title: An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 When Administered Alone and in Combination With Low-Dose Cytarabine (LDAC) or Decitabine in Patients With Acute Myeloid Leukemia (AML)

summary: This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, when administered alone and in combination with low-dose cytarabine (LDAC) or Decitabine for the treatment of adults with Acute Myeloid Leukemia (AML) and AML secondary to myeloproliferative neoplasms (MPN). Participants must be relapsed/refractory (having failed prior therapy) and will be assigned to receive monotherapy (KRT-232 alone) or combination therapy (KRT-232 with LDAC or KRT-232 with Decitabine).

lead_sponsor: Kartos Therapeutics, Inc.

location_country:
Germany
Italy
Poland
Hungary
Israel
United Kingdom
Australia
Belgium
United States
Korea, Republic of
Spain
France

location_facility: szabolcs-szatmár-bereg megyei kórházak és egyetemi oktatókórház Jósa András Oktatókórház

location_facility: Centre Hospitalier Universitaire (CHU) de Nice

location_facility: Hospital Universitario Virgen de la Victoria de Málaga

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

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

location_facility: Universitaria Maggiore della Carità Novara

location_facility: AORMN Hospital Hematology and BMT Center

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Del-Pesti Centrumkorhaz Orszagos Hematologiai es Infektologi

location_facility: Centre Hospitalier Universitaire (CHU) de Bordeaux

location_facility: Oxford University Hospitals NHS Trust, Churchill Hospital

location_facility: Hospital Universitari Germans Trias i Pujol


title: A Multi-Center Randomised Open-Label Phase 2 Study to Assess the Safety, Tolerability and Efficacy of Fimaporfin-Induced Photochemical Internalisation of Gemcitabine Complemented by Gemcitabine/Cisplatin Chemotherapy Versus Gemcitabine/Cisplatin Alone in Patients With Inoperable Cholangiocarcinoma

acronym: RELEASE

summary: This study will assess the safety and effectiveness of fimaporfin-induced photochemical internalisation (PCI) of gemcitabine complemented by systemic gemcitabine/cisplatin chemotherapy compared to gemcitabine/cisplatin alone, in patients with inoperable cholangiocarcinoma (CCA). Participants will be randomly assigned to one of the treatment groups and will receive study treatment for 6 months, followed by assessments every 3 months, as applicable.

study_start_date_type: Actual

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: PCI Biotech AS

location_country:
Finland
Germany
Italy
Poland
Norway
Denmark
Sweden
Belgium
United States
Korea, Republic of
Spain
Taiwan
Ukraine
France

location_facility: CHU Dupuytren, 2 Avenue Martin Luther King

location_facility: MNPE of Kharkiv Regional Council Regional Clinical Specialized Dispensary of Radiation Protection

location_facility: SI Institute for General and Urgent Surgery n.a. V.T. Zaitseva of NAMS of Uktraine

location_facility: Karolinska Universitetssjukhuset Solna, P.O Bäckencancer, Karolinska Universitetssjukhuset

location_facility: Pusan National University Hospital, 179 Gudeok-ro, Seo-gu

location_facility: Taichung Veterans General Hospital, No. 1650 Taiwan Boulevard, Sec. 4

location_facility: University of Chicago Medical Center, 5841 South Maryland Avenue

location_facility: Asan Medical Center, 88 Olympic-ro 43-gil, Songpa-gu

location_facility: Chang Gung Memorial Hospital, Linkou, Dept. of Medical Oncology, 5 Fuxing Street, Guishan

location_facility: Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon

location_facility: Klinikum Nürnberg Nord, Medizinische Klinik 6 - (Schwerpunkte Gastroenterologie, Hepatologie, Endokrinologie)

location_facility: National Cancer Center, 323 Ilsan-ro, Ilsandong-gu

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital, 222 Banpo-Daero Seocho-gu

location_facility: Kyungpook National University Chilgok Hospital, 807 Hoguk-ro, Buk-gu

location_facility: Emory University Hospital, 1365C Clifton Road NE

location_facility: Azienda Ospedaliero Universitaria Di Modena Policlinico

location_facility: Institut Gustave Roussy, Département de gastro-entérologie

location_facility: Taipei Veterans General Hospital, No. 201, Sction 2, Shi-pai Road

location_facility: Klinikum Mannheim Universitätsklinikum gGmbH

location_facility: Municipal Nonprofit Enterprise City Hospital #3 of Zaporizhzhia City Council

location_facility: SI "National Institute of Surgery and Transplantology n.a. O.O. Shalimov " of NAMS of Ukraine

location_facility: The Mayo Clinic Hospital - Saint Mary's Campus, 1216 Second Street Southwest

location_facility: Klinikum der Ludwig-Maximilians-Universität MünchenKlinik

location_facility: Severance Hospital Yonsei University Health System, 50-1, Yonsei-Ro, Seodaemun-Gu

location_facility: Hospital Universitario HM Sanchinarro - CIOCC

location_facility: Zaklad Opieki Zdrowotnej MSW z Warminsko-Mazurskim Centrum Onkologii

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Tampereen yliopistollinen sairaala, Syöpätautien klinikka

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Oslo Universitetssykehus HF Radiumhospitalet

location_facility: Universitätsklinikum Hamburg Eppendorf, I. Medizinische Klinik und Poliklinik (Gastroenterologie mit Sektionen Infektiologie und Tropenmediz)

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


type: Other Identifier

type: Registry Identifier

title: Efficacy and Safety of Concizumab Prophylaxis in Patients With Haemophilia A or B With Inhibitors

summary: This study will test how well a new medicine called concizumab works in the body of people with haemophilia A or B with inhibitors. The purpose is to show that concizumab can prevent bleeds in the body and is safe to use. Participants who usually only take medicine to treat bleeds (on-demand) will be placed in one of two groups. In one group, participants will get study medicine from the start of the study. In the other group, participants will continue with their normal medicine and get study medicine after 6 months. Which treatment the participant gets is decided by chance. Participants who usually take medicine to prevent bleeds (prophylaxis treatment) or who are already being treated with concizumab (study medicine) will receive the study medicine from the start of the study. Participants will get 1 injection with the study medicine every day under the skin. This participants will have to do themselves and can be done at home. The study doctor will hand out the medicine in the form of a pen-injector. The pen-injector will contain the study medicine. The study will last for about six years. The length of time the participants will be in the study depends on when they agreed to take part or when the medicine is available for purchase in their country (12 November 2025 at the latest). Participants will have to come to the clinic for up to 41 times. The time between visits will be approximately 4 weeks for the first 6 to 12 months, depending on the group participants are in and approximately 8 weeks for the rest of the study. Participants will be asked to record information into an electronic diary during the study and may also be asked to wear an activity tracker.

status: Active, not recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S

location_country:
Poland
Algeria
Australia
Japan
Thailand
Turkey
Croatia
Czechia
Serbia
France
Portugal
Slovakia
Denmark
United States
Ukraine
India
Malaysia
Italy
Norway
United Kingdom
Austria
Mexico
Korea, Republic of
Spain
South Africa
Bulgaria
Russian Federation
Sweden

status_simplified: Ongoing


title: Aldose Reductase Inhibition for Stabilization of Exercise Capacity in Heart Failure (ARISE-HF): A Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy

summary: This is a multicenter, randomized, placebo-controlled, 2-part study to evaluate the safety and efficacy of AT-001 in adult patients (N=675) with Diabetic Cardiomyopathy at high risk of progression to overt heart failure.

lead_sponsor: Applied Therapeutics, Inc.

location_country:
Germany
Poland
United Kingdom
Hong Kong
Australia
United States
Spain
Czechia
Canada
France

location_facility: LMC Diabetes & Endocrinology Ltd. - Toronto

location_facility: LMC Diabetes & Endocrinology Ltd. - Brampton

location_facility: Hôpital Jean-Verdier - AP-HP; Service Endocrinologie Diabétologie Nutrition

location_facility: Prywatny Gabinet Lekarski Centrum Medyczne Diabetika

location_facility: Hospital Abente y Lago (Complejo Universitario de la Coruña)

location_facility: Centre for Studies in Family Medicine, Western Centre for Public Health and Family Medicine, Western University

location_facility: CHU de Nantes, Clinique d'Endocrinologie

location_facility: Barwon Health-University Hospital Geelong

location_facility: University of California, San Diego (UCSD)

location_facility: ZKS - Zentrum Klinische Studien Sudbrandenburg GmbH

location_facility: Institut Universitaire de Cardiologie et de Pneumologie De Quebec

location_facility: Prince of Wales Hospital; Chinese University of Hong Kong; Dept of Medicine and Therapeutics

location_facility: Centrum Medyczne Medyk Stanislaw Mazur Sp. z o.o. SK

location_facility: University of California - Irvine Medical Center

location_facility: LMC Diabetes & Endocrinology Ltd. - Etobicoke

location_facility: Hospital de la Santa Creu i Sant Pau Barcelona

location_facility: Topolowa MEDICENTER Mrózek & wspólnicy sp.j.

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Barts and The London School of Medicine & Dentistry

location_facility: LMC Diabetes & Endocrinology Ltd. - Thornhill

location_facility: Westside Medical Associates of Los Angeles

location_facility: Herz-und Diabeteszentrum NRW Universitaetsklinik der Ruhr-Universitaet Bochum

location_facility: NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny

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

location_facility: Nemocnice Pardubickeho kraje, a.s., Nemocnice Pardubice

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca

location_facility: 4 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny ZOZ we Wroclawiu

location_facility: Juno Research, LLC - Southwest Houston Site


type: EudraCT Number

title: An Open-Label, Phase I Study to Evaluate the Safety, Pharmacokinetics and Preliminary Antitumor Activity of RO7227166 (a CD19 Targeted 4-1BB Ligand) in Combination With Obinutuzumab and in Combination With Glofitamab Following a Pre-Treatment Dose of Obinutuzumab Administered in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

summary: This is a phase I/II, open-label, dose-escalation study designed to evaluate the safety, tolerability, and efficacy of RO7227166 in participants with relapsed/refractory Non-Hodgkin's Lymphoma (r/r NHL). RO7227166 will be administered by intravenous (IV) infusion in combination with obinutuzumab and in combination with glofitamab. A fixed dose of obinutuzumab (Gpt; pre-treatment) will be administered seven days prior to the first administration of RO7227166 and seven days prior to the first administration of glofitamab. This entry-into-human study is divided into a dose-escalation stage (Part I and Part II) and a dose expansion stage (Part III).

status: Recruiting

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:
Italy
United Kingdom
Denmark
Australia
Belgium
United States
Spain
France

location_facility: CHU DE RENNES - CHU Pontchaillou; Service d'Hématologie Clinique Adulte

location_facility: Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Hematologia

location_facility: Washington University School of Medicine

location_facility: University College London Hospitals NHS Foundation Trust; NIHR UCLH Clinical Research Facility

location_facility: Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia

location_facility: Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT


lead_sponsor: Novartis Pharmaceuticals

summary: This clinical study was designed to support the dose selection for future studies by evaluating efficacy and safety of different QBW251 doses in Chronic obstructive pulmonary disease (COPD) patients with chronic bronchitis and a history of exacerbations, compared to placebo, when added to a triple inhaled therapy of LABA, LAMA and ICS.

status: Completed

title: A 24-week Multi-center, Double-blind, Placebo Controlled Dose-range Finding Study to Investigate the Efficacy and Safety of Oral QBW251 in COPD Patients on Triple Inhaled Therapy (LABA / LAMA / ICS)

source: euctr

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

location_country:
Germany
Poland
Argentina
Australia
Japan
Thailand
Turkey
Czechia
Canada
France
Colombia
Slovakia
Hungary
Hong Kong
Denmark
United States
Belgium
Philippines
Italy
Guatemala
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Greece

status_simplified: Completed


title: Abbott DBS Post-Market Study of Outcomes for Indications Over Time

acronym: ADROIT

summary: The purpose of this international study is to evaluate long-term safety and effectiveness of Abbott deep brain stimulation (DBS) systems for all indications, including Parkinson's disease, essential tremor or other disabling tremor and dystonia.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Abbott Medical Devices

location_country:
Germany
Finland
Italy
United Kingdom
Australia
United States
Spain
Taiwan
France

location_facility: Allegheny General Hospital Department of Neurosurgery

location_facility: Hospital Universitari Germans Trias I Pujol

location_facility: UKE Hamburg (Universitatsklinik Eppendorf)

location_facility: UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz

location_facility: Thomas Jefferson Department or Neurosurgery

location_facility: Wright State University & Premier Health

location_facility: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

location_facility: Medizinische Einrichtungen der Universität Düsseldorf

location_facility: University of South Florida - Department of Neurology

intervention_type: Device


lead_sponsor: Incyte Corporation

summary: The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adolescent and adult participants with non-segmental vitiligo for whom total body involved vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).

ReferenceType: derived

ReferenceCitation: Rosmarin D, Passeron T, Pandya AG, Grimes P, Harris JE, Desai SR, Lebwohl M, Ruer-Mulard M, Seneschal J, Wolkerstorfer A, Kornacki D, Sun K, Butler K, Ezzedine K; TRuE-V Study Group. Two Phase 3, Randomized, Controlled Trials of Ruxolitinib Cream for Vitiligo. N Engl J Med. 2022 Oct 20;387(16):1445-1455. doi: 10.1056/NEJMoa2118828.

oa_host_type: publisher

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

location_facility: McGill University Health Centre / Carey/Wang Clinic

location_facility: Multiprofile Hospital For Active Treatement - Clinic of Dermatology and Venerology

location_facility: Hopital Charles Nicolle Chu Rouen - Hopital de Bois-Guillaume

location_facility: Forcare Clinical Research Fcr Forward Clinical Trials, Inc

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Synexus Polska Sp. Z O.O. Oddzial W Poznaniu

location_facility: Dermatology Associates of Plymouth Meeting

location_facility: University of California San Francisco Sub Location

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

location_facility: Synexus Polska Sp. Z O.O. Oddzial W Gdyni

location_facility: International Clinical Research Tennessee Llc

location_facility: Synexus - Polska Sp Z Oo Oddzial W Gdansk

location_facility: Poradnia Dermatologiczno-Wenerologiczna Mediderm S.C. Nzoz

location_facility: University Clinic Carl Gustav Carus, Technical University Dresden

location_facility: Dermatology Clinical Research Center of San Antonio

location_facility: Synexus Polska Sp. Z O.O. Oddzial We Wroclawiu

location_facility: Cognitive Clinical Trials Scottsdale Btc Ppds

title: Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1): A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by an Extension Period in Participants With Vitiligo

location_country:
Germany
Italy
Poland
United States
Spain
Bulgaria
Canada
France


title: A Phase 1 Open-Label Study Evaluating the Safety and Tolerability, and Pharmacokinetics of Navitoclax Monotherapy and in Combination With Ruxolitinib in Myeloproliferative Neoplasm Subjects

summary: There are 5 parts to this study for which the primary objectives are to evaluate safety, tolerability, and pharmacokinetics (PK) of navitoclax when administered alone (Part 1) or when administered in combination with ruxolitinib (Part 2). In Part 2, participants must have been receiving a stable dose of ruxolitinib therapy for at least 12 weeks prior to study enrollment. In Part 3, all eligible participants will receive navitoclax, with the primary objective being to evaluate potential navitoclax effect on QTc prolongation. In Part 4, effect of navitoclax is evaluated on the PK, safety, and tolerability of a single dose of celecoxib. In Part 5, all eligible participants will receive ruxolitinib twice daily and navitoclax once daily for drug-drug interaction (DDI) assessment, followed by continued administration of navitoclax in combination with ruxolitinib.

design_allocation: Non-Randomized

lead_sponsor: AbbVie

location_country:
Germany
Italy
United Kingdom
Japan
Sweden
Belgium
United States
Spain
Turkey
Croatia
Taiwan
Bulgaria
Serbia
France

location_facility: Virginia Commonwealth University Medical Center Main Hospital /ID# 228169

location_facility: China Medical University Hospital /ID# 215634

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 221408

location_facility: Juntendo University Hospital /ID# 213255

location_facility: Dokuz Eylul University Medical Faculty /ID# 239952

location_facility: CHU Amiens-Picardie Site Sud /ID# 240792

location_facility: University of Yamanashi Hospital /ID# 229279

location_facility: East Carolina University Brody School of Medicine /ID# 238560

location_facility: Providence Medical Foundation /ID# 242558

location_facility: ASST Spedali civili di Brescia /ID# 224962

location_facility: Pennsylvania Cancer Specialists Research Institute - Gettysburg /ID# 242550

location_facility: Karolinska University Hospital /ID# 239992

location_facility: Gloucestershire Hospitals NHS Foundation Trust /ID# 241189

location_facility: Onc/Hematology West PC dba Nebraska Cancer Specialists /ID# 242554

location_facility: Moores Cancer Center at UC San Diego /ID# 229584

location_facility: Klinicki bolnicki centar Zagreb /ID# 240140

location_facility: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS /ID# 224071

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 215631

location_facility: University Clinical Center Serbia /ID# 240674

location_facility: Norton Cancer Institute - St Matthews /ID# 239300

location_facility: Gabrail Cancer Center Research /ID# 228924

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 226041

location_facility: Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 224835

location_facility: Centre Antoine Lacassagne - Nice /ID# 242293

location_facility: Linkoping University Hospital /ID# 239995

location_facility: Universitaetsklinikum Freiburg /ID# 222791

location_facility: Brigitte Harris Cancer Pavilion /ID# 238686

location_facility: Northwestern University Feinberg School of Medicine /ID# 224203

location_facility: Universitaetsmedizin Rostock /ID# 225436

location_facility: Shonan Kamakura General Hospital /ID# 224315

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 224839


title: A Phase 1, Multicenter, Open-label, Dose Finding Study of CC-99712, a BCMA Antibody-Drug Conjugate, in Subjects With Relapsed and Refractory Multiple Myeloma

summary: Study CC-99712-MM-001 is an open-label, Phase 1, dose escalation (Part A) and expansion (Part B), First-in-Human (FIH) clinical study of CC-99712 in monotherapy or combination with BMS-986405 in participants with relapsed and refractory multiple myeloma (MM). The dose escalation part (Part A) of the study will evaluate the safety and tolerability of escalating doses of CC-99712, administered intravenously (IV) in monotherapy (Arm 1) or combination with BMS-986405 (Arm 2), to determine the maximum tolerated dose (MTD) of CC-99712 guided by a Bayesian logistic regression model (BLRM). A modified accelerated titration design will also be used for Arm 1 and Arm 2. The MTD may be established separately for CC-99712 administered at Q3W and/ or Q4W schedules. The expansion part (Part B) will further evaluate the safety and efficacy of CC-99712 in monotherapy (Arm 1) or combination (Arm 2) administered at or below the MTD in selected expansion cohorts in order to determine the RP2D. One or more doses or dosing regimens may be selected for cohort expansion. All participants will be treated until confirmed disease progression per IMWG criteria, unacceptable toxicity, or participants//Investigator decision to withdraw.

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

lead_sponsor: Celgene

location_country:
Italy
United States
Spain
Canada
France

location_facility:
Local Institution - 107
Local Institution - 106
Local Institution - 105
Local Institution - 101
Hopital Saint Antoine
CHU Montpellier - Hôpital Saint Eloi
Local Institution - 102
Local Institution - 501
Local Institution - 405
Local Institution - 103
Local Institution - 202
Local Institution - 401
Local Institution - 104
Local Institution - 404
Institut Paoli Calmettes
Local Institution - 201
Local Institution - 402
Local Institution - 403
Centre Hospitalier Lyon Sud


acronym: DUPISTAD

lead_sponsor: Sanofi

summary:
Primary Objective:

To evaluate the effect of dupilumab on sleep quality in adult participants with moderate to severe atopic dermatitis (AD).

Secondary Objectives:

To evaluate the effect of dupilumab on objective and subjective quantitative sleep parameters, AD related outcomes, and daytime consequences of sleep deprivation.

To continue to assess the safety and tolerability throughout the study.

sponsor_collaborators:
Sanofi
Regeneron Pharmaceuticals

location_facility:
Investigational Site Number :0360001
Investigational Site Number :7840001
Investigational Site Number :3800006
Investigational Site Number :2760004
Investigational Site Number :7840002
Investigational Site Number :8400002
Investigational Site Number :8400007
Investigational Site Number :8260002
Investigational Site Number :8400008
Investigational Site Number :7240001
Investigational Site Number :8400003
Investigational Site Number :8400001
Investigational Site Number :3800003
Investigational Site Number :2500002
Investigational Site Number :0360007
Investigational Site Number :3760005
Investigational Site Number :8400005
Investigational Site Number :0360006
Investigational Site Number :2500001
Investigational Site Number :3800005
Investigational Site Number :3800002
Investigational Site Number :7240006
Investigational Site Number :0360003
Investigational Site Number :7240005
Investigational Site Number :2760005
Investigational Site Number :2500006
Investigational Site Number :7240010
Investigational Site Number :8260004
Investigational Site Number :7240002
Investigational Site Number :2760006
Investigational Site Number :2760002
Investigational Site Number :3800001
Investigational Site Number :7560001
Investigational Site Number :2760001
Investigational Site Number :7240003
Investigational Site Number :8400012
Investigational Site Number :3760003
Investigational Site Number :7240008
Investigational Site Number :2500003
Investigational Site Number :8400013
Investigational Site Number :3800004
Investigational Site Number :7240004

title: A Randomized Double-blind, Placebo-controlled Study Evaluating the Effect of Dupilumab on Sleep in Adult Patients With Moderate to Severe Atopic Dermatitis (AD)

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

location_country:
Germany
France
Italy
United Kingdom
Australia
Switzerland
United Arab Emirates
United States
Spain
Israel


summary:
This is a Phase I/II, multicenter, open-label, multi-arm study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of idasanutlin, administered as a single agent or in combination with chemotherapy or venetoclax, in pediatric and young adult participants with acute leukemias or solid tumors.

This study is divided into three parts: Part 1 will begin with dose escalation of idasanutlin as a single agent in pediatric participants with relapsed or refractory solid tumors to identify the maximum tolerated dose (MTD)/maximum administered dose (MAD) and to characterize dose-limiting toxicities (DLTs). Following MTD/MAD identification, three separate safety run-in cohorts in neuroblastoma, acute myeloid leukemia (AML), and acute lymphoblastic leukemia (ALL) will be conducted to identify the recommended Phase 2 dose (RP2D) of idasanutlin in each combination, with chemotherapy or venetoclax. Part 2 will evaluate the safety and early efficacy of idasanutlin in combination with chemotherapy or venetoclax in newly enrolled pediatric and young adult participants in neuroblastoma, AML,and ALL cohorts at idasanutlin RP2D. Part 3 will potentially be conducted as an additional expansion phase of the idasanutlin combination cohorts in neuroblastoma, AML, or ALL for further response and safety assessment.

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Lucile Packard Children's Hospital at Stanford University; Thoracic Oncology

location_facility: The Royal Victoria Infirmary; Paediatric and Adolescent Oncology Unit

location_facility: Arkansas Children's Hospital Research Institute

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Huntsman Cancer Institute at The University of Utah

location_facility: The University of Texas MD Anderson Cancer Center

title: A Phase I/II, Multicenter, Open-Label, Multi-Arm Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Activity of Idasanutlin in Combination With Either Chemotherapy or Venetoclax in the Treatment of Pediatric and Young Adult Patients With Relapsed/Refractory Acute Leukemias or Solid Tumors

ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the 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 Sharing of Clinical Study 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).

location_country:
United Kingdom
Netherlands
United States
Spain
Canada
France


acronym: PICTURE

lead_sponsor: Guerbet

summary: the trial aims to evaluate the Efficacy and Safety of gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

location_facility: Axis Heilsa S. de R.L. de C.V. (Althian)

location_facility: ASL 1 Abruzzo Avezzano-Sulmona-L'Aquila, Ospedale Regionale San Salvatore

location_facility: South Carolina Clinical & Translational Research (SCTR) Institute

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont - Idegsebeszeti Klinika

location_facility: Azienda Sanitaria Universitaria Integrata di Trieste-PO Cattinara

location_facility: Uniwersyteckie Centrum Kliniczne w Gdańsku, Zakład Radiologii

location_facility: University of Missouri Hospital and Clinic

location_facility: CHRU - Hôpital Roger Salengro - Neurologie

location_facility: Istituto Neurologico Mediterraneo-Neuromed, I.R.C.C.S.

location_facility: University Of Washington - Medical Center

title: Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

primary_purpose: Diagnostic

location_country:
Germany
Italy
Poland
Hungary
Mexico
Belgium
United States
Korea, Republic of
Spain
Taiwan
France


title: A Phase 1/2 of Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of TPX-0022 in Adult Subjects With Locally Advanced or Metastatic NSCLC, Gastric Cancer, or Solid Tumors Harboring Genetic Alterations in MET

summary: A phase 1/2, first-in-human, open-label study of the safety, tolerability, PK, and efficacy of the novel MET/CSF1R/SRC inhibitor TPX-0022 in adult subjects with advanced or metastatic NSCLC, Gastric Cancer, or solid tumors harboring genetic alterations in MET. (SHIELD-I)

lead_sponsor: Turning Point Therapeutics, Inc.

location_country:
Korea, Democratic People's Republic of
United States
Spain
Korea, Republic of
France

location_facility:
Local Institution - 6302
Local Institution - 2109
Local Institution - 4201
Local Institution - 6303
Local Institution - 2113
Local Institution - 4203
Local Institution - 2103
Local Institution - 2102
Local Institution - 2101
Local Institution - 4102
Local Institution - 2111
Local Institution - 4204
Local Institution - 6304
Local Institution - 2105
Local Institution - 6301
Local Institution - 4104
Local Institution - 2106
Local Institution - 2112
Local Institution - 2107
Local Institution - 2108
Local Institution - 4101
Local Institution - 2104
Local Institution - 4103
Local Institution - 4202


title: A Phase 2 Open-Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects With Metastatic Solid Tumors

summary: The goal of this clinical study is to learn more about the study drug, sacituzumab govitecan-hziy, in participants with metastatic (cancer that has spread) solid tumors.

lead_sponsor: Gilead Sciences

location_country:
Hong Kong
Australia
Belgium
United States
Spain
Taiwan
Canada
France

location_facility: Washington University School of Medicine - Siteman Cancer Center

location_facility: University Hospitals Cleveland Medical Center

location_facility: London Health Sciences Centre- Victoria Hospital

location_facility: Department of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital

location_facility: SIU School of Medicine, Simmons Cancer Institute at SIU

location_facility: Mater Cancer Centre, Mater Misericordiae Limited

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

location_facility: The Andrew Love Cancer Centre, Geelong Hospital

location_facility: Weill Cornell Medicine - Upper East Side

location_facility: Institut Claudius Régaud - IUCT Oncopole

location_facility: Christus Highland Cancer Treatment Center

location_facility: University of Michigan Rogel Cancer Center

location_facility: USOR - Arizona Oncology - Glendale - Saguaro Cancer Center

location_facility: Hospital Clínico Universitario de Valencia

location_facility: North Mississippi Medical Center - Hematology and Oncology - Tupelo

location_facility: Willamette Valley Cancer Institute and Research Center - Eugene

location_facility: University of Colorado Hospital - Anschutz Cancer Pavilion

location_facility: New York Oncology Hematology - Albany Medical Center


lead_sponsor: LEO Pharma

summary: This was a double-blind, multi-centre, randomised, vehicle-controlled, within-subject phase 2a trial. The trial was designed to establish the efficacy and safety of delgocitinib cream in the treatment of adult subjects with discoid lupus erythematosus (DLE).

ReferenceCitation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.

oa_host_type: repository

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Wiley

location_facility:
LEO Pharma Investigational site
LEO Pharma Investigational Site

title: Efficacy and Safety of Twice-daily Application of Delgocitinib Cream 20 mg/g for 6 Weeks in Subjects With Active Discoid Lupus Erythematosus.

ipd_sharing_description:
De-identified individual patient data (IPD) can be made available to researchers in a closed environment for a specified period of time.

Data sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.

location_country:
United States
Denmark
Germany
France


title: Pulmonary Hemodynamics During Exercise - Research Network

acronym: PEX-NET

summary: The purpose of this Clinical Research Collaboration is to investigate the prognostic implications of pulmonary hemodynamics during exercise based on a large scale multi-centre approach by using retrospective and prospective analysis of hemodynamic data.

ipd_sharing: Undecided

lead_sponsor: Medical University of Graz

sponsor_collaborators:
Medical University of Graz
European Respiratory Society

location_country:
Germany
Italy
Poland
United Kingdom
Denmark
Australia
Brazil
Netherlands
Austria
Belgium
Switzerland
United States
Spain
France

location_facility: University of California, Los Angeles, Lung & Heart-Lung Transplant and Pulmonary Hypertension Programs, David Geffen School of Medicine

location_facility: University of Cologne, Klinik III fuer Innere Medizin

location_facility: Mayo Clinic, Division of Cardiovascular Diseases, Department of Medicine

location_facility: Centre Chirurgical Marie Lannelongue, Thoracic and Vascular Surgery

location_facility: Johns Hopkins Hospital, Advanced HF, MCS, Transplant Cardiology, Baltimore, Maryland, USA

location_facility: Justus-Liebig-University Giessen, Department of Internal Medicine

location_facility: Centre de Référence de l'Hypertension Pulmonaire, Université ParisSud - Université Paris-Saclay, Hôpital Bicêtre, Assistance Publique Hôpitaux de Paris

location_facility: Royal Prince Alfred Hospital, Respiratory Medicine

location_facility: Department of Cardiology, Aarhus University Hospital, Denmark

location_facility: University of Arizona, Banner University Medical Center

location_facility: Harvard Medical School, Brigham and Women's Hospital

location_facility: Massachusetts General Hospital, Cardiology Division and Pulmonary Unit

location_facility: Sorbonne Universités, Neurophysiologie respiratoire expérimentale et clinique

location_facility: Imperial College, NHS Healthcare NHS Trust, National Pulmonary Hypertension Service

location_facility: Academic Teaching Hospital of the Julius Maximilian University of Würzburg

location_facility: Royal Hallamshire Hospital, Sheffield Pulmonary Vascular Disease Unit

location_facility: University of Minnesota Medical School, Division of Cardiology, Department of Medicine, Lillehei Heart Institute Minneapolis, Minnesota, USA

location_facility: University of Rome La Sapienza, Cardiovascular and Respiratory Sciences

location_facility: University Hospital of Zurich, Internal Medicine

location_facility: Otwock Medical Center of Postgraduate Education, Department of Pulmonary Circulation and Thromboembolic Diseases

location_facility: Thorax Clinic Heidelberg, Centre for Pulmonary Hypertension

location_facility: Free University of Brussels, Faculty of Medicine, Physiology

intervention_type: Diagnostic Test

lead_sponsor_type: academique


lead_sponsor: Bristol-Myers Squibb

summary: The purpose of this study is to assess the safety and efficacy of oral deucravacitinib in participants with moderate to severe ulcerative colitis (UC).

location_facility: Nizhniy Novgorod Regional Clinical Hospital N.A. Semashko

location_facility: Texas Digestive Disease Consultants - Southlake

location_facility: National Hospital Organization Takasaki General Medical Center

location_facility: Charite Universitatsmedizin Berlin - Campus Virchow-Klinikum

location_facility: New York University Langone Medical Center

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Jadwiga Miecz

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

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

location_facility: Multidisciplinary Consultative and Diagnostic Center

location_facility: Connecticut Clinical Research Foundation

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Centrum Zdrowia Matki Dziecka i Mlodziezy

location_facility: Universitatsklinikum Carl Gustav Carus Dresden

location_facility: National Hospital Organization Hirosaki National Hospital

location_facility: Clinica Medica Azienda Ospedaliera Universitaria

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Penn State Health Milton S. Hershey Medical Center

location_facility: Texas Digestive Disease Consultants - Gastroenterology Associates - Baton Rouge

location_facility: Novosibirsk State Regional Clinical Hospital

location_facility: Shiga University of Medical Science Hospital

location_facility: Policlinico Universitario Campus Bio-Medico

location_facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico SantOrsola-Malpighi

location_facility: Gastroenterology Research of San Antonio

title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Australia
Japan
Belgium
United States
Korea, Republic of
Czechia
Russian Federation
France


title: A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-blind Study in Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP) to Evaluate the Pharmacokinetics, Safety and Efficacy of rADAMTS-13 (SHP655) Administered in Addition to Standard Of Care (SoC) Treatment

acronym: SOAR-HI

summary: The purpose of this study is to evaluate the pharmacokinetics, safety, and efficacy of rADAMTS-13 (SHP655) administered in addition to standard of care (SoC) treatment of acquired thrombotic thrombocytopenic purpura (aTTP) participants.

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Shire

collaborators: Takeda Development Center Americas, Inc.

location_country:
Germany
Italy
United Kingdom
United States
Spain
Canada
France

location_facility: University Hospitals Cleveland Medical Center

location_facility: Hospital Universitari i Politècnic la Fe

location_facility: London Health Sciences Centre (LHSC) - University Hospital

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Medical University of South Carolina (MUSC)

location_facility: Hospital General Universitario de Alicante

location_facility: The Ohio State University Wexner Medical Center

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Hospital General Universitario Gregorio Maranon


lead_sponsor: Alexion Pharmaceuticals, Inc.

summary: The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab for the treatment of participants with generalized myasthenia gravis (gMG).

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis

location_country:
Germany
Italy
Portugal
Israel
Denmark
Japan
Netherlands
Austria
Switzerland
United States
Korea, Republic of
Spain
Czechia
Canada
France


lead_sponsor: Hansa Biopharma AB

summary:
The purpose of this study is to investigate how efficiently the study medication imlifidase reduces the amount of donor specific antibodies (DSA) in comparison with plasma exchange (PE) therapy, in patients who have an active or chronic active antibody mediated rejection (AMR) after recently been kidney transplanted. The purpose is also to investigate and compare safety for these two treatments.

20 patients will be treated with imlifidase and 10 with PE.

location_facility: CHU Grenoble Alpes - Néphrologie, dialyse et transplantation

location_facility: Hôpital Necker - Service de Néphrologie - Transplantation

location_facility: Charité-Universitätsmedizin. Dept. of Nephrology and Medical Intensive Care

location_facility: Hôpital Saint-Louis. Service de Néphrologie et Transplantation

location_facility: Universitätsklinik für Innere Medizin III, Klinische Abteilung für Nephrologie MUW

location_facility: New York University Grossman School of Medicine

title: A Randomized, Open-Label, Multi-Centre, Active Control, Efficacy and Safety Study of Imlifidase in Eliminating Donor Specific Anti-HLA Antibodies in the Treatment of Active Antibody-Mediated Rejection in Kidney Transplant Patients

location_country:
Germany
Australia
Austria
United States
France


acronym: SHINE

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

summary:
The primary objective of the study is to evaluate the long-term safety and tolerability of TV-46000. The primary safety and tolerability endpoint is the frequency of all adverse events, including serious adverse events. For new participants, the total duration of participant participation in the study is planned to be up to 80 weeks (including a screening period of up to 4 weeks, a 12-week oral conversion/stabilization stage [Stage 1], a 56-week double-blind maintenance stage [Stage 2], and a follow-up period [8 weeks]). For roll-over participants, the total duration of participant participation in the study is planned to be up to 64 weeks (including up to 56 weeks in the maintenance stage [Stage 2] and a follow-up period [8 weeks]). Participants who started Stage 2 who relapse or meet 1 or more of the withdrawal criteria should be invited to perform the Early Termination visit as soon as possible within 4 weeks of the last injection. Participants who withdraw from the study before completing the 56-week maintenance stage will have follow-up procedures and assessments performed at their follow-up visits. During the follow-up period, participants will be treated according to the investigator's judgment.

All participants will be treated with active drug.

location_facility:
Teva Investigational Site 59148
Teva Investigational Site 35260
Teva Investigational Site 14796
Teva Investigational Site 14785
Teva Investigational Site 14859
Teva Investigational Site 14774
Teva Investigational Site 14763
Teva Investigational Site 14794
Teva Investigational Site 14815
Teva Investigational Site 14770
Teva Investigational Site 59154
Teva Investigational Site 14816
Teva Investigational Site 80157
Teva Investigational Site 14871
Teva Investigational Site 14390
Teva Investigational Site 14391
Teva Investigational Site 14782
Teva Investigational Site 80156
Teva Investigational Site 14818
Teva Investigational Site 14786
Teva Investigational Site 14791
Teva Investigational Site 14814
Teva Investigational Site 14415
Teva Investigational Site 14414
Teva Investigational Site 14861
Teva Investigational Site 59144
Teva Investigational Site 14780
Teva Investigational Site 14778
Teva Investigational Site 14771
Teva Investigational Site 14389
Teva Investigational Site 14856
Teva Investigational Site 14876
Teva Investigational Site 14764
Teva Investigational Site 59149
Teva Investigational Site 14832
Teva Investigational Site 14809
Teva Investigational Site 14867
Teva Investigational Site 14829
Teva Investigational Site 14405
Teva Investigational Site 14788
Teva Investigational Site 14401
Teva Investigational Site 14776
Teva Investigational Site 14400
Teva Investigational Site 14868
Teva Investigational Site 14395
Teva Investigational Site 59150
Teva Investigational Site 11174
Teva Investigational Site 14869
Teva Investigational Site 14801
Teva Investigational Site 14813
Teva Investigational Site 14396
Teva Investigational Site 14810
Teva Investigational Site 14865
Teva Investigational Site 11170
Teva Investigational Site 14875
Teva Investigational Site 80161
Teva Investigational Site 14863
Teva Investigational Site 14772
Teva Investigational Site 59152
Teva Investigational Site 14787
Teva Investigational Site 14792
Teva Investigational Site 11171
Teva Investigational Site 80162
Teva Investigational Site 14799
Teva Investigational Site 80160
Teva Investigational Site 14777
Teva Investigational Site 11169
Teva Investigational Site 14393
Teva Investigational Site 59146
Teva Investigational Site 14817
Teva Investigational Site 14783
Teva Investigational Site 35259
Teva Investigational Site 14805
Teva Investigational Site 14862
Teva Investigational Site 11173
Teva Investigational Site 14793
Teva Investigational Site 14802
Teva Investigational Site 14866
Teva Investigational Site 14773
Teva Investigational Site 59151
Teva Investigational Site 14807
Teva Investigational Site 14826
Teva Investigational Site 35256
Teva Investigational Site 14827
Teva Investigational Site 14811
Teva Investigational Site 35257
Teva Investigational Site 14860
Teva Investigational Site 14821
Teva Investigational Site 80155
Teva Investigational Site 14416

title: A Study to Evaluate the Safety, Tolerability, and Effect of Risperidone Extended-Release Injectable Suspension (TV-46000) for Subcutaneous Use as Maintenance Treatment in Adult and Adolescent Patients With Schizophrenia

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request

location_country:
France
United States
Bulgaria
Canada
Israel


title: A Phase 2b Dose-finding Study for SAR442168, a Bruton's Tyrosine Kinase Inhibitor, in Participants With Relapsing Multiple Sclerosis

summary:
Primary Objective:

To determine the dose-response relationship for SAR442168 to reduce the number of new active brain lesions.

Secondary Objectives:

To evaluate efficacy of SAR442168 on disease activity as assessed by imaging measures.
To evaluate the safety and tolerability of SAR442168.

ReferenceCitation: Reich DS, Arnold DL, Vermersch P, Bar-Or A, Fox RJ, Matta A, Turner T, Wallstrom E, Zhang X, Mares M, Khabirov FA, Traboulsee A; Tolebrutinib Phase 2b Study Group. Safety and efficacy of tolebrutinib, an oral brain-penetrant BTK inhibitor, in relapsing multiple sclerosis: a phase 2b, randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2021 Sep;20(9):729-738. doi: 10.1016/S1474-4422(21)00237-4.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

location_country:
Slovakia
Netherlands
United States
Spain
Czechia
Ukraine
Canada
Estonia
Russian Federation
France

location_facility:
Investigational Site Number 2030003
Investigational Site Number 7240001
Investigational Site Number 8400003
Investigational Site Number 8040002
Investigational Site Number 8400006
Investigational Site Number 8040006
Investigational Site Number 7240005
Investigational Site Number 1240001
Investigational Site Number 8040009
Investigational Site Number 8400007
Investigational Site Number 2030007
Investigational Site Number 8400008
Investigational Site Number 2030001
Investigational Site Number 2030002
Investigational Site Number 2500002
Investigational Site Number 7240006
Investigational Site Number 7030001
Investigational Site Number 8040003
Investigational Site Number 1240002
Investigational Site Number 6430007
Investigational Site Number 2500001
Investigational Site Number 6430001
Investigational Site Number 8400009
Investigational Site Number 8040007
Investigational Site Number 2030006
Investigational Site Number 6430002
Investigational Site Number 6430004
Investigational Site Number 8040001
Investigational Site Number 7240003
Investigational Site Number 2500004
Investigational Site Number 8400005
Investigational Site Number 8400004
Investigational Site Number 5280001
Investigational Site Number 7240004
Investigational Site Number 5280002
Investigational Site Number 2030004
Investigational Site Number 8400001
Investigational Site Number 8400002
Investigational Site Number 6430006
Investigational Site Number 2330001
Investigational Site Number 7030002
Investigational Site Number 7240002
Investigational Site Number 2030005
Investigational Site Number 8040005
Investigational Site Number 6430005
Investigational Site Number 2500003
Investigational Site Number 6430003
Investigational Site Number 1240003


lead_sponsor: Boehringer Ingelheim

summary: To evaluate the long-term safety and efficacy of spesolimab in patients with GPP, who have completed previous spesolimab trials and are qualified for entry in this trial.

location_facility: National Hospital of Dermatology and Venereology

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi

location_facility: Klinikum der Universität München - Campus Innenstadt

location_facility: The Second Affiliated Hospital Zhejiang University School of Medicine

location_facility: Chang Gung Medical Foundation (CGMF) - Linkou Bran

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: Second Affiliated Hospital of Xi'an JiaoTong University

location_facility: Center for Skin Research, Testing and Product Development

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: LLC Skin Disease Clinic of Pier Volkenstein, St. Petersburg

location_facility: Hedi Chaker Hospital, Department of Dermatology

location_facility: Tokyo Medical University Ibaraki Medical Center

location_facility: Sun yet-sen Memorial Hospital, Sun yet-sen Univesity

location_facility: FSBEI HE "Kirov State Medical University"

title: Effisayil™ ON: An Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Spesolimab Treatment in Patients With Generalized Pustular Psoriasis (GPP)

ipd_sharing_description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

location_country:
Germany
Argentina
Japan
Thailand
Vietnam
Turkey
Chile
France
United States
Tunisia
Belgium
China
Malaysia
Philippines
Italy
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation


title: A Randomized Controlled Non-inferiority Trial to Evaluate the Safety and Efficacy of the Passeo-18 Lux Drug-coated Balloon of Biotronik in the Treatment of Subjects With Stenotic, Restenotic or Occlusive Lesions of the Femoropopliteal Artery Compared to the Medtronic IN.PACT Admiral Drug-coated Balloon

acronym: BIOPACT-RCT

summary:
The BIOPACT RCT tiral investigates the efficacy and safety of stenosis, restenosis or occlusions in the femoropopliteal artery of patients presenting a rutherford classification 2,3 or 4 with a Passeo-18 Lux drug-coated balloon of Biotronik. The Paclitaxel eluting balloons are designed for percutaneous transluminal angioplasties in which the balloon will dilate the artery upon inflation and deliver the paclitaxel locally.

An expected total of 151 patients will be treated with the Passeo-18 Lux and compared to a control group of another 151 patients that will be treated with the IN.PACT Admiral drug-coated balloon of Medtronic. Assignment to the treatment groups will be at random. The study will be conducted in two phases. A first pilot study phase of 120 patients distributed evenly over both treatment groups and a second phase to formally test the non-inferiority hypothesis.

The balloon is coated with Paclitaxel intended to avoid cellular proliferation. The drug is released by means of rapid inflation as to release a high dose in a short amount of time. Patients will be invited for a follow-up visit at 1, 6 and 12 months post-procedure.

The primary efficacy endpoints are defined as follows. Freedom from clinically-driven target lesion revascularization at 12 months. Freedom from device- and procedure-related death through 30 days post-index procedure, major target limb amputation through 12 months post-procedure and clinically-driven target vessel revascularization through 12 months post-index procedure. The secondary endpoints are defined as acute device success, acute procedural success , freedom from all cause of death, major target limb amputation and clinically driven target vessel revascularisation through 30 days post-procedure, sustained clinical improvement, no major adverse events through 6 and 12 months post-procedure, primary patency, target lesion revascularisation, target vessel revascularisation, binary restenosis, major target limb amputation, thrombosis at target lesion, change of walking impairment questionnaire score from baseline, change in target limb rutherford classification or ABI.

ReferenceCitation: Deloose K, Lansink W, Brodmann M, Werner M, Keirse K, Goueffic Y, Verbist J, Maene L, Hendriks J, Brunet J, Ducasse E, Levent K, Sauguet A, Deglise S, Vandael F. Methodology of the BIOPACT RCT, a Multi-center, Randomized, Non-inferiority Trial Evaluating Safety and Efficacy of Passeo-18 Lux Drug-Coated Balloon (DCB) of Biotronik Compared to the Medtronic IN.PACT Admiral DCB in the Treatment of Subjects with Lesions of the Femoropopliteal Artery. Cardiovasc Intervent Radiol. 2022 Dec;45(12):1855-1859. doi: 10.1007/s00270-022-03259-z. Epub 2022 Sep 4.

oa_host_type: closed

publisher_dissemination: Springer-Nature

lead_sponsor: ID3 Medical

location_country: Switzerland Austria Belgium France

location_facility: Centre Hospitalier Universitaire Vaudois


title: An Open-label Extension Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease Patients With Motor Fluctuations

summary: The purpose of this study is to evaluate the long-term safety and clinical utility of IPX203 in the treatment of participants with advanced Parkinson's disease (PD) who have motor fluctuations.

lead_sponsor: Impax Laboratories, LLC

location_country:
Germany
Italy
Poland
United Kingdom
United States
Spain
Czechia
France

location_facility: NZOZ Neuromed M. i M. Nastaj Sp.p. (800)

location_facility: Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice, Neurologicka klinika (702)

location_facility: Neurology Consultants of Dallas, PA (108)

location_facility: Department "G. F. Ingrassia" section of neuroscience - Policlinico "Vittorio Emanuele" (608)

location_facility: University of Arkansas for Medical Sciences (117)

location_facility: ChristianaCare Neurology Specialists (153)

location_facility: Premiere Research Institute at Palm Beach Neurology (174)

location_facility: Houston Methodist Neurological Institute/Movement Disorders Clinic (135)

location_facility: Hospital Universitario Vall d'Hebron (505)

location_facility: Kliniken Beelitz GmbH, neurologisches Fachkrankenhaus fur Bewegungsstorungen/Parkinson (300)

location_facility: Fondazione I st ituto Neurologico Nazionale "C. Mondino" (606)

location_facility: Hospital Universitario Ramon y Cajal (500)

location_facility: Hospital Universitari General de Catalunya (504)

location_facility: Department of neuroscience, mental health and sensory system (NeSMOS), "Sapienza" University (603)

location_facility: Roseman Medical Research Institute / Roseman Medical Group (154)

location_facility: VCU Health- Neuroscience Orthopaedic and Wellness Center(124)

location_facility: University of Kansas Medical Center (118)

location_facility: Centre d'lnvestigation Clinique 1436- CHU Purpan- Hopital Pierre Paul Riquet (403)

location_facility: Hospital de Ia Santa Creu i Sant Pau (502)

location_facility: Booth Gardner Parkinson's Care Center (112)

location_facility: University of Rome Tor Vergata/Hospital Tor Vergata (605)

location_facility: University Hospitals Cleveland Medical Center (123)

location_facility: Hospital Universitario Infanta Sofia(513)

location_facility: Hoag Memorial Hospital Presbyterian (134)

location_facility: NZOZ Neuro-Kard Ilkowski i Partnerzy Spolka Partnerska Lekarzy (801)

location_facility: CHU de Clermont-Ferrand-Hopital Gabriel Montpied (404)

location_facility: Azienda Ospedaliero-Universitaria Pisana (602)

location_facility: Neurologicka ordinace FORBELI s.r.o. (706)

location_facility: Gemeinschaftspraxis Dr. med. J. Springub/W. Schwarz, Studienzentrum Nordwest (306)

location_facility: Parkinson's Disease and Movement Disorders Center of Boca Raton (121)

location_facility: Hospital Universitario y Politecnico La Fe Avenida Fernando Abril Martorell (515)

location_facility: Hospital Universitari Mutua Terrassa (506)

location_facility: Germanes Hospitalaries Del Sagrat Cor De Jesus Hospital Sant Rafael (516)

location_facility: CHU de Montpellier, Hopital Gui de Chauliac (405)

location_facility: Krakowska Akademia Neurologii Sp. Zo.o.(802)

location_facility: Hospital General Universitario de Elche (509)

location_facility: University of Florida Health Science Center (129)

location_facility: The Movement Disorder Clinic of Oklahoma (115)

location_facility: University of Colorado Hospital Anschutz Outpatient Pavilion (120)

location_facility: University of Texas Southwestern Medical Center (143)

location_facility: University of Toledo, Gardner-McMaster Parkinson Center (122)

location_facility: Cleveland Clinic Lou Ruvo Center for Brain Health (142)

location_facility: St. Joseph's Hospital & Medical Center - Barrow Neurological Institute (156)

location_facility: Fakultni nemocnice u sv. Anny v Brne, I. neurologicka klinika (704)

location_facility: Hospital Universitario Virgen del Rocio (503)

location_facility: St. Josef-Hospital, Universitatsklinik fur Neurologie Klinisches Forschungszentrum fur Neurodegeneration (301)

location_facility: Klinikum rechts der lsar der Technischen Universitat Munchen Klinik und Poliklinik fur Neurologie (303)

location_facility: Klinik Haag i. OB Geriatric Hospital Krankenhausstrabe 4 (305)

location_facility: Hospital Universitario Quiron Dexeus (501)

location_facility: Dr. med. Reinhardt Ehret Neuroloqie Berlin Schlobstr. 29 (309)

location_facility: Imperial College Healthcare NI-lS Trust (200)

location_facility: Keek School of Medicine of USC/ University of Southern California (106)

location_facility: Centro Ricerca Parkinson San Raffaele Cassino (601)

location_facility: Centre Hospitalier Universitaire de Nice (400)

location_facility: Northwestern Medical Group Neurology Clinic (145)

location_facility: Parkinson's Disease Treatment Center of Southwest Florida (131)

location_facility: Hospital Universitario de Ia Princesa (508)

location_facility: Indiana University Health Neuroscience Center(164)

location_facility: Henry Ford West Bloomfield Hospital(100)

location_facility: Medical Professional Clinical Research Center, Inc. (163)


title: An Open-Label, Multicenter, Phase Ib Study To Evaluate Safety And Therapeutic Activity Of RO6874281, An Immunocytokine, Consisting Of Interleukin-2 Variant (IL-2v) Targeting Fibroblast Activation Protein-Α (FAP), In Combination With Pembrolizumab (Anti-PD-1), In Participants With Advanced Or Metastatic Melanoma

summary: This is an open-label, multicenter, Phase Ib study to evaluate the safety and therapeutic activity of RO6874281 in combination with pembrolizumab. The study will consist of 3 parts: a safety run-in (Part I: Cohorts 1.1. and 1.2) and two expansion parts (Parts II and III). Part II will start once all participants in Cohort 1.1 have completed the observation period. Part III will start once all participants in Cohorts 1.1 and 1.2 have completed the observation period.

ipd_sharing_description: "Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). 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:
Australia
Belgium
United States
Spain
Canada
Russian Federation
France

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Russian Oncology Research Center n.a. N.N. Blokhin

location_facility: Clinica Universidad de Navarra Madrid; Servicio de Oncología

location_facility: Hospital Universitari Vall d'Hebron; Oncology

location_facility: Hospital Clínic i Provincial; Servicio de Oncología

location_facility: Peter Maccallum Cancer Institute; Clinical Trial Unit

location_facility: Centre Eugene Marquis; Service d'oncologie

location_facility: FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

location_facility: P.A. Gertsen Cancer Research Inst. ; Chemotherapy Dept

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Main Military Clinical Hospital named after N.N. Burdenko


title: Phase I/Ib First-in-Human Study of EOS100850 as a Single Agent and in Combination With Pembrolizumab and/or Chemotherapy in Participants With Advanced Cancers

summary: Multicenter, open-label, dose-escalation Phase I/Ib clinical study to evaluate the safety and tolerability, the MTD/RP2D, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of EOS100850 as a Single Agent and in Combination with Pembrolizumab and/or Chemotherapy in Participants with Advanced Cancers.

lead_sponsor: iTeos Therapeutics

sponsor_collaborators:
iTeos Therapeutics
Merck Sharp & Dohme LLC

location_country:
United Kingdom
Belgium
United States
Spain
Korea, Republic of
France

location_facility: The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital

location_facility: John Theurer Cancer Center, Hackensack University Medical Center

location_facility: Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie- Pôle Régional de Cancérologie

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Universidad de Navarra - Clinica Universitaria de Navarra

location_facility: St Mary's Hospital, The Catholic University of Korea

location_facility: Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Rene Gauducheau

location_facility: START Madrid-HM CIOCC Hospital Universitario HM Sanchinarro

location_facility: Centre de Lutte Contre le Cancer (CLCC) - Universite de Lyon - Centre Leon-Berard


acronym: ISAKIDS

summary:
Primary Objective:

Evaluate the anti-leukemic activity of isatuximab in combination with standard chemotherapies in pediatric participants of ages 28 days to less than 18 years with Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML)

Secondary Objectives:

Safety and tolerability assessments
Assessment of infusion reactions (IRs)
Pharmacokinetics (PK) of isatuximab
Minimal residual disease
Overall response rate
Overall survival
Event free survival
Duration of response
Relationship between clinical effects and CD38 receptor density and occupancy

location_facility: Sarah Cannon Research Institute-Site Number:8400001

location_facility: Children's Medical Center of Dallas-Site Number:8400002

title: Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination With Chemotherapy in Pediatric Patients From 28 Days to Less Than 18 Years of Age With Relapsed/Refractory B or T Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia in First or Second Relapse

location_country:
Germany
Italy
Portugal
Hungary
Argentina
Denmark
Norway
Brazil
Netherlands
Mexico
Sweden
United States
Korea, Republic of
Greece
Peru
France


lead_sponsor: Allergan

summary: This study evaluated the efficacy, safety and tolerability of atogepant in participants with chronic migraine. This study included a 12-week treatment period.

ReferenceCitation: Boinpally R, McNamee B, Yao L, Butler M, McGeeney D, Borbridge L, Periclou A. A Single Supratherapeutic Dose of Atogepant Does Not Affect Cardiac Repolarization in Healthy Adults: Results From a Randomized, Single-Dose, Phase 1 Crossover Trial. Clin Pharmacol Drug Dev. 2021 Sep;10(9):1099-1107. doi: 10.1002/cpdd.940. Epub 2021 May 4.

evidence: oa repository (via OAI-PMH doi match)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

ReferenceCitation: Min KC, Kraft WK, Bondiskey P, Colon-Gonzalez F, Liu W, Xu J, Panebianco D, Mixson L, Dockendorf MF, Matthews CZ, Boinpally R. Atogepant Is Not Associated With Clinically Meaningful Alanine Aminotransferase Elevations in Healthy Adults. Clin Transl Sci. 2021 Mar;14(2):599-605. doi: 10.1111/cts.12917. Epub 2020 Nov 24.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

unpaywall_oa_status: gold

location_facility: Higashi Sapporo Neurology and Neurosurgery Clinic /ID# 234549

location_facility: Tri-Service General Hospital /ID# 237657

location_facility: Atsuchi Neurosurgical Hospital /ID# 234779

location_facility: Josephson-Wallack-Munshower Neurology - NE /ID# 238234

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 237291

location_facility: Japanese Red Cross Shizuoka Hospital /ID# 234372

location_facility: Saitama Medical University Hospital /ID# 237019

location_facility: MedStar Georgetown Neurology /ID# 236324

location_facility: J. Lewis Research, Inc. / Foothill Family Clinic /ID# 236395

location_facility: Raleigh Neurology Associates /ID# 237141

location_facility: The Royal Melbourne Hospital /ID# 236859

location_facility: Ottawa Headache Centre Research Inc /ID# 236432

location_facility: Clinical Research Institute, Inc /ID# 238299

location_facility: The second Affiliated hospital of Zhejiang University school of Medicine /ID# 238260

location_facility: Northwest Clinical Research Center /ID# 237581

location_facility: Hospital Clinico Universitario de Valencia /ID# 237400

location_facility: Dartmouth-Hitchcock Medical Center /ID# 237444

location_facility: The Second Affiliated Hospital of Guangzhou Medical University /ID# 238133

location_facility: Specjalistyczne Gabinety Sp. z o.o. /ID# 236348

location_facility: Preferred Primary Care Physicians, Inc. /ID# 236439

location_facility: Schuster Medical Research Institute /ID# 236447

location_facility: University of Texas Southwestern Medical Center /ID# 236941

location_facility: DOI Internal Medicine-Neurology Clinic /ID# 234562

location_facility: Tianjin Huanhu Hospital (THH) /ID# 236524

location_facility: Seoul National University Hospital /ID# 237786

location_facility: AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 236361

location_facility: Sentara Neurology Specialists - Virginia Beach /ID# 234349

location_facility: J. Lewis Research, Inc. Foothill Family Clinic South /ID# 236297

location_facility: Hospital Universitario Virgen del Rocio /ID# 237106

location_facility: Azienda Ospedaliero Universitaria Careggi /ID# 237598

location_facility: Nowon Eulji Medical Center, Eulji University /ID# 236306

location_facility: Dokkyo Medical University Hospital /ID# 236810

location_facility: Albany Medical Center Rheumatology /ID# 236540

location_facility: Kazan State Medical University /ID# 236298

location_facility: Hospital Clinico Universitario Lozano Blesa /ID# 237373

location_facility: Pusan National University Hospital /ID# 237120

location_facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 236500

location_facility: Yonsei University Health System Severance Hospital /ID# 237839

location_facility: Dent Neurosciences Research Center, Inc. /ID# 237040

location_facility: Hospital Universitario y Politecnico La Fe /ID# 237087

location_facility: Clinical Neuroscience Solutions - Memphis /ID# 237478

location_facility: Clinique des cephalees de Montreal /ID# 236266

location_facility: The Second Hospital of Shanxi Medical University /ID# 236529

location_facility: Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 237256

location_facility: Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 236289

location_facility: Accel Research Sites - St Petersburg Clinical Research Unit /ID# 237161

location_facility: Sendai Headache and Neurology Clinic Medical Corporation /ID# 234496

location_facility: Taipei Veterans General Hosp /ID# 237236

location_facility: Chinese PLA General Hospital /ID# 238237

location_facility: Centrum Medyczne Pratia Gdynia /ID# 237077

location_facility: Premiere Research Institute - Palm Beach /ID# 238192

location_facility: Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 237692

location_facility: Stetson-University of Cincinnati /ID# 236453

location_facility: Saitama Neuropsychiatric Institute /Id# 234550

location_facility: George Washington University Medical Faculty Associates /ID# 238011

location_facility: LMU Klinikum Campus Grosshadern /ID# 236293

location_facility: Hospital Clinico Universitario de Valladolid /ID# 234406

location_facility: CH Annecy Genevois Site Annecy /ID# 236385

location_facility: Abington Neurological Associates - Abington /ID# 236258

location_facility: Beth Israel Deaconess Medical Center /ID# 237540

location_facility: Headache Neurology Research Institute /ID# 236464

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 237847

location_facility: Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 237492

location_facility: Peking University Third Hospital /ID# 238150

location_facility: Hospital Universitario Vall d'Hebron /ID# 236467

location_facility: Stortorgets Neurologmottagning /ID# 236454

location_facility: Albuquerque Clinical Trials, Inc /ID# 236853

location_facility: Montreal Neurological Institut /ID# 236329

location_facility: Alpine Clinical Research Center /ID# 234346

location_facility: Guangzhou First People's Hospital /ID# 236510

location_facility: Central Clinical Hospital RZHD Medicine /ID# 237024

location_facility: AP-HM - Hopital de la Timone /ID# 236285

location_facility: Baptist Health Center for Clinical Research /ID# 237361

location_facility: Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 236723

location_facility: Centrum Leczenia Padaczki i Migreny /ID# 236386

location_facility: Tongji Hospital Tongji Medical College of HUST /ID# 237835

location_facility: Accel Research Sites - Tampa Clinical Research Unit /ID# 237485

location_facility: King's College Hospital NHS Foundation Trust /ID# 236301

location_facility: The First Affiliated Hospital of Zhengzhou University /ID# 237025

location_facility: The Second Hospital of Jilin University /ID# 236520

location_facility: State Autonomous Healthcare Institution Republican Clinical Neurology Centre /ID# 236354

location_facility: Hospital Clínico Universitario de Santiago-CHUS /ID# 237623

location_facility: Vancouver Island Health Authority /ID# 238053

location_facility: California Headache and Balance Center /ID# 236246

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 237645

location_facility: The Second Hospital of Soochow University /ID# 234296

location_facility: Dongtan Sacred Heart Hospital /ID# 238097

title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine (Progress)

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:
Germany
Italy
Poland
United Kingdom
Denmark
Australia
Japan
Sweden
United States
China
Korea, Republic of
Spain
Taiwan
Czechia
Canada
Russian Federation
France


lead_sponsor: Agios Pharmaceuticals, Inc.

summary: This is a multicenter, open-label, extension study to evaluate the long-term safety, tolerability, and efficacy of treatment with AG-348 in participants who were previously enrolled in Study AG348-C-006 or Study AG348-C-007.

ReferenceCitation: Rab MAE, Van Oirschot BA, Kosinski PA, Hixon J, Johnson K, Chubukov V, Dang L, Pasterkamp G, Van Straaten S, Van Solinge WW, Van Beers EJ, Kung C, Van Wijk R. AG-348 (Mitapivat), an allosteric activator of red blood cell pyruvate kinase, increases enzymatic activity, protein stability, and ATP levels over a broad range of PKLR genotypes. Haematologica. 2021 Jan 1;106(1):238-249. doi: 10.3324/haematol.2019.238865.

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: UCSF Benioff Children's Hospital, Oakland

location_facility: Università della Campania "Luigi Vanvitelli"

location_facility: Wayne State University School of Medicine

location_facility: CHU Hopitaux de Bordeaux - Hôpital Saint-André

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: Charite - UB - CVK - Medizinische Klinik

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Htal Clínico Universitario Virgen de la Arrixaca.

location_facility: Indiana Hemophilia & Thrombosis Center Inc.

location_facility: Hacettepe University Faculty of Medicine

location_facility: Kansai Medical University, Dep. of Pediatrics, Hirakata Hospital

title: An Open-Label, Multicenter, Extension Study of AG-348 in Adult Subjects With Pyruvate Kinase Deficiency Previously Enrolled in AG-348 Studies

location_country:
Germany
Ireland
Italy
United Kingdom
Denmark
Japan
Brazil
Netherlands
Switzerland
United States
Korea, Republic of
Spain
Thailand
Turkey
Canada
France


title: Establishing the Safety and Efficacy of Reloxaliase (Oxalate Decarboxylase) in Patients With Enteric Hyperoxaluria: A Phase III Randomized, Double-Blind, Placebo-Controlled Study (URIROX-2)

summary: The purpose of this study is to determine the efficacy, durability and long-term safety of reloxaliase in patients with enteric hyperoxaluria.

ReferenceType: background

ReferenceCitation: Langman CB, Grujic D, Pease RM, Easter L, Nezzer J, Margolin A, Brettman L. A Double-Blind, Placebo Controlled, Randomized Phase 1 Cross-Over Study with ALLN-177, an Orally Administered Oxalate Degrading Enzyme. Am J Nephrol. 2016;44(2):150-8. doi: 10.1159/000448766. Epub 2016 Aug 17.

ReferenceCitation: Lingeman JE, Pareek G, Easter L, Pease R, Grujic D, Brettman L, Langman CB. ALLN-177, oral enzyme therapy for hyperoxaluria. Int Urol Nephrol. 2019 Apr;51(4):601-608. doi: 10.1007/s11255-019-02098-1. Epub 2019 Feb 19.

lead_sponsor: Allena Pharmaceuticals

location_country:
Germany
Italy
Portugal
United Kingdom
Romania
Brazil
Switzerland
Austria
Belgium
Mexico
United States
Spain
Croatia
Canada
Russian Federation
France

location_facility: Long Island Gastrointestinal Research Group

location_facility: Inselspital, Universitaetsspital Bern Inselspital Bern University Hospital

location_facility: New York University School of Medicine- Langone Medical Center

location_facility: Ohio State University (OSU)-Renal Division

location_facility: Lifespan Physician Group Minimally Invasive Urology Institute

location_facility: University of North Carolina (UNC) - Chapel Hill

location_facility: Fondazione Policlinico Universitario A.Gemelli IRCCS - Universita Cattolica del Sacro Cuore

location_facility: South Tyneside District Hospital - South Shields

location_facility: Azienda USL Toscana Centro-Ospedale Santa Maria Nuova

location_facility: Centro Hospitalar Universitario de Sao Joao

location_facility: Clinical Research Solutions- Middleburg Heights

location_facility: University of Wisconsin - Division of Nephrology

location_facility: Centre de Recherche Du Centre Hospitalier de l'Universite de Montreal

location_facility: Clinstile, S.A. de C.V- Col. Roma Norte Delegacion

location_facility: University of Texas Health Science Center at San Antonio

location_facility: South Florida Nephrology Group PA Research Div

location_facility: University of Cincinnati (UC) - Department of Nephrologyv

location_facility: Centro specializado en Diabetes, Obesidad y Prevencion de Enfermedades Cardiovasculares

location_facility: Arizona Kidney Disease and Hypertension Center (AKDHC)- Glendale

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV) Lausanne Nephrology Department

location_facility: University of Florida College of Medicine

location_facility: Chesapeake Urology Associates, LLC d/b/a/ Chesapeake Urology Research Associates

location_facility: University of California- San Francisco (UCSF)

location_facility: Oregon Health and Science University (OHSU)

location_facility: Spitalul Clinic Universitar de Urgenta Bucuresti

location_facility: Medizinische Universitat Wien, Innere Medizin III

location_facility: Alliance for Multispecialty Research, LLC

location_facility: Mayo Clinic- Department of Nephrology Hyperoxaluria Center

location_facility: Urological Associates of Southern Arizona

location_facility: University of Alberta- Division of Urology

location_facility: Arizona Kidney Disease and Hypertension Center (AKDHC)- Phoenix

location_facility: Universite Libre de Bruxelles -Hospital Erasme

location_facility: University of California, San Diego (UCSD) Health System

location_facility: Saratov State Medical University, n.a. V.I. Razumosky

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino IST

location_facility: University of Alabama- Department of Urology

location_facility: ICARO Investigaciones en Medicina SA de CV/Hospital Christus Muguerza

location_facility: UVC Brugmann University Hospital- Centre Hospitalier Universitaire

location_facility: Baylor Scott and White Research Institute- Temple

location_facility: Centru de Diagnostic si Tratament Affidea- Medicina Interna


acronym: MAGNOLIA

lead_sponsor: BeiGene

summary: This is a single arm study to evaluate the efficacy, safety and tolerability of zanubrutinib (BGB-3111) in participants with relapsed/refractory marginal zone lymphoma (R/R MZL).

ReferenceCitation: Stephen Opat, Robert Marcus, MA, FRCP, FRCPath, Craig A. Portell, MD, William Reed, MD, Chris Tankersley, Jane Huang, MD, Judith Trotman, MBChB, FRACP, FRCPA. Phase 2 Study of Zanubrutinib (BGB-3111) in Patients with Relapsed/Refractory Marginal Zone Lymphoma. Blood. 2019; 134(1):5256. https://doi.org/10.1182/blood-2019-122629

ReferenceCitation: Stephen Opat, et al. Efficacy and Safety of Zanubrutinib in Patients with Relapsed/Refractory Marginal Zone Lymphoma: Initial Results of the MAGNOLIA (BGB-3111-214) Trial. Presented at the 62nd American Society of Hematology (ASH) Annual Meeting, December 5-8, 2020. Abstract 339.

ReferenceCitation: Opat S, Tedeschi A, Linton K, McKay P, Hu B, Chan H, Jin J, Sobieraj-Teague M, Zinzani PL, Coleman M, Thieblemont C, Browett P, Ke X, Sun M, Marcus R, Portell CA, Ardeshna K, Bijou F, Walker P, Hawkes EA, Mapp S, Ho SJ, Talaulikar D, Zhou KS, Co M, Li X, Zhou W, Cappellini M, Tankersley C, Huang J, Trotman J. The MAGNOLIA Trial: Zanubrutinib, a Next-Generation Bruton Tyrosine Kinase Inhibitor, Demonstrates Safety and Efficacy in Relapsed/Refractory Marginal Zone Lymphoma. Clin Cancer Res. 2021 Dec 1;27(23):6323-6332. doi: 10.1158/1078-0432.CCR-21-1704. Epub 2021 Sep 15.

ReferenceCitation: Opat S, Tedeschi A, Hu B, et al: Long-term efficacy and safety of zanubrutinib in patients with relapsed/refractory marginal zone lymphoma. 2022 ASH Annual Meeting and Exposition. Abstract 234. Presented December 10, 2022.

location_facility: Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)

location_facility: Institute of Hematology and Hospital of Blood Disease

location_facility: The First Affiliated Hospital, College of Medicine, Zhejiang University

location_facility: Centre de Lutte Contre Le Cancer - Institut Bergonie

location_facility: Azienda Ospedaliero - Universitaria Maggiore delle Carità

location_facility: The Charlotte-Mecklenburg Hospital Authority

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

title: A Phase 2, Open-label Study of Zanubrutinib (BGB-3111) in Patients With Relapsed or Refractory Marginal Zone Lymphoma

location_country:
Italy
New Zealand
United Kingdom
Australia
United States
China
Korea, Republic of
Czechia
France


title: ASSIST Registry to Assess the Procedural Success and Clinical Outcomes Associated With Various Operator Techniques for Mechanical Thrombectomy in Large Vessel Occlusions (LVO).

summary: The purpose of this Registry is to assess the procedural success and clinical outcomes associated with various operator techniques for mechanical thrombectomy in large vessel occlusions (LVO).

lead_sponsor: Stryker Neurovascular

location_country:
Germany
Italy
United Kingdom
Switzerland
Belgium
United States
Korea, Republic of
Spain
Czechia
Canada
France

location_facility: WellStar Health System/ Kennestone Hospital

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: University of Oklahoma Medical Center (OU - OKC)

location_facility: Hospital Universitario Central de Asturias - HUCA

location_facility: The Catholic University of Korea, St. Vincent's Hospital


title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects With Moderately to Severely Active Ulcerative Colitis

summary: Study CYC-202 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of ST-0529 in subjects with moderately to severely active UC, defined as a score of 5 to 9 on the 3-Component Adapted Mayo Score (comprised of rectal bleeding, stool frequency and endoscopy sub-scores; score range 0-9).

lead_sponsor: Sublimity Therapeutics Holdco Limited

sponsor_collaborators:
Sublimity Therapeutics Holdco Limited
Dr. Falk Pharma GmbH

location_country:
Germany
Belarus
Ireland
Italy
Poland
Hungary
Israel
Romania
United Kingdom
United States
Spain
Ukraine
Bulgaria
Canada
Serbia
Russian Federation
France

location_facility: Krankenhaus Walfriede, Akademisches Lehrkrankenhaus der Charite

location_facility: North-Western State Medical University n.a. I.I.Mechnikov

location_facility: University College London Hospital NHS Foundation Trust

location_facility: Royal Liverpool & Broadgreen University Hospitals NHS Trust

location_facility: A.0.U. di Modena - Policlinico S.C. di Gastroenterologia

location_facility: Communal Nonprofit Enterprise "Odesa Regional Clinical Hospital"

location_facility: Communal Non-profit Enterprise "Vinnytsia City Clinical Hospital #1"

location_facility: Universitatsklinikum Freiburg, Medizinische Klinik

location_facility: Oddział Kliniczny Gastroenterologii Ogólnej i Onkologicznej SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego UM

location_facility: Municipal Institution "Uzhhorod Central District Hospital"

location_facility: Universität Leipzig, Klinik f. Gastroenterologie und Rheumatologie

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Medizinische Klinik für Gastroenterologie, Infektiologie, Rheumatologie charite

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Kharkiv City Clinical Hospital No 2 n.a. prof. O.O.Shalimov

location_facility: Klinik für Gastroenterologie, Pulmologie und allg. lnnere Medizin

location_facility: CHU Amiens Picardie - Service Hépato-Gastroentérologie

location_facility: Fondazione IRCCS Policlinico San Matteo - Medicina Generale I

location_facility: Clinical Hospital Center "Dr Dragisa Misovic-Dedinje"

location_facility: Dalhousie University - Queen Elizabeth II Health Sciences Centre

location_facility: Communal Nonprofit Enterprise "Lviv Clinical Emergency Care Hospital"

location_facility: Fondazione Casa Sollievo della Sofferenza

location_facility: Ukrainian-German Gastroenterology Center "BYK-Kyiv"

location_facility: Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust

location_facility: Scientific Research Center Eco-Safety LLC

location_facility: Communal Nonprofit Entreprise, "Lviv Clinical Emergency Care Hospital", 1st Therapeutic Dpt

location_facility: Saint-Petersburg State Medical Academy n.a. I.I. Mechnikov of Federal Agency of Healthcare & Social Development

location_facility: CHU de Saint-Etienne - Service de Gastro-Entérologie-Hépatologie

location_facility: Institute of Gastroenterology, Meir Medical Center

location_facility: Communal Nonprofit Enterprise "Ternopil University Hospital" of Ternopil Regional Council

location_facility: Hôpital de Brabois Service d'Hépato-Gastro-Entérologie

location_facility: Non state Public Health Institution "Railway clinical hospital on station Samara" of joint stock company Russian railways

location_facility: Hospital Universitario Virgen de la Macarena

location_facility: Gastroenterology Institute, Emek Medical Center

location_facility: Clinical-Hospital Centre Bezanijska Kosa - Gastroenterology Department

location_facility: Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Zentrym für Innere Medizin

location_facility: Agaplesion Markus Krankenhaus Medizinischen Klinik I, Gastroenterologie, Hepatologie, Onkologie, lnfektiologie

location_facility: Ivano-Frankivsk National Medical University, Regional Clinical Hospital

location_facility: Semmelweis University, AOK Varosmajori Sziv- es Ergyogyaszati Klinika,

location_facility: South Eastern Health & Social Care Trust, Ulster Hospital

location_facility: Communal Institution of Kyiv Regional Council "Kyiv Regional Clinical Hospital"


lead_sponsor: EMD Serono Research & Development Institute, Inc.

summary: The main purpose of this study is to evaluate safety and efficacy in participants treated with concomitant chemoradiation therapy (cCRT) plus M7824 followed by M7824 compared to cCRT plus placebo followed by durvalumab.

location_facility: University of California Irvine Medical Center

location_facility: South West Healthcare - South West Oncology

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: St. Antonius Ziekenhuis - Dept Pulmonology - Nieuwegein

location_facility: ICO l´Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia

location_facility: Complejo Hospitalario Universitario de Santiago - Servicio de Oncologia Medica

location_facility: Holy Cross Hospital - Michael and Dianne Bienes CCC

location_facility: Sylvester Comprehensive Cancer Center - University of Miami Health System

location_facility: UCLA Hematology Oncology - Main Site - 2020 Santa Monica

location_facility: Baptist Health Lexington Oncology Associates

location_facility: Fakultni nemocnice Olomouc - Dept of Onkologicka klinika

location_facility: Cancer Institute Hospital of JFCR - Dept of Respiratory Medicine

location_facility: Hospital Universitario Nuestra Señora de Valme - Servicio de Oncologia

location_facility: HGB - Hospital Giovanni Battista - Mãe de Deus Center - Centro de Pesquisa Clínica - Instituto do Câncer

location_facility: Aichi Cancer Center Hospital - Dept of Respiratory Medicine

location_facility: A. C. Camargo Cancer Center - Fundação Antônio Prudente

location_facility: Hospital de Câncer de Barretos - Fundação Pio XII

location_facility: Kanagawa Cancer Center - Dept of Respiratory Medicine

location_facility: St Vincent's Hospital Melbourne - PARENT

location_facility: Hospital del Mar - Servicio de Oncologia

location_facility: Hospital Universitari Vall d'Hebron - Dept of Oncology

location_facility: University of Texas MD Anderson Cancer Center - Unit 432 Thoracic Head and Neck Medical Oncology

location_facility: University of Maryland - DUPLICATE/Pediatric Surgery

location_facility: Hospital Universitario Clinico San Carlos - Servicio de Oncologia

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

location_facility: Centro Polivalente de Asistencia e Inv. Clinica CER

location_facility: Kobe City Hospital Organization Kobe City Medical Center General Hospital - Dept of Respiratory Medicine

location_facility: Clinique et Maternite St Elisabeth Namur

location_facility: Hematology Oncology Center of Nyack Hospital

location_facility: Osaka Medical Center for Cancer and Cardiovascular Diseases

location_facility: Hôpital Nord - AP-HM Marseille# - Service d'Oncologie Multidisciplinaire

location_facility: Hospital Universitario Virgen del Rocio - Servicio de Oncologia

location_facility: Hospital Universitario Virgen Macarena - Servicio de Oncologia

location_facility: BC Cancer Agency Center for the Southern Interior

location_facility: The James Cancer Hospital and Solove Research Institute

location_facility: Hospital Regional Universitario de Malaga

location_facility: Centre Hospitalier de la Côte Basque - Service de Pneumologie

location_facility: Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris - Service d'Oncologie Médicale

location_facility: Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica

location_facility: University of Colorado Health - Memorial Hospital - Memorial Hospital

location_facility: National Cancer Center Hospital East - Dept of Respiratory Medicine

location_facility: Seoul National University Bundang Hospital

location_facility: Pius-Hospital Oldenburg - Klinik f. Haematologie und Onkologie

location_facility: Hospital Universitari Quiron Dexeus - Servicio de Oncologia Medica

location_facility: Nippon Medical School Hospital - Dept of Respiratory Medicine

location_facility: Clinica Universidad de Navarra (MAD) - Oncology Service

location_facility: CHU Nantes - Hôpital Guillaume et René Laënnec - Service de Pneumologie

location_facility: The University of Chicago Medical Center

location_facility: Hospital Universitari i Politecnic La Fe - Servicio de Oncologia Medica

location_facility: Kurume University Hospital - Dept of Lung Cancer Center

location_facility: Franciscan St. Francis Health Cancer Center

location_facility: Meander Medisch Centrum - Dep of Pulmonology

location_facility: Hospital Alvaro Cunqueiro - Servicio de Oncologia

location_facility: ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira

location_facility: Asklepios Klinik Harburg - Medizinische Abteilung I

location_facility: Saitama Medical University International Medical Center - Dept of Respiratory Medicine

location_facility: Hospital Universitario 12 de Octubre - Servicio de Oncologia

location_facility: Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia

location_facility: Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital - Dept of Respiratory Medicine

title: A Multicenter, Double Blind, Randomized, Controlled Study of M7824 With Concurrent Chemoradiation Followed by M7824 Versus Concurrent Chemoradiation Plus Placebo Followed by Durvalumab in Participants With Unresectable Stage III Non-small Cell Lung Cancer

ipd_sharing_description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

location_country:
Germany
Argentina
Australia
Brazil
Japan
Netherlands
Belgium
United States
China
Korea, Republic of
Spain
Taiwan
Czechia
Canada
France


title: A Phase 1 First-in Human, Multi-Center, Open Label Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and RP2D of Livmoniplimab (ABBV-151) as a Single Agent and in Combination With Budigalimab (ABBV-181) in Subjects With Locally Advanced or Metastatic Solid Tumors

summary: The study will determine the recommended Phase 2 dose (RP2D) of livmoniplimab (ABBV-151) administered as monotherapy and in combination with budigalimab (ABBV-181) as well as to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of livmoniplimab alone and in combination with budigalimab. The study will consist of 2 parts: dose escalation and dose expansion.

lead_sponsor: AbbVie

location_country:
Israel
Australia
Japan
Belgium
United States
Korea, Republic of
Spain
Taiwan
Canada
Puerto Rico
France

location_facility: Yonsei University Health System Severance Hospital /ID# 218512

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 220928

location_facility: National Cancer Center Hospital /ID# 209421

location_facility: Princess Margaret Cancer Centre /ID# 209423

location_facility: China Medical University Hospital /ID# 218492

location_facility: AdventHealth Cancer Institute - Orlando /ID# 226953

location_facility: Carolina BioOncology Institute /ID# 208358

location_facility: The Ohio State University - The James /ID# 217611

location_facility: Hospital Clinico Universitario de Valencia /ID# 221107

location_facility: Indiana Univ School Medicine /ID# 208384

location_facility: Hospital Clinic de Barcelona /ID# 221106

location_facility: National Cancer Center Hospital East /ID# 224808

location_facility: The Chaim Sheba Medical Center /ID# 209037

location_facility: Pan American Center for Oncology Trials, LLC /ID# 217475

location_facility: National Taiwan University Hospital /ID# 218490

location_facility: Seoul National University Hospital /ID# 218513

location_facility: CHU Toulouse - Hopital Purpan /ID# 218667

location_facility: Tel Aviv Sourasky Medical Center /ID# 222199