea, Republic of
France
Chile
Colombia

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Lietuvos sveikatos mokslu universiteto ligonine viesoji istaiga Kauno klinikos

location_facility: Università Cattolica del Sacro Cuore Policlinico Universitario Agostino Gemelli

location_facility: Van Yuzuncu Yil Universitesi Dursun Odabas Tip Merkezi

location_facility: Wielkopolskie Centrum Onkologii imienia Marii Sklodowskiej-Curie

location_facility: Hospital da Senhora da Oliveira Guimaraes, EPE

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

location_facility: Izmir Ataturk Egitim ve Arastirma Hastanesi

location_facility: University Multiprofile Hospital for Active Treatment Pulmed OOD

location_facility: Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II

location_facility: Instituto de Ensino e Pesquisa Sao Lucas Iep Sao Lucas

location_facility: The Cancer Institute Hospital of Japanese Foundation for Cancer Research

location_facility: Kobe City Medical Center General Hospital

location_facility: Wojewodzki Szpital im Sw Ojca Pio w Przemyslu

location_facility: Viesoji istaiga Klaipedos universitetine ligonine

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Azienda Ospedaliera San Giovanni Addolorata

location_facility: Investigacion Biomedica para el Desarrollo de Farmacos SA de CV

location_facility: Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz

location_facility: Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

location_facility: Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Investigación Biomédica para el Desarrollo de Fármacos SA de CV

location_facility: Complexo Hospitalario Universitario de Ourense

location_facility: Anticancer Hospital of Thessaloniki Theageneio

location_facility: Oncosite Centro de Pesquisa Clinica Em Oncologia LTDA

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Josa Andras Oktatokorhaz

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona Ospedale Civile Maggiore Borgo Trento

location_facility: Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucuresti

location_facility: Azienda Ospedaliera Cardinale Giovanni Panico

location_facility: Sakarya Universitesi Egitim ve Arastirma Hastanesi

location_facility: Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD

location_facility: Azienda Ospedaliero Universitaria Integrata Santa Maria della Misericordia

location_facility: Azienda Unita Saniataria Locale IRCCS di Reggio Emilia

location_facility: Sunnybrook Research Institute Sunnybrook Health Sciences Centre

location_facility: Instituto Brasileiro de Controle do Cancer Ibcc

location_facility: Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Centrum Onkologii im prof Franciszka Lukaszczyka w Bydgoszczy

location_facility: Vilnius University Hospital Santaros Clinic Public Institution

location_facility: Hospital General Universitario Jose Maria Morales Meseguer

location_facility: Azienda Ospedaliera Rilievo Nazionale e Alta Specializzazione Garibaldi Nesima

location_facility: SPZOZ Opolskie Centrum Onkologii imienia prof Tadeusza Koszarowskiego w Opolu

location_facility: Centre Hospitalier Regional Universitaire de Besancon - Hopital Jean Minjoz

location_facility: The Catholic University of Korea Seoul St Marys Hospital

location_facility: Istituto Ospedaliero Fondazione Poliambulanza

location_facility: Azienda Ospedaliera Ordine Mauriziano di Torino

location_facility: Azienda Ospedaliero Universitaria di Cagliari Policlinico Duilio Casula

location_facility: Centre Hospitalier Universitaire de Liege - Sart Tilman

location_facility: Multiprofile Hospital for Active Treatment Park Hospital EOOD

location_facility: Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio

location_facility: Centre Hospitalier Universitaire Nord de Saint Etienne - Hôpital Nord

location_facility: Multiprofile Hospital for Active Treatment Serdika EOOD

location_facility: Centro Hospitalar de Entre o Douro e Vouga, EPE - Hospital Sao Sebastiao

location_facility: Instituto Argentino de Diagnostico y Tratamiento IADT

location_facility: University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi

location_facility: Centro Hospitalar e Universitario de Coimbra EPE

location_facility: Seoul National University Bundang Hospital

location_facility: Sociedad de Beneficencia Hospital Italiano

location_facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez

location_facility: Hospital Regional Universitario de Malaga

location_facility: Hospital Universitario Fundacion Favaloro

location_facility: Kliniki Neuroradiochirurgii Spzoo Radom Centr Onkolo im Bohater Radomsk Czerwca -76 Szpital Specjal

location_facility: Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda EAD

location_facility: Healthier Hematology & Oncology Excelsior Integrated Medical Group

location_facility: Severance Hospital Yonsei University Health System

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Kocaeli Universitesi Arastirma ve Uygulama Hastanesi

location_facility: James Lind Centro de Investigacion del Cancer

location_facility: Spitalul Judeţean de Urgenţă Dr.Constantin Opriş Baia Mare

location_facility: Ondokuz Mayis Universitesi Saglik Uygulama ve Arastirma Merkezi

location_facility: University of California Los Angeles Bowyer Hematology-Oncology Clinic


title: A Phase III, Open Label, Randomised, 3-Arm, Multi-Centre Study of Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (SAMETA)

acronym: SAMETA

summary: A clinical trial to compare the effectiveness of savolitinib plus durvalumab versus sunitinib in MET-driven (hepatocyte growth factor receptor), unresectable and locally advanced or metastatic PRCC (Papillary Renal Cell Carcinoma)

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Romania
Czechia
Poland
Hong Kong
Russian Federation
Australia
Argentina
India
Israel
Turkey
Mexico
Singapore
Slovakia
Brazil
Canada
China
Germany
Taiwan
Korea, Republic of
France
Chile
Netherlands


title: A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease

summary: This study will evaluate the efficacy, safety, and pharmacokinetics of astegolimab in combination with standard of care chronic obstructive pulmonary disease (COPD) maintenance therapy in patients with COPD who are former or current smokers and have a history of frequent exacerbations.

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

lead_sponsor: Genentech, Inc.

location_country:
Spain
United Kingdom
United States
Romania
Belgium
South Africa
Czechia
Poland
Austria
Australia
Argentina
Israel
Mexico
Sweden
Canada
Germany
Bulgaria
Denmark
New Zealand
Korea, Republic of
France
Chile
Netherlands

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska lek.

location_facility: Catholic Univ. of Incheon St.Mary's Hospital

location_facility: Zentrum fuer ambulante pneumologische Forschung Marburg GbR

location_facility: Centro de Investigaciones Clínicas Belgrano

location_facility: Florida Institute for Clinical Research, LLC

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Clinique de pneumologie et du sommeil de Lanaudiere

location_facility: Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Dr.Nikola Penchev-Paza

location_facility: Gemeinscharftspraxis Dres Jung - Deggingen

location_facility: Medical Center Leo Clinic EOOD, branch Lovech

location_facility: SEC Clinical Research LLC - Andalusia - ClinEdge - PPDS

location_facility: University of Florida College of Medicine Jacksonville

location_facility: Sherman Clinical Research - ClinEdge - PPDS

location_facility: Pulmonary Specialists of the Palm Beaches

location_facility: Medical Center New rehabilitation center EOOD

location_facility: Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOOD

location_facility: Instituto de Investigaciones Clinicas-Mar del Plata

location_facility: Instituto Jalisciense de Investigacion Clinica S.A. de C.V.

location_facility: Unidad de Investigacion Clinica En Medicina (Udicem) S.C.

location_facility: Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olec-Cudzik; Krzysztof Cudzik

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: University of Cape Town Lung Institute; Lung Clinical Research

location_facility: Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.

location_facility: Centrum Medyczne Bydgoszcz- PRATIA - PPDS

location_facility: Twoja Przychodnia Centrum Medyczne Nowa Sol

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Horizon Clinical Research Group: Houston Pulmonary Sleep & Allergy Associates -Clinedge - PPDS

location_facility: St. Francis Sleep; Allergy & Lung Institute

location_facility: Clinical Site Partners - Leesburg Suite 101 - HyperCore - PPDS

location_facility: Centro de Investigaciones Medicas Respiratorias

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Neomed Out-Patient Treatment and Diagnosis Medical Center SRL

location_facility: Investigaciones en Patologias Respiratorias

location_facility: Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica

location_facility: Clinical Site Partners - Winter Park - HyperCore - PPDS

location_facility: University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD

location_facility: Columbus Regional Research Institute at Talbotton - IACT - HyperCore - PPDS

location_facility: Instituto de Medicina Respiratoria, IMeR; Clinic/Outpatient Facility

location_facility: Instituto De Enfermedades Respiratorias E Investigacion Medica

location_facility: University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

location_facility: Medizinische Universitat Wien Medical University of Vienna

location_facility: PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna

location_facility: CARE - Centro de Alergia y Enfermedades Respiratorias

location_facility: Sierra Clinical Research - ClinEdge - PPDS

location_facility: Private Practice Dr Jean Benoit Martinot

location_facility: Spitalul Clinic de Pneumoftiziologie Constanta

location_facility: Leon Daniello Pneumophthisiology Clinical Hospital

location_facility: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

location_facility: Hospital Universitario Virgen de Las Nieves

location_facility: Piedmont Research Partners LLC - Clinedge - PPDS

location_facility: EMED Centrum Uslug Medycznych Ewa Smialek

location_facility: Centro de Investigaciones Medicas Mar Del Plata

location_facility: Centro de Investigacion y Atencion Integral Durango CIAID

location_facility: Zentrum fuer Pneumologie, Onkologie und Schlafmedizin am Diako

location_facility: Centro Integral de Medicina Respiratoria (CIMER)

location_facility: Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD

location_facility: Hospital Universitario Fundacion Jimenez Diaz.

location_facility: South Texas Medical Research Institute, Inc., dba TTS Research - ClinEdge - PPDS

location_facility: Sf. Ioan cel Nou Emergency County Hospital

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k.

location_facility: Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa


title: A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Mitapivat in Subjects With Sickle Cell Disease

lead_sponsor: Agios Pharmaceuticals, Inc.

location_country:
Brazil
United Kingdom
Italy
Lebanon
Canada
France
United States
Israel
Turkey
Belgium
Netherlands

location_facility: Hammoud Hospital University Medical Center

location_facility: Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

location_facility: University of Texas Health Science Center of Houston

location_facility: Cure 4 The Kids Foundation, A Division of Roseman University of Health Sciences

location_facility: Hospital Das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP

location_facility: Kaiser Permanente - Largo Medical Center

location_facility: Penn State Health Milton S. Hershey Medical Center

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: American University of Beirut Medical Center

location_facility: Mississippi Center for Advanced Medicine

location_facility: Seattle Cancer Care Alliance, University of Washington

location_facility: East Carolina University - Brody School of Medicine

location_facility: Boston Medical Center & Boston University School of Medicine

location_facility: Penn Medicine - University of Pennsylvania Health System

summary: This clinical trial is a Phase 2/3 study that will determine the recommended dose of mitapivat and evaluate the efficacy and safety of mitapivat in sickle cell disease by testing how well mitapivat works compared to placebo to increase the amount of hemoglobin in the blood and to reduce or prevent the occurrence of sickle cell pain crises. In addition, the long-term effect of mitapivat on efficacy and safety will be explored in an open-label extension portion.


title: A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab in Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

acronym: BRUIN CLL-313

summary: The purpose of this study is to compare the efficacy and safety of pirtobrutinib (LOXO-305; Arm A) compared to BR (Arm B) in patients with CLL/SLL who have not been treated. Participation could last up to five years.

lead_sponsor: Loxo Oncology, Inc.

location_country:
Poland
Taiwan
Portugal
Spain
Ireland
Austria
Australia
Italy
New Zealand
Russian Federation
United Kingdom
Hungary
Korea, Republic of
United States
France
China
Japan
Bulgaria
Czechia

location_facility: Dokkyo Medical University - Koshigaya Hospital

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C

location_facility: North Shore Hospital, Haematology Research

location_facility: The First People's Hospital of Hangzhou Linping District

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: Istituto di Ematologia-C.R.E.O. (Centro di Ricerche Emato-Oncologich)

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology

location_facility: Azienda sanitaria integrata università di Trieste

location_facility: Chu Nimes/Institut De Cancerologie Du Gard

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Klinika Hematoonkologii i Transplantacji Szpiku SPSK1 Lublin

location_facility: Institute of hematology&blood disease hospital

location_facility: Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga)

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

location_facility: Shengjing Hospital of China Medical University

location_facility: A.O.U. Citta' della Salute e della Scienza di Torino

location_facility: Oncology-Hematology Associates of West Broward

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Cuire - Państwowy Instytut Badawczy

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

location_facility: West China Hospital of Sichuan University

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Academician I.P. Pavlov First St-Petersburg State Medical University

location_facility: Szpital Uniwersytecki nr 2 im. dr Jana Biziela w BydgoszczyKlinika Hematologii

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

location_facility: The Catholic University of Korea-Seoul St. Mary's Hospital

location_facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE

location_facility: Hospital Universitario Central de Asturias

location_facility: Hospital of University of Occupational and Environmental Health


title: A Phase 2a, Multi-Center, Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease

acronym: APOLLO-CD

summary:
The purpose of this study is to assess the safety and efficacy of PRA023 in participants with moderately to severely active Crohn's Disease.

After the completion of the 12-week induction period, all participants have the option to continue in the open-label extension for another 38 weeks.

status: Active, not recruiting

lead_sponsor: Prometheus Biosciences, Inc.

location_country:
Poland
Georgia
Australia
Canada
United States
France
Belgium
Czechia

location_facility:
Prometheus Biosciences Selected Center
Prometheus Biosciences Selected Site


title: A Modular Phase II, Open-Label, Multicentre Study to Assess the Efficacy and Safety of Capivasertib in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (CAPITAL)

acronym: CAPITAL

summary: This study is an open-label, multicenter Phase II study of capivasertib administered orally in participants with Relapsed or Refractory (R/R) B-cell Non-Hodgkin's Lymphoma (NHL).

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Denmark
Spain
United Kingdom
Canada
Korea, Republic of
United States
France


acronym: EMERALD

title: A Two-cohort, Open-label, Single Arm, Multicenter Study to Evaluate Efficacy, Safety and Tolerability, PK and PD, of Emapalumab in Children and Adults With MAS in Still's Disease or With MAS in Systemic Lupus Erythematous

lead_sponsor: Swedish Orphan Biovitrum

location_country:
Poland
Spain
Italy
Canada
Sweden
France
United States
Belgium
Japan
Germany
Czechia

location_facility: Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie

location_facility: Rheumatology Clinic at University of Washington Medical Center - Roosevelt

location_facility: Nationwide Children's Hospital, Abigail Wexner Research Institute

location_facility: Osaka Medical and Pharmaceutical University Hospital

location_facility: University of Minnesota Masonic Children's Hospital

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: IRCCS - Materno-Infantile Burlo Garofolo

location_facility: Szpital Specjalistyczny im. J. Dietla w Krakowie

location_facility: Ortopedyczno - Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Centre Hospitalier de l'Université de Montréal

location_facility: Centre Hospitalier Universitaire Sainte-Justine

location_facility: Hospital Universitari i Politècnic La Fe

summary: The purpose of this study is to assess the safety, tolerability and efficacy of emapalumab in children and adults with macrophage activation syndrome (sHLH/MAS) in Still's disease (including systemic juvenile idiopathic arthritis and adult onset Still's disease) or with sHLH/MAS in systemic lupus erythematous, resenting an inadequate response to high dose glucocorticoid treatment.


acronym: Ravulizumab versus Placebo in Adult Participants with Dermatomyositis.

title: A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Dermatomyositis

lead_sponsor: Alexion Pharmaceuticals

location_country:
Spain
Italy
United Kingdom
Korea, Republic of
United States
France
Japan
Germany

summary: This is a Phase 2/3, double-blind, randomized, placebo-controlled, parallel group, multicenter study to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ravulizumab in adult participants with dermatomyositis (DM).


title: A 52 Week, Multi-center, Randomized, Double-blind Placebo-controlled Study to Assess the Clinical Efficacy and Safety of Ligelizumab (QGE031) in Decreasing the Sensitivity to Peanuts in Patients With Peanut Allergy

summary: This is a 52-week, Phase 3 multi-center, randomized, double-blind and placebo-controlled study to assess the safety and clinical efficacy of two dosing regimens of ligelizumab (240 mg and 120 mg) subcutaneous injection every 4 weeks (SCq4w) in participants with a medically confirmed diagnosis of IgE-mediated peanut allergy.

ipd_sharing_description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Denmark
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
United States
France
Japan
Germany


title: A Phase 3b, Randomized, Open-label, Parallel-Group Study to Evaluate Different Dosing Regimens of Intravenous Efgartigimod to Maximize and Maintain Clinical Benefit in Patients With Generalized Myasthenia Gravis

acronym: ADAPT NXT

summary:
The purpose of this open-label study is to investigate the efficacy, safety, and tolerability of a continuous regimen of efgartigimod compared with a cyclic regimen in participants with Generalized Myasthenia Gravis (gMG).

Study details include:

The study duration will be up to 128 weeks (including screening)

Part A (regimen comparison period) - 21 weeks
Part B (extension period) - up to 105 weeks

The visit frequency, including virtual visits, will be weekly through Week 21 and every 5 weeks for the remainder of the study.

ipd_sharing: Undecided

lead_sponsor: argenx

location_country:
Poland
Spain
Italy
Austria
Georgia
Netherlands
Canada
United States
France
Belgium
Germany

location_facility:
Investigator Site 23 - FR0330005
Investigator Site 25 - FR0330003
Investigator Site 29 - CA0019003
Investigator Site 5 - PL0480002
Investigator Site 4 - PL0480001
Investigator Site 3 - GEO9950003
Investigator Site 28 - BE0320001
Investigator Site 27 - AT0430001
Investigator Site 12 - US0010004
Investigator Site 10 - US0010007
Investigator Site 7 - US0010001
Investigator Site 20 - FR0330001
Investigator Site 1 - GEO9950001
Investigator Site 16 - US0010009
Investigator Site 18 - ES0340002
Investigator Site 21 - IT0390002
Investigator Site 11 - US0010011
Investigator Site 15 - US0010014
Investigator Site 14 - US0010010
Investigator Site 9 - 0010006
Investigator Site 26 - AT0430002
Investigator Site 8 - US0010003
Investigator Site 2 - GEO9950002
Investigator Site 33 - DE0490004
Investigator Site 36 - DE0490002
Investigator Site 22 - IT0390001
Investigator Site 35 - NL0310001
Investigator Site 6 - US0010008
Investigator Site 31 - IT0390005
Investigator Site 19 - ES0340001
Investigator Site 30 - IT0390004
Investigator Site 13 - US0010013
Investigator Site 34 - DE0490005
Investigator Site 32 - DE0490001
Investigator Site 24 - FR0330004
Investigator Site 17 - US0010012


title: A Phase III, Multi-center, Open-label, Randomized Study of Oral Asciminib Versus Investigator Selected TKI in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase

summary: The study is designed to compare the efficacy of asciminib 80 mg QD versus Investigator selected TKI for the treatment of newly diagnosed, previously untreated patients with Ph+ CML-CP. The Investigator selected TKI will be one of the following treatment options for first-line treatment of CML-CP - imatinib 400 mg QD or nilotinib 300 mg BID or dasatinib 100 mg QD or bosutinib 400 mg QD.

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided are anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Portugal
Austria
Australia
Russian Federation
India
Israel
Norway
Malaysia
Singapore
Sweden
Slovakia
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Finland
Korea, Republic of
France
Netherlands

location_facility: Chattanooga Oncology and Hematology Associates PC Tennessee Oncology Chattanooga

location_facility: University of Iowa Hospitals and Clinics Univ of Iowa Hosp & Clinic

location_facility: Florida Cancer Specialists Dept of Oncology (2)

location_facility: University of TX MD Anderson Cancer Center

location_facility: Illinois Cancer Care P.C. IL Cancer Specialists

location_facility: University of Michigan Clinical Trials Office

location_facility: University of Massachusetts Medical Center Dept of Oncology

location_facility: Wake Forest University Baptist Medical Center Comprehensive Cancer Ctr


title: Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

summary: The purpose of this study is to evaluate the efficacy and safety of nipocalimab compared to placebo in participants with generalized myasthenia gravis (gMG).

lead_sponsor: Janssen Research & Development, LLC

location_country:
Denmark
Poland
Taiwan
Spain
Colombia
Italy
Australia
Mexico
Canada
United Kingdom
Sweden
Korea, Republic of
United States
France
China
Belgium
Japan
Germany
Czechia

location_facility: Washington University School of Medicine

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Tianjin Medical University General Hospital

location_facility: Central South University Xiangya Hospital The First Affiliated Hospital of Hunan Medical College

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Pusan National University Yangsan Hospital

location_facility: University of Colorado - Anschutz Medical Campus

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

location_facility: Azienda ospedaliera Sant'Andrea di Roma- Università di Roma La Sapienza

location_facility: Fujian Medical University Union Hospital

location_facility: The Second Affiliated Hospital of Air Force Medical University - Tangdu Hospital

location_facility: Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego Uniwersytetu Medycznego w Łodzi

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Qianfoshan hospital of Shandong Province

location_facility: FM Clinical Research, LLC South Florida Neurology Associates, P. A.

location_facility: Beijing Tiantan Hospital, Capital Medical University

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: West China Hospital of Sichuan University

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Chang Gung Memorial Hospital Kaohsiung Branch

location_facility: DKD HELIOS Klinik Wiesbaden, Fachbereich Neurologie

location_facility: NZOZ Wielospecjalistyczna Poradnia Lekarska 'Synapsis'

location_facility: Korea University Medical Center (KUMC) - Korea University Anam Hospital

location_facility: The First Bethune Hospital of Jilin University

location_facility: IRCCS C. Mondino, Istituto Neurologico Nazionale, Fondazione

location_facility: Universitätsklinikum Schleswig Holstein Campus Lübeck

location_facility: Centrum Neurologii Klinicznej, Krakowska Akademia Neurologii

location_facility: Xuanwu Hospital, Capital Medical University

location_facility: Neuromuscular Research Center and Clinic

location_facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine