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.

lead_sponsor: AbbVie

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

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

location_facility: Universitaetsmedizin Rostock /ID# 225436

location_facility: Karolinska University Hospital /ID# 239992

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

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

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

location_facility: Shonan Kamakura General Hospital /ID# 224315

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

location_facility: Gabrail Cancer Center Research /ID# 228924

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

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

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

location_facility: Juntendo University Hospital /ID# 213255

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

location_facility: Centre Antoine Lacassagne - Nice /ID# 242293

location_facility: University Clinical Center Serbia /ID# 240674

location_facility: Providence Medical Foundation /ID# 242558

location_facility: ASST Spedali civili di Brescia /ID# 224962

location_facility: Dokuz Eylul University Medical Faculty /ID# 239952

location_facility: Brigitte Harris Cancer Pavilion /ID# 238686

location_facility: Gloucestershire Hospitals NHS Foundation Trust /ID# 241189

location_facility: Linkoping University Hospital /ID# 239995

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

location_facility: Klinicki bolnicki centar Zagreb /ID# 240140

location_facility: Universitaetsklinikum Freiburg /ID# 222791

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

location_facility: China Medical University Hospital /ID# 215634

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

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

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

location_facility: University of Yamanashi Hospital /ID# 229279


ipd_sharing: Yes

status: Completed

primary_purpose: Treatment

intervention_type: Drug

acronym: DUPISTAD

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)

study_completion_date_type: Actual

lead_sponsor: Sanofi

type: EudraCT Number

type: Other Identifier

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

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

enrollment_type: Actual

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

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

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.

lead_sponsor_type: industriel

status_simplified: Completed


ipd_sharing: No

status: Recruiting

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

study_completion_date_type: Anticipated

lead_sponsor: Hoffmann-La Roche

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).

enrollment_type: Anticipated

location_country:
United Kingdom
Spain
Canada
United States
France

location_facility: Arkansas Children's Hospital Research Institute

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

location_facility: Huntsman Cancer Institute at The University of Utah

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

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Hospital Infantil Universitario Nino Jesus

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.

status_simplified: Ongoing


primary_purpose: Diagnostic

acronym: PICTURE

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

lead_sponsor: Guerbet

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

location_facility: University of Missouri Hospital and Clinic

location_facility: CHRU - Hôpital Roger Salengro - Neurologie

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

location_facility: University Of Washington - Medical Center

location_facility: Azienda Sanitaria Universitaria Integrata di Trieste-PO Cattinara

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

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

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

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont - Idegsebeszeti Klinika

location_facility: Uniwersyteckie Centrum Kliniczne w Gdańsku, Zakład Radiologii

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


title: 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 to determine the safety, tolerability, PK, and preliminary efficacy of the novel MET/CSF1R/SRC inhibitor TPX-0022 in adult subjects with advanced NSCLC, Gastric Cancer, or solid tumors harboring genetic alterations in MET. The study will proceed in two parts: a dose-escalation and dose-expansion.

lead_sponsor: Turning Point Therapeutics, Inc.

location_country:
Korea, Republic of
United States
Spain
France

location_facility: University of California Irvine Chao Family Comprehensive Cancer Center

location_facility: Sarah Cannon Research Institute at HealthONE

location_facility: Yonsei Cancer Center, Severance Hospital

location_facility: University of Michigan Rogel Cancer Center

location_facility: Washington University School of Medicine in St. Louis

location_facility: University of Texas MD Anderson Cancer Center

location_facility: HM Centro Integral Oncológico Clara Campal - START Madrid

location_facility: University California San Diego Moores Cancer Center

location_facility: Hopital d'Instruction des Armees de Begin - Clinical Research Unit


status: Active, not recruiting

title: A Phase 1/2a Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab Administered in Combination With Ipilimumab or Ipilimumab Alone in Participants With Unresectable or Metastatic Melanoma Who Have Progressed on Anti-PD-1 Therapy

lead_sponsor: Bristol-Myers Squibb

location_country:
Spain
Canada
United States
France
Belgium
Germany

location_facility:
Local Institution - 0037
Local Institution - 0022
Local Institution - 0036
Local Institution - 0027
Local Institution - 0040
Local Institution - 0005
Local Institution - 0048
Local Institution - 0029
Local Institution - 0033
Local Institution - 0021
Local Institution - 0015
Local Institution - 0003
Local Institution - 0018
Local Institution - 0038
Local Institution - 0030
Local Institution - 0026
Local Institution - 0016
Local Institution - 0034
Local Institution - 0023
Local Institution - 0028
Local Institution - 0001
Local Institution - 0020
Local Institution - 0031
Local Institution - 0035
Local Institution - 0002
Local Institution - 0044
Local Institution - 0004
Local Institution - 0008
Local Institution - 0032
Local Institution - 0017

summary: The primary purpose of this study is to characterize the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine the recommended dose of relatlimab in combination with ipilimumab (for dose escalation). It is also to evaluate the safety, tolerability, and preliminary efficacy of the recommended dose of relatlimab in combination with ipilimumab versus ipilimumab monotherapy (for dose expansion).


title: A 52-week, Phase 3, Multicentre, Randomised, Double Blind, Efficacy and Safety Study, Comparing GSK3196165 With Placebo and With Tofacitinib in Combination With Conventional Synthetic DMARDs, in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic DMARDs or Biologic DMARDs

acronym: contRAst 2

summary: This study [contRAst 2 (201791: NCT03970837)] is a phase 3, randomized, multicenter, double blind study to assess the safety and efficacy of GSK3196165 in combination with csDMARD(s), for the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to csDMARD(s) or bDMARD(s). The study will consist of a screening phase of up to 6 weeks followed by a 52 week treatment phase in which participants will be randomized in a ratio of 6:6:3:1:1:1 to receive GSK3196165 150 milligrams (mg) subcutaneous (SC) weekly, GSK3196165 90 mg SC weekly, tofacitinib capsules (cap) 5 mg twice a day or placebo (three arms, each placebo arm will have 12 weeks placebo followed by 40 weeks active treatment) respectively, all in combination with csDMARD(s). Participants who, in investigator's judgement will benefit from extended treatment with GSK3196165 may be included in the long-term extension study [contRAst X (209564: NCT04333147)]. For those participants who do not continue into the long term-extension study, there will be an 8 week safety follow-up visit following the treatment phase.

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline

location_country:
Poland
Brazil
Spain
United Kingdom
Russian Federation
Australia
Estonia
Argentina
Mexico
Thailand
Hungary
Korea, Republic of
United States
France
China
Colombia
Japan
Germany
Bulgaria

intervention_type: Biological


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

summary: The primary objective of this study is to assess the objective response rate (ORR) of sacituzumab govitecan-hziy in adult participants with metastatic solid tumors.

lead_sponsor: Gilead Sciences

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

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

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

location_facility: Institut Claudius Régaud - IUCT Oncopole

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

location_facility: University Hospitals Cleveland Medical Center

location_facility: The Andrew Love Cancer Centre, Geelong Hospital

location_facility: Christus Highland Cancer Treatment Center

location_facility: Miami Cancer Institute at Baptist Health, Inc.

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

location_facility: New York Oncology Hematology - Albany Medical Center

location_facility: Washington University School of Medicine - Siteman Cancer Center

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Los Angeles Hematology Oncology Medical Group

location_facility: Weill Cornell Medicine - Upper East Side

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Willamette Valley Cancer Institute and Research Center - Eugene

location_facility: London Health Sciences Centre- Victoria Hospital

location_facility: University of Colorado Hospital - Anschutz Cancer Pavilion


status: Terminated

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

lead_sponsor: LEO Pharma

ReferenceType: derived

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:CD007478. doi: 10.1002/14651858.CD007478.pub2.

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:
Denmark
United States
Germany
France

location_facility:
LEO Pharma Investigational site
LEO Pharma Investigational Site

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).

status_simplified: Unknown


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.

study_type: Observational

time_perspective: Prospective

ipd_sharing: Undecided

lead_sponsor: Medical University of Graz

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

location_facility: Department of Cardiology, Aarhus University Hospital, Denmark

location_facility: Thorax Clinic Heidelberg, Centre for Pulmonary Hypertension

location_facility: Royal Hallamshire Hospital, Sheffield Pulmonary Vascular Disease Unit

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

location_facility: Massachusetts General Hospital, Cardiology Division and Pulmonary Unit

location_facility: Royal Prince Alfred Hospital, Respiratory Medicine

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

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

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

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

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

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

location_facility: Sorbonne Universités, Neurophysiologie respiratoire expérimentale et clinique

location_facility: University of Cologne, Klinik III fuer Innere Medizin

location_facility: University Hospital of Zurich, Internal Medicine

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

location_facility: Centre Chirurgical Marie Lannelongue, Thoracic and Vascular Surgery

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

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

location_facility: University of Arizona, Banner University Medical Center

intervention_type: Diagnostic Test

lead_sponsor_type: academique


intervention_type: Other

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

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

location_facility: Clinica Medica Azienda Ospedaliera Universitaria

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Jadwiga Miecz

location_facility: H-T. Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia

location_facility: Novosibirsk State Regional Clinical Hospital

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

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

location_facility: Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi

location_facility: National Hospital Organization Takasaki General Medical Center

location_facility: Southern Star Research Institute - Medical Center Office

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel

location_facility: Multidisciplinary Consultative and Diagnostic Center

location_facility: Universitatsklinikum Carl Gustav Carus Dresden

location_facility: Texas Digestive Disease Consultants - Southlake

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: National Hospital Organization Hirosaki National Hospital

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Shiga University of Medical Science Hospital

location_facility: New York University Langone Medical Center

location_facility: Penn State Health Milton S. Hershey Medical Center

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Gastroenterology Research of San Antonio

location_facility: Centrum Zdrowia Matki Dziecka i Mlodziezy

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

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

location_facility: Charite Universitatsmedizin Berlin - Campus Virchow-Klinikum

location_facility: Connecticut Clinical Research Foundation

location_facility: Advanced Research Institute - New Port Richey

location_facility: Policlinico Universitario Campus Bio-Medico

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).


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

location_country:
Spain
Italy
United Kingdom
Canada
United States
France
Germany

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

location_facility: Hospital Universitari i Politècnic la Fe

location_facility: Hospital General Universitario de Alicante

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Medical University of South Carolina (MUSC)

location_facility: University Hospitals Cleveland Medical Center

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: The Ohio State University Wexner Medical Center

location_facility: Hospital General Universitario Gregorio Maranon


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

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).

lead_sponsor: Alexion Pharmaceuticals

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


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

lead_sponsor: Hansa Biopharma AB

location_country:
Austria
Australia
United States
France
Germany

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

location_facility: CHU Grenoble Alpes - Néphrologie, dialyse et transplantation

location_facility: Hôpital Necker - Service de Néphrologie - Transplantation

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.


acronym: SHINE

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

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

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:
Canada
United States
Israel
France
Bulgaria

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

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.


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, Wallström E, Zhang X, Mareš 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.

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

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


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)

lead_sponsor: Boehringer Ingelheim

design_allocation: Non-Randomized

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

location_facility: Second Affiliated Hospital of Xi'an JiaoTong University

location_facility: Hedi Chaker Hospital, Department of Dermatology

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: National Hospital of Dermatology and Venereology

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

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

location_facility: Klinikum der Universität München - Campus Innenstadt

location_facility: Tokyo Medical University Ibaraki Medical Center

location_facility: FSBEI HE "Kirov State Medical University"

location_facility: 2nd Affiliated Hosp Zhejiang University College of Medical

location_facility: Center for Skin Research, Testing and Product Development

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

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

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi

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.


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, Gouëffic Y, Verbist J, Maene L, Hendriks J, Brunet J, Ducasse E, Levent K, Sauguet A, Déglise 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 Sep 4. doi: 10.1007/s00270-022-03259-z. [Epub ahead of print]

lead_sponsor: ID3 Medical

location_country: Austria France Switzerland Belgium

location_facility: Centre Hospitalier Universitaire Vaudois

intervention_type: Device


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 subjects with advanced Parkinson's disease (PD) who have motor fluctuations.

lead_sponsor: Impax Laboratories, LLC

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

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

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

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

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

location_facility: Indiana University Health Neuroscience Center(164)

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

location_facility: Henry Ford West Bloomfield Hospital(100)

location_facility: University of Florida Health Science Center (129)

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

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

location_facility: Northwestern Medical Group Neurology Clinic (145)

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

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

location_facility: Hospital Universitario Quiron Dexeus (501)

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

location_facility: University of Arkansas for Medical Sciences (117)

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

location_facility: University Hospitals Cleveland Medical Center (123)

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

location_facility: The Movement Disorder Clinic of Oklahoma (115)

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

location_facility: Hospital General Universitario de Elche (509)

location_facility: Hospital Universitario Vall d'Hebron (505)

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

location_facility: Hospital Universitario Infanta Sofia(513)

location_facility: Neurology Consultants of Dallas, PA (108)

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

location_facility: Azienda Ospedaliero-Universitaria Pisana (602)

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

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

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

location_facility: Hospital Universitario Ramon y Cajal (500)

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

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

location_facility: Centre Hospitalier Universitaire de Nice (400)

location_facility: University of Texas Southwestern Medical Center (143)

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

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

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

location_facility: ChristianaCare Neurology Specialists (153)

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

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

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

location_facility: Hospital Universitari General de Catalunya (504)

location_facility: Hospital Universitario de Ia Princesa (508)

location_facility: Hospital Universitario Virgen del Rocio (503)

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

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

location_facility: Hospital Universitari Mutua Terrassa (506)

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

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

location_facility: Centro Ricerca Parkinson San Raffaele Cassino (601)

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

location_facility: Hoag Memorial Hospital Presbyterian (134)

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

location_facility: University of Kansas Medical Center (118)

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

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

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

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


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)."

location_country:
Spain
Russian Federation
Australia
Canada
United States
France
Belgium

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

location_facility: Hospital Universitari Vall d'Hebron; Oncology

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Centre Eugene Marquis; Service d'oncologie

location_facility: Peter Maccallum Cancer Institute; Clinical Trial Unit

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Clinica Universidad de Navarra Madrid; Servicio de Oncología

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

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

location_facility: Hospital Clínic i Provincial; Servicio de Oncología

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


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)

lead_sponsor: Allergan

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.

ReferenceCitation: Min KC, Kraft WK, Bondiskey P, Colón-González 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.

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

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

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

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

location_facility: Japanese Red Cross Shizuoka Hospital /ID# 234372

location_facility: Clinical Neuroscience Solutions - Memphis /ID# 237478

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

location_facility: Atsuchi Neurosurgical Hospital /ID# 234779

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

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

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

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

location_facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 237835

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

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

location_facility: Tri-Service General Hospital /ID# 237657

location_facility: Azienda Ospedaliero Universitaria Careggi /ID# 237598

location_facility: Hospital Clinico Universitario Lozano Blesa /ID# 237373

location_facility: Hospital Universitario Virgen del Rocio /ID# 237106

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

location_facility: Saitama Medical University Hospital /ID# 237019

location_facility: Albany Medical Center Rheumatology /ID# 236540

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

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

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

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

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

location_facility: Alpine Clinical Research Center /ID# 234346

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

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

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

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

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

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

location_facility: California Headache and Balance Center /ID# 236246

location_facility: Saitama Neuropsychiatric Institute /Id# 234550

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

location_facility: Centrum Leczenia Padaczki i Migreny /ID# 236386

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

location_facility: Stetson-University of Cincinnati /ID# 236453

location_facility: CH Annecy Genevois Site Annecy /ID# 236385

location_facility: Dokkyo Medical University Hospital /ID# 236810

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

location_facility: Taipei Veterans General Hosp /ID# 237236

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

location_facility: Headache Neurology Research Institute /ID# 236464

location_facility: Abington Neurological Associates - Abington /ID# 236258

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

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

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

location_facility: Montreal Neurological Institut /ID# 236329

location_facility: Chinese PLA General Hospital /ID# 238237

location_facility: Clinical Research Institute, Inc /ID# 238299

location_facility: Pusan National University Hospital /ID# 237120

location_facility: Centrum Medyczne Pratia Gdynia /ID# 237077

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

location_facility: Northwest Clinical Research Center /ID# 237581

location_facility: Clinique des cephalees de Montreal /ID# 236266

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

location_facility: Ottawa Headache Centre Research Inc /ID# 236432

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

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

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

location_facility: The Royal Melbourne Hospital /ID# 236859

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

location_facility: Seoul National University Hospital /ID# 237786

location_facility: Peking University Third Hospital /ID# 238150

location_facility: Hospital Clinico Universitario de Valencia /ID# 237400

location_facility: Dartmouth-Hitchcock Medical Center /ID# 237444

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

location_facility: Dongtan Sacred Heart Hospital /ID# 238097

location_facility: Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 237492

location_facility: LMU Klinikum Campus Grosshadern /ID# 236293

location_facility: Central Clinical Hospital RZHD Medicine /ID# 237024

location_facility: Raleigh Neurology Associates /ID# 237141

location_facility: MedStar Georgetown Neurology /ID# 236324

location_facility: Schuster Medical Research Institute /ID# 236447

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

location_facility: Stortorgets Neurologmottagning /ID# 236454

location_facility: Kazan State Medical University /ID# 236298

location_facility: Albuquerque Clinical Trials, Inc /ID# 236853

location_facility: Hospital Clinico Universitario de Valladolid /ID# 234406

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

location_facility: Vancouver Island Health Authority /ID# 238053

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

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

location_facility: Beth Israel Deaconess Medical Center /ID# 237540

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


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

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

location_facility: Urological Associates of Southern Arizona

location_facility: South Tyneside District Hospital - South Shields

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

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

location_facility: Ohio State University (OSU)-Renal Division

location_facility: Azienda USL Toscana Centro-Ospedale Santa Maria Nuova

location_facility: Mayo Clinic- Department of Nephrology Hyperoxaluria Center

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

location_facility: University of California- San Francisco (UCSF)

location_facility: UVC Brugmann University Hospital- Centre Hospitalier Universitaire

location_facility: Lifespan Physician Group Minimally Invasive Urology Institute

location_facility: Universite Libre de Bruxelles -Hospital Erasme

location_facility: Medizinische Universitat Wien, Innere Medizin III

location_facility: Alliance for Multispecialty Research, LLC

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

location_facility: Baylor Scott and White Research Institute- Temple

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

location_facility: Spitalul Clinic Universitar de Urgenta Bucuresti

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

location_facility: South Florida Nephrology Group PA Research Div

location_facility: University of Alabama- Department of Urology

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

location_facility: University of Texas Health Science Center at San Antonio

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

location_facility: University of Florida College of Medicine

location_facility: Centru de Diagnostic si Tratament Affidea- Medicina Interna

location_facility: Centro Hospitalar Universitario de Sao Joao

location_facility: Inselspital, Universitaetsspital Bern Inselspital Bern University Hospital

location_facility: University of Alberta- Division of Urology

location_facility: University of Wisconsin - Division of Nephrology

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

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

location_facility: Clinical Research Solutions- Middleburg Heights

location_facility: Oregon Health and Science University (OHSU)

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino IST

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

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

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

location_facility: Long Island Gastrointestinal Research Group


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

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

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

location_facility: Hospital Universitario Central de Asturias - HUCA

location_facility: WellStar Health System/ Kennestone Hospital

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Hospital Universitario Marqués de Valdecilla


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

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

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

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

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

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

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

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

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

location_facility: Universität Leipzig, Klinik f. Gastroenterologie und Rheumatologie

location_facility: Fondazione IRCCS Policlinico San Matteo - Medicina Generale I

location_facility: Royal Liverpool & Broadgreen University Hospitals NHS Trust

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

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Hospital Universitario Virgen de la Macarena

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

location_facility: Institute of Gastroenterology, Meir Medical Center

location_facility: Fondazione Casa Sollievo della Sofferenza

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

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

location_facility: Dalhousie University - Queen Elizabeth II Health Sciences Centre

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

location_facility: Universitatsklinikum Freiburg, Medizinische Klinik

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

location_facility: Krankenhaus Walfriede, Akademisches Lehrkrankenhaus der Charite

location_facility: University College London Hospital NHS Foundation Trust

location_facility: Medizinische Klinik für Gastroenterologie, Infektiologie, Rheumatologie charite

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

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

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

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

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

location_facility: Municipal Institution "Uzhhorod Central District Hospital"

location_facility: CHU Amiens Picardie - Service Hépato-Gastroentérologie

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

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

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

location_facility: Communal Nonprofit Enterprise "Odesa Regional Clinical Hospital"

location_facility: Gastroenterology Institute, Emek Medical Center

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

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Clinical-Hospital Centre Bezanijska Kosa - Gastroenterology Department

location_facility: Scientific Research Center Eco-Safety LLC


intervention_type: Radiation

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

lead_sponsor: EMD Serono Research & Development Institute, Inc.

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

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

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

location_facility: The University of Chicago Medical Center

location_facility: BC Cancer Agency Center for the Southern Interior

location_facility: University of California Irvine Medical Center

location_facility: Hospital Universitario Virgen del Rocio - Servicio de Oncologia

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

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

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

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

location_facility: Hospital del Mar - Servicio de Oncologia

location_facility: Hospital Universitari Quiron Dexeus - Servicio de Oncologia Medica

location_facility: Baptist Health Lexington Oncology Associates

location_facility: Holy Cross Hospital - Michael and Dianne Bienes CCC

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

location_facility: South West Healthcare - South West Oncology

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

location_facility: Hospital Alvaro Cunqueiro - Servicio de Oncologia

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

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

location_facility: St. Antonius Ziekenhuis - Dept Pulmonology - Nieuwegein

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

location_facility: Hospital Universitario 12 de Octubre - Servicio de Oncologia

location_facility: Nippon Medical School Hospital - Dept of Respiratory Medicine

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

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

location_facility: Kanagawa Cancer Center - Dept of Respiratory Medicine

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

location_facility: Meander Medisch Centrum - Dep of Pulmonology

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

location_facility: University of Maryland - DUPLICATE/Pediatric Surgery

location_facility: Fakultni nemocnice Olomouc - Dept of Onkologicka klinika

location_facility: The James Cancer Hospital and Solove Research Institute

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

location_facility: Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia

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

location_facility: Hospital Universitario Clinico San Carlos - Servicio de Oncologia

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

location_facility: Asklepios Klinik Harburg - Medizinische Abteilung I

location_facility: Hospital Universitario Virgen Macarena - Servicio de Oncologia

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

location_facility: Centro Polivalente de Asistencia e Inv. Clinica CER

location_facility: Seoul National University Bundang Hospital

location_facility: Clinique et Maternite St Elisabeth Namur

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

location_facility: Hospital Regional Universitario de Malaga

location_facility: St Vincent's Hospital Melbourne - PARENT

location_facility: Franciscan St. Francis Health Cancer Center

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

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

location_facility: Osaka Medical Center for Cancer and Cardiovascular Diseases

location_facility: Hematology Oncology Center of Nyack Hospital

location_facility: Aichi Cancer Center Hospital - Dept of Respiratory Medicine

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

location_facility: Hospital de Câncer de Barretos - Fundação Pio XII

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

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

location_facility: Kurume University Hospital - Dept of Lung Cancer Center

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

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.


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

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

lead_sponsor: AbbVie

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

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

location_facility: Hospital Universitario 12 de Octubre /ID# 248366

location_facility: China Medical University Hospital /ID# 218492

location_facility: Hospital Clinico Universitario de Valencia /ID# 221107

location_facility: AdventHealth Cancer Institute - Orlando /ID# 226953

location_facility: The Chaim Sheba Medical Center /ID# 209037

location_facility: Indiana Univ School Medicine /ID# 208384

location_facility: Tel Aviv Sourasky Medical Center /ID# 222199

location_facility: Carolina BioOncology Institute /ID# 208358

location_facility: National Taiwan University Hospital /ID# 218490

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 220928

location_facility: Seoul National University Hospital /ID# 218513

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

location_facility: Princess Margaret Cancer Centre /ID# 209423

location_facility: Hospital Clinic de Barcelona /ID# 221106

location_facility: CHU Toulouse - Hopital Purpan /ID# 218667

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

location_facility: National Cancer Center Hospital East /ID# 224808

location_facility: National Cancer Center Hospital /ID# 209421


title: A Randomized, Controlled, Open-labeled, Multi-center Clinical Trial to Evaluate the Safe and Effective Performance of the Lungpacer Diaphragm Pacing Therapy System in Patients Who Have Failed to Wean From Mechanical Ventilation.

summary:
This clinical investigation is an open-label, multi-center RCT to demonstrate the safety and effective performance of the Lungpacer DPTS (plus standard of care) as compared to Control (standard of care only) in patients aged 18 years or older who are receiving mechanical ventilation. Eligible Subjects will have received mechanical ventilation for ≥96 hours (4 days) and failed two weaning attempts.

The goal or outcome is to show a numerically greater proportion of subjects weaned in the Treatment (Lungpacer DPTS) group as compared to the Control group.

ipd_sharing_description: Only investigators participating in this clinical trial will be able to see final de-identified participant data at the completion of the study.

lead_sponsor: Lungpacer Medical Inc.

location_country:
Germany
United States
France

location_facility: University of Colorado Anschutz Medical Campus

location_facility: University of North Carolina School of Medicine

location_facility: Indiana University Health Methodist Hospital

location_facility: Western Michigan University Homer Stryker M.D. School of Medicine

location_facility: University of Texas Southwestern, Zale Lipshy Hospital

location_facility: Joseph M Still Burn Center at Doctors Hospital Augusta

location_facility: Northwell Health; Long Island Jewish Medical Center

location_facility: CHI Health Creighton University Medical Center - Bergan Mercy

location_facility: Northwestern University Feinberg School of Medicine


acronym: CONTRAIL I

title: A 12-month, Open-label, Multicenter, Randomized, Safety, Efficacy, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Two Regimens of Anti-CD40 Monoclonal Antibody, CFZ533 vs. Standard of Care Control, in Adult de Novo Liver Transplant Recipients With a 12-month Additional Follow-up and a Long-term Extension (CONTRAIL I)

lead_sponsor: Novartis Pharmaceuticals

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

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

location_country:
Spain
Italy
Netherlands
Argentina
Hungary
France
United States
Belgium
Germany
Czechia

summary: The purpose of this study is to investigate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of two CFZ533 dose regimens in liver transplant recipients.


acronym: DISCREET

title: A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double Blind-Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis

lead_sponsor: Amgen

type: Registry Identifier

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

location_country:
Italy
Canada
Puerto Rico
United States
France
Belgium
Germany

location_facility: Azienda Ospedaliera Bianchi Melacrino Morelli

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: ISA - Interdisciplinary Study Association GmbH

location_facility: Azienda Sanitaria Locale 1 Ospedale Regionale San Salvatore

location_facility: Centre Hospitalier Universitaire (CHU) de Bordeaux - Hopital Saint-Andre

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Centre Hospitalier Universitaire Saint Pierre

location_facility: Azienda Sanitaria Universitaria Integrata di Trieste

location_facility: Universita degli Studi di Roma La Sapienza Ospedale A Fiorini di Terracina

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Luebeck

summary:
This Phase 3 multicenter, randomized, placebo-controlled, double-blind study is designed to evaluate the efficacy and safety of apremilast in subjects with moderate to severe genital psoriasis (modified sPGA-G ≥3, moderate or severe).

Approximately 286 subjects with moderate to severe genital psoriasis will be randomized 1:1 to receive either apremilast 30 mg BID or placebo for the first 16 weeks.


title: A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors

summary: The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB086550 in participants with advanced solid tumors who have failed prior treatments.

ReferenceCitation: Koblish HK, Wu L, Wang LS, Liu PCC, Wynn R, Rios-Doria J, Spitz S, Liu H, Volgina A, Zolotarjova N, Kapilashrami K, Behshad E, Covington M, Yang YO, Li J, Diamond S, Soloviev M, O'Hayer K, Rubin S, Kanellopoulou C, Yang G, Rupar M, DiMatteo D, Lin L, Stevens C, Zhang Y, Thekkat P, Geschwindt R, Marando C, Yeleswaram S, Jackson J, Scherle P, Huber R, Yao W, Hollis G. Characterization of INCB086550: A Potent and Novel Small-Molecule PD-L1 Inhibitor. Cancer Discov. 2022 Jun 2;12(6):1482-1499. doi: 10.1158/2159-8290.CD-21-1156.

lead_sponsor: Incyte Corporation

location_country:
United Kingdom
Italy
United States
France
Belgium

location_facility: Istituto Nazionale Tumori Irccs Fondazione Pascale

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte

location_facility: Imperial College Healthcare Nhs Trust - Hammersmith Hospital

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

location_facility: Fondazione Irccs Istituto Nazionale Dei Tumori

location_facility: Universitaire Ziekenhuis Leuven - Gasthuisberg

location_facility: University of Pennsylvania Health System

location_facility: Institut Universitaire Du Cancer de Toulouse Oncopole


title: HELIOS-A: A Phase 3 Global, Randomized, Open-label Study to Evaluate the Efficacy and Safety of ALN-TTRSC02 in Patients With Hereditary Transthyretin Amyloidosis (hATTR Amyloidosis)

summary: The purpose of this study is to evaluate the efficacy and safety of vutrisiran (ALN-TTRSC02) in participants with hereditary transthyretin amyloidosis (hATTR amyloidosis). Participants will receive vutrisiran subcutaneous (SC) injection once every 3 months (q3M) or the reference comparator patisiran intravenous (IV) injection once every 3 weeks (q3w) during the 18 month Treatment Period. This study will use the placebo arm of the APOLLO study (NCT01960348) as an external comparator for the primary and most other efficacy endpoints during the 18 Month Treatment Period. Following the 18 Month Treatment Period, all participants will be randomized to receive vutrisiran SC injection once every 6 months (q6M) or q3M in the Randomized Treatment Extension (RTE) Period.

ReferenceCitation: Adams D, Tournev IL, Taylor MS, Coelho T, Planté-Bordeneuve V, Berk JL, González-Duarte A, Gillmore JD, Low SC, Sekijima Y, Obici L, Chen C, Badri P, Arum SM, Vest J, Polydefkis M; HELIOS-A Collaborators. Efficacy and safety of vutrisiran for patients with hereditary transthyretin-mediated amyloidosis with polyneuropathy: a randomized clinical trial. Amyloid. 2022 Jul 23:1-9. doi: 10.1080/13506129.2022.2091985. [Epub ahead of print]

lead_sponsor: Alnylam Pharmaceuticals

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Portugal
Australia
Argentina
Mexico
Sweden
Malaysia
Cyprus
Brazil
Canada
Germany
Bulgaria
Taiwan
Greece
Korea, Republic of
France
Netherlands


title: Efficacy and Safety of Fixed-Dose Combination (FDC) Products Containing Trazodone and Gabapentin in Patients Affected by Painful Diabetic Neuropathy: Randomized, Controlled, Dose Finding Study.

summary: The primary objective of the study is to collect preliminary information on the effect of three doses of trazodone/gabapentin FDC products on pain intensity in patients with painful diabetic neuropathy after 8-week treatment period.

lead_sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A

location_country:
Poland
France
United Kingdom
Czechia

location_facility: Fondation Hôtel Dieu Groupe SOS Service de Diabétologie

location_facility: Diabetologická ambulance Milan Kvapil s.r.o.

location_facility: Nemocnice Pardubického kraje a.s. Pardubická nemocnice Neurologická klinika

location_facility: Centrum Badań Klinicznych Ośrodek Badań Wczesnej Fazy

location_facility: GHR MSA - Hôpital Emile Muller Service de Diabétologie-Endocrinologie-Nutrition

location_facility: Clinical Research Facility Royal Hallamshire Hospital

location_facility: Lancashire Clinical Research Facility The Avondale Unit Royal Preston Hospital

location_facility: WroMedica I. Bielicka, A. Strzałkowska s.c.

location_facility: CHU de Nantes - Hôpital Guillaume-et-René-Laënnec Clinique d'Endocrinologie, maladies métaboliques et nutrition CIC Endocrino - Nutrition - UF 7015

location_facility: Centre de Recherche Clinique G.H.M les Portes du Sud Departement d'Endocrinologie

location_facility: Instytut Medycyny Wsi im. Witolda Chodźki Klinika Diabetologii

location_facility: Manchester Clinical Research Facility Manchester Royal Infirmary

location_facility: Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne DIAB-ENDO-MET

location_facility: Medical Innovation Development and Research Unit (MIDRU) Heartlands Hospital

location_facility: Pro Familia Altera Poradnia Wielospecjalistyczna

location_facility: Diabetes Centre George Eliot Hospital NHS Trust


acronym: FOREMOST

title: A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Early, Oligoarticular Psoriatic Arthritis Despite Initial Stable Treatment With Either NSAIDS and/or ≤ 1 Conventional Synthetic DMARD

location_country:
Spain
Italy
Austria
Netherlands
Russian Federation
Canada
United Kingdom
United States
France
Belgium
Germany

location_facility: Ziekenhuis Netwerk Antwerpen Jan Palfijn

location_facility: Moscow Regional Research Institute n.a. Vladimirsky

location_facility: Research Institute of Clinical and Experimental Lymphology

location_facility: Arthritis and Rheumatic Disease Specialties

location_facility: Municipal Budgetary Healthcare Institution City Emergency Hospital

location_facility: Dr. Sabeen Anwar Medicine Professional Corporation

location_facility: Providence Saint Jude Heritage Medical Group

location_facility: Accurate Clinical Research, Inc. Baytown

location_facility: Center for Rheumatology, Immunology, and Arthritis

location_facility: Arizona Arthritis and Rheumatology Research, PLLC

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt/Main

location_facility: Humanitas Research Hospital Humanitas Mirasole

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Arthritis and Rheumatology Center of Michigan

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Assistance Publique- Hopitaux de Paris AP-HP

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona Ospedale G B Rossi Borgo Roma

location_facility: Klein and Associates MD, PA - Cumberland

location_facility: Carol and Frank Morsani Center for Advanced Health Care

location_facility: Universitaetsklinikum Allgemeines Krankenhaus Wien Universitaetsklinik fur Innere Medizin I

location_facility: Arthritis, Rheumatic, and Back Disease Associates

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: Mechnikov North-Western State Medical University

location_facility: Centre Hospitalier Universitaire Brugmann

location_facility: University of Florida College of Medicine

location_facility: University Hospitals Cleveland Medical Center

location_facility: AO Ospedale Policlinico Consorziale Di Bari

location_facility: Precision Comprehensive Clinical Research Solutions

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

location_facility: Policlinico San Matteo Universita Di Pavia

location_facility: Paramount Medical Research and Consulting LLC

location_facility: Integral Rheumatology and Immunology Specialists

location_facility: Arthritis and Osteoporosis Center of Southwest Ohio

location_facility: Research Institute of Rheumatology named after V.A.Nasonova

summary: This clinical study will test the effects of a drug called apremilast in oligoarticular psoriatic arthritis with less than 5 years of disease duration. In previous studies, apremilast has been shown to be safe and efficacious in reducing signs and symptoms of psoriatic arthritis, as well as improving physical function. This study will compare the effects of apremilast to placebo on psoriatic arthritis subjects in which the number of affected joints is limited (greater than 1 but less or equal to 4). About 285 patients worldwide will take part in this study.


title: A Phase III Multicenter, Randomized, Open Label Study of APR-246 in Combination With Azacitidine Versus Azacitidine Alone for the Treatment of (Tumor Protein) TP53 Mutant Myelodysplastic Syndromes

summary: A Phase III, multicenter, randomized study to compare the rate of complete response (CR) and duration of CR, in patients with TP53-mutated MDS who will receive APR-246 and azacitidine or azacitidine alone.

lead_sponsor: Aprea Therapeutics

location_country:
United States
France

location_facility: University of Pittsburgh Medical Center, Hillman Cancer Center

location_facility: Robert H Lurie Comprehensive Cancer Center, Northwestern University

location_facility: University of Pennsylvania, Abramson Cancer Center

location_facility: Stanford University Cancer Research Center

location_facility: University of Iowa Hospitals and Clinics, Holden Cancer Center

location_facility: Memorial Health Care System South Florida


acronym: PRONTO-Peds

title: A Prospective, Randomized, Double-Blind Comparison of LY900014 to Humalog With an Open-Label Postprandial LY900014 Treatment Group in Children and Adolescents With Type 1 Diabetes

lead_sponsor: Eli Lilly and Company

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

location_country:
Denmark
Poland
Brazil
Spain
Italy
Austria
Russian Federation
United Kingdom
Ukraine
Puerto Rico
United States
France
China
Israel
Mexico
Japan
Germany
Czechia

location_facility: Diabetes and Glandular Disease Research Associates PA

location_facility: Odesa regional children's clinical hospital

location_facility: Research Institute for Pediatric Endocrinology

location_facility: Children's Hospital Los Angeles - Dept of Endocrinology

location_facility: Zaporizhzhia regional clinical children hospital

location_facility: Hospital Universitario La Fe de Valencia

location_facility: St. George's University Hospitals NHS Foundation Trust

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: Institute of the Health Care of Children & Adolescents

location_facility: Vinnytsia Regional Clinical Highly Specialized Endocrinology Center

location_facility: Unidad de Investigacion Clinica Cardiometabolica de Occidente

location_facility: Smolensk Regional Children's Clinical Hospital

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Children's Hospital Capital Institute of Pediatrics

location_facility: V.P. Komisarenko Institute of Endocrinology and Metabolism of NAMS of Ukraine

location_facility: MultiCare Institute for Research & Innovation

location_facility: Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)

location_facility: Soroka Medical Center - Pediatric Outpatient Clinic

location_facility: Niigata University Medical & Dental Hospital

location_facility: Siberian State Medical University of Roszdrav

location_facility: Tokyo Women's Medical University Hospital

location_facility: Diabetologische Schwerpunktpraxis Dr. Ziegler

location_facility: Hôpital Universitaire Necker enfants malades

location_facility: The Fourth Affiliated Hospital of Harbin Medical University

location_facility: Texas Institute for Kidney and Endocrine Disorders

location_facility: Iowa Diabetes and Endocrinology Research Center

location_facility: Ivano-Frankivsk regional clinical children hospital

location_facility: Stanford University School of Medicine - Division of Pediatric Endocrinology & Diabetes

location_facility: Center of Excellence in Diabetes & Endocrinology

location_facility: Rambam Medical Center - Department of Pediatrics A, Ruth Rappaport Children's Hospital

location_facility: St.Petersburg Children's City Polyclinic #44

location_facility: Indiana University- Riley Children's Hospital

location_facility: Samarskiy Regional Children's Clinical Hospital

location_facility: Medizinisches Versorgungszentrum am Universitätsklinikum Leipzig GmbH

location_facility: Rocky Mountain Diabetes and Osteoporosis Center

location_facility: Shamir Medical Center (Asaf Harofe)-Pediatric Endocrinology Unit

location_facility: San Jorge Children and Women's Hospital- Shipping Location

location_facility: University of South Florida Diabetes & Endocrinology Center

location_facility: Hospital Universitario Central de Asturias

location_facility: Morozovsky Children's City Clinical Hospital

summary: The reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog) in children and adolescents with type 1 diabetes (T1D).


title: A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Two Doses of GLPG1690 in Addition to Local Standard of Care for Minimum 52 Weeks in Subjects With Idiopathic Pulmonary Fibrosis

lead_sponsor: Galapagos NV

ReferenceCitation: Deng X, Salgado-Polo F, Shao T, Xiao Z, Van R, Chen J, Rong J, Haider A, Shao Y, Josephson L, Perrakis A, Liang SH. Imaging Autotaxin In Vivo with (18)F-Labeled Positron Emission Tomography Ligands. J Med Chem. 2021 Oct 28;64(20):15053-15068. doi: 10.1021/acs.jmedchem.1c00913. Epub 2021 Oct 18.

ReferenceCitation: Maher TM, Kreuter M, Lederer DJ, Brown KK, Wuyts W, Verbruggen N, Stutvoet S, Fieuw A, Ford P, Abi-Saab W, Wijsenbeek M. Rationale, design and objectives of two phase III, randomised, placebo-controlled studies of GLPG1690, a novel autotaxin inhibitor, in idiopathic pulmonary fibrosis (ISABELA 1 and 2). BMJ Open Respir Res. 2019 May 21;6(1):e000422. doi: 10.1136/bmjresp-2019-000422. eCollection 2019.

location_country:
Poland
Italy
Netherlands
New Zealand
Argentina
Canada
Hungary
Korea, Republic of
United States
France
Israel
South Africa
Mexico
Japan
Germany

location_facility: University of Arizona College of Medicine

location_facility: Tohoku Medical and Pharmaceutical Hospital

location_facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

location_facility: Instituto de Investigaciones Clínicas Mar Del Plata

location_facility: Centre Hospitalier Regional Universitaire Montpellier

location_facility: Soon Chun Hyang University Hospital Seoul

location_facility: National Hospital Organization Ibarakihigashi National Hospital

location_facility: McGill University Health Centre Research Institute

location_facility: CEMER Centro Médico de Enfermedades Respiratorias

location_facility: Centro de Investigación Medico Biologica y de Terapia Avanzada S.C.

location_facility: Medical University of South Carolina - PPDS

location_facility: PULMAG Arkadiusz Brodowski, Grzegorz Gasior S. C.

location_facility: Kobe City Medical Center General Hospital

location_facility: Dr Anil Dhar Professional Medicine Corporation

location_facility: Hospital Privado Centro Médico de Córdoba

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktató Kórház

location_facility: University of California, San Francisco Medical Center

location_facility: Universitätsmedizin Greifswald Klinik und Poliklinik für Innere Medizin B

location_facility: Institut Universitaire de Cardiologie et de Pneumologie

location_facility: Mercy Health - St. Vincent Medical Center

location_facility: Center Hospital of the National Center for Global Health and Medicine

location_facility: Groupe Hospitalier Bichat Claude Bernard

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Krankenhaus Bethanien - Klinik für Pneumologie und Allergologie

location_facility: Soon Chun Hyang University Hospital Bucheon

location_facility: GRAŻYNA JASIENIAK-PINIS ATOPIA Niepubliczny Zakład Opieki Zdrowotnej Poradnie Specjalistyczne

location_facility: University of Michigan Health System (UMHS)

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Hospital Universitatorio Dr. Jose Eleuterio González

location_facility: Seoul National University Bundang Hospital

location_facility: Unidad de Investigación Clínica En Medicina SC

location_facility: SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

location_facility: Hôtel Dieu Du Centre Hospitalier de L'université de Montréal

location_facility: Instituto Nacional De Enfermedades (INER)

location_facility: University of Cape Town Lung Institute (UCTLI)

location_facility: Presidio Ospedaliero GB Morgagni L Pierantoni

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Hospital Zonal Especializado de Agudos y Crónicos Dr. Antonio A. Cetrangolo

location_facility: National Hospital Organization Himeji Medical Center

summary: The main purpose of this study was to see how GLPG1690 works together with the current standard treatment on your lung function and IPF disease in general. The study also investigated how well GLPG1690 is tolerated (for example if you get any side effects while on study drug).


title: Advisor HD Grid Observational Study

summary: The aim of this study is to quantify and characterize the outcomes of radiofrequency (RF) ablation after, and the utility of electroanatomical mapping with the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (hereafter called "HD Grid") and EnSite Precision™ Cardiac Mapping System (SV 2.2 or higher, hereafter called "EnSite Precision") with HD Wave Vmax voltage mapping (hereafter called "HD Wave") in subjects with PersAF or VT in real-world clinical settings.

lead_sponsor: Abbott Medical Devices

location_country:
Denmark
Portugal
Spain
Italy
Austria
Australia
Netherlands
Canada
France
South Africa
Germany

location_facility: Medizinische Einrichtungen der Universität zu Köln

location_facility: Herzzentrum Dresden GmbH Universitätsklinik

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Institut de Cardiologie de Quebec (Hôpital Laval)

location_facility: A. ö. Krankenhaus der Elisabethinen Linz

location_facility: Institute Cardio. Paris-Sud - Institut Jacques Cartier

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: UKE Hamburg (Universitatsklinik Eppendorf)