title: AN OPEN-LABEL, 3-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) MONOTHERAPY AND ELRANATAMAB + DARATUMUMAB VERSUS DARATUMUMAB + POMALIDOMIDE + DEXAMETHASONE IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST 1 PRIOR LINE OF THERAPY INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR

summary: The purpose of this study is to evaluate whether the BCMA-CD3 bispecific antibody elranatamab, alone and/or in combination with the anti-CD38 monoclonal antibody, daratumumab, can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone. People with multiple myeloma who have received previous treatment including lenalidomide and a proteasome inhibitor will be enrolled in the study. Part 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab. People participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will compare the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab compared to daratumumab, pomalidomide, and dexamethasone. Participants in both parts of the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study.

location_country:
Spain
Italy
United Kingdom
Belgium
Japan
Czechia
Poland
Austria
Australia
Argentina
Turkey
Norway
Sweden
Brazil
Canada
China
Germany
Taiwan
Greece
New Zealand
Finland
Korea, Republic of
France
Netherlands

location_facility: Chang Gung Memorial Hospital at Kaohsiung

location_facility: Chonnam National University Hwasun Hospital

location_facility: Theageneio Cancer Hospital of Thessaloniki

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)

location_facility: Tianjin Medical University General Hospital

location_facility: Hospital Universitario Madrid Sanchinarro

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

location_facility: Hospital Santa Cruz / Centro de Pesquisa

location_facility: Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu

location_facility: Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku

location_facility: Universitaetsklinikum Allgemeines Krankenhaus Wien

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: ESHO Empresa de Serviços Hospitalares S.A/ Hospital Samaritano de Higienópolis

location_facility: Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi

location_facility: Instituto de Educação, Pesquisa e Gestão e Saúde

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa

location_facility: The Second Hospital of Hebei Medical University

location_facility: FUNDALEU -Fundación para combatir la leucemia

location_facility: Queen Elizabeth II Health Science Centre

location_facility: Uniwersyteckie Centrum Kliniczne WUM Centralny Szpital Kliniczny

location_facility: Inonu Universitesi Turgut Ozal Tıp Merkezi

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

location_facility: Erciyes Universitesi Tıp Fakultesi Hastaneleri

location_facility: Alexander Fleming S.A (Instituto Medico Especializado Alexander Fleming)

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: Institute of hematology&blood disease hospital

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Nanfang Hospital of Southern Medical University

location_facility: FUNDALEU - Fundacion para combatir la Leucemia

location_facility: Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: BP - A Beneficencia Portuguesa de São Paulo

location_facility: CHU de Poitiers, Hôpital de la Milétrie, Pôle Régional de Cancérologie

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi

location_facility: Seoul National University Bundang Hospital

location_facility: Beijing Peking Union Medical College Hospital

location_facility: ASST Santi Paolo e Carlo Ospedale San Carlo Borromeo SSD di Onco-Ematologia (Edificio C-piano terra)

location_facility: Hamilton Health Sciences-Juravinski Cancer Centre

location_facility: National Hospital Organization Shibukawa Medical Center

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: Institut Català d'Oncologia - L'Hospitalet

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

location_facility: Aydın Adnan Menderes Universitesi Hastanesi

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

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

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: Hospital Universitari De Girona Doctor Josep Trueta

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Ankara Universitesi Tip Fakultesi Hastanesi

location_facility: QEII Health Sciences Centre - Victoria General Site


type: EudraCT Number

title: AdvanTIG-205: A Phase 2, Randomized Study of Ociperlimab (BGB-A1217) and Tislelizumab With Chemotherapy in Patients With Previously Untreated Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer (NSCLC)

summary: This is a randomized investigator and patient blinded, sponsor unblinded, multicenter study that evaluates the safety and efficacy of ociperlimab with tislelizumab and histology-based chemotherapy compared with treatment with tislelizumab and histology-based chemotherapy in participants with previously untreated locally advanced, unresectable, or metastatic NSCLC

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: Yes

lead_sponsor: BeiGene

location_country:
Spain
Austria
Australia
Korea, Republic of
United States
France
China

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

location_facility: Olivia Newton-John Cancer Wellness & Research Centre

location_facility: University of North Carolina at Chapel Hill

location_facility: Cancer Center of Guangzhou Medical University

location_facility: The second Affiliated Hospital of Chongqing Medical University

location_facility: First Affiliated Hospital, School of Medicine, Shihezi University

location_facility: University of Iowa Hospitals and Clinics

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: Peninsula & South Eastern Hematology and Oncology Group

location_facility: First Affiliated Hospital of Zhengzhou University

location_facility: Huashan hospital affiliated to Fudan University

location_facility: Hopital Charles Nicolle - Centre Hospitalier Universitaire de Rouen

location_facility: Klinik Penzing - Wiener Gesundheitsverband

location_facility: Hospital Universitario Central de Asturias

location_facility: Affiliated Tumor Hospital of Harbin Medical University

location_facility: Cha Bundang Medical Center, Cha University

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Consorcio Hospitalario Provincial de Castellón

location_facility: Clinica Universitaria de Navarra, Madrid

location_facility: Xin Qiao Hospital Affiliated to The Army Medical University

location_facility: Samsung Medical Center - Hematology-Oncology

location_facility: Universitätsklinik für Innere Medizin III, mit Hämatologie, internistischer Onkologie, Hämostaseologie, Infektiologie, Rheumatologie und Onkologisches Zentrum

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


type: Other Identifier

title: Phase 2 Study of Pembrolizumab and Chemotherapy in Patients With Newly Diagnosed Classical Hodgkin Lymphoma (KEYNOTE-C11)

summary: The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) monotherapy, followed by chemotherapy, followed by pembrolizumab consolidation. The primary hypothesis of the study is that the complete response (CR) rate at the end of study intervention according to Lugano 2014 response criteria is higher than conventional chemotherapy.

status: Active, not recruiting

ReferenceType: derived

ReferenceCitation: Allen PB, Lu X, Chen Q, Kane KL, Chmiel JS, Barnea Slonim L, Sukhanova M, Savas H, Evens AM, Advani R, Pro B, Karmali R, Palmer B, Bayer R, Eisner RM, Mou E, Dillehay G, Gordon LI, Winter JN. Sequential Pembrolizumab and AVD is Highly Effective at any PD-L1 Expression Level in Untreated Hodgkin Lymphoma. Blood Adv. 2022 Sep 9. pii: bloodadvances.2022008116. doi: 10.1182/bloodadvances.2022008116. [Epub ahead of print]

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Poland
Spain
Italy
Russian Federation
Australia
Canada
United States
Chile
France
Israel
Turkey

location_facility: Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 1031)

location_facility: Liverpool Hospital-Haematology ( Site 0906)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

location_facility: Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 1204)

location_facility: Szpital Wojewódzki w Opolu-Hematology Department ( Site 0401)

location_facility: Almazov National Medical Research Centre ( Site 0704)

location_facility: Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen-Service d'Hématologie ( Si

location_facility: OptumCare Cancer Care-Research Department ( Site 0005)

location_facility: Bnai Zion Medical Center-Hematology ( Site 1909)

location_facility: ASST Grande Ospedale Metropolitano Niguarda ( Site 1803)

location_facility: Policlinico S. Orsola- Malpighi-Istituto di Ematologia L. e A. Seragnoli ( Site 1800)

location_facility: Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou-haematology ( Site 1502)

location_facility: Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 1504)

location_facility: Peter MacCallum Cancer Centre ( Site 0905)

location_facility: Instituto Nacional del Cancer ( Site 1205)

location_facility: Hospital Universitario 12 de Octubre ( Site 1032)

location_facility: Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0403)

location_facility: centre hospitalier lyon sud-Service Hématologie ( Site 1501)

location_facility: Northwestern Memorial Hospital ( Site 0002)

location_facility: Mater Misericordiae Limited ( Site 0904)

location_facility: Sheba Medical Center-Hemato Oncology ( Site 1904)

location_facility: Azienda Ospedaliera Spedali Civili di Brescia-Hemathology ( Site 1801)

location_facility: First Pavlov State Medical University of Saint Petersburg-Raisa Gorbacheva Memorial Institut for Pe

location_facility: University of Tennessee Medical Center-Cancer Institute ( Site 0006)

location_facility: Klinika Hematologii - Instytut Hematologii i Transfuzjologii-Klinika Hematologii ( Site 0402)

location_facility: Centro Investigación del Cáncer James Lind ( Site 1200)

location_facility: McGill University Health Centre ( Site 0209)

location_facility: Moscow City Clinical Hospital S.P. Botkin ( Site 0702)

location_facility: Princess Alexandra Hospital-Division of Cancer Services Trials Unit ( Site 0907)

location_facility: St Joseph Heritage Healthcare-Oncology ( Site 0004)

location_facility: Monash Health-Haematology Research ( Site 0908)

location_facility: Hopital du Sacre-Coeur de Montreal ( Site 0206)

location_facility: Clínica Alemana de Santiago ( Site 1206)

location_facility: Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0205)

location_facility: Ankara University Hospital Cebeci-hematology ( Site 5000)

location_facility: Vehbi Koc Vakfi - Amerikan Hastanesi ( Site 5001)

location_facility: Fondazione Policlinico Universitario Agostino Gemelli-ISTITUTO DI EMATOLOGIA ( Site 1804)

intervention_type: Biological


title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis

summary: This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab compared with placebo in participants with generalized myasthenia gravis (gMG).

lead_sponsor: Hoffmann-La Roche

location_country:
Denmark
Poland
Taiwan
Brazil
Spain
Italy
Russian Federation
Australia
Netherlands
Argentina
Canada
Korea, Republic of
United States
France
China
Turkey
Japan
Germany

location_facility: A.O. Sant'Andrea; UOC Neurologia, Dip. di Neuroscienze, Salute Mentale e Organi di Senso (NESMOS)

location_facility: Box Hill Hospital; Department of Neurology

location_facility: University of Iowa Hospitals & Clinics; Department of Neurology

location_facility: St. Josef-Hospital, Klinik für Neurologie

location_facility: Novosibirsk State Regional Clinical Hospital

location_facility: Tianjin Medical University General Hospital

location_facility: Nagasaki Kawatana Medical Center; Neurology

location_facility: Pusan National University Yangsan Hospital

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia

location_facility: Washington University School of Medicine; Department of Neurology

location_facility: Fondazione Istituto Neurologico Mondino IRCCS; SC Neuroncologia e neuroinfiammazione

location_facility: International University of Health and Welfare Narita Hospital; Neurology

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

location_facility: West China Hospital - Sichuan University

location_facility: Hospital Universitario la Fe; Servicio de Neurologia

location_facility: Tokyo Women's Medical University Hospital; Neurology

location_facility: A.R.N.A.S. Civico Di Cristina Benfratelli; U.O.C. Neurologia con Stroke Unit

location_facility: FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency

location_facility: MUCH - Montreal Neurological Institute & Hospital

location_facility: Univeristätsklinikum Leipzig; Klinik und Poliklinik für Neurologie

location_facility: Taipei Veterans General Hospital-Neurology

location_facility: Aarhus Universitetshospital; Neurologisk Klinik

location_facility: The First Affiliated Hospital Of Shandong First Medical University

location_facility: Klinika Neurologii Dorosłych, Uniwersyteckie Centrum Kliniczne

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Fundación Scherbovsky; General Department

location_facility: Hacettepe University Medical Faculty; Neurology

location_facility: Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY

location_facility: Severance Hospital, Yonsei University Health System

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari

location_facility: Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie

location_facility: Hopital Timone Adultes; Neurologie Mal Neuro Musculaires

location_facility: Universitätsklinikum Essen (AöR); Klinik für Neurologie

location_facility: CHU Nice - Hôpital Pasteur 2; SYST NERVEUX PERIPHERIQUE MUSCLE

location_facility: Clinica Universitaria de Navarra; Servicio de Neurología

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Neurologia

location_facility: Chang Gung Medical Foundation Linkou Branch

location_facility: University of California Irvine - Manchester Pavilion

location_facility: Hospital Universitari de Bellvitge; Servicio de Neurologia

location_facility: Hospital Universitario Infanta Sofia; Servicio de Neurologia

location_facility: Ondokuz Mayis Univ. Med. Fac.; Neurology

location_facility: Dokkyo Medical University Saitama Medical Center; Neurology

location_facility: Beijing Tiantan Hospital,Capital Medical University

location_facility: Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K

location_facility: Azienda Ospedaliera A. Cardarelli; Dipartimento medico polispecialistico

location_facility: Osaka Toneyama Medical Center; Neurology

location_facility: University of Florida Jacksonville Physicians Inc. (UFJPI)

location_facility: Sapporo Medical University Hospital; Neurology

location_facility: Kocaeli University Hospital; Department of Neurology

location_facility: Xiangya Hospital Central South University

location_facility: Rigshospitalet; Klinik for Nerve- og Muskelsygdomme

location_facility: National Center of Social Significant Disease

location_facility: Tokyo Medical And Dental University, Medical Hospital; Neurology

location_facility: Hospital de Donostia Unidad Demencias; Consultas de Neurología

location_facility: Zespol Poradni Specjalistycznych - Poradnia Neurologiczna; Szpital Uniwersytecki w Krakowie

location_facility: The Affiliated Hospital of Guizhou Medical University

intervention_type: Other


title: A Phase 3b, Multi-center, Open-label, Treatment Optimization Study of Oral Asciminib in Patients With Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Previously Treated With 2 or More Tyrosine Kinase Inhibitors.

summary:
The purpose of the study is to optimize the treatment of asciminib in patients with chronic myelogenous leukemia in chronic phase (CML-CP) previously treated with 2 or more Tyrosine Kinase Inhibitors (TKIs). Patients for this study will be identified based on warning criteria and resistance definition following European Leukemia Network (ELN) 2020 recommendations.

In addition, the study will investigate the use of two different posologies. For this, patients will receive asciminib 40 mg (twice-daily) BID or of 80 mg (once daily) once daily (QD).

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Poland
Spain
Greece
Austria
Italy
Oman
Argentina
Canada
Russian Federation
United Kingdom
Vietnam
Korea, Republic of
France
Malaysia
Singapore
Germany


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Young Adult Subjects With Dravet Syndrome (DS)

lead_sponsor: Takeda

type: Registry Identifier

source: euctr

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.

location_country:
Poland
Brazil
Serbia
Spain
Greece
Italy
Australia
Latvia
Canada
Mexico
Netherlands
Russian Federation
Ukraine
Hungary
United States
France
China
Belgium
Japan
Germany

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: University of California Benioff Children's Hospital

location_facility: Childrens' Hospital of Athens 'P. and A. Kyriakou'

location_facility: Children's Hospital of Chongqing Medical University

location_facility: Hospital Regional Universitario de Malaga Hospital General

location_facility: Guangzhou Women And Children's Medical Center

location_facility: ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS

location_facility: Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN

location_facility: CNPE Clinical Hospital Psychiatry of the Executive Body of the Kyiv City Council KCSA

location_facility: Krankenhaus Mara gGmbH - Epilepsiezentrum Bethel

location_facility: Kumamoto-Ezuko Medical Center for The Severely Disabled

location_facility: National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders

location_facility: Kanagawa Prefectural Hospital Organization Kanagawa Children's Medical Center

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: National Center of Neurology and Psychiatry

location_facility: SI Ukr. Med. Rehabilitation Center For Children With Organic Injury of Nervous System of MoH of Ukr

location_facility: Krasnoyarsk State Medical University n.a. V.F. Voyno-Ysenetskiy

location_facility: Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet

location_facility: Childrens National Medical Center - Fairfax

location_facility: Hopital Universitaire des Enfants Reine Fabiola

location_facility: Russian National Research Medical University n.a. N.I.Pirogov

location_facility: The Second Affiliated Hospital of Guangzhou Medical University

location_facility: Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: University of Iowa Hospitals & Clinics - (CRS)

location_facility: Clinic for Neurology and Psychiatry for Children and Youth

location_facility: Children and Youth Health Care Institute of Vojvodina

location_facility: Communal Non-commercial Enterprise Iv-Frank Regional Childrens Clinical Hosp of Iv-Frank RC

location_facility: Klinikum der Johann-Wolfgang Goethe-Universitat

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: Clinical Integrative Research Center of Atlanta

location_facility: Municipal Institution Dnipropetrovsk Regional Children Clinical Hospital of DRC

location_facility: Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

location_facility: Dzieciecy Szpital Kliniczny im. Jozefa Polikarpa Brudzinskiego w Warszawie

location_facility: Instituto de Neurologia de Curitiba (INC)

location_facility: IRCCS Ospedale Pediatrico Bambino Gesu - INCIPIT - PIN

location_facility: Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)

location_facility: Communal Non-profit Enterprise City Childrens Clinical Hospital #6 of DCC

location_facility: National Hospital Organization Nishi-Niigata Chuo National Hospital

location_facility: Beijing Children's Hospital,Capital Medical University

location_facility: Mother and Child Health Care Institute of Serbia Dr Vukan Cupic

location_facility: Stichting Epilepsie Instellingen Nederland

location_facility: Multicare Health System - Mary Bridge Pediatrics

location_facility: Kleinwachau Sachsisches Epilepsiezentrum Radeberg Gemeinnutzige Gmbh

summary:
The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of convulsive seizures in children and young adults with DS.

Participants will receive their standard antiseizure therapy, plus either a tablet of soticlestat or placebo for 16 weeks. A placebo looks just like soticlestat but will not have any medicine in it.

Participants may continue treatment in an extension study, based on the extension study's entry criteria. Those that want to stop treatment will have a gradual dose reduction during 1 week and then be followed up for 2 weeks.


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS)

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: University of California Benioff Children's Hospital

location_facility: Children's Hospital of Chongqing Medical University

location_facility: Hospital Regional Universitario de Malaga Hospital General

location_facility: Guangzhou Women And Children's Medical Center

location_facility: ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS

location_facility: Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN

location_facility: CNPE Clinical Hospital Psychiatry of the Executive Body of the Kyiv City Council KCSA

location_facility: Krankenhaus Mara gGmbH - Epilepsiezentrum Bethel

location_facility: Kumamoto-Ezuko Medical Center for The Severely Disabled

location_facility: National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders

location_facility: Institute of Neurology and Neurosurgery at Saint Barnabas, LLC

location_facility: Cook Children's Medical Center - Jane and John Justin Neurosciences Center

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Medical University of South Carolina Children Hospital - PIN

location_facility: National Center of Neurology and Psychiatry

location_facility: SI Ukr. Med. Rehabilitation Center For Children With Organic Injury of Nervous System of MoH of Ukr

location_facility: Krasnoyarsk State Medical University n.a. V.F. Voyno-Ysenetskiy

location_facility: Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet

location_facility: Childrens National Medical Center - Fairfax

location_facility: Hopital Universitaire des Enfants Reine Fabiola

location_facility: Russian National Research Medical University n.a. N.I.Pirogov

location_facility: The Second Affiliated Hospital of Guangzhou Medical University

location_facility: Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: University of Utah - Primary Children's Hospital - PPDS

location_facility: University of Iowa Hospitals & Clinics - (CRS)

location_facility: Clinic for Neurology and Psychiatry for Children and Youth

location_facility: Children and Youth Health Care Institute of Vojvodina

location_facility: Communal Non-commercial Enterprise Iv-Frank Regional Childrens Clinical Hosp of Iv-Frank RC

location_facility: Northwell Health Physician Partners - Neurology at Lenox Hill

location_facility: MultiCare Institute for Research & Innovation (Tacoma)

location_facility: Xiangya Hospital Central South University

summary:
The aims of the study are:

to learn if soticlestat, when given as add-on therapy, reduces the number of major motor drop seizures in children, teenagers, and adults with Lennox-Gastaut Syndrome.
to assess the safety profile of soticlestat when given in combination with other therapies.

Participants will receive their standard antiseizure therapy, plus either tablets of soticlestat or placebo. A placebo looks just like soticlestat but will not have any medicine in it. Participants will take soticlestat or placebo for 16 weeks, followed by a gradual dose reduction for 1 week. Then, participants will be followed up for 2 weeks.


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Non-Segmental Vitiligo

lead_sponsor: AbbVie

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

enrollment_type: Actual

location_country:
Japan
United States
Canada
France

location_facility: Tokyo Medical University Hospital /ID# 230288

location_facility: Dr. Chih-ho Hong Medical Inc. /ID# 228403

location_facility: Michigan Center for Research Company /ID# 228054

location_facility: University of Texas Health Science Center at Houston /ID# 229399

location_facility: HCL - Hopital Edouard Herriot /ID# 228194

location_facility: Essential Medical Research, LLC /ID# 228074

location_facility: Chu de Nice-Hopital L'Archet Ii /Id# 228192

location_facility: Centre de recheche dermatologique du Quebec Metropolitain /ID# 228388

location_facility: Oregon Medical Res Center PC /ID# 228073

location_facility: CHU Toulouse - Hopital Larrey /ID# 228196

location_facility: Nippon Medical School Hospital /ID# 230361

location_facility: Virginia Clinical Research, Inc. /ID# 228050

location_facility: Yamagata University Hospital /ID# 230362

location_facility: Oregon Dermatology and Research Center /ID# 228007

location_facility: Medical University of South Carolina /ID# 228067

location_facility: Remington-Davis Clinical Research /ID# 229401

location_facility: International Clinical Research - Tennessee LLC /ID# 228059

location_facility: Nagoya City University Hospital /ID# 228725

location_facility: University of California Irvine /ID# 229390

location_facility: Yamanashi Prefectural Central Hospital /ID# 229441

location_facility: Wiseman Dermatology Research /ID# 228410

summary:
Vitiligo is a common chronic autoimmune disease that causes the body's immune system to attack its own pigment producing skin cells. This study is to evaluate how safe and effective upadacitinib is in participants with non-segmental vitiligo. Adverse effects and change in disease activity will be assessed.

Upadacitinib is being evaluated for the treatment of non-segmental vitiligo. The study will enroll approximately 160 participants aged 18-65 with non-segmental vitiligo in 5 treatment arms across 35 sites worldwide.

Participants will either receive study drug vs placebo oral tablets once daily (QD) for 24 weeks (Period A). In Period B (up to 52 weeks), participants who received placebo during the first 24 weeks will switch to study drug. Participants who received study drug during the first 24 weeks, will continue to receive study drug.

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


title: A Phase 1/1b Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of KIN-2787 in Participants With BRAF and/or NRAS Mutation-positive Solid Tumors.

summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-2787 in adults with BRAF/NRAS-mutated advanced or metastatic solid tumors.

design_allocation: Non-Randomized

lead_sponsor: Kinnate Biopharma

location_country:
Taiwan
Spain
Australia
United States
France
Netherlands

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: Vall d'Hebron Institute of Oncology (VHIO)

location_facility: Sarah Cannon Research Institute - Lake Nona


title: A Phase 1/2 Non-randomized, Open-label, Multi-cohort, Multi-center Study Assessing the Clinical Benefit of SAR444245 (THOR- 707) Combined With Cemiplimab for the Treatment of Participants With Advanced Unresectable or Metastatic Skin Cancers

summary:
Primary Objective:

-To determine the antitumor activity of SAR444245 in combination with cemiplimab.

Secondary Objectives:

To determine the recommended phase 2 dose and to assess the safety profile of SAR444245 when combined with cemiplimab
To assess other indicators of antitumor activity
To assess the concentrations of SAR444245 when given in combination with cemiplimab
To assess the immunogenicity of SAR444245
To assess active concentrations of cemiplimab when given in combination with SAR444245

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

lead_sponsor: Sanofi

location_country:
Portugal
Spain
Ireland
Italy
Australia
Russian Federation
United States
Chile
France
Germany

location_facility: University of Minnesota-Site Number:8400012

location_facility: Beverly Hills Cancer Center & Optima Diagnostic Imaging-Site Number:8400007

location_facility: Mount Sinai Health System-Site Number:8400006


title: A Phase 2, Randomized, Open-Label Study of Trilaciclib Administered With First-Line Platinum-Based Chemotherapy and Avelumab Maintenance Therapy in Patients With Untreated, Locally Advanced or Metastatic Urothelial Carcinoma (PRESERVE 3)

summary: This is a Phase 2, multicenter, randomized, open-label study evaluating the safety and efficacy of trilaciclib administered with platinum-based chemotherapy followed by trilaciclib administered with avelumab maintenance therapy compared with platinum-based chemotherapy followed by avelumab maintenance therapy in patients receiving first-line treatment for advanced/metastatic bladder cancer.

ipd_sharing: No

lead_sponsor: G1 Therapeutics, Inc.

location_country:
Spain
Georgia
Hungary
United States
France

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Hopitaux Universitaires de Strasbourg - Service Oncologie et Hématologie

location_facility: University of North Carolina at Chapel Hill

location_facility: Fundación Instituto Valenciano de Oncología

location_facility: Institut Bergonié - Oncologie Médicale et Pédiatrique

location_facility: Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol

location_facility: Centre Léon Bérard - Département d'oncologie médicale

location_facility: LTD "Multiprofile Clinic Consilium Medulla"

location_facility: Hospital Clinic de Barcelona - Servicio de Oncología Médica

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendeloint

location_facility: The Oncology Institute of Hope and Innovation

location_facility: National Center of Urology Named after Laur Managadze

location_facility: The Harry and Jeanette Weinberg Cancer Institute

location_facility: ALTHAIA, Xarxa Assistencial Universitiria de Manresa

location_facility: Hôpital Européen Georges Pompidou - Service d'Oncologie Médicale


title: A Phase 1B/2 Randomized, Multicenter, Open-Label Study Of Iberdomide (CC-220) In Combination With Polatuzumab Vedotin Plus Rituximab Or Tafasitamab Or Rituximab Plus Chemotherapy For Subjects With Relapsed Or Refractory Aggressive B-Cell Lymphoma

summary: This is a Phase 1b/2 randomized study of Iberdomide (CC-220) added to 3 different combination regimens (polatuzumab vedotin plus rituximab (Cohort A), tafasitamab (Cohort B), rituximab plus gemcitabine and platinum-based chemotherapy (Cohort C)) for participants with relapsed or refractory aggressive B-cell lymphoma (R/R a-BCL). All 3 cohorts will be open for enrollment at study start. Part 1 (dose escalation) will be followed by Part 2 (dose expansion), in which participants will be randomized to one of three cohorts, with CC-220 at the recommended Phase 2 Dose in combination with the Cohorts A, B and C treatment that is compared to their individual standard of care regimen.

study_start_date_type: Anticipated

status: Withdrawn

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

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

lead_sponsor: Celgene

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

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: Nottingham University Hospitals NHS Trust

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Complejo Asistencial Universitario de Salamanca - H. Clinico

location_facility: University Hospital Southampton NHS Foundation Trust - Southampton General Hospital

location_facility: Hospital Universitario Germans Trias i Pujol

status_simplified: Unknown


title: A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma

lead_sponsor: Kite, A Gilead Company

location_country:
Spain
United Kingdom
Netherlands
United States
France
Germany

location_facility: University California Los Angeles (UCLA)

location_facility: Munich University of Technology-Medical Faculty- Ethics Committee

location_facility: Advocate Aurora Health - Advocate Lutheran General Hospital

location_facility: Cleveland Clinic - Taussig Cancer Institute

location_facility: Johannes Gutenberg University Hospital-University Mainz

summary: The primary objective is to evaluate the efficacy of brexucabtagene autoleucel (KTE-X19) in participants with relapsed/refractory (r/r) mantle cell lymphoma (MCL) in Cohort 3 of this study.


title: A Phase 2, Double-blind, Randomized, Placebo-controlled Study Assessing Efficacy and Safety of SAR441344, a CD40L-antagonist Monoclonal Antibody, in Participants With Relapsing Multiple Sclerosis

summary:
Primary Objective:

To determine the efficacy of SAR441344 as measured by reduction of the number of new active brain lesions

Secondary Objective:

To evaluate efficacy of SAR441344 on disease activity as assessed by other MRI measures
To evaluate the safety and tolerability of SAR441344
To evaluate pharmacokinetics of SAR441344

location_country:
Spain
Russian Federation
Canada
Ukraine
United States
France
Turkey
Germany
Bulgaria
Czechia

location_facility:
Investigational Site Number :6430001
Investigational Site Number :6430005
Investigational Site Number :7920004
Investigational Site Number :7920003
Investigational Site Number :2030003
Investigational Site Number :8040006
Investigational Site Number :2030004
Investigational Site Number :6430004
Investigational Site Number :2500006
Investigational Site Number :8400004
Investigational Site Number :7240003
Investigational Site Number :8040008
Investigational Site Number :2500003
Investigational Site Number :8400001
Investigational Site Number :7240002
Investigational Site Number :8400007
Investigational Site Number :8400002
Investigational Site Number :8400006
Investigational Site Number :1000002
Investigational Site Number :2030001
Investigational Site Number :2760004
Investigational Site Number :2500002
Investigational Site Number :2760001
Investigational Site Number :1240001
Investigational Site Number :7920001
Investigational Site Number :2760012
Investigational Site Number :7920002
Investigational Site Number :8040003
Investigational Site Number :6430003
Investigational Site Number :6430006
Investigational Site Number :2760003
Investigational Site Number :8040002
Investigational Site Number :2760005
Investigational Site Number :6430007
Investigational Site Number :2500004
Investigational Site Number :2760011
Investigational Site Number :8040010
Investigational Site Number :8040004
Investigational Site Number :2030005
Investigational Site Number :8400003
Investigational Site Number :7240004
Investigational Site Number :1000001
Investigational Site Number :2030002
Investigational Site Number :1000003
Investigational Site Number :6430008
Investigational Site Number :8040005
Investigational Site Number :2500007
Investigational Site Number :6430002


title: Renal Mode of Action of Semaglutide in Patients With Type 2 Diabetes and Chronic Kidney Disease

acronym: REMODEL

summary:
We are doing this study to learn more about how semaglutide may help fight chronic kidney disease in people with type 2 diabetes. We are doing this by looking into how semaglutide works in the kidneys.

Participants will either get semaglutide or placebo (a 'dummy' medicine) - which treatment participants get is decided by chance.

Semaglutide is a medicine doctors can prescribe in some countries for the treatment of type 2 diabetes.

Participants will get the study medicine in a pen. Participants will use the pen to inject the medicine into the skin once a week.

The study will last for about 1 year. Participants will have 11 visits to the clinic, and 2 phone visits. Some of the visits could be in different locations.

Study staff will take blood samples at most of these visits. At 9 visits, participants will be asked to bring a sample of their first morning urine. At 4 of the visits participants will have to bring urine that they have collected over the last 24 hours.

The study includes magnetic resonance imaging (MRI) scans of participants' kidneys which is a test that shows a detailed picture of organs and other parts inside the body. The scan will last for 30 minutes, and is free of radiation.

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

lead_sponsor: Novo Nordisk A/S

location_country:
Denmark
Poland
Spain
Italy
Canada
United States
France
South Africa


acronym: COMMUTE-a

title: A Phase III, Multicenter, Single-Arm Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Adult and Adolescent Patients With Atypical Hemolytic Uremic Syndrome (aHUS)

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

location_country:
Poland
Brazil
Spain
Italy
Mexico
Canada
Hungary
United States
France
China
Israel
Belgium
Japan
Germany
Peru
South Africa
Turkey

location_facility: University of California Irvine Chao Family Comprehensive Cancer Center

location_facility: Klinik für Nephrologie des Universitätsklinikum Essen; Klinik für Infektiologie - MFZ

location_facility: Santa Casa de Misericordia; de Belo Horizonte

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS; U.O.C. Nefrologia

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: Instituto Nacional de Ciencias; Medicas y Nutricion; Salvador Zubiran

location_facility: Presidio Ospedaliero Maggiore Policlinico Fondazione IRCCS; Pad Croff Div Nefrologia Dialisi

location_facility: Az. Osp. Careggi; Reparto Di Nefrologia, Dialisi E Trapianti

location_facility: SAMODZIELNY PUBLICZNY CENTRALNY SZPITAL KLINICZNY; Department KLINIKA NEFROLOGII, DIALIZOTERAPII I C

location_facility: UPECLIN Hospital das Clinicas da Faculdade de Medicina de Botucatu

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Nefrologia

location_facility: Erciyes University Medical Faculty; Internal Medicine

location_facility: Klinik II für Nephrologie, Rheumatologie, Diabetologie und Allgemeine Innere Medizin

location_facility: Szpital Kliniczny nr 1 im. prof. Szyszko; Oddz. Nefrologii Dzieciecej z Pododdziałem Dializoterapii

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Medizinische Hochschule Hannover; Klinik für Nieren- und Hochdruckerkrankungen

location_facility: Peking University First Hospital; NEPHROLOGY

location_facility: Istanbul University Istanbul Medical Faculty; Department of Internal Medicine

location_facility: Beijing Children's Hospital, Capital Medical University

location_facility: The Ohio State University Wexner Medical Center

location_facility: Universitätsklinikum Essen; Klinik für Kinder- und Jugendmedizin Pädiatrie II

location_facility: Hôpital Robert Debré; Nephrologie pediatrique

location_facility: Centro para el Desarrollo de la Medicina y de Asistencia

location_facility: UT Health Science Center; SouthTexas Pediatric Blood and Cancer Ctr

location_facility: Inkosi Albert Luthuli Central Hospital; Pediatric Nephrology

location_facility: Hospital Clinic i Provincial; Servicio de Nefrologia

location_facility: Inonu University Faculty of Medicine Turgut Ozal Medical Center

location_facility: Hôpital Arnaud de Villeneuve; Néphrologie pédiatrique

location_facility: Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Chorob Nerek i Nadciśnienia Dzieci i Mlodziezy

location_facility: Red Cross War Memorial Children's Hospital; Pediatric Nephrology

location_facility: Hospital Universitario 12 de Octubre; Servicio de Nefrologia

location_facility: Rambam Medical Center; Department of Nephrology and Hypertension

location_facility: A.O. Universitaria S. Martino Di Genova; Nefrologia

location_facility: Instytut "Centrum Zdrowia Matki Polki; Klinika Pediatrii i Immunologii i Nefrologii

location_facility: Necmettin Erbakan University Meram Medical Faculty ; Internal Diseases

location_facility: Del- Pesti Centrumkorhaz- Szent Laszlo Korhaz Telephely

summary: This study aims to evaluate the efficacy and safety of crovalimab in adult and adolescent participants with aHUS.


title: A Randomized, Double-blind, Placebo-controlled Study of ALPN-101 in Systemic Lupus Erythematosus

acronym: Synergy

summary: This is Phase 2, multinational, randomized, blinded study to evaluate the safety, tolerability, efficacy, immunogenicity, pharmacokinetics and pharmacodynamics of ALPN-101 in adults with moderate to severe active systemic lupus erythematosus (SLE)

lead_sponsor: Alpine Immune Sciences, Inc.

location_country:
Poland
Spain
Hungary
Korea, Republic of
United States
France

location_facility:
Investigational Site (118)
Investigational Site (169)
Investigational Site (162)
Investigational Site (180)
Investigational Site (155)
Investigational Site (161)
Investigational Site (170)
Investigational Site (156)
Investigational Site (139)
Investigational Site (106)
Investigational Site (158)
Investigational Site (154)
Investigational Site (108)
Investigational Site (121)
Investigational Site (109)
Investigational Site (186)
Investigational Site (171)
Investigational Site (123)
Investigational Site (145)
Investigational Site (178)
Investigational Site (183)
Investigational Site (115)
Investigational Site (137)
Investigational Site (165)
Investigational Site (120)
Investigational Site (113)
Investigational Site (175)
Investigational Site (122)
Investigational Site (124)
Investigational Site (163)
Investigational Site (112)
Investigational Site (114)
Investigational Site (166)
Investigational Site (179)
Investigational Site (117)
Investigational Site (160)
Investigational Site (173)
Investigational Site (131)
Investigational Site (164)
Investigational Site (172)
Investigational Site (125)
Investigational Site (181)
Investigational Site (104)
Investigational Site (152)
Investigational Site (133)
Investigational Site (151)
Investigational Site (167)
Investigational Site (138)
Investigational Site (116)
Investigational Site (119)
Investigational Site (142)
Investigational Site (174)
Investigational Sites (134, 153)
Investigational Site (128)
Investigational Site (149)
Investigational Site (110)
Investigational Site (107)
Investigational Site (143)
Investigational Site (126)
Investigational Site (127)


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging, Phase 2b Study to Evaluate Efficacy and Safety of Tezepelumab for the Treatment of Chronic Spontaneous Urticaria

acronym: INCEPTION

summary: The primary objective of this study is to evaluate the effect of tezepelumab on improvement in the Urticaria Activity Score over 7 days (UAS7).

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

lead_sponsor: Amgen

location_country:
Poland
Spain
Greece
Italy
Canada
Korea, Republic of
United States
France
Japan
Germany

location_facility: Fujita Health University Bantane Hospital

location_facility: Cutis Wellness Dermatology and Dermatopathology, PLLC

location_facility: Dermatology Research Institute Incorporated

location_facility: Dermatology and Ophthalmology Kume Clinic

location_facility: Hallym University Dongtan Sacred Heart Hospital

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: Washington University School of Medicine

location_facility: Hospital General Universitario de Valencia

location_facility: Azienda Ospedaliero Universitaria di Modena

location_facility: Kliniczny Szpital Wojewodzki nr 1 im Fryderyka Chopina

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Klinika Osipowicz and Turkowski Spzoo Opieka Wielospecjalistyczna Osipowicz and Turkowski

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Centre Hospitalier Universitaire Archet 2

location_facility: Family Allergy and Asthma Research Institute

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: AMICARE z ograniczona odpowiedzialnoscia spolka komandytowa

location_facility: Clinique Spécialisée en Allergie de la Capitale

location_facility: Gordon Sussman Clinical Research Incorporated

location_facility: The Allergy Asthma and Sinus Center, East Tennessee Center for Clinical Research

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon

location_facility: George Papageorgiou General Hospital of Thessaloniki

location_facility: David Fivenson MD Professional Liability Company

location_facility: Henry Ford Medical Center - New Center One

location_facility: Hallym University Kangnam Sacred Heart Hospital

location_facility: Dr. S. K. Siddha Medicine Professional Corporation

location_facility: Clinical Research Center Spzoo Medic-R Spolka Komandytowa

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino

location_facility: Attikon University General Hospital of Athens

location_facility: Centre Hospitalier Universitaire de Brest - Hôpital Morvan

location_facility: Seoul National University Bundang Hospital


title: A Phase 1/2 Dose Escalation and Dose Expansion Study of ZN-c3 in Combination With Gemcitabine in Adult and Pediatric Subjects With Relapsed or Refractory Osteosarcoma

summary: This is a phase 1/2 study of ZN-c3 in combination with gemcitabine in adult and pediatric subjects with relapsed or refractory osteosarcoma.

lead_sponsor: K-Group Beta

location_country:
United States
France

location_facility:
Site 3606
Site 0103
Site 0106
Site 0197
Site 3601
Site 0122
Site 0193
Site 0105
Site 3605
Site 0124
Site 3602
Site 0123
Site 3604
Site 0188
Site 0195
Site 0107


title: A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With T-DXd

summary: A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients who were previously treated with T-DXd

lead_sponsor: Ambrx, Inc.

location_country:
Australia
Korea, Republic of
United States
France

location_facility:
Korea University Anam Hospital
Research site
Research Site
University Hospital Geelong


title: A Phase 1b/2 Study of BMS-986158 Monotherapy and in Combination With Either Ruxolitinib or Fedratinib in Participants With DIPSS-Intermediate or High Risk Myelofibrosis

summary: The purpose of this study is to assess the safety, tolerability, and efficacy of BMS-986158 alone and in combination with either Ruxolitinib or Fedratinib in participants with Dynamic International Prognostic Scoring System (DIPSS)-intermediate or high risk blood cancer. Part 1 consists of BMS-986158 in combination with either Ruxolitinib or Fedratinib and Part 2 consists of BMS-986158 in combination with either Ruxolitinib or Fedratinib and BMS-986158 alone.

lead_sponsor: Bristol-Myers Squibb

location_country:
Spain
Italy
Australia
United States
Israel
France
Germany

location_facility: University of Massachusetts Medical School-Division of Hematology/Oncology

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Moores Cancer Center-Clinical Trials Office - Hematology


title: Open Label, Multicenter Phase II Study of the C5a Antibody IFX-1 Alone or IFX-1 + Pembrolizumab in Patients With PD-1 or PD-L1 Resistant/Refractory Locally Advanced or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC)

summary: This is an open-label, "non comparative", non-randomized, Phase II study. Patients will be enrolled in 2 treatment arms

lead_sponsor: InflaRx GmbH

location_country:
Spain
United States
France
Belgium
Germany

location_facility: University Hospital Leipzig, Department of Dermatology, Venereology and Allergology

location_facility: University Hospital Regensburg, Clinic and Policlinic for Dermatology

location_facility: University Hospital Tuebingen, Department of Dermatology

location_facility: University Hospital Erlangen, Department of Dermatology

location_facility: University Hospital Center of Grenoble Alpes, Department of Dermatology

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Frankfurt University Clinic, Department of Dermatology, Venereology and Allergology

location_facility: University Hospital Center of Poitiers, Department of Oncology

location_facility: University Duisburg-Essen, University Hospital Essen, Department of Dermatology

location_facility: CHU APHM la Timone / Aix Marseille University, Dermatology and Skin Cancer Department

location_facility: University Clinical Hospital of Salamanca

location_facility: MD Anderson International Cancer Center Spain


title: A First in Human Study of the Menin-KMT2A (MLL1) Inhibitor JNJ-75276617 in Participants With Acute Leukemia

summary: The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D[s]) of JNJ-75276617 in Part 1 (Dose Escalation) and to determine safety and tolerability at the RP2D(s) in Part 2 (Dose Expansion).

ipd_sharing_description:
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
United Kingdom
Spain
Australia
United States
France

location_facility: Centre Hospitalier Universitaire (CHU) de Bordeaux Hopital HautLeveque Centre Francois Magendie

location_facility: University of California Irvine Medical Center

location_facility: Guy's and St Thomas' NHS Foundation Trust

location_facility: Institut Universitaire du Cancer Toulouse Oncopole


title: A Phase 3, Open-label, Randomized, Noninferiority Trial of Subcutaneous Formulation of Nivolumab Versus Intravenous Nivolumab in Participants With Advanced or Metastatic Clear Cell Renal Cell Carcinoma Who Have Received Prior Systemic Therapy

location_country:
Poland
Brazil
Portugal
Romania
Ireland
Italy
New Zealand
Russian Federation
Argentina
Finland
Spain
United States
Chile
France
Turkey
Mexico
Czechia

location_facility: SBIH Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine

location_facility: Budgetary Healthcare Institution of Omsk Region - Clinical Oncological Dispensary

summary: The purpose of this study is to evaluate the drug levels, efficacy, safety, and tolerability of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread.


title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Pediatric Subjects With Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment

lead_sponsor: Neurocrine Biosciences

location_country:
Poland
Spain
Greece
Italy
Canada
United States
France
Belgium
Germany

summary: This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 28 weeks in approximately 81 pediatric patients with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. The study consists of a 28-week double blind, placebo-controlled period, followed by 24 weeks of treatment with crinecerfont. Duration of participation is approximately 14 months.


title: A Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis

summary:
This is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial. Participants will be screened within 4 weeks prior to the Baseline (Day 1) Visit. Approximately 300 participants who meet the trial eligibility criteria will be randomized on Day 1 in a 1:1:1 ratio to receive HZN-825 300 mg QD, HZN-825 300 mg BID or placebo for 52 weeks.

The trial will include up to a 4-week Screening Period and a 52-week Double-blind Treatment Period. Participants will take their first dose of trial drug at the clinic and will return to the clinic for trial visits at Week 4 and every 6 weeks thereafter until Week 52. All participants who complete the Double-blind Treatment Period (Week 52) will be eligible to enter a 52-week extension trial (HZNP-HZN-825-302, NCT not available yet). Participants not entering the extension will return to the clinic for a Safety Follow-up Visit 4 weeks after the last dose of trial drug.

ipd_sharing: Undecided

lead_sponsor: Horizon Therapeutics Ireland DAC

location_country:
Poland
Portugal
Spain
Greece
Austria
Italy
Netherlands
Argentina
Korea, Republic of
United States
France
Israel
Mexico
Japan
Germany

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: Consultorio de Investigaciones Reumatologicas

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Medicover Integrated Clinical Services sp. z o.o

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

location_facility: Arizona Arthritis and Rheumatology Research, PLLC

location_facility: Centro de Investigaciones Médicas Tucumán

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Osaka Medical and Pharmaceutical University Hospital

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: Fondazione IRCCS Policlinico San Matteo di Pavia

location_facility: Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi

location_facility: Hospital Conde de Bertiandos Unidade Local de Saúde Do Alto Minho

location_facility: Centro de Investigación y Tratamiento Reumatológico S.C

location_facility: Unidad de Atencion Medica e Investigacion en Salud

location_facility: CITER, Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas SA de CV

location_facility: Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin

location_facility: Clinica de Investigacion en Reumatologia y Obesidad

location_facility: Michigan Medicine University of Michigan

location_facility: Aprillus Asistencia e Investigacion de Arcis Salud SRL

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Centro de Estudios de Investigacion Basica Y Clinica SC

location_facility: Seoul National University Bundang Hospital

location_facility: University of Miami Miller School of Medicine

location_facility: Centro de Alta Especialidad En Reumatologia E Investigacion Del Potosi SC

location_facility: Ippokratio General Hospital of Thessaloniki

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

location_facility: Centro Hospitalar E Universitário de Coimbra EPE


title: 58-Week Open-label Trial of Tavapadon in Parkinson's Disease (TEMPO-4 Trial)

summary: The purpose of this study is to evaluate the safety and efficacy of long-term administration of flexible doses of tavapadon in participants with Parkinson's Disease.

status: Enrolling by invitation

lead_sponsor: Cerevel Therapeutics, LLC

location_country:
Poland
Serbia
Spain
Italy
Australia
Canada
Ukraine
Hungary
United States
France
Israel
Germany
Bulgaria
Czechia

location_facility:
Kraków
Muenchen
Tampa, Florida
Prague,
Medical Center, Zaporizhzhya
Spokane, Washington
Muenster
Houston, Texas
Lady Lake, Florida
Creteil,
Lawrence, Massachusetts
Bochum
Sevilla
West Bloomfield, Michigan
Asheville, North Carolina
Haifa
Shoham
Barcelona
Vinnitsa
Torino
Kansas City
Boca Raton, Florida
Pasadena, California
Pecs
Sofia
Padova
Woolloongabba, Queensland
Terrassa
Philadelphia, Pennsylvania
Georgetown, Texas
Medical center VITA1, Pleven
Toulouse Cedex 9
Petah Tiqva
Little Rock, Arkansas
Zaporizhia
Stadtroda
Pheonix, Arizona
Coral Springs, Florida
Florida, United States
Albany, New York
Lublin
Lviv
Maitland, Florida
Los Angeles, California
Chocen
Kirkland, Washington
Chicago, Illinois
Boulevard Pinel, Bron
Budapest
Clayton, Victoria
Reseda, California
Pamplona
Winfield, Illinois
Gera
Nîmes cedex 09
Dayton, Ohio
Ancona
Belgrade
Syracuse, New York
Durham, North Carolina
Fountain Valley, California
Haag in Oberbayern
Ottawa, Ontario
Round Rock, Texas
Milano
Winter Park, Florida
Grenoble cedex
Virginia Beach, Virginia
Rychnov nad Kněžnou
Port Charlotte, Florida
Erina, New South Wales
Fresno, California
Warsaw
Pisa
Toledo, Ohio
München
Lubbock, Texas
Belgrade,
Katowice
Elche
Siemianowice Slaskie
Tatabanya
Zaporiizhzhya
Toms River, New Jersey
Birmingham, Alabama
Rock Hill, South Carolina
Scarborough, Maine
Rome
Valencia
Madrid
Cincinnati, Ohio
Cracow
North Dartmouth, Massachusetts
Englewood, Colorado
Parkville, Victoria
Dnipro
Móstoles, Madrid
Berlin
Pleven
San Sebastian
Ocala, Florida
Sant Cugat del Vallés Barcelona
Boston, Massachusettes
Tel Aviv
Burlington, Vermont
Scottsdale, Arizona
Las Vegas, Nevada
Richmond, Virginia


title: A Phase 2, Multicenter, Randomized, Study of Trastuzumab Deruxtecan in Participants With HER2-overexpressing Locally Advanced, Unresectable or Metastatic Colorectal Cancer (DESTINY-CRC02)

lead_sponsor: Daiichi Sankyo, Inc.

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https:// vivli.org/ourmember/daiichi-sankyo/

location_country:
Taiwan
Spain
Italy
United Kingdom
Australia
Korea, Republic of
United States
France
Belgium
Japan

location_facility: Asst Grande Ospedale Metropolitano Niguarda

location_facility: Severance Hospital Yonsei University Health System

location_facility: National Hospital Organization Osaka National Hospital

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Sarah Cannon (Tennessee Oncology - Nashville)

location_facility: Hospital Clinico y Provincial de Barcelona

summary: This study will evaluate the efficacy, safety, and pharmacokinetics of Trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor 2 (HER2)-overexpressing locally advanced, unresectable, or metastatic colorectal cancer (mCRC).


title: A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of MK-5475 in Adults With Pulmonary Arterial Hypertension

summary:
This is a two-part (Phase 2/Phase 3) study of MK-5475, an inhaled soluble guanylate cyclase stimulator, in participants with pulmonary arterial hypertension (PAH).

The first part (Phase 2) will assess three different doses of MK-5475 compared to placebo in a base period of 12 weeks, followed by comparison of three different doses of MK-5475 during an optional 24 month extension period. The treatment dose with the best efficacy and safety profile in the phase 2 cohort base period will be selected for use in the second part (Phase 3) of the study. The primary hypothesis of Phase 2 is that at least one MK-5475 dose is superior to placebo in reducing pulmonary vascular resistance (PVR) from baseline at week 12.

The purpose of the second part (Phase 3) of the study is to confirm the efficacy, safety, and tolerability of MK-5475 at the selected dose compared to placebo during a 12 week base period followed by an extension period of up to 5 years. The primary hypothesis of Phase 3 is that MK-5475 is superior to placebo in increasing 6-minute walk distance (6MWD) from baseline at week 12.

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Poland
United Kingdom
Colombia
Greece
Australia
Italy
Argentina
Canada
Mexico
New Zealand
Russian Federation
Sweden
United States
France
Israel
Turkey
Belgium
Germany

location_facility: Norton Pulmonary Specialists ( Site 0048)

location_facility: Instituto de Investigaciones Clinicas Quilmes ( Site 0141)

location_facility: University of Texas Southwestern Medical Center at Dallas ( Site 0012)

location_facility: CHRU Brest - Hopital Cavale Blanche ( Site 0254)

location_facility: Houston Methodist Research Institute ( Site 0036)

location_facility: Operadora de Hospitales Angeles. S.A. de C.V. -Sucursal Lomas ( Site 0653)

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi ( Site 0509)

location_facility: Universitaetsklinikum Leipzig ( Site 0285)

location_facility: Istanbul Uni. Kardiyoloji Enstitusu ( Site 0502)

location_facility: Indiana University Health Methodist Hospital ( Site 0045)

location_facility: University of California Davis Health-Internal Medicine: Pulmonary, Critical Care and Sleep Medicine

location_facility: Georgetown University Hospital ( Site 0025)

location_facility: Specjalistyczny Szpital im. Dr Alfreda Sokolowskiego w Walbrzychu ( Site 0351)

location_facility: Hospital Universitario Austral ( Site 0138)

location_facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 0504)

location_facility: Hospital El Cruce Nestor Carlos Kirchner ( Site 0132)

location_facility: Azienda Ospedaliera Policlinico Umberto I ( Site 0301)

location_facility: University of Iowa Hospital and Clinics ( Site 0009)

location_facility: Medizinische Hochschule Hannover ( Site 0284)

location_facility: CHU de Toulouse - Hopital Larrey ( Site 0258)

location_facility: Fondazione IRCCS Policlinico San Matteo ( Site 0302)

location_facility: Clinical Trials Unit at Eastowne Medical Office Building ( Site 0019)

location_facility: Sahlgrenska Universitetssjukhuset-Cardiology Research Unit ( Site 0452)

location_facility: Hospital Privado Universitario de Córdoba ( Site 0137)

location_facility: Almazov National Medical Research Centre of the Ministry of Health ( Site 0402)

location_facility: Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 0554)

location_facility: Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0276)

location_facility: Centro Cardiovascular Colombiano Clínica Santa María ( Site 0154)

location_facility: Fundacion Cardiovascular de Colombia ( Site 0155)

location_facility: Dokuz Eylul University Faculty of Medicine ( Site 0505)

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0510)

location_facility: Shaare Zedek Medical Center ( Site 0331)

location_facility: Royal Brompton and Harefield NHS Trust ( Site 0553)

location_facility: Wolfson Medical Center [Holon, Israel] ( Site 0333)

location_facility: Centro Cardiologico Monzino IRCCS ( Site 0306)

location_facility: Instituto Nacional de Cardiología -Ignacio Chavez ( Site 0651)

location_facility: University of Kansas Medical Center ( Site 0038)

location_facility: Institut Coeur Poumon - CHRU de Lille ( Site 0252)

location_facility: Hospital Universitario San Ignacio ( Site 0152)

location_facility: AHEPA University General Hospital of Thessaloniki ( Site 0577)

location_facility: Consultorio 1020 Hospital Angeles Xalapa ( Site 0654)

location_facility: Scientific Research Institute Complex Problems Cardiovascular Disease ( Site 0403)

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0501)

location_facility: University of Nebraska Medical Center ( Site 0041)

location_facility: Centre Hospitalier Universitaire de Rouen ( Site 0253)

location_facility: University of Colorado - Denver ( Site 0003)

location_facility: Ospedale San Gerardo - ASST Monza ( Site 0304)

location_facility: Sentara Norfolk General Hospital ( Site 0014)

location_facility: Klinikum Würzburg Mitte-Medizinische Klinik - Schwerpunkt Pneumologie & Beatmungsmedizin ( Site 0280

location_facility: Akdeniz Uni.Tip Fakultesi Saglik Uygulama ve Arastirma Merkezi ( Site 0508)

location_facility: University of New Mexico, Health Sciences Center ( Site 0028)

location_facility: Universitaetsklinikum Giessen und Marburg GmbH ( Site 0279)

location_facility: Golden Jubilee National Hospital ( Site 0556)

location_facility: Instituto Cardiovascular de Rosario ( Site 0128)

location_facility: Sanatorio de la Trinidad Mitre ( Site 0130)

location_facility: University of Naples Federico II ( Site 0308)

location_facility: Cardiovascular Institute of North Colorado - Banner Health ( Site 0013)

location_facility: West Virginia University-WVU Heart and Vascular Institute ( Site 0051)

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie ( Site 0352)

location_facility: University Health Network - Toronto General Hospital ( Site 0104)

location_facility: Eskisehir Osmangazi Uni. Tip Fakultesi Hastanesi ( Site 0506)


title: EPIK-O: A Phase III, Multi-center, Randomized (1:1), Open-label, Active-controlled, Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Olaparib as Compared to Single Agent Cytotoxic Chemotherapy, in Participants With no Germline BRCA Mutation Detected, Platinum-resistant or Refractory, High-grade Serous Ovarian Cancer

summary: The objective of this study is to assess the efficacy and safety of the combination of alpelisib and olaparib compared with single agent cytotoxic chemotherapy in patients with platinum resistant or refractory high-grade serous ovarian cancer, with no germline BRCA mutation detected.

ReferenceCitation: Konstantinopoulos PA, Gonzalez-Martin A, Cruz FM, Friedlander M, Glasspool R, Lorusso D, Marth C, Monk BJ, Kim JW, Hinson P, Ajipa O, Pretre V, Han Y, Matulonis UA. EPIK-O/ENGOT-OV61: Alpelisib plus olaparib vs cytotoxic chemotherapy in high-grade serous ovarian cancer (phase III study). Future Oncol. 2022 Sep 6. doi: 10.2217/fon-2022-0666. [Epub ahead of print] Review.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Czechia
Portugal
Austria
Australia
Russian Federation
Argentina
Turkey
Mexico
Malaysia
Singapore
Slovakia
Brazil
Canada
China
Germany
Denmark
Taiwan
Finland
Korea, Republic of
France
Netherlands

location_facility: Florida Cancer Specialists Dept of Oncology (2)

location_facility: Texas Oncology, P.A. Texas Oncology - South Austin

location_facility: Texas Oncology Charles A. Sammons Cancer Ctr

location_facility: University of Cincinnati Dept of Oncology


title: A Multi-arm Phase 1b Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma

summary: The purpose of this study is to characterize the safety and tolerability of teclistamab when administered in different combination regimen and to identify the optimal dose(s) of teclistamab combination regimens.

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

location_country:
United Kingdom
Australia
United States
France
Belgium

location_facility: Washington University School of Medicine

location_facility: Institut Universitaire du cancer de Toulouse-Oncopole

location_facility: Indiana University Melvin and Bren Simon Cancer Center


title: A Phase 2, Single-arm, Open-label Clinical Trial of Pembrolizumab Plus Lenvatinib in Participants With First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (nccRCC) (KEYNOTE-B61)

summary: This study is being performed as a single-arm open-label study in order to rapidly provide information on the potential benefits of the combination of pembrolizumab and lenvatinib in participants with previously untreated advanced/metastatic non-clear cell renal cell carcinoma.

location_country:
Poland
Spain
Ireland
Italy
Australia
Russian Federation
Canada
United Kingdom
Ukraine
Hungary
Korea, Republic of
United States
France
Turkey

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás C

location_facility: Georgetown University Medical Center ( Site 0001)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

location_facility: Vanderbilt University Medical Center ( Site 0008)

location_facility: Luxmed Onkologia sp. z o. o. ( Site 0802)

location_facility: Cherkasy Regional Oncology Dispensary ( Site 0504)

location_facility: Dnepropetrovsk Regional Clinical Hospital Mechnikov-Department of urology ( Site 0508)

location_facility: Ashford Cancer Centre Research ( Site 0404)

location_facility: Macquarie University-MQ Health Clinical Trials Unit ( Site 0405)

location_facility: Azienda Ospedaliera Santa Maria Terni-SC Oncologia ( Site 0900)

location_facility: Országos Onkológiai Intézet-Urogenital Tumors Department and Clinical Pharmacology ( Site 0304)

location_facility: MEDICAL COLLEGE OF WISCONSIN ( Site 0006)

location_facility: Seattle Cancer Care Alliance ( Site 0014)

location_facility: Tallaght University Hospital ( Site 1600)

location_facility: Chernihiv Medical Center of Modern Oncology ( Site 0509)

location_facility: centre hospitalier lyon sud ( Site 1003)

location_facility: Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1007)

location_facility: BC Cancer Vancouver-Clinical Trials Unit ( Site 1500)

location_facility: CHU de Quebec - Université Laval - Hotel Dieu de Quebec ( Site 1502)

location_facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 0303)

location_facility: Russian Scientific Center of Radiology-Russian Scientific Center of Radiology ( Site 0602)

location_facility: Cambridge University Hospital ( Site 1200)

location_facility: Asan Medical Center-Department of Oncology ( Site 1300)

location_facility: SHBI Leningrad Regional Clinical Oncology Dispensary-Clinical Trials Department ( Site 0607)

location_facility: Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si

location_facility: Centre de Cancérologie du Grand Montpellier ( Site 1005)

location_facility: Nizhegorodsky Regional Oncology Dispensary, Branch #2-chemotherapy ( Site 0605)

location_facility: Volga District Medical Center-Urology Department ( Site 0604)

location_facility: CNPE "Regional Center of Oncology"-oncourology department ( Site 0502)

location_facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma-Oncology Unit ( Site 0902)

location_facility: Fundación Instituto Valenciano de Oncología-Oncologico ( Site 0202)

location_facility: Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu M-chemotherapy department ( Site 0800)

location_facility: Ankara University Hospital Cebeci ( Site 1105)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 0015)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 1103)

location_facility: Comprehensive Cancer Centers of Nevada ( Site 0010)

location_facility: Hacettepe Universitesi-oncology hospital ( Site 1101)

location_facility: Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1302)

location_facility: St. Vincent Frontier Cancer Center ( Site 0004)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0903)

location_facility: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0201)

location_facility: Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 0300)

location_facility: Sunnybrook Health Sciences Centre ( Site 1501)

location_facility: Istanbul Universitesi Cerrahpasa ( Site 1104)

location_facility: Princess Margaret Cancer Centre ( Site 1504)

location_facility: Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 0901)

location_facility: Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 0200)

location_facility: Ege University Medicine of Faculty ( Site 1102)


title: A Phase Ib Multicenter, Open-label Dose-escalation Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan (T-DXd) and Durvalumab in Combination With Cisplatin, Carboplatin or Pemetrexed in First-line Treatment of Patients With Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 Overexpression (HER2+) (DESTINY-Lung03)

summary: DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with durvalumab and chemotherapy in patients with HER2 positive advanced and metastatic non-small cell lung cancer. The efficacy will be also analyzed as a secondary endpoint.

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

lead_sponsor: AstraZeneca

location_country:
Poland
Taiwan
Spain
Italy
Australia
Netherlands
Canada
Thailand
Korea, Republic of
United States
France
Singapore
Belgium
Philippines
Malaysia


title: A Phase 2, Open-label, Multicenter Study of TL-895 in Subjects With Relapsed/Refractory Myelofibrosis, Janus Kinase Inhibitor Intolerant Myelofibrosis and Janus Kinase Inhibitor Treatment Ineligible Myelofibrosis

summary: This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis. Participants must be relapsed/refractory (e.g., having failed prior therapy), intolerant, or ineligible to receive JAKi treatment.

lead_sponsor: Telios Pharma, Inc.

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

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)

location_facility: AUSL della Romagna-Ospedale S.Maria delle Croci

location_facility: Universidade de Sao Paulo - Hospital das Clinicas da Faculdade de Medicina

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden

location_facility: Azienda Ospedaliero Universitaria Policlinico Umberto I

location_facility: University of Colorado - Aurora Cancer Center

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

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

location_facility: National Specialized Hospital for Active Treatment of Hematological Diseases

location_facility: University of Cincinnati (UC) Physicians Company, LLC

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu, Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku

location_facility: Grande Ospedale Metropolitano Bianchi Melacrino Morelli

location_facility: University of Texas, MD Anderson Cancer Center

location_facility: Azienda Ospedaliero Universitaria Maggiore Della Carita'

location_facility: Hematologista e Pesquisadora Clínica Hospital A Beneficência Portugues

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Instituto de Estudos e Pesquisas Sao Lucas - IEP - Sao Lucas

location_facility: Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktatókórház Megyei-Városi Tüdőgondozó Intézete

location_facility: Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy, Klinika Hematologi

location_facility: Praxisklinik fur Hamatologie und Onkologie

location_facility: Chang Gung Memorial Hospital - Kaohsiung Branch

location_facility: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

location_facility: Azienda Ospedaliera di Perugia-Ospedale S. Maria della Misericordia

location_facility: Institut Catala d'Oncologia - L'Hospitalet

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco - Presidio Ospedaliero G. Rodolico

location_facility: Klinika Hematologii Collegium Medicum Uniwersytetu Jagiellonskiego

location_facility: Markhot Ferenc Oktatokorhaz es Rendelointezet

location_facility: Klinik fur Innere Medizin IV - Hamatologie/Onkologie, Universitatsklinikum Hall


title: An Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis

summary: The purpose of this study is to assess the safety, tolerability and efficacy of additional 6-week treatment cycles with rozanolixizumab in study participants with generalized myasthenia gravis (gMG).

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

lead_sponsor: UCB Biopharma SRL

location_country:
Denmark
Poland
Taiwan
Serbia
Spain
Italy
Georgia
Russian Federation
Canada
United States
France
Japan
Germany
Czechia


acronym: XTEND-ed

title: A Phase 3 Open-label, Multicenter Study of the Long-term Safety and Efficacy of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients With Severe Hemophilia A

lead_sponsor: Bioverativ, a Sanofi company

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Australia
Argentina
Brazil
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Taiwan
Greece
Ireland
Korea, Republic of
France
Netherlands

location_facility: Orthopaedic Institute for Children-Site Number:8400003

location_facility: Children's Hospital Of Iowa-Site Number:8400011

location_facility: University of Florida Health-Site Number:8400008

location_facility: Cincinnati Children's Hospital Medical Center-Site Number:8400012

location_facility: Hemostasis and Thrombosis Center of Nevada-Site Number:8400001

location_facility: Children's Hospital Los Angeles-Site Number:8400009

location_facility: Rush University Medical Center-Site Number:8400010

location_facility: University of Michigan Medical Center-Site Number:8400006

location_facility: University of California San Diego-Site Number:8400007

location_facility: Michigan State University School Of Med-Site Number:8400002

summary:
Primary Objective:

- To evaluate the long-term safety of BIVV001 in previously treated subjects with hemophilia A

Secondary Objectives:

To evaluate the efficacy of BIVV001 as a prophylaxis treatment.
To evaluate the efficacy of BIVV001 in the treatment of bleeding episodes.
To evaluate BIVV001 consumption for prevention and treatment of bleeding episodes.
To evaluate the effect of BIVV001 prophylaxis on joint health outcomes.
To evaluate the effect of BIVV001 prophylaxis on Quality of Life (QoL) outcomes.
To evaluate the safety and tolerability of BIVV001 treatment.
To assess the PK of BIVV001 based on the one stage activated partial thromboplastin time (aPTT) and two-stage chromogenic FVIII activity assays (only applicable to Arm B).
To evaluate the efficacy of BIVV001 for perioperative management


title: A Phase III Randomized, Open-Label Active Comparator-Controlled Multicenter Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients With Primary Membranous Nephropathy

summary: This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics (PK) of obinutuzumab compared with tacrolimus in participants with primary membranous nephropathy (pMN).

ReferenceCitation: Dossier C, Hogan J. Response to Majeranowski. Pediatr Nephrol. 2021 Jun;36(6):1653. doi: 10.1007/s00467-021-04982-4. Epub 2021 Mar 10.

lead_sponsor: Hoffmann-La Roche

location_country:
Poland
Brazil
Spain
Italy
Russian Federation
Argentina
Ukraine
United States
France
China
Israel
Turkey

location_facility: Hopital Tenon; Service de Nephrologie et Dialyses

location_facility: Szpital Uniwersytecki im.dr.A.Jurasza w Bydgoszczy; Klinika Nefrologii, Nadcisnienia Tetniczego

location_facility: ASST Monza - Ospedale San Gerardo; Clinica Nefrologica

location_facility: Hospital Italiano de Buenos Aires; Rheumatology department

location_facility: Hospital Britanico Buenos Aires; Rheumatology Service

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku; II Klinika Nefrologii

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu; Klinika Nefrologii

location_facility: Mayo Clinic; Nephrology and Hypertension

location_facility: Hadassah Medical Orgainastion; Nephrology

location_facility: Regional Clinical Hospital n.a I.I. Mechnicov

location_facility: Accel Research Sites; Mid-Florida Kidney and Hypertension Care

location_facility: Hospital do Rim e Hipertensão - Fundação Oswaldo Ramos

location_facility: The First Affiliated Hospital of Xian Jiao Tong University

location_facility: The 1st Affiliated hospital of Fujian Medical University

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine

location_facility: West China Hospital - Sichuan University

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

location_facility: Hospital Universitari de Bellvitge; Servicio de Nefrologia

location_facility: Kaiser Permanente - San Francisco Medical Center

location_facility: Hopital Bichat Claude Bernard; Nephrologie

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

location_facility: Chinese People's Liberation Army Eastern Theater General Hospital

location_facility: General Hospital of Ningxia Medical University

location_facility: Istanbul University Istanbul Medical Faculty; Department of Internal Medicine

location_facility: Keck School of Medicine - University of Southern California

location_facility: HOPITAL HENRI MONDOR; SERVICE DE Nephrologie

location_facility: A.O. Spedali Civili Di Brescia-P.O. Spedali Civili; Nefrologia

location_facility: Henry Ford Hospital; Div of Nephrology & Hypertension

location_facility: Akdeniz University Medical Faculty; Internal Medicine, Nephrology

location_facility: Institute of Nephrology NAMS of Ukraine; Department of Nephrology, Dialysis and IT Support

location_facility: Policlinico di Bari; Divisione di Nefrologia, Dialisi e Trapianto

location_facility: Hospital General Universitaro Gregorio Marañon ;Servicio de Nefrologia

location_facility: Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego; Oddzial Nefrologii

location_facility: Hacettepe Uni School of Medicine; Nephrology

location_facility: Uniwersytecki Szpital Kliniczny im WAM CSW; Klinika Nefrologii i Transplantologii Nerek

location_facility: Hospital Clinic i Provincial; Servicio de Nefrologia

location_facility: Nanfang Hospital, Southern Medical University

location_facility: University of Colorado in Denver-Anschutz Medical Campus

location_facility: First Moscow State Medical University n.a. I.M. Sechenov

location_facility: Hospital Universitario 12 de Octubre; Servicio de Nefrologia

location_facility: Penn State Univ. Milton S. Hershey Medical Center

location_facility: Ser Servicos Especializados Em Reumatologia

location_facility: Hospital das Clinicas - FMUSP; Nefrologia

location_facility: Rambam Medical Center; Department of Nephrology and Hypertension

location_facility: Ospedale San Giovanni Bosco; Unita Operativa Nefrologia Dialisi

location_facility: Autonomous non-commercial organization "Medical Research Center of Drug Therapy "Yuninova"

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Hopital Rangueil; Service de Nephrologie & D'Immunologie Clinique

location_facility: A.O. U. Federico II; U.O. di Nefrologia - Dipartimento di Sanità Pubblica

location_facility: Hospital Universitario Dr. Peset; Servicio de Nefrologia

location_facility: Istanbul Florence Nightingale Hospital; Nephrology


title: An Adaptive, Randomized, Placebo-controlled, Double-blind, Multi-center Study of Oral Etavopivat, a Pyruvate Kinase Activator in Patients With Sickle Cell Disease (HIBISCUS)

summary: This clinical trial is a Phase 2/3 study that will evaluate the efficacy and safety of etavopivat and test how well etavopivat works compared to placebo to improve the amount of hemoglobin in the blood and to reduce the number of vaso-occlusive crises (times when the blood vessels become blocked and cause pain).

ReferenceCitation: Forsyth S, Schroeder P, Geib J, Vrishabhendra L, Konstantinidis DG, LaSalvia K, Ribadeneira MD, Wu E, Kelly P, Kalfa TA. Safety, Pharmacokinetics, and Pharmacodynamics of Etavopivat (FT-4202), an Allosteric Activator of Pyruvate Kinase-R, in Healthy Adults: A Randomized, Placebo-Controlled, Double-Blind, First-in-Human Phase 1 Trial. Clin Pharmacol Drug Dev. 2022 May;11(5):654-665. doi: 10.1002/cpdd.1058. Epub 2022 Jan 12.

lead_sponsor: Forma Therapeutics, Inc.

location_country:
Spain
Greece
Italy
Lebanon
United Kingdom
Canada
United States
France
Germany

location_facility: Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco"

location_facility: General Hospital of Thessaloniki "Hippokration"

location_facility: University of Maryland School of Medicine

location_facility: Cincinnati Childrens Hospital Medical Center

location_facility: University of Alabama at Birmingham (UAB)

location_facility: Hospital Universitari Vall d'Hebron de Barcelona

location_facility: Guy's and St Thomas' NHS Foundation Trust

location_facility: Universite de Montreal - Centre Hospitalier Universitaire (CHU) Sainte-Justine

location_facility: Augusta University Center for Blood Disorders.

location_facility: UCSF Benioff Children's Hospital Oakland

location_facility: Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz

location_facility: Medical University of South Carolina (MUSC)

location_facility: St. Jude Children's Research Hospital (SJCRH)

location_facility: Children's Healthcare of Atlanta - Pediatric Research Center

location_facility: Oxford University Hospitals NHS Trust - Churchill Hospital - Cancer and Haematology Centre

location_facility: University of Connecticut (UCONN) Health

location_facility: Washington University School of Medicine Barnes - Jewish Hospital

location_facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga

location_facility: Collaborative Neuroscience Research, LLC.

location_facility: American University of Beirut Medical Center

location_facility: East Carolina University (ECU) Physicians

location_facility: The Royal Hallamshire Hospital, Sheffield Teaching Hospital NHS Foundation Trust

location_facility: University of Illinois at Chicago Sickle Cell Center

location_facility: UC Davis Medical Center - UC Davis Comprehensive Cancer Center - Hemotology/Oncology Clinic

location_facility: The University of Texas Health Science Center at Houston

location_facility: Foundation for Sickle Cell Disease Research