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

acronym: ARNASA

summary: This study will evaluate the efficacy and safety of astegolimab compared with placebo in participants with chronic obstructive pulmonary disease (COPD) who are former or current smokers and have a history of frequent exacerbations.

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

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Thailand
Chile
Czechia
Canada
France
Hungary
Hong Kong
Switzerland
United States
Latvia
Kenya
Romania
Belgium
Philippines
Italy
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Israel

location_facility: Allergy Center at Brookstone Research - Centricity Research - HyperCore - PPD

location_facility: Wojewodzki Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie

location_facility: Centro Respiratorio Integral LTDA. (CENRESIN)

location_facility: Washington University School of Medicine in St. Louis

location_facility: Vital Prospects Clinical Research Institute PC - CRN

location_facility: AES - DRS - Synexus Leipzig Research Centre

location_facility: Dr Anil Dhar Professional Medicine Corporation

location_facility: Praxis fur Kardiologie und Pneumologie Dr. med. Karin Forster

location_facility: Synexus Clinical Research US, Inc. - Phoenix West

location_facility: AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Czestochowie

location_facility: Consultorios Medicos Organizacion de Buen Ayre SRL

location_facility: Tennessee Comprehensive Lung & Sleep Center

location_facility: ABC-Pulmo NZOZ Agnieszka Dobielska, Jaroslaw Dobie

location_facility: Centrum Medyczne CLW-med Aneta Cichomska , Joanna Luka -Wendrowska

location_facility: AES - DRS - Synexus Clinical Research US, Inc. - The Villages

location_facility: ASHA Clinical Research - ClinEdge - PPDS

location_facility: AES - DRS - Synexus Frankfurt Research Centre

location_facility: Prywatna Praktyka Lekarska Adam Smialowski

location_facility: Multiprofile Hospital for Active Treatment Puls AD PPDS

location_facility: Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD

location_facility: AES - DRS - Synexus Berlin Research Centre

location_facility: Allergy Asthma and Sinus Center-Greenfield

location_facility: Synexus Clinical Research US, Inc. - Birmingham

location_facility: Centrum Medyczne Lukamed Joanna Luka-Wendrowska

location_facility: AES - DRS - Synexus Clinical Research US, Inc. - New York

location_facility: Instituto Medico de la Fundacion Estudios Clinicos

location_facility: Lekarze Specjalisci J. Malolepszy i Partnerzy

location_facility: Multiprofile Hospital For Active Treatment Sveta Ekaterina - Dimitrovgrad EOOD

location_facility: Soon Chun Hyang University Hospital Bucheon

location_facility: Hassman Research Institute - HRI - Berlin - CenExel - PPDS

location_facility: Clinical Trials Center of Middle Tennessee

location_facility: Nexo Salud Investigacion Clinica - Riobamba 429

location_facility: Servicio de Investigacion de Patologias Alergicas-Instituto ABC

location_facility: Georgios Papanikolaou General Hospital of Thessaloniki

location_facility: Postgraduate Medical Training Institute University of Latvia

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

location_facility: Synexus Polska Sp. z o.o. Oddzial w Gdyni

location_facility: Instituto de Investigaciones En Alergia Y Enfermedades Respiratorias

location_facility: AES - AS - Glenny Corp. S.A. Buenos Aires

location_facility: Daugavpils Regional Hospital, Outpatient Clinic

location_facility: AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Clinical Research Associates Of Central Pa , Llc

location_facility: Plicní ambulance MUDr. I. Cierná Peterová s.r.o.

location_facility: Srinagarind Hospital, Khon Kaen University

location_facility: AES - DRS - Synexus Clinical Research US, Inc. - Tucson

location_facility: AES - DRS - Synexus Hexham Clinical Research Centre

location_facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

location_facility: AES - DRS - Synexus Clinical Research US, Inc. - Vista

location_facility: Diagnostic-Consultative Center Aleksandrovska EOOD

location_facility: Centrum Medyczne Katowice - PRATIA - PPDS

location_facility: Diagnostic- Consultative Center Convex EOOD

location_facility: AES - DRS - Synexus Debrecen Magyarorszag Egeszsegugyi Szolgaltato Kft

location_facility: Groupe Hospitalier Cochin St Vincent de Paul La Roche Guyon

location_facility: Wellnow Urgent Care and Research ? Springdale

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Velocity Clinical Research - Gaffney - PPDS

location_facility: AES - DRS - Synexus - Helderberg Clinical Research Centre

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Pauls Stradins Clinical University Hospital

location_facility: ME Clinical Respiratory Research Hamburg GmbH

location_facility: Prywatny Gabinet Pulmonologiczny Joanna Nowacka-Apiyo

location_facility: Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Victor Babes Craiova

location_facility: Nebraska Medical Research Institute, Inc. - CRN

location_facility: AES - DRS - Synexus Clinical Research US, Inc. - Atlanta

location_facility: CINME S.A. ? Centro de Investigaciones Metabolicas - Rx Trials LLC

location_facility: Multiprofile Hospital for Active Treatment - Silistra AD

location_facility: Sala de primeros auxilios Alberto Mignaburu

location_facility: Fondazione IRCCS Policlinico San Matteo di Pavia

location_facility: WellNow Urgent Care & Research - Huber Heights

location_facility: Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

location_facility: University General Hospital of Heraklion

location_facility: AES - DRS - Synexus Watermeyer Clinical Research Centre

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Gabinet Pulmonologii i Diagnostyki Chorob Alergicznych Dorota Malosek

location_facility: CEPROSS- Centro Profesional San Salvador

location_facility: Fifth Multiprofile Hospital for Active Treatment - Sofia EAD

location_facility: AES - DRS - Synexus Polska Sp. Z o.o. Oddzial w Lodzi

location_facility: Care Access Research - Fayetteville - PPDS

location_facility: Medicross Pretoria West, Jongaie Research

location_facility: Clinical Research Health Network (CREA-N)

location_facility: Viltis Medica Specjalistyczna Praktyka Lekarska Lek. Med. Agata Kot

location_facility: AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie

location_facility: Kaohsiung Medical University Hospital; Chung-Ho Memorial Hospital

location_facility: AES DRS Medical Center Synexus Sofia EOOD

location_facility: University General Hospital of Alexandroupolis

location_facility: Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska


title: A Phase 2 Open-Label Study to Evaluate Etavopivat for the Treatment of Anemia in Patients With Myelodysplastic Syndromes (MDS)

summary: The purpose of this study is to evaluate the safety and efficacy of etavopivat (FT-4202) for the treatment of anemia in adult patients with very low risk, low risk, or intermediate risk MDS.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Forma Therapeutics, Inc.

location_country:
United States
Canada
Germany
France

location_facility: University of Maryland Greenebaum Comprehensive Cancer Center

location_facility: Columbia University Irving Medical Center

location_facility: University of British Columbia - St. Paul's Hospital

location_facility: Nice University Hospital - Hôpital de l'Archet

location_facility: University of Miami Hospital and Clinics

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: LOGGIC/FIREFLY-2: A Phase 3, Randomized, International Multicenter Trial of DAY101 Monotherapy Versus Standard of Care Chemotherapy in Patients With Pediatric Low-Grade Glioma Harboring an Activating RAF Alteration Requiring First-Line Systemic Therapy

summary: This is a 2-arm, randomized, open-label, multicenter, global, Phase 3 trial to evaluate the efficacy, safety, and tolerability of DAY101 monotherapy versus standard of care (SoC) chemotherapy in patients with pediatric low-grade glioma (LGG) harboring an activating rapidly accelerated fibrosarcoma (RAF) alteration requiring front-line systemic therapy.

design_allocation: Randomized

lead_sponsor: Day One Biopharmaceuticals, Inc.

collaborators: SIOPe Brain Tumor Group LOGGIC Consortium

location_country:
Finland
Germany
New Zealand
Australia
Czechia
Canada
France
Slovenia
Hungary
Denmark
Switzerland
United States
Belgium
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Greece
Israel

location_facility: Centre Hospitalier de l'Université Laval et Centre Mère-Enfant Soleil

location_facility: University of Michigan - - C.S. Mott Children's Hospital

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

location_facility: Centre Hospitalier Universitaire Vaudois Lausanne

location_facility: SickKids - The Hospital for Sick Children

location_facility: Fakultní Nemocnice Brno - D?tská Nemocnice

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: SingHealth Group - KK Women's and Children's Hospital

location_facility: University Hospitals Bristol and Weston NHS Foundation Trust

location_facility: The Edmond and Lily Safra Children's Hospital

location_facility: Schneider Children's Medical Center of Israel

location_facility: Semmelweis Egyetem Tűzoltó utcai II. Sz. Gyermekgyógyászati Kliniká

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Helsingin yliopistollinen sairaala (HUS)

location_facility: Riley Hospital for Children at Indiana University Health

location_facility: Drottning Silvias barn- och ungdomssjukhus

location_facility: Starship Paediatric Blood & Cancer Center

location_facility: Azienda Ospedaliera di Rilievo Nazional Santobono Pausilipon

location_facility: Hospital Infantil Universitario Niño Jesús

location_facility: University of Texas Southwestern Medical Center

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: The Royal Children's Hospital - Children's Cancer Centre


title: A Phase 2a, Randomized, Open-Label Study to Evaluate Multiple Dosing Regimens of Subcutaneous ALXN1820 in Adult Participants With Sickle Cell Disease

acronym: PHOENIX

summary: The primary objective of this study is to assess the safety and tolerability of ALXN1820 SC (subcutaneous) in participants with SCD (Sickle Cell Disease).

status: Active, not recruiting

ipd_sharing: Yes

ipd_sharing_description: Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.

lead_sponsor: Alexion Pharmaceuticals, Inc.

location_country:
United States
France


title: A Pharmacokinetic Subtrial in Adolescent Patients With Hereditary Angioedema Type I or II Participating in the KVD900-302 Trial

summary: This is a multicenter pharmacokinetic (PK) subtrial to investigate the PK profile of KVD900 in adolescent patients 12 to 17 years of age with Hereditary Angioedema (HAE) type I or II.

ipd_sharing: No

ipd_sharing_description: Data will not be shared until all global regulatory filings are complete.

lead_sponsor: KalVista Pharmaceuticals, Ltd.

location_country:
Germany
New Zealand
Slovakia
Israel
United Kingdom
Romania
Australia
Japan
Netherlands
Austria
United States
Spain
Greece
Bulgaria
France

location_facility:
KalVista Investigative Site
Kalvista Investigative Site
KalVista Investgative Site


type: Other Identifier

type: EudraCT Number

title: A Phase 3, Multicenter, Randomized Clinical Study to Evaluate Mirikizumab in Pediatric Crohn's Disease

acronym: AMAY

summary:
Study participants will be screened during the platform study and randomly assigned to receive mirikizumab or another intervention. The purpose of the mirikizumab study is to evaluate efficacy, safety, tolerability, and how well mirikizumab absorbs into the body of pediatric participants with Crohn's disease.

Study periods for the intervention-specific appendix (ISA) will be as follows:

A 12-week induction period
A maintenance period from Week 12 to Week 52, and
A safety follow-up period up to 16 weeks.

The study will last about 74 weeks and may include up to 19 visits.

study_start_date_type: Anticipated

status: Not yet recruiting

design_allocation: Non-Randomized

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

lead_sponsor: Eli Lilly and Company

location_country:
Italy
Poland
Portugal
Israel
Norway
United Kingdom
Australia
Brazil
Japan
Austria
Belgium
Netherlands
United States
Korea, Republic of
Spain
Canada
France

location_facility: Women'S and Children'S Hospital, Adelaide

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer

location_facility: Children's & Women's Health Centre of British Columbia

location_facility: Children's Center for Digestive Health Care, LLC

location_facility: Texas Children's Hospital -Research Resource Office

location_facility: Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

location_facility: National Center For Child Health And Development

location_facility: Associação Hospitalar de Proteção à Infância Dr. Raul Carneiro

location_facility: Arkansas Children's Hospital Research Institute

location_facility: University of North Carolina at Chapel Hill

location_facility: Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

location_facility: Uniwersytecki Szpital Dziecięcy w Krakowie

location_facility: Hospital Universitari i Politecnic La Fe

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

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

location_facility: University of California-San Francisco-Mission Bay

location_facility: Hadassah University Hospital - Mount Scopus

location_facility: Yokohama City University Medical Center, Center of IBD

location_facility: Columbia University Medical Center/New York Presbyterian

location_facility: Hospital da Criança Santo Antônio - Irmandade da Santa Casa de Misericórdia de Porto Alegre

location_facility: Royal Hospital for Children and Young People

location_facility: HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas

location_facility: Great Ormond Street Hospital for Children

location_facility: Kyungpook National University Chilgok Hospital

location_facility: HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás


type: Registry Identifier

title: A Phase 3 Randomized Clinical Study of MK-4280A (Coformulated Favezelimab [MK-4280] Plus Pembrolizumab [MK-3475]) Versus Physician's Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (KEYFORM-008)

summary: The purpose of this study is to compare efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) with physician's choice chemotherapy of bendamustine or gemcitabine in participants with PD-(L)1-refractory, relapsed or refractory classical Hodgkin Lymphoma. The study will also assess the safety and tolerability of coformulated favezelimab/pembrolizumab. The primary study hypotheses are that coformulated favezelimab/pembrolizumab is superior to physician's choice chemotherapy with respect to progression-free survival (PFS) and overall survival (OS).

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Germany
Poland
Israel
United Kingdom
Australia
Brazil
Sweden
Switzerland
Belgium
United States
China
Korea, Republic of
Spain
Turkey
Canada
France

location_facility: Hospital Universitario Marqués de Valdecilla ( Site 1805)

location_facility: Anhui Provincial Cancer Hospital ( Site 0501)

location_facility: University of Kentucky Chandler Medical Center ( Site 2201)

location_facility: Sun Yat-sen University Cancer Center-Internal medicine ( Site 0500)

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden-University Cancer Center Early Clinical Trial Unit (

location_facility: Fudan University Shanghai Cancer Center ( Site 0520)

location_facility: Universitätsklinikum Münster - Albert Schweitzer Campus ( Site 0806)

location_facility: Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1900)

location_facility: Hospital Paulistano-Americas Oncologia ( Site 0207)

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Hematologii, Nowotworów Krwi i

location_facility: Johns Hopkins University-The Sidney Kimmel Comprehensive Cancer Center ( Site 2206)

location_facility: Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 0506)

location_facility: Rabin Medical Center-Hemato-Oncology ( Site 1001)

location_facility: Universitaetsklinikum Koeln-Klinik I für Innere Medizin ( Site 0801)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site

location_facility: Peking University Third Hospital-Hematology ( Site 0519)

location_facility: Universitätsklinikum Leipzig ( Site 0803)

location_facility: Xiangya Hospital Central South University ( Site 0513)

location_facility: Hacettepe Universite Hastaneleri-Department of Hematology ( Site 2006)

location_facility: Hospital Universitario de Salamanca - Complejo Asistencial U-Servicio de Hematologia ( Site 1801)

location_facility: Skånes Universitetssjukhus Lund ( Site 1901)

location_facility: The First Hospital of Jilin University-Hematology ( Site 0516)

location_facility: Universitaetsklinikum Ulm-Department of Internal Medicine III ( Site 0805)

location_facility: St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 2105)

location_facility: Pusan National University Hospital-Internal Medicine ( Site 1704)

location_facility: West China Hospital of Sichuan University-Head and Neck Oncology ( Site 0502)

location_facility: Royal Perth Hospital-Haematology ( Site 0004)

location_facility: Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi

location_facility: CENTRE LEON BERARD-Medical oncology ( Site 0703)

location_facility: Fred Hutchinson Cancer Center ( Site 2212)

location_facility: The First Affiliated hospital of Xiamen University ( Site 0512)

location_facility: Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 0704)

location_facility: Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 0002)

location_facility: Seoul National University Hospital ( Site 1701)

location_facility: Cleveland Clinic-Taussig Cancer Center ( Site 2203)

location_facility: Hospital General Universitario de Alicante ( Site 1806)

location_facility: University Hospitals Cleveland Medical Center ( Site 2214)

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0202)

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0509)

location_facility: Hospital Universitari Vall d'Hebron ( Site 1803)

location_facility: Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 2000)

location_facility: Hadassah Medical Center-Hemato-Oncology ( Site 1000)

location_facility: Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1702)

location_facility: Sheba Medical Center-Hemato Oncology ( Site 1005)

location_facility: Kocaeli Üniversitesi-Hematology ( Site 2009)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 2217)

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE ( Site 0706)

location_facility: Ospedale Regionale Bellinzona e Valli-IOSI ( Site 1600)


title: An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema Type I or II

summary: This is an open-label, multicenter extension trial to evaluate the long-term safety of KVD900 in patients who are 12 years or older with HAE type I or II.

location_country:
Germany
Poland
New Zealand
Australia
Japan
France
Portugal
Slovakia
Hungary
United States
North Macedonia
Romania
Italy
United Kingdom
Netherlands
Austria
Spain
Greece
South Africa
Bulgaria
Israel

location_facility:
KalVista Investigative Site
Kalvista Investigative Site
KalVista Investgative Site


title: Prospective, Long-Term, Interventional, Active Extension Study to Evaluate the Safety and Tolerability of NBI-921352 as Adjunctive Therapy in Subjects With Focal Onset Seizures (FOS)

summary: This Phase 2, prospective, interventional, active extension study was designed to evaluate the long-term safety and tolerability of NBI-921352 as adjunctive therapy in adult participants with focal onset seizures who completed 11 weeks of treatment in randomized, double-blind, placebo-controlled Study NBI-921352-FOS2021. Eligible participants may enroll directly following the completion of the Week 11 study visit of Study NBI-921352-FOS2021 or after a gap following completion of that study.

status: Enrolling by invitation

lead_sponsor: Neurocrine Biosciences

location_country: Italy Hungary Australia Belgium Spain Czechia France

status_simplified: Unknown


title: A Phase 2a/2b, Open-label, Proof of Concept (Phase 2a) and Double-blind, Randomized, Placebo-Controlled (Phase 2b), Multicenter, Efficacy, and Safety Study of AG-946 in Participants With Anemia Due to Lower-Risk Myelodysplastic Syndromes

summary: This purpose of this study is to establish proof of concept of AG-946 in participants with LR-MDS in Phase 2a and to compare the effect of AG-946 versus placebo and to detect a dose response for erythroid response in participants with LR-MDS in Phase 2b.

lead_sponsor: Agios Pharmaceuticals, Inc.

location_country:
Germany
Italy
Poland
Israel
United Kingdom
Australia
Austria
United States
Korea, Republic of
Spain
Greece
Czechia
France

location_facility: Fondazione IRCCS Policlinico San Matteo di Pavia

location_facility: Western General Hospital Edinburgh - PPDS

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: Innovative Clinical Research Institute Whittier

location_facility: Azienda Ospedaliera Ordine Mauriziano di Torino

location_facility: Complejo Asistencial Universitario de Salamanca - H. Clinico

location_facility: MTZ Clinical Research Powered by PRATIA - PPDS

location_facility: Washington University School of Medicine

location_facility: Hospital Universitario Virgen del Rocio - PPDS

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

location_facility: Hospital Universitario HM Sanchinarro - CIOCC

location_facility: Pratia Onkologia Katowice - PRATIA - PPDS

location_facility: SPZOZ MiSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie


lead_sponsor: AstraZeneca

summary: TROPION-PanTumor03 will investigate the safety, tolerability, and anti-tumour activity of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced/Metastatic Solid Tumours.

sponsor_collaborators:
AstraZeneca
Daiichi Sankyo, Inc.

title: A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced/Metastatic Solid Tumours

source: euctr

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.

location_country:
Germany
Italy
Poland
United Kingdom
Japan
Switzerland
United States
China
Korea, Republic of
Spain
Turkey
Taiwan
Canada
France


title: A Phase 2/3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy

summary: The purpose of this study is to evaluate the efficacy, safety, drug levels, and drug effects of ozanimod in pediatric participants with moderately to severely active Crohn's Disease.

lead_sponsor: Bristol-Myers Squibb

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

location_facility: Dartmouth-Hitchcock Medical Center (DHMC) - Children's Hospital at Dartmouth (CHaD) - Lebanon

location_facility: University of Iowa Stead Family Children's Hospital

location_facility: Arnold Palmer Hospital for Children - Center for Digestive Health and Nutrition - Downtown Orlando

location_facility: Mary Bridge Children's Outpatient Center - Tacoma

location_facility: University of Rochester Medical Center (URMC) - Golisano Children's Hospital (GCH)

location_facility: Icahn School of Medicine - The Mount Sinai Hospital - The Susan and Leonard Feinstein IBD Center

location_facility: Mayo Clinic - Children's Center - Rochester

location_facility: Washington University School of Medicine in St. Louis - St. Louis Children's Hospital

location_facility: Seattle Children's Hospital, Research and Foundation

location_facility: Children's Hospital of Wisconsin - Neenah Clinic

location_facility: Valley Medical Group (VMG) - Pediatric Gastroenterology

location_facility: University Hospitals Cleveland Medical Center

location_facility: Oklahoma Pediatric Digestive Institute (OPDI)

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Johns Hopkins Children's Center - Pediatric Inflammatory Bowel Disease (IBD) Center

location_facility: UC Davis Medical Center - UC Davis Medical Group - Pediatric Specialty Clinics

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

location_facility: AdventHealth (Florida Hospital) Medical Group - Pediatric Gastroenterology - Orlando

location_facility: Cedars-Sinai Medical Center (CSMC) - Maxine Dunitz Children's Health Center


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

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

status: Completed

study_completion_date_type: Actual

primary_purpose: Prevention

enrollment_type: Actual

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

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

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

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

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

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

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

location_facility: Southland Clinical Research Center ( Site 0026)

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

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

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

location_facility: Advanced Medical Research Institute ( Site 0018)

location_facility: Meridian Clinical Research, LLC ( Site 0009)

location_facility: Gachon University Gil Medical Center ( Site 0755)

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

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

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

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

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

location_facility: Hamilton Medical Research Group ( Site 0114)

location_facility: Maccabi Healthcare Services ( Site 0306)

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

location_facility: National Cheng Kung University Hospital ( Site 0801)

location_facility: Diex Recherche Sherbrooke Inc. ( Site 0101)

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

location_facility: Hospital Universitari de Bellvitge ( Site 0505)

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

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

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

location_facility: Korea University Ansan Hospital ( Site 0751)

location_facility: Korea University Guro Hospital ( Site 0750)

location_facility: centre hospitalier lyon sud ( Site 0204)

location_facility: Maccabi Health Services - Holon ( Site 0305)

location_facility: National Taiwan University Hospital ( Site 0800)

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

location_facility: Central Research Associates ( Site 0024)

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

location_facility: Hospital Internacional Xanit ( Site 0520)

intervention_type: Biological

status_simplified: Completed


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intravenous Efzofitimod in Patients With Pulmonary Sarcoidosis

summary: This is a multicenter, randomized, double-blind, placebo-controlled, study comparing the efficacy and safety of intravenous (IV) efzofitimod 3 mg/kg and 5 mg/kg versus placebo after 48 weeks of treatment. This study will enroll adults with histologically confirmed pulmonary sarcoidosis receiving stable treatment with oral corticosteroid (OCS), with or without immunosuppressant therapy.

ipd_sharing: Undecided

lead_sponsor: aTyr Pharma, Inc.

sponsor_collaborators:
aTyr Pharma, Inc.
Kyorin Pharmaceutical Co.,Ltd

location_country:
Italy
United Kingdom
Japan
Netherlands
United States
Spain
France

location_facility:
Kyorin Investigative Site
aTyr Investigative Site


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

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

lead_sponsor: Insulet Corporation

location_facility: State University of New York, Upstate Medical University

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

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

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

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

intervention_type: Device


title: A Long-term Extension (LTE) Study to Characterize the Safety and Efficacy of Danicopan as an Add-on Therapy to a Complement Component 5 Inhibitor (C5i) in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Previously Treated With Danicopan in an Alexion-sponsored Clinical Study

summary: This is a single-arm long-term extension study that will enroll participants with PNH who have completed participation in Alexion-sponsored clinical studies with danicopan as an add on therapy to a C5i.

location_country:
Italy
Poland
United Kingdom
Japan
Brazil
United States
Korea, Republic of
Spain
Thailand
Malaysia
Canada
France


title: A Phase 3, Open-label, Randomized Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Patients With EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy

summary: The purpose of the study is to simplify amivantamab intravenous administration and to reduce dose times, by assessing a new formulation of amivantamab, amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), for subcutaneous administration. This formulation has the potential to enhance both the patient and physician experience with amivantamab by providing easier and accelerated administration.

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:
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Canada
France
Portugal
United States
China
Malaysia
Italy
United Kingdom
Korea, Republic of
Spain
Taiwan
Israel

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Private Specialist Hospitals - MedPolonia

location_facility: Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II

location_facility: Fundacao Sao Francisco Xavier HMC Unidade de Oncologia

location_facility: Affiliated Hospital of North Sichuan Medical College

location_facility: Impar Servicos Hospitalares SA - Hospital Nove de Julho

location_facility: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

location_facility: Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy

location_facility: IADT Instituto Argentino de Diagnostico y Tratamiento

location_facility: National Hospital Organization Himeji Medical Center

location_facility: Providence Oncology and Hematology Care Clinic - Westside

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Krakowski Szpital Specjalityczny im. Jana Pawla II

location_facility: National Hospital Organization Osaka Toneyama Medical Center

location_facility: Uniao Brasileira de Educaçao e Assistencia-Hospital Sao Lucas da PUCRS

location_facility: Shengjing Hospital of China Medical University

location_facility: Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

location_facility: UPCO Unidade de Pesquisa Clinica em Oncologia

location_facility: CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia

location_facility: University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: National Hospital Organization Iwakuni Clinical Center

location_facility: City of Hope Orange County Lennar Foundation Cancer Center

location_facility: NYU Langone Health Laura and Isaac Perlmutter Cancer Center

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc

location_facility: First Affiliated Hospital of Gannan Medical University

location_facility: National Hospital Organization Yamaguchi Ube Medical Center

location_facility: Seoul National University Bundang Hospital

location_facility: Chonnam National University Hwasun Hospital

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

location_facility: The First Affiliated Hospital, Sun Yat-sen University

location_facility: The First People's Hospital Of Changzhou

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: CEMIC (Centro de Educación Médica e Investigaciones Clínicas)

location_facility: Phramongkutklao Hospital and Medical College

location_facility: Sun Yat-Sen Memorial Hospital Sun Yat-sen University

location_facility: Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

location_facility: Instituto Cionc de Ensino e Pesquisa S/S

location_facility: National Taiwan University Cancer Center

location_facility: Universitaetsklinikum Giessen und Marburg GmbH

location_facility: Harbin medical university cancer hospital

location_facility: Beijing Chest hospital, Capital medical university

location_facility: Beijing Shijitan Hospital, Capital Medical University

location_facility: CHA Bundang Medical Center, CHA University

location_facility: The Second Affiliated Hospital of Zhejiang University College of Medicine

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

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

location_facility: Beijing Friendship Hospital Capital Medical University


title: A Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients With Advanced NSCLC and Other Solid Tumors (ALKOVE-1)

summary:
Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-655, determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ALK- positive (ALK+) NSCLC and other solid tumors.

Phase 1 will determine the RP2D and, if applicable, the MTD of NVL-655 in patients with advanced ALK+ solid tumors.

Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of NVL-655 at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of NVL-655 in patients with advanced ALK-positive NSCLC and other solid tumors.

lead_sponsor: Nuvalent Inc.

location_country:
United Kingdom
Australia
United States
Spain
Canada
France

location_facility: University of California, Davis Comprehensive Cancer Center

location_facility: University of California Irvine Medical Center

location_facility: Laura & Isaac Perlmutter Cancer Center at NYU Langone Health


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

acronym: SUMMIT

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

location_country:
Germany
Poland
United States
Spain
Canada
France

location_facility: CHU de Grenoble - Hopital Albert Michallon

location_facility: The Pennsylvania Centre for Dermatology, LLC

location_facility: Universitätsklinikum Schleswig Holstein Campus Lübeck

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

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

location_facility: The Guenther Dermatology Research Centre

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


acronym: DELTA TEEN

lead_sponsor: LEO Pharma

summary:
The purpose of this trial is to test if delgocitinib cream is effective at treating chronic hand eczema (CHE) and what side effects it may have, in children aged 12-17. There will be a range of assessments that rate the severity and extent of CHE symptoms, general health and quality of life.

Delgocitinib is a cream that suppresses specific processes in the body's response to diseases like CHE, such as inflammation.

The trial will last up to 22 weeks and has a 1-4 week screening period, a 16 week treatment period and a 2 week follow up period. During the treatment period each child will use either delgocitinib cream or a cream vehicle twice a day. Which cream each child receives is chosen randomly by a computer. The cream vehicle is made of the same ingredients as the delgocitinib cream except for the active medical ingredient. There will be 8 visits with the trial doctor.

title: A Phase 3 Clinical Trial to Evaluate Efficacy and Safety of Twice-daily Applications of Delgocitinib Cream 20 mg/g Compared With Cream Vehicle for a 16-week Treatment Period in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema

location_country:
Poland
United Kingdom
Australia
Belgium
Spain
Canada
France


lead_sponsor: Takeda

summary: The main aim is to see how TAK-062 works to reduce celiac-related symptoms and improve small intestinal damage due to gluten exposure, in participants with celiac disease (CeD) attempting to maintain a gluten-free diet (GFD) in treated participants versus placebo controls.

location_facility: Hopital Europeen Georges Pompidou Gastro Enterologie et Oncologie Digestive

location_facility: So. California Research Institute Med Group Inc./West Gastroenterology Med Group

location_facility: John Radcliffe Hospital Dept of Gastroenterology

location_facility: CHU Lille - Hopital Claude Huriez Service des maladies de I'appareil digestif

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: The Ulster Hospital Department of Gastroenterology

location_facility: Washington University, School of Medicine

location_facility: FutureMeds Krakow prev. Krakowskie Centrum Medyczne Sp. z o.o.

location_facility: Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS UOC Medicina Interna e Gastroenterologia

location_facility: Gastroenterology Associates of Pensacola, PA

location_facility: Hopital Rangueil Service de Gastro Enterologie et Nutrition

location_facility: Bradford Teaching Hospitals NHS Foundation Trust

location_facility: One of a Kind Clinical Research Center LLC

location_facility: Ospedale Umberto I di Torino S.C. Gastroenterologia

location_facility: Royal Hallamshire Hospital Dept of Gastroenterology

location_facility: CHU Saint Etienne - Hopital Nord Service de Gastro-Enterologie et Hepatologie

location_facility: Hospital Universitario Miguel Servet Servicio de Aparato Digestivo

location_facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Internal Medicine

location_facility: Komisja Bioetyczna przy Okregowej Izbie Lekarskiej w Warszawie

location_facility: Hospital Clinico Universitario Virgen de la Victoria Digestive Service

location_facility: University of Washington Division of Gastroenterology

location_facility: King's College Hospital Dept of Gastroenterology

location_facility: New York University Medical Center PRIME

location_facility: Hospital Universitario Virgen Macarena Digestive Service

location_facility: Cleveland Clinic - Gastroenterology and Hepatology

location_facility: Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello) U.O. Gastroenterologia

location_facility: Royal London Hospital Dept of Gastroenterology

location_facility: Eastern Pennsylvania Gastroeneterology and Liver Specialists

title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of TAK-062 for the Treatment of Active Celiac Disease in Subjects Attempting a Gluten-Free Diet

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:
Italy
Poland
United Kingdom
Belgium
United States
Spain
Canada
France


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

acronym: EMERALD

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

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

ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

lead_sponsor: Biogen

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

location_facility: Centro de Investigacion Medico Asistencial S.A.S

location_facility: Osaka Medical and Pharmaceutical University Hospital

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Tianjin Medical University General Hospital

location_facility: Centro Multidisciplinar de Estudos Clínicos - CEMEC

location_facility: The Second Affiliated Hospital of Nanchang University

location_facility: Rheumatology Associates of Central Florida

location_facility: Centro de Investigacion Clínica GRAMEL S.C

location_facility: Instituto de Investigaciones Clinicas Quilmes

location_facility: The Third Affiliated Hospital, Sun Yat-sen University

location_facility: Institute of Treatment and Rehabilitation "Niska Banja"

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

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

location_facility: SP Szpital Kliniczny nr 1 PUM im. prof. Tadeusza Sokolowskiego

location_facility: Hospital of the University of Occupational and Environmental Health

location_facility: Diseño y Planeacion en Investigacion Medica S.C.

location_facility: Xiangya Hospital, Central South University

location_facility: Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: Centro de Investigaciones Medicas Tucuman

location_facility: Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

location_facility: Kobe City Hospital Organization Kobe City Medical Center General Hospital

location_facility: Washington University, School of Medicine

location_facility: The 2nd Xiangya Hospital of Central South University

location_facility: Vita Verum Medical Egeszsegugyi Szolgaltato

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.

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

location_facility: The First Affiliated Hospital of Chengdu Medical College

location_facility: L2IP - Instituto de Pesquisas Clínicas Ltda.

location_facility: Arthritis and Osteoporosis Associates of New Mexico

location_facility: Clinica San Felipe - Centro de Investigacion Clinica Inmunoreumatologia

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

location_facility: S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L

location_facility: Azienda Socio Sanitaria Territoriale Gaetano Pini (Gaetano Pini-CTO)

location_facility: Centro de Investigaciones Medicas Mar del Plata

location_facility: Investigacion y Biomedicina de Chihuahua, S.C.

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

location_facility: CETI - Centro de Estudos em Terapias Inovadoras Ltda.

location_facility: Spitalul Clinic Judetean de Urgenta Cluj Napoca

location_facility: HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará

location_facility: University of Miami Miller School of Medicine

location_facility: Szpital Uniwersytecki nr 2 im.dr J. Biziela

location_facility: Hospital das Clínicas da Faculdade de Medicina da UNICAMP

location_facility: CER San Juan Centro Polivalente de Asistencia e Inv. Clinica

location_facility: Hogar Clínica San Juan de Dios - Arequipa

location_facility: Ruijin Hospital of Shanghai Jiaotong University School of Medicine

location_facility: Santa Casa de Misericórdia de Belo Horizonte

location_facility: Centro de Investigacion en Reumatologia y Especialidades Medicas CIREEM S.A.S.

location_facility: NYU Langone Ambulatory Care Brooklyn Heights

location_facility: CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos

location_facility: Hospital General de Agudos Dr. J. M. Ramos Mejia

location_facility: Inland Rheumatology Clinical Trials, Inc.

location_facility: Japanese Red Cross Society Himeji Hospital

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto

location_facility: Centro Privado de Medicina Familiar - Mind Out Research

location_facility: CHU Clermont Ferrand - Hopital Gabriel Montpied

location_facility: Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty

location_facility: Niepubliczny Zakład Opieki Zdrowotnej "Biogenes" Sp. z o.o.

location_facility: University of California San Diego School of Medicine

location_facility: Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch

location_facility: SPb SBIH "Clinical Rheumatological Hospital # 25"

location_facility: Far Eastern University - Dr. Nicanor Reyes Medical Foundation

location_facility: Paramount Medical Research & Consulting, LLC

location_facility: Beijing Chaoyang Hospital, Capital Medical University

location_facility: People's Hospital of Xinjiang Uighur Autonomous Region

location_facility: Oncovida - Centro de Onco-Hematologia de Mato Grosso

location_facility: Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran

location_facility: Precision Comprehensive Clinical Research Solutions

location_facility: Centro de Investigacion y Atencion Integral Durango CIAID

location_facility: Clinical Hospital Center "Bezanijska kosa"

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Clinical Research of West Florida - Corporate

location_facility: Arthritis & Rheumatic Disease Specialties

location_facility: Hospital Nacional Edgardo Rebagliati Martins

location_facility: Centre for Rheumatology, Immunology and Arthritis

location_facility: SBIH "Orenburg Regional Clinical Hospital"

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

location_facility: AA MRC LLC Ahmed Arif Medical Research Center

location_facility: The University of Texas Health Science Center at San Antonio

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

location_facility: Centro Peninsular de Investigacion Clinica, SCP

location_facility: Groupe Hospitalier Pellegrin - Hôpital Pellegrin

location_facility: V.A. Nasonova Research Rheumatology Institute

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Consultorio Particular del Dr. Miguel Cortes Hernandez


title: A Phase 3, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease

acronym: FUZION CD

summary: The purpose of this study to evaluate the clinical efficacy of guselkumab in fistulizing, perianal Crohn's disease and to assess the overall safety of guselkumab.

lead_sponsor: Janssen-Cilag Ltd.

location_country:
Germany
Poland
Australia
Japan
Czechia
Canada
France
Portugal
Hungary
United States
Italy
Jordan
United Kingdom
Netherlands
Korea, Republic of
Saudi Arabia
Spain
Greece
Taiwan
Israel

location_facility: Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika

location_facility: Academisch Medisch Centrum Universiteit van Amsterdam

location_facility: Hospital of the University of Occupational and Environmental Health

location_facility: St George's University Hospital NHS Foundation Trust

location_facility: Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar

location_facility: London North West University Healthcare NHS Trust

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: Universitatsklinikum Schleswig Holstein Kiel

location_facility: The Hospital of Hyogo College of Medicine

location_facility: H. Santo António - Centro Hospitalar do Porto

location_facility: Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Washington University School of Medicine

location_facility: Seoul National University Bundang Hospital

location_facility: University of Kentucky Chandler Medical Center

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

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

location_facility: Chang Gung Memorial Hospital Linkou Branch

location_facility: Hull University Teaching Hospitals NHS Trust

location_facility: GASTROMED Kopon, Zmudzinski i wspolnicy SP.j., Specjalistyczne Centrum Gastrologii i Endoskopii

location_facility: Gastromed Kralisz Romatowski Stachurska Sp. j.


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

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

location_country:
United States
Spain
Germany
France

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Institut Universitaire du Cancer Toulouse Oncopole


title: A Phase 2, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination With Bevacizumab and FOLFIRI Versus Bevacizumab and FOLFIRI in Previously Treated Advanced Inoperable Metastatic Colorectal Cancer (mCRC)

acronym: ELEVATE CRC

summary:
The goals of this clinical study are to learn more about the safety, tolerability and effectiveness of magrolimab in combination with bevacizumab and 5-fluorouracil, irinotecan, and leucovorin (FOLFIRI) in previously treated participants with advanced inoperable metastatic colorectal cancer (mCRC).

The primary objectives of this study are: (safety run-in cohort) to evaluate safety and tolerability, and the recommended Phase 2 dose (RP2D) and (randomized cohort) to evaluate the efficacy of magrolimab in combination with bevacizumab and 5-fluorouracil, irinotecan, and leucovorin (FOLFIRI) in previously treated participants with advanced inoperable metastatic colorectal cancer (mCRC).

lead_sponsor: Gilead Sciences

location_country:
Germany
Italy
Hong Kong
Australia
Belgium
United States
Spain
Canada
Puerto Rico
France

location_facility: City of Hope ( City of Hope National Medical Center, City of Hope Medical Center )

location_facility: Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - Medical Oncology Department

location_facility: Fort Wayne Medical Oncology and Hematology, Inc.

location_facility: University of California Los Angeles (UCLA)

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Centre Léon Bérard - Centre de Lutte contre le Cancer

location_facility: San Bortolo General Hospital- Oncology Department

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico - Istituto Clinico Humanitas

location_facility: Baylor College of Medicine Medical Center

location_facility: Hematology Oncology Associates of Central New York, PC

location_facility: Azienda Ospedaliera Universitaria Pisana- UO Oncologia Medica

location_facility: Klinikum rechts der Isar der TU Munchen Zentrum fur klinische Studien der Klinik und Poliklinik fur Innere Medizin III

location_facility: Institut Català d'Oncologia- Hospital Duran I Reynals

location_facility: Centre Hospitalier Regional Universitaire Hopital Besancon

location_facility: Pan American Center for Oncology Trials, LLC


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

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

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

lead_sponsor: Gedeon Richter Plc.

location_country:
Italy
United States
Spain
Czechia
France

location_facility: University Hospitals Cleveland Medical Center

location_facility: Hospital Universitario Virgen de la Victoria

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

location_facility: Parc Taulí Sabadell Hospital Universitari

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

location_facility: Hospital Regional Universitario de Málaga - Hospital General

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

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

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

location_facility: Hospital General Universitario Dr. Balmis

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Azienda Ospedaliera Universitaria "Federico II"


title: The ASCEND Study: A Phase III, Multicenter, Double Blinded Vehicle Controlled Study of TMB-001 With a Parallel Optional Maximal Use Arm- in Treatment of RXLI or ARCI Ichthyosis in Subjects Aged >6

acronym: ASCEND

summary:
This is a randomized, double-blind and vehicle-controlled Phase III study to evaluate the safety and efficacy of topical TMB-001 0.05% ointment for the treatment of CI in subjects with either the RXLI or ARCI subtypes.

In addition, a subset of preselected centers will recruit subjects in parallel with either the RXLI or ARCI subtypes for enrollment into an Optional Maximal Use arm for evaluation of the systemic exposure and safety of topical TMB-001 0.05% ointment for the treatment of CI.

The Phase III Study is designed in three periods:

• Period 1 - Induction (3 weeks): At the beginning of the 3-week Induction Period, eligible subjects will be randomized (2:1 ratio) to either TMB-001 0.05% once-a-day (QD) or Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™) provided by the Sponsor.

• Period 2 - Treatment (9 weeks): The dosing frequency in the 9-week treatment period will be increased in each treatment group to TMB-001 0.05% BID or Vehicle BID. Mandatory bland emollient will be discontinued.

• Period 3 - Maintenance (12 weeks): At Week 12, eligible subjects in the TMB-001 treatment group will be randomized (1:1 ratio) to an open-label treatment with TMB-001 0.05% BID or TMB-001 0.05% QD. To be eligible, subjects must have achieved a ≥1-point reduction in IGA score from Baseline. Subjects with less than a 1-point reduction in IGA score from Baseline will be discontinued from the study.

Vehicle-treated subjects who achieved <1-point reduction in IGA score from Baseline are eligible to cross over to the TMB-001 0.05% BID treatment group. Subjects with a ≥1-point reduction in IGA score from Baseline will be discontinued from the study.

Subjects at the end of the study or subjects discontinued from the study at any time will be followed-up for additional 2 weeks for AEs.

lead_sponsor: Timber Pharmceuticals LLC

location_country:
Germany
Italy
United States
Canada
France

location_facility: University of Mississippi Medical Center (UMMC) - Face and Skin Center

location_facility: Ambulatorio Malattie Rare IRCCS Sant'Orsola

location_facility: Katholisches Kinderkrankenhaus Wilhelmstift GmbH

location_facility: Ambulatorio di Malattie Rare Dermatologiche e Immunopatologia Cutanea

location_facility: Northwestern University - Feinberg School of Medicine - Dermatology Department

location_facility: The Indiana Clinical Trials Center (Optima Research)

location_facility: U.O. di Dermatologia e Venereologia Universitaria

location_facility: Austin Institute for Clinical Research, Inc.

location_facility: U.O.C. di Dermatologia Dipartimento Pediatrico Universitario Ospedaliero

location_facility: Medical Dermatology Specialists (US Derm Partners)

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: Children's Hospital of Philadelphia (CHOP)

location_facility: University of Miami, Dermatology Clinical Trial Unit


acronym: TH HBV ASO-001

lead_sponsor: GlaxoSmithKline

summary: This study will assess the safety, efficacy and immune response following the sequential treatment of GlaxoSmithKline's (GSK) ASO compound (GSK3228836) and CHB-TI (GSK3528869A) in participants 18 to 65 years stable on NA treatment for CHB. The aim is to quantify the efficacy of sequential therapy as well as to determine an added value of sequential therapy over GSK3228836 therapy in CHB patients treated with NAs. In addition, the study will assess the effect of different treatment durations of GSK3228836 (12 or 24 weeks) prior to initiating GSK3528869A treatment.

title: A Phase 2, Single-blinded, Randomised, Controlled Multi-country Study to Evaluate the Safety, Reactogenicity, Efficacy and Immune Response Following Sequential Treatment With an Anti-sense Oligonucleotide (ASO) Against Chronic Hepatitis B (CHB) Followed by Chronic Hepatitis B Targeted Immunotherapy (CHB-TI) in CHB Patients Receiving Nucleos(t)Ide Analogue (NA) Therapy

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

location_country:
Germany
Italy
Poland
United Kingdom
Hong Kong
Romania
Singapore
Belgium
Spain
Thailand
Turkey
Taiwan
Bulgaria
Philippines
France


title: A Phase 2/3 Study to Evaluate the Efficacy and Safety of Unesbulin in Unresectable or Metastatic, Relapsed or Refractory Leiomyosarcoma

acronym: SUNRISELMS

summary: This study will compare the efficacy and safety of unesbulin plus dacarbazine versus placebo plus dacarbazine in participants with unresectable or metastatic, relapsed or refractory LMS who have received at least 1 prior line of systemic therapy.

lead_sponsor: PTC Therapeutics

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Australia
Brazil
Netherlands
United States
Spain
Canada
France

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Northwestern Medicine - Warrenville Cancer Center

location_facility: Institut Catala d'Oncologia (Hospital Duran y Reynals)

location_facility: University of Florida (UF) Health Cancer Center - Orlando Health

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: CIP - Centro Integrado de Pesquisas do Hospital de Base de Sao Jose do Rio Preto

location_facility: Hospital Sao Rafael - Instituto D'Or da Bahia

location_facility: Eszak-Pesti Centrumkorhaz - Honvedkorhaz

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Zespól Poradni Specjalistycznych "TERMEDICA"

location_facility: Universite de Montreal - Hopital Maisonneuve-Rosemont (HMR)

location_facility: David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow

location_facility: University of California, Los Angeles (UCLA) - Jonsson Comprehensive Cancer Center

location_facility: Klinikum der Ludwig-Maximilians-Universitaet Muenchen

location_facility: Instituto do Cancer do Estado de São Paulo (ICESP)


title: An Adaptive, Randomized, Double-blind, Dose Exploration, Parallel Group, Placebo Controlled, Multicenter Phase 2 Trial to Evaluate the Efficacy, Safety and Tolerability of LNP023 in Combination With Standard-of-care With and Without Oral Corticosteroids in Patients With Active Lupus Nephritis Class III-IV, +/- V

summary: The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment.

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:
Germany
India
Portugal
Hungary
Hong Kong
Israel
Singapore
Brazil
Mexico
United States
China
Spain
Malaysia
Turkey
Puerto Rico
France


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

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

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

lead_sponsor: Incyte Corporation

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

location_facility: University of Minnesota Health Clinics and Surgery Center

location_facility: Orlando Health Cancer Institute Downtown Orlando

location_facility: Ico Girona Hospital Universitari de Girona Dr Josep Trueta

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

location_facility: Rigshospitalet Uni of Hospital of Copenhagen

location_facility: University of Illinois Hospital & Health Sciences System

location_facility: Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza

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

location_facility: Hospital General Universitario Vall D Hebron

location_facility: Klinikum Der Johann Wolfgang Goethe University

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Hospital General Universitario de Valencia

location_facility: The Royal Marsden Nhs Foundation Trust - Chelsea

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

location_facility: UC Health At Cincinnati Va Medical Center

location_facility: The Royal Marsden Nhs Foundation Trust - Sutton

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

location_facility: University of Pittsburgh Medical Center Health System

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

location_facility: Netherlands Cancer Institute Antoni Van Leeuwenhoek Ziekenhuis

location_facility: Columbia University Irving Medical Center


title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3, Three-way Crossover Trial to Evaluate the Efficacy and Safety of Two Dose Levels of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema Type I or II

summary: This study is a randomized, double-blind, placebo-controlled, phase III, three-way crossover clinical trial evaluating the efficacy and safety of KVD900, in the treatment of hereditary angioedema attacks in adolescent and adult Patients

ipd_sharing_description: Data will not be shared until all global regulatory filings are complete

lead_sponsor: KalVista Pharmaceuticals, Ltd.

location_country:
Germany
Poland
New Zealand
Australia
Japan
Canada
France
Portugal
Slovakia
Hungary
United States
North Macedonia
Romania
Puerto Rico
Italy
United Kingdom
Netherlands
Spain
Greece
Bulgaria
Israel

location_facility:
KalVista Investigative Site
Kalvista Investigative Site
KalVista Investgative Site


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

acronym: AQUARIUS

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

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

location_facility: Università Degli Studi Di Napoli Federico Ii

location_facility: West China Hospital, Si Chuan University

location_facility: Smilow Cancer Hospital/Yale Cancer Center

location_facility: Universitaetsklinikum Heidelberg Medizinische Klinik V

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

location_facility: Ruijin Hospital, Shanghai Jiao Tong University

location_facility: First affiliated Hospital of Zhejiang University

location_facility: Hospital Maastricht University Medical Center

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


title: A Phase 1, Open-Label, Multicenter Study of INCB123667 as Monotherapy in Participants With Selected Advanced Solid Tumors

summary: This is an open-label, dose-escalation and dose-expansion study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCB123667 when administered as monotherapy at the RDE(s) in participants with selected advanced or metastatic solid tumors. Part 1A (dose escalation) will determine the recommended dose of INCB123667 for expansion (RDE) and the maximum tolerated dose (MTD). Part 1B (cohort dose expansion phase) will further explore antitumor activity of INCB123667 as a monotherapy in 6 tumor-specific cohorts at the RDE(s) defined in Part 1A.

location_country:
Italy
United Kingdom
Japan
Netherlands
Switzerland
United States
France

location_facility: City of Hope-Lennar Foundation Cancer Center

location_facility: Oncological Institute of Southern Switzerland

location_facility: Centre Hospitalier Universitaire Vaudois (Chuv)

location_facility: Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

location_facility: Fondazione Irccs Istituto Nazionale Del Tumori Di Milano

location_facility: Centro Ricerche Cliniche Di Verona (Crc)

location_facility: University of Pennsylvania Abramson Cancer Center

location_facility: Texas Oncology-Fort Worth South Henderson

location_facility: Inselspital Universitatsklinik Fur Medizinische Onkologie

location_facility: Istituto Nazionale Tumori Irccs Fondazione Pascale

location_facility: University of Pittsburgh Cancer Institute Cancer Services

location_facility: Imperial College Healthcare Nhs Trust - Hammersmith Hospital

location_facility: Saitama Medical University International Medical Center


title: A Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-finding Study Evaluating Efficacy, Safety and Tolerability of BI 1291583 qd Over at Least 24 Weeks in Patients With Bronchiectasis (AirleafTM)

summary:
This study is open to adults with bronchiectasis. People can join the study if they produce sputum and have a history of flare-ups (also called exacerbations).

The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis.

Participants are put into 4 groups randomly, which means by chance. Participants in groups 1, 2, and 3 get different doses of BI 1291583. Participants in group 4 get placebo. Placebo tablets look like BI 1291583 tablets, but do not contain any medicine. Participants take the tablets once a day.

Participants are in the study for between 6 months and 1 year. During this time, they visit the study site about 10 times and get about 5 phone calls from the site staff.

The doctors document when participants experience flare-ups during the study. The time to the first flare-ups is compared between the treatment groups. Doctors also regularly check participants' health and take note of any unwanted effects.

ipd_sharing_description:
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link http://trials.boehringeringelheim.com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
Poland
Australia
Japan
Turkey
Czechia
Canada
France
Portugal
Hungary
Denmark
United States
Latvia
Belgium
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Greece
Bulgaria
Israel

location_facility: NewYork-Presbyterian/Weill Cornell Medical Center

location_facility: Klinikum der Universität München - Campus Innenstadt

location_facility: Marmara University Pendik Training and Research Hospital

location_facility: Institute for Translational Oncology Research

location_facility: Sureyyapasa Egitim ve Arastirma Hastanesi

location_facility: University of Texas Health Science Center at Tyler

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

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

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

location_facility: Respiratory Medicine Centre, private prac., Bialystok

location_facility: New York University Langone Medical Center

location_facility: University of Florida College of Medicine

location_facility: Centre Hospitalier de l'Universite de Montreal (CHUM)

location_facility: Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

location_facility: Daugavpils Regional Hospital LTD Centre Outpatient Clinic

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Hospital Universitario Nuevo de Nuevo León - CEPREP

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Niigata University Medical and Dental Hospital

location_facility: Copenhagen University Hospital, Rigshospitalet

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: Med.Center OLVI Health Center Assotiation,Private Practice

location_facility: Altamed Specjalistyczna Praktyka Lekarska Pawel Siwinski

location_facility: Oaxaca Site Management Organization, S.C.

location_facility: Dr. Piotr Napora, Center of Clinical Research


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

acronym: ARDA

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

lead_sponsor: argenx

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

location_facility:
Investigator site 13-FR0330042
Investigator Site 7 - US0010143
Investigator site 41 - DE490042
Investigator site 35-IT0390059
Investigator site 26 - UK0440034
Investigator site 16-IT0390057
Investigator site 29 - DE0490040
Investigator site 23 - IT0390058
Investigator site 39 - CAN19010
Investigator Site 8 - US0010071
Investigator site 34 - DE490011
Investigator site 28 - PL0480045
Investigator site 18-UK0440033
Investigator site 27 - UK0440026
Investigator Site 5 - SP0340044
Investigator site 33 - DE490045
Investigator site 21-US0010135
Investigator site 17-ES0340056
Investigator site 40 - US10015
Investigator site 10-NL0310013
Investigator site 15-FR0330038
Investigator Site 4 - BE0320027
Investigator site 1 - US0010068
Investigator site 37 - DE0490044
Investigator site 19-US0010013
Investigator site 22 - US0010121
Investigator site 14-FR0330039
Investigator site 12-FR0330037
Investigator site 32 - US10006
Investigator site 25 - NL0310010
Investigator site 31 - US10175
Investigator site 24 - IT0390056
Investigator site 30 - US0010173
Investigator Site 9 - US0010019
Investigator site 20-US0010126
Investigator site 3 - PL0480043
Investigator site 38 - CAN19007
Investigator site 11-AT0430012
Investigator site 2 - US0010066
Investigator Site 6 - SP0340043

intervention_type: Other


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

acronym: MINDway

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

lead_sponsor: MorphoSys AG

location_country:
France
Italy
Poland
Austria
United States
Korea, Republic of
Spain
Czechia
Israel

location_facility: Hospital Universitario Fundacion Jimenez Diaz

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

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

location_facility: Fondazione IRCCS Policlinico San Matteo di Pavia

location_facility: ASST di Monza - Azienda Ospedaliera San Gerardo

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

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu

location_facility: Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon

location_facility: Fondazione del Piemonte per l'Oncologia (IRCCS)

location_facility: Complejo Asistencial Universitario de Salamanca - H. Clinico

location_facility: Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii

location_facility: Daegu Catholic University Medical Center

location_facility: Hadassah Medical Center - Hadassah Ein Kerem

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

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

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: SPZOZ MiSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie


title: A Phase 4 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens

summary: The purpose of this study is to compare the efficacy and safety of daily and every other day dosing of rimegepant to placebo as a preventive treatment for episodic migraine.

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
Germany
Italy
Poland
United Kingdom
Sweden
Austria
United States
Spain
Canada
France

location_facility: Azienda Ospedaliera San Giuseppe Moscati-Unita di Neurologia

location_facility: Indywidualna Praktyka Lekarska Dr Hab. Med. Anna Szczepanska-Szerej

location_facility: Neurorehabilitation Unit-ICOT Istituto Marco Pasquali

location_facility: ASST Spedali Civili di Brescia, U.O. Neurologia

location_facility: Studieenheten Akademiskt Specialistcentrum SLSO

location_facility: Hospital Clinico Universitario de Valladolid • HCUV

location_facility: Dent Neurosciences Research Center, Inc.

location_facility: Arztepartnerschaft Dr. med. J. Springub/ W. Schwarz -Studienzentrum Nord-West

location_facility: Neurologisches Facharztzentrum Berlin (NFZB) - Sankt Gertrauden-Krankenhaus Location

location_facility: Azienda Ospedaliera Sant'Andrea, UOC Neurologia

location_facility: Wasatch Clinical Research , LLC(Administrative Location)

location_facility: Mirtorabi Medicine Professional Corporation

location_facility: Paracelsus Medizinischen Privatuniversitaet - Christian-Doppler-Klinik (CDK)

location_facility: Krakowska Akademia Neurologil Sp. Z o.o.

location_facility: Ludwig-Maximilians-Universitaet Muenchen Klinikum der Universitaet Muenchen - Campus Grosshadern

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: Ospedale Sant Andrea - Facolta Medicina Psicologia - Universita degli Studi di Roma Sapienza

location_facility: NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS

location_facility: IRCCS Istituto delle Scienze Neurologiche Bologna

location_facility: Neurology Service: Hospital Universitario Marques de Valdecilla

location_facility: Clinical Investigation Specialists, Inc.

location_facility: Siteworks - Zentrum fur klinische Studien Hannover

location_facility: Ospedale di Cattinara, Centro per la Diagnosi e Terapia delle Cefalee

location_facility: Alliance for Multispecialty Research, LLC

location_facility: Krakowska Akademia Neurologii Sp. Z o.o.

location_facility: Universitaetsklinikum Essen - Klinik und Poliklinik fuer Neurologie - Schwindel-Zentrum Essen

location_facility: Fondazione Mondino - Istituto Neurologico Nazionale IRCCS

location_facility: Royal Primary Care Ashgate, Chesterfield Royal Hospital, NHS Foundation Trust

location_facility: Calgary Headache & Assessment Management Program (CHAMP)

location_facility: Upstate Clinical Research Associates, LLC

location_facility: Neurology Offices of South Florida, PLLC

location_facility: NeuroMed Campus - Neurologische Gemeinschaftspraxis am St. Elisabeth Krankenhaus

location_facility: MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak

location_facility: California Neuroscience Research Medical Group, inc.

location_facility: Centro per la Diagnosi e Terapia delle Cefalee Azienda Ospedaliero-Universitaria di Trieste

location_facility: Fachuebergreifende Gemeinschaftspraxis Dr.Med. Joachim Springub & Wolfgang Schwarz


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

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

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

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

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

lead_sponsor: AbbVie

sponsor_collaborators: AbbVie Genmab

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

location_facility: Hospital Infantil Universitario Nino Jesus /ID# 240717

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

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

location_facility: Universitair Ziekenhuis Leuven /ID# 242384

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

location_facility: CHU Bordeaux - Hopital Pellegrin /ID# 240832

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

location_facility: National Cancer Center Hospital /ID# 246722

location_facility: Nicklaus Children's Hospital /ID# 241174

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

location_facility: IRCCS Ospedale Pediatrico Bambino Gesu /ID# 240039

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

location_facility: Universitaetsklinikum Erlangen /ID# 240861

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

location_facility: National Taiwan University Hospital /ID# 242890

location_facility: Universitaetsklinikum Giessen und Marburg /ID# 240787

location_facility: The Chaim Sheba Medical Center /ID# 240670

location_facility: Seoul National University Hospital /ID# 239894

location_facility: Azienda Ospedaliero Universitaria Meyer /ID# 240049

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

location_facility: Universitaetsklinikum Muenster /ID# 239970

location_facility: Cincinnati Childrens Hospital Medical Center /ID# 239823


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

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

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

lead_sponsor: Amgen

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

location_facility: Azienda Ospedaliero Universitaria Luigi Vanvitelli

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

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Azienda Unita Locale Socio Sanitaria Berica 8

location_facility: National Hospital Organization Osaka National Hospital

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

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Azienda Sanitaria Locale 5 Spezzino Ospedale S Andrea

location_facility: Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden

location_facility: Universitaetsmedizin Goettingen - Georg-August-Universitaet

location_facility: White Plains Hospital Center for Cancer Care

location_facility: Azienda Ospedaliero Universitaria di Cagliari Policlinico Duilio Casula

location_facility: Severance Hospital Yonsei University Health System

location_facility: Azienda Ospedaliera Cardinale Giovanni Panico

location_facility: Health Pharma Professional Research SA de CV

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Charite Universitaetsmedizin Berlin, Charité Campus Virchow-Klinikum

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

location_facility: Hospital General Universitario de Valencia

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Klinikum der Universitaet Muenchen Campus Grosshadern

location_facility: Istituto Ospedaliero Fondazione Poliambulanza

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Azienda Ospedaliera Universitaria Pisana Ospedale Santa Chiara

location_facility: Azienda Ospedaliera San Giovanni Addolorata

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Azienda Ospedaliero Universitaria Maggiore della Carita

location_facility: Lancaster General Hospital Ann B Barshinger Cancer Institute

location_facility: Azienda Ospedaliera Rilievo Nazionale e Alta Specializzazione Garibaldi Nesima

location_facility: Complexo Hospitalario Universitario de Ourense

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Johns Hopkins University School of Medicine

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

location_facility: Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

location_facility: Universitaetsklinikum der Eberhard Karls Universitaet Tuebingen

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

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

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Centre Hospitalier Universitaire de Lyon - Hopital Edouard Herriot


title: A Phase 2 Study of PHE885, B-cell Maturation Antigen (BCMA)- Directed CAR-T Cells in Adult Participants With Relapsed and Refractory Multiple Myeloma.

summary: This is a Phase II study to determine the efficacy and safety of PHE885, a BCMA-directed CAR-T cell therapy, manufactured with a new process. The CAR-T cell therapy will be investigated as a single agent in relapsed and refractory multiple myeloma

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.

The Trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Germany
Italy
Israel
Singapore
United Kingdom
Australia
Brazil
Japan
United States
Saudi Arabia
Spain
Greece
Canada
France

location_facility: Emory University School of Medicine/Winship Cancer Institute