type: Registry Identifier

title: A Phase 2 Non-randomized, Open-label, Multi-cohort, Multi-center Study Assessing the Clinical Benefit of SAR444245 (THOR-707) Combined With Other Anticancer Therapies for the Treatment of Participants With Lung Cancer or Pleural Mesothelioma

summary:
Primary Objective:

-To determine the antitumor activity of SAR444245 in combination with other anticancer therapies.

Secondary Objectives:

To confirm the dose and to assess the safety profile of SAR444245 when combined with other anticancer therapies.
To assess other indicators of antitumor activity.
To assess the pharmacokinetic (PK) profile of SAR444245 when given in combination with pembrolizumab.
To assess the immunogenicity of SAR444245.

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

lead_sponsor: Sanofi

sponsor_collaborators:
Sanofi
Merck Sharp & Dohme LLC

location_country:
Italy
Poland
Argentina
Australia
Japan
United States
Korea, Republic of
Spain
Chile
Taiwan
Puerto Rico
France

location_facility: Thomas Jefferson University Hospital-Site Number:8400009

location_facility: Hematology Oncology Clinic-Site Number:8400010

location_facility: Mount Sinai Medical Center-Site Number:8400006

location_facility: Thomas Jefferson University - North East-Site Number:8401009

location_facility: The Sarah Cannon Research Institute-Site Number:8400003

location_facility: Oncology Health Group-Site Number:8400001

location_facility: Cleveland Clinic Foundation-Site Number:8400004


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: Bristol-Myers Squibb

summary: The purpose of this study is to evaluate the superiority in efficacy of abatacept compared with adalimumab, on background methotrexate, in adults with early, seropositive, and shared epitope-positive rheumatoid arthritis and an inadequate methotrexate response.

location_facility: NYU Langone Ambulatory Care Brooklyn Heights

location_facility: Hospital Santa Maria della Misericordia in Perugia-Unit of Rheumatology, Department of Medicine and

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

status: Active, not recruiting

title: A Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment With Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive Rheumatoid Arthritis Who Have "Shared Epitope" HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Anticipated

location_country:
Germany
Italy
Poland
United Kingdom
Argentina
Australia
Japan
Switzerland
Mexico
United States
Spain
Taiwan
Czechia
France

study_type: Interventional

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase 1b, Dose Escalation and Expansion Study of Lemzoparlimab With or Without Dexamethasone and in Combination With Anti-Myeloma Regimens for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma

summary:
Multiple myeloma (MM) accounts for more than 10% of all blood cancers and 1% of all cancers. The purpose of this study is to assess how safe lemzoparlimab is and how lemzoparlimab moves through the body of adult participants with MM when given with or without dexamethasone, and in combination with other anti-myeloma regimens. Adverse events and change in disease activity will be assessed.

Lemzoparlimab is an investigational drug being developed for the treatment of relapsed/refractory (R/R) MM. Study doctors put the participants in groups called treatment arms. Two different dose levels of lemzoparlimab will be explored. Each treatment arm receives a different treatment combination depending on stage of the study and eligibility. This study will include a dose escalation phase to determine the best dose of lemzoparlimab, followed by a dose expansion phase to confirm the dose. Approximately 163 adult participants with R/R MM will be enrolled in the study in approximately 60 sites worldwide.

In the Dose Escalation arms, participants will receive intravenous (IV) lemzoparlimab with or without dexamethasone (oral/IV) in combination with pomalidomide (oral) or carfilzomib (IV) or subcutaneous (SC) daratumumab in 28-day cycles. In the Dose Expansion arms, participants will receive lemzoparlimab (IV) alone or with dexamethasone (oral/IV) in combination with pomalidomide (oral) or carfilzomib (IV) or daratumumab (SC) in 28-day cycles.

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 and side effects.

status: Terminated

study_completion_date_type: Actual

design_allocation: Non-Randomized

ipd_sharing: No

lead_sponsor: AbbVie

location_country:
Germany
France
Australia
Japan
United States
Spain
Israel

location_facility: University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 229309

location_facility: Rutgers Cancer Institute of New Jersey /ID# 230174

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 228559

location_facility: Norton Cancer Institute - St Matthews /ID# 229319

location_facility: Hospital Universitario Reina Sofia /ID# 229388

location_facility: The Queen Elizabeth Hospital /ID# 229345

location_facility: University Hospital Kyoto Prefectural University of Medicine /ID# 241833

location_facility: Tel Aviv Sourasky Medical Center /ID# 229478

location_facility: Hospital Unversitario Marques de Valdecilla /ID# 229354

location_facility: Hospital Parc de Salut del Mar /ID# 229371

location_facility: Hadassah Medical Center-Hebrew University /ID# 229477

location_facility: Sylvester Comprehensive Cancer Center /ID# 228817

location_facility: Hospital Santa Creu i Sant Pau /ID# 229369

location_facility: Columbia University Medical Center /ID# 229971

location_facility: Hospital Universitario 12 de Octubre /ID# 229355

location_facility: Perelman Center for Advanced Medicine - /ID# 228693

location_facility: Hospital Clínico Universitario de Santiago-CHUS /ID# 229356

location_facility: The Chaim Sheba Medical Center /ID# 229483

status_simplified: Unknown


lead_sponsor: Novartis Pharmaceuticals

summary: This is a long term safety study for patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment

location_facility:
Memorial Sloan Kettering
Novartis Investigative Site
Uni of TX MD Anderson Cancer Cntr
Oregon Health Sciences University .
Michigan Med University of Michigan .

status: Recruiting

title: An Open Label, Multi-center Asciminib Roll-over Study to Assess Long-term Safety in Patients Who Have Completed a Novartis Sponsored Asciminib Study and Are Judged by the Investigator to Benefit From Continued Treatment

enrollment_type: Anticipated

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

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

location_country:
Germany
Poland
Argentina
Japan
Brazil
Turkey
Czechia
Canada
France
Portugal
Denmark
United States
Romania
Lebanon
Italy
United Kingdom
Singapore
Austria
Mexico
Korea, Republic of
Saudi Arabia
Spain
Taiwan
Bulgaria
Russian Federation

ipd_sharing: Yes


title: An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined With a Tyrosine Kinase Inhibitor (TKI) in Patients With Relapsed or Refractory Ph+ Chronic Myeloid Leukemia (CML)

summary:
This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Ph+ Chronic Myeloid Leukemia (CML) who have relapsed or are refractory or intolerant to a Tyrosine Kinase Inhibitor (TKI).

This study is a global, open label Phase 1b/2 to determine the efficacy and safety of KRT-232 in patients with chronic phase CML (CML-CP) and accelerated phase (CML-AP) who have failed TKI treatments.

lead_sponsor: Kartos Therapeutics, Inc.

location_country:
Italy
Poland
United States
Korea, Republic of
Spain
Canada
Russian Federation
France

location_facility: National Medical Research Center of Hematology

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

location_facility: Azienda Ospedaliero - Universitaria Mater Domini

location_facility: Almazov National Medical Research Center

location_facility: Georgia Cancer Center at Augusta University

location_facility: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori


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

acronym: Synergy

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

lead_sponsor: Alpine Immune Sciences, Inc.

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

location_facility:
Investigational Site (171)
Investigational Site (164)
Investigational Site (138)
Investigational Site (165)
Investigational Sites (134)
Investigational Site (179)
Investigational Site (160)
Investigational Site (173)
Investigational Site (187)
Investigational Site (156)
Investigational Site (104)
Investigational Site (112)
Investigational Site (188)
Investigational Site (127)
Investigational Site (107)
Investigational Site (155)
Investigational Site (166)
Investigational Site (174)
Investigational Site (189)
Investigational Site (186)
Investigational Site (133)
Investigational Site (125)
Investigational Site (149)
Investigational Site (108)
Investigational Site (163)
Investigational Site (118)
Investigational Site (193)
Investigational Site (128)
Investigational Site (121)
Investigational Site (180)
Investigational Site (119)
Investigational Site (137)
Investigational Site (109)
Investigational Site (182)
Investigational Site (116)
Investigational Site (161)
Investigational Site (184)
Investigational Site (120)
Investigational Site (139)
Investigational Site (169)
Investigational Site (190)
Investigational Site (152)
Investigational Site (162)
Investigational Site (183)
Investigational Site (175)
Investigational Site (191)
Investigational Site (106)
Investigational Site (124)
Investigational Site (115)
Investigational Site (170)
Investigational Site (181)
Investigational Site (143)
Investigational Site (110)


title: A Phase 1b/2a Basket Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Combination Therapy With the Anti CD19 Monoclonal Antibody Tafasitamab and the PI3Kδ Inhibitor Parsaclisib in Adult Participants With Relapsed/Refractory Non Hodgkin Lymphoma or Chronic Lymphocytic Leukemia

acronym: topMIND

summary: The purpose of this single-arm, open-label, Phase 1b/2a, multicenter basket study is to evaluate whether tafasitamab and parsaclisib can be safely combined at the recommended Phase 2 dose (RP2D) and dosing regimen that was established for each of the 2 compounds as a treatment option for adult participants with R/R B-cell malignancies.

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
Austria
Belgium
United States
Spain
France

location_facility: S Orsolas University Hospital Seragnoli Institute of Hematology

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: University of Alabama At Birmingham Comprehensive Cancer Center

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu

location_facility: Hospital General Unviersitario de Alicante

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Hanusch-Krankenhaus Der Wiener Gebietskrankenkasse

location_facility: Fondazione Irccs Istituto Nazionale Dei Tumori

location_facility: Istituto Nazionale Tumori Irccs Fondazione Pascale

location_facility: Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

location_facility: Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori

location_facility: Hospital Universitario Central de Asturias

location_facility: Centro Integral Oncologico Clara Campal (Ciocc)

location_facility: Hospital General Universitario de Valencia

location_facility: Indiana Blood and Marrow Transplantation

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

location_facility: Hospital General Universitario Vall D Hebron

location_facility: Azienda Ospedaliero Universitaria Pisana


title: Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing

acronym: MODULAR ATP

summary: The MODULAR ATP Clinical Study is designed to demonstrate safety, performance, and effectiveness of the Modular Cardiac Rhythm Management (mCRM) Therapy System.

ipd_sharing_description: There is no plan to share IPD with other researchers in this study.

lead_sponsor: Boston Scientific Corporation

location_country:
Italy
United Kingdom
Netherlands
Austria
United States
Spain
Czechia
Canada
France

location_facility: Institut Universitaire de Cardilogie et Pnuemologie de Quebec (IUCPQ)

location_facility: Institut de Cardiologie de Quebec (Montreal Heart)

location_facility: Hospital of the University of Pennsylvania

location_facility: Cooper Hospital - University Medical Center

location_facility: Penn State Health Milton S. Hershey Medical Center

location_facility: Banner University Medical Center Phoenix

intervention_type: Device


title: An Open Label, Phase 1, Treatment Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of IDE397 (MAT2A Inhibitor) In Adult Participants With Advanced Solid Tumors

summary: This is a Phase 1, open-label, multicenter, dose escalation and expansion study of the safety, PK, PD, and anti-tumor activity of IDE397 as a single agent and in combination with docetaxel or paclitaxel, in adult patients with selected advanced or metastatic MTAP-deleted advanced solid tumors who are unresponsive to standard of care therapy or for whom no curative therapy is available. IDE397 is a small molecule inhibitor of methionine adenosyltransferase 2 alpha (MAT2A).

lead_sponsor: IDEAYA Biosciences

location_country:
Australia
United States
Spain
Korea, Republic of
Taiwan
France

location_facility: The Sarah Cannon Research Institute/Tennessee Oncology

location_facility: Hospital Universitario 12 de Octubre (H12O)

location_facility: Columbia University Medical Center - Herbert Irving Pavilion

location_facility: START Madrid-HM - Centro Integral Oncológico Clara Campal (CIOCC)

location_facility: NEXT Madrid, Universitary Hospital QuironSAlud

location_facility: The Kinghorn Cancer Centre, St Vincent's Health Network Sydney

location_facility: University of Arkansas for Medical Sciences

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: Southern Oncology Clinical Research Unit

location_facility: Institut Claudius Regaud - IUCT-Oncopole


title: A Phase 1, Multi-center, Open-label, Dose Finding Study of CC-96191 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia

summary:
This Phase 1, clinical study of CC-96191 will explore the safety, tolerability and preliminary biological and clinical activity of CC-96191 as a single-agent in the setting of Relapsed or refractory acute myeloid leukemia (R/R AML).

The dose escalation (Part A) of the study will explore escalating intravenous doses of CC-96191 to estimate the MTD and/or RP2D of CC-96191 as monotherapy.

The expansion (Part B), will further evaluate the safety and efficacy of CC-96191 administered at or below the MTD in one or more expansion cohorts in order to determine the RP2D.

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

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

lead_sponsor: Celgene

location_country:
United States
Canada
France

location_facility: Winship Cancer Institute of Emory University

location_facility: The University of Texas - MD Anderson Cancer Center

location_facility: Mt. Sinai Medical Center Division of Hematology/Oncology


acronym:
Combined PhIIa/b in NASH

 Essai combiné de phase IIa/b dans la NASH

lead_sponsor: Boehringer Ingelheim

summary:
This study is open for men and women with a liver disease called nonalcoholic steatohepatitis (NASH) and liver fibrosis. The purpose of the study is to find out whether a medicine called BI 456906 helps patients with NASH and liver fibrosis. The study tests 3 different doses of BI 456906 to find the dose that helps best. Participants are put into 4 groups randomly, which means by chance. There are 3 groups that each receive a different dose of BI 456906 and there is 1 group that receives placebo. BI 456906 and placebo are given as an injection under the skin once per week. The placebo injection looks like the BI 456906 injection but does not contain any medicine.

Participants are in the study for a little over 1 year (60 weeks). During this time, they visit the study site several times and have some video calls in addition. At the visits, the study doctors take different measurements. To see whether the treatment works, the doctors take a very small sample of liver tissue (biopsy) from each participant at the start and at the end of the study. They also examine the liver by ultrasound and MRI. The doctors also regularly check the general health of the participants.

location_facility: Tokyo Medical and Dental University Hospital

location_facility: First People's hospital of Yunann Province

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Ordensklinikum Linz GmbH - Barmherzige Schwestern

location_facility: University Hospital Kyoto Prefectural University of Medicine

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

location_facility: Japan Community Health Care Organization Hokkaido Hospital

location_facility: National Chen Kung University, Dept of Neurology

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

location_facility: National Diabetes and Obesity Research Institute

location_facility: Private health care facility "Your Health EL" LLC

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: General Hospital of Thessaloniki "Hippokrateio"

location_facility: Hospital General Universitario de Valencia

location_facility: Leids Universitair Medisch Centrum (LUMC)

location_facility: Synexus Polska SCM Sp. z o.o. Gdansku, Gdansk

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: The First Afiliated Hospital, Sun Yet-sen University

location_facility: Medical University of Graz State Hospital - University Hospital Graz

location_facility: Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH

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

location_facility: American Research Corporation at the Texas Liver Institute

location_facility: National Hospital Organization Yokohama Medical Center

location_facility: IRCCS Ospedale "Casa Sollievo della Sofferenza"

location_facility: University Clinical Center Professor Gibinskiego

location_facility: Shaare Zedek Medical Center, Jerusalem 91031

location_facility: Beijing Ditan Hospital Capital Medical University

location_facility: University of Iowa Hospitals and Clinics

location_facility: The First Affiliated Hospital of Wenzhou Med College

location_facility: Centro Hospitalar Universitário São João,EPE

status: Completed

title: Multicenter, Double-blind, Parallel-group, Randomized, 48 Weeks, Dose-ranging, Placebo-controlled Phase II Trial to Evaluate Efficacy, Safety and Tolerability of Multiple Subcutaneous (s.c.) Doses of BI 456906 in Patients With Non-alcoholic Steatohepatitis (NASH) and Fibrosis.

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

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

The data shared are the raw clinical study data sets.

location_country:
Germany
Poland
New Zealand
Australia
Japan
Czechia
Canada
France
Portugal
Hungary
Hong Kong
United States
Belgium
China
Malaysia
Italy
United Kingdom
Singapore
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan
Israel

status_simplified: Completed


title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Mitapivat in Subjects With Transfusion-Dependent Alpha- or Beta-Thalassemia (ENERGIZE-T)

acronym: ENERGIZE-T

summary: The primary purpose of this study is to compare the effect of mitapivat versus placebo on transfusion burden in participants with transfusion-dependent alpha- or beta-thalassemia (TDT).

lead_sponsor: Agios Pharmaceuticals, Inc.

location_country:
Germany
Brazil
Thailand
Turkey
Canada
France
Denmark
United States
Lebanon
Malaysia
Italy
United Kingdom
Netherlands
United Arab Emirates
Saudi Arabia
Spain
Greece
Taiwan
Bulgaria

location_facility: Toronto General Hospital, University Health Network

location_facility: Imperial College Healthcare NHS Trust - Hammersmith Hospital

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

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

location_facility: Srinagarind Hospital, Khon Kaen University

location_facility: Children's Hospital Agia Sophia, National and Kapodistrian University of Athens Medical School

location_facility: Penn Medicine - University of Pennsylvania Health System

location_facility: Amsterdam Universitair Medisch Centrum, Locatie AMC

location_facility: Charité - UB - CVK - Medizinische Klinik

location_facility: AOU L. Vanvitelli Universita degli Studi della Campania Luigi Vanvitelli

location_facility: Seattle Cancer Care Alliance, University of Washington

location_facility: King Abdullah International Medical Research Center


title: A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination With Aflibercept, Compared With Aflibercept Alone, in Participants With nAMD

acronym: COAST

summary: A 2-year phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.

lead_sponsor: Opthea Limited

location_country:
Germany
Poland
Argentina
Australia
Brazil
Croatia
Czechia
Canada
France
Lithuania
Colombia
Slovakia
Hungary
Denmark
United States
Latvia
India
Estonia
Puerto Rico
Philippines
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Israel

location_facility:
COAST
COAST Invesigational Site
COAST Investigational Site
COAST Investigational site
COAST Investigational Study

intervention_type: Procedure


title: A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination With Ranibizumab, Compared With Ranibizumab Alone, in Participants With nAMD

acronym: ShORe

summary: A 2-year, phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Thailand
Czechia
Canada
France
Colombia
Hungary
Denmark
United States
Latvia
Ukraine
India
Malaysia
Italy
United Kingdom
Korea, Republic of
Spain
Greece
Bulgaria
Israel

location_facility:
ShORe Investigational site
ShORe Investiagational Site
ShORe Investiagtional Site
ShORe Investigational Site


title: A Phase 2 Open-Label Clinical Trial of ADP-A2M4CD8 in Subjects With Advanced Esophageal or Esophagogastric Junction Cancers

summary: This study will investigate the efficacy of ADP-A2M4CD8 T-cell therapy in subjects who have the appropriate human leukocyte antigen (HLA) and tumor antigen status and whose esophageal or esophagogastric junction (EGJ) cancer expresses the MAGE-A4 protein.

lead_sponsor: Adaptimmune

sponsor_collaborators:
Adaptimmune
ICON plc

location_country:
United Kingdom
United States
Spain
Canada
France

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

location_facility: McGill University Health Centre Glen Site

location_facility: Centre Leon-Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est (CRCL)

location_facility: University Of Wisconsin Clinical Science Center

location_facility: Washington University School of Medicine- Siteman Cancer Center

location_facility: Providence Cancer Institute Franz Clinic

location_facility: Froedtert Hospital and Medical College of Wisconsin

location_facility: Hospital Clinico Universitario de Valencia

location_facility: University Of Texas, MD Anderson Cancer Center

location_facility: Hospital Universitario Madrid Sanchinarro (CIOCC)

intervention_type: Genetic


title: A Combined Phase 2/3 12-week, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of AMT-101 in Subjects With Chronic Antibiotic-resistant Pouchitis

acronym: FILLMORE

summary: Phase 2 Study Investigating the Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitis

lead_sponsor: Applied Molecular Transport

location_country:
Germany
Hungary
United Kingdom
Netherlands
Switzerland
Belgium
United States
Spain
Canada
France

location_facility: Groupe santé CHC / Clinique du MontLégia, Liege

location_facility: Gastrointestinal Asssociates- GIA Clinical Trials, LLC

location_facility: Hospital Universitario y Politecnico La Fe de Valencia

location_facility: Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar

location_facility: University of Utah Health Sciences Center

location_facility: UZ Leuven - University Hospital Gasthuisberg

location_facility: Semmelweis Egyetem I. sz Belgyogyaszati Klinika

location_facility: Praxis fur Gastroenterologie am Bayerischen Platz


title: A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion

acronym: COMINO

summary: This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled, parallel-group study evaluating the efficacy, safety, and pharmacokinetics of faricimab administered by intravitreal (IVT) injection at 4-week intervals until Week 24, followed by a double-masked period of study without active control to evaluate faricimab administered according to a personalized treatment interval (PTI) dosing regimen in patients with macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO).

ipd_sharing_description:
For eligible studies, qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).

lead_sponsor: Hoffmann-La Roche

sponsor_collaborators:
Hoffmann-La Roche
Chugai Pharmaceutical

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Czechia
France
Portugal
Hungary
Hong Kong
United States
China
Italy
United Kingdom
Singapore
Austria
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel

location_facility: Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

location_facility: Hospital de Santa Creu I Sant Pau; Servicio de Oftalmologia

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik

location_facility: Queen Mary Hospital; Department of Ophthalmology

location_facility: Szegedi Tudományegyetem ÁOK; Department of Ophtalmology

location_facility: Tokyo Medical University Hachioji Medical Center

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

location_facility: Chang Gung Medical Foundation - Linkou; Ophthalmology

location_facility: Irccs Ospedale San Raffaele;U.O. Oculistica

location_facility: 1 Saint-Petersburg St. Med. University named after academician I.P.Pavlov; Chair of ophathalmology

location_facility: Gabinet Okulistyczny Prof Edward Wylegala

location_facility: Changhua Christian Hospital; Department of Ophthalmology

location_facility: Tokyo Women's Medical University Hospital

location_facility: Eye Hospital, Wenzhou Medical University

location_facility: FSBI ?Scientific Research Institute of Eye Diseases? of Russian Academy of medical Sciences

location_facility: The 2nd Affiliated Hospital of Harbin Medical University

location_facility: Universitätsklinikum Freiburg, Klinik für Augenheilkunde

location_facility: VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota

location_facility: Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre

location_facility: Internationale Innovative Ophthalmochirurgie GbR; c/o Makula-Netzhaut-Zentrum Breyer Kaymak Klabe

location_facility: California Eye Specialists Medical group Inc.

location_facility: Centre Ophtalmologique; Imagerie et laser

location_facility: Hospital Universitario Rio Hortega; Servicio de Oftalmologia

location_facility: Complejo Hospitalario de Navarra; Servicio de oftalmologia

location_facility: Retina Consultants of Southern Colorado PC

location_facility: Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia

location_facility: Intersec Research and Technology Complex ?Eye Microsurgery? n.a. S.N. Fyodorov; Cheboksary Branch

location_facility: Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL

location_facility: Centres Ophtalmologique St Exupéry; Ophtalmologie

location_facility: Kansai Medical University Medical Center

location_facility: SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej

location_facility: Taipei Veterans General Hospital; Ophthalmology

location_facility: University Retina and Macula Associates, PC

location_facility: Hospital Clinic de Barcelona; Consultas Externas Oftalmologia

location_facility: Seoul National University Bundang Hospital

location_facility: Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT

location_facility: O?rodek Chirurgii Oka Prof. Zagórskiego Na??czów

location_facility: The University of Hong Kong-Shenzhen Hospital; Local Ethic Committee

location_facility: Tan Tock Seng Hospital; Ophthalmology Department

location_facility: Northern California Retina Vitreous Associates

location_facility: Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)

location_facility: Szpital Specjalistyczny nr 1; Oddzial Okulistyki

location_facility: Centro de Oftalmologia Barraquer; Servicio Oftalmologia

location_facility: Specjalistyczny O?rodek Okulistyczny Oculomedica

location_facility: Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika

location_facility: Zhongshan Ophthalmic Center, Sun Yat-sen University

location_facility: Northwestern Medical Group/Northwestern University

location_facility: Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico

location_facility: General Teaching Hospital Prague; Ophthalmology clinic

location_facility: Bristol Eye Hospital;Retinal Treatment and Research Unit

location_facility: Hospital de Santa Maria; Servico de Oftalmologia

location_facility: Centro Hospitalar E Universitário de Coimbra EPE - Serviço Oftalmologia; Serviço Oftalmologia

location_facility: Mid Atlantic Retina - Wills Eye Hospital


title: Randomised, Double-blind, Double-dummy, Multicentre Trial to Evaluate the Efficacy and Safety of Three Different Weekly Dosages of Calcifediol Versus Placebo in Subjects With Either Vitamin D Deficiency or Insufficiency.

acronym: WORFEROL

summary: This is a randomised, double-blind, double-dummy, multicentre, dose-ranging clinical trial in subjects with vitamin D deficiency or insufficiency. Its general objective is to determine the efficacy and safety of different doses of calcifediol soft gelatin capsules (SGCs) compared to placebo.

lead_sponsor: Faes Farma, S.A.

location_country: Italy Slovakia Spain Czechia Bulgaria Serbia France

location_facility: Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico -UOC Endocrinologia e Malattie Metaboliche

location_facility: Poliklinika Choceň - Neurologická ambulance

location_facility: Klinički centar Vojvodine, Klinika za endokrinologiju, dijabetes i bolesti metabolizma

location_facility: Azienda Ospedaliero Universitaria - Università degli Studi della Campania Luigi Vanvitelli - UOC di Medicina Fisica e Riabilitazione

location_facility: DANIMED, s.r.o., Ambulancia klinickej imunológie a alergológie

location_facility: Fondazione PTV -Policlinico Ospedaliero Universitario Tor Vergata - U.O.C. Ortopedia e Traumatologia

location_facility: Individual Practice Ambulatory for Specialized Medical Care - Cardiology, Obstetrics and Gynecology

location_facility: IRCCS Ospedale San Raffaele /Unità di Endocrinologia

location_facility: ALERSA, s.r.o., Ambulancia klinickej imunológie a alergológie

location_facility: Centrum gynekologické rehabilitace s.r.o.

location_facility: Medical Centre Asklepion - Research in human medicine

location_facility: ANA JJ, s.r.o., Ambulancia klinickej imunológie a alergológie

location_facility: Hospital Universitario Quirónsalud Madrid

location_facility: Complejo Asistencial Universitario de Salamanca

location_facility: Pľúcna ambulancia Hrebenár, s.r.o. - Pneumologicko-ftizeologická ambulancia

location_facility: MEDILEX, s.r.o., Ambulancia vnútorného lekárstva

location_facility: Centrum pro diagnostiku a léčbu myasthenia gravis - Neurologická klinika 1. LF UK a VFN v Praze

location_facility: Zoll-Med, s.r.o., Ambulancia klinickej imunológie a alergológie

location_facility: Endomed, s.r.o. - Gastroenterologická ambulancia

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: RS centrum - Neurologická klinika 1.LF UK a VFN v Praze

location_facility: Klinički centar Kragujevac, Centar za reumatologiju, alergologiju i kliničku imunologiju, Odeljenje za reumatologiju

location_facility: Institut za lečenje i rehabilitaciju "Niška Banja" Niš, Klinika za reumatologiju

location_facility: KARDIO 1, s.r.o., Kardiologická ambulancia

location_facility: Kardioamb, s.r.o., Kardiologická a interná ambulancia

location_facility: Opšta bolnica "Đorđe Joanović" Zrenjanin, Odeljenje za reumatologiju

location_facility: ALERGO H2B, s.r.o., Ambulancia klinickej imunológie a alergológie

location_facility: KK Neuro, s.r.o., Neurologická ambulancia

location_facility: Diagnostic & Consultative Center "Sveta Anna" EOOD

location_facility: IN MEDIC s.r.o., Neurologická ambulancia

location_facility: AOU Pisana - Centro di Farmacologia Clinica per la Sperimentazione dei Farmaci

location_facility: Specijalna bolnica za reumatske bolesti Novi Sad

location_facility: UOC di Riabilitazione -Azienda Ospedaliero Universitaria Paolo Giaccone Palermo


lead_sponsor: BeiGene

summary: A study of tislelizumab (BGB-A317) plus ociperlimab versus tislelizumab plus placebo as second-line treatment in participants with programmed cell death protein-ligand 1 (PD-L1) tumor area positivity (TAP) ≥ 10% unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma.

location_facility: Severance Hospital, Yonsei University Health System

location_facility: The Second Affiliated Hospital of Nanchang University

location_facility: Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University

location_facility: Nanfang Hospital of Southern Medical University

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

location_facility: Quanzhou First Hospital of Fujian Province

location_facility: Cancer Hospital of Shantou University Medical College

location_facility: The First Affiliated Hospital of Xinxiang Medical University

location_facility: The First Affiliated Hospital of Xinjiang Medical University

location_facility: The First People's Hospital of Changzhou

location_facility: Affiliated Hospital of Jiangnan University

location_facility: Meizhou Hospital Affiliated to Sun Yat-sen University

location_facility: First Affiliated Hospital of Kunming Medical University

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: The First Affiliated Hospital of Zhengzhou University

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

location_facility: Heping Hospital Affiliated to Changzhi Medical College

location_facility: Hwa Mei Hospital, University of Chinese Academy of Sciences

location_facility: Guangdong Provincial Hospital of Chinese Medicine

location_facility: Hospital Universitario Madrid Sanchinarro

location_facility: Guangxi Medical University Affiliated Tumor Hospital

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: First Affiliated Hospital of Xiamen University

location_facility: Chonnam National University Hwasun Hospital

location_facility: Hospital Regional Universitario de Málaga

location_facility: Hospital Clinico Universitario de Valencia - Incliva

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

location_facility: Harbin Medical University Cancer Hospital

location_facility: Beijing Friendship Hospital, Capital Medical University

location_facility: The Affiliated Hospital of Xuzhou Medical University

location_facility: Hopital Europeen Georges Pompidou - Digestive Oncology

location_facility: Songklanagarind Hospital, Prince of Songkla University

location_facility: Centre Hospitalier Universitaire d'Amiens - Hopital Sud

location_facility: The Second Hospital of Anhui Medical University

location_facility: General Hospital of Ningxia Medical University

location_facility: Tianjin Medical University Cancer Institute & Hospital

title: A Phase 2, Multicenter, Randomized, Placebo-Controlled Study to Compare the Efficacy of Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Plus Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) Versus Tislelizumab Plus Placebo as Second-Line Treatment in Patients With PD-L1 Tumor Area Positivity (TAP) ≥ 10% Unresectable, Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

location_country:
Korea, Republic of
China
Spain
Thailand
Taiwan
France


acronym: PIVOT IO 020

intervention_type: Biological

lead_sponsor: Bristol-Myers Squibb

summary: The purpose of this study is to first, in Part A, assess the safety, tolerability and drug levels of Bempegaldesleukin (BEMPEG) in combination with nivolumab and then, in Part B, to estimate the preliminary efficacy in children, adolescents and young adults with recurrent or treatment-resistant cancer.

sponsor_collaborators:
Bristol-Myers Squibb
Nektar Therapeutics

location_facility:
Local Institution - 0028
Local Institution - 0014
Local Institution - 0029
Local Institution - 0016
Local Institution - 0003
Local Institution - 0015
Local Institution - 0037
Local Institution - 0027
Local Institution - 0011
Local Institution - 0009
Local Institution - 0001
Local Institution - 0002
Local Institution
Local Institution - 0008
Local Institution - 0039
Local Institution - 0059
Local Institution - 0038
Local Institution - 0013

title: Phase 1/2 Study of Bempegaldesleukin in Combination With Nivolumab in Children, Adolescents, and Young Adults With Recurrent or Refractory Malignancies (PIVOT IO 020)

location_country:
Germany
Italy
Australia
United States
Spain
France


title: A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension

summary: The purpose of this study is to assess the safety and efficacy of Rodatristat Ethyl in pulmonary arterial hypertension (PAH) patients.

lead_sponsor: Altavant Sciences GmbH

location_country:
Germany
Italy
Moldova, Republic of
Poland
United Kingdom
Austria
Belgium
United States
Bosnia and Herzegovina
Latvia
Spain
Czechia
Ukraine
Bulgaria
Canada
Serbia
France

location_facility: Institute for Cardiovascular diseases of Vojvodina

location_facility: University of North Carolina Medical Center - Chapel Hill

location_facility: Sir Mortimer B. Davis Jewish General Hospital

location_facility: UZ Leuven - Campus Gasthuisberg - Pneumologie

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im Fryderyka Chopina

location_facility: University Clinical Centre of the Republic of Srpska

location_facility: Centre Hospitalier Universitaire (CHU) de Caen - Hopital Cote de Nacre

location_facility: George Washington University Medical Center

location_facility: Washington University School of Medicine

location_facility: Brown University - Rhode Island Hospital

location_facility: Jeffrey S. Sager, MD Medical Corporation

location_facility: Dnipropetrovsk Regional Clinical Diagnostic Center

location_facility: Institute for Pulmonary Diseases of Vojvodina

location_facility: University of California San Diego Health Sciences

location_facility: Universitätsklinikum Giessen und Marburg

location_facility: University of New Mexico Heath Science Center

location_facility: London Health Sciences Centre - Victoria Hospital

location_facility: AKH- Wien, Medizinische Univsersität Wien

location_facility: Wojewodzki Specjalistyczny Szpital im. dr Wl. Bieganskiego

location_facility: AOU S.Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Can

location_facility: Umberto I Policlinico di Roma, Università La Sapienza

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

location_facility: University Health Network, Toronto General Hospital

location_facility: IRCCS Policlinico San Matteo, Università degli studi di Pavi


title: A Phase 2 Randomized Study of Loncastuximab Tesirine Versus Idelalisib in Patients With Relapsed or Refractory Follicular Lymphoma (LOTIS-6)

summary: This study aims to evaluate the efficacy of single agent loncastuximab tesirine compared to idelalisib in participants with relapsed or refractory follicular lymphoma.

lead_sponsor: ADC Therapeutics S.A.

location_country:
France
Italy
Poland
Hungary
United Kingdom
Switzerland
Belgium
United States
Spain
Israel

location_facility: Comprehensive Cancer Centers of Nevada - Central Valley

location_facility: Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

location_facility: Account University College London Hospitals NHS Foundation Trust

location_facility: Szpitale Pomorskie Spółka Z Ograniczoną Odpowiedzialnością

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Centre Hospitalier Universitaire Universite Catholique de Louvain

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Centre de Lutte Contre le Cancer - Centre Henri-Becquerel

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: Summit Medical Group - Florham Park Campus

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Hospital Universitario Quirónsalud Madrid


title: Choice of Optimal Transcatheter Treatment for Mitral Insufficiency Registry

acronym: CHOICE-MI

summary: This multinational, investigator-initiated, retrospective study aims to investigate outcomes of patients, who underwent transcatheter mitral valve implantation (TMVI), in comparison to those screened for TMVI but deemed ineligible, who subsequently underwent interventional mitral valve edge-to-edge repair, mitral valve surgery or medical/conservative therapy.

study_type: Observational

time_perspective: Retrospective

lead_sponsor: Universitätsklinikum Hamburg-Eppendorf

sponsor_collaborators:
Universitätsklinikum Hamburg-Eppendorf
Montreal Heart Institute
University Hospital, Bordeaux

location_country:
Germany
Italy
Norway
United Kingdom
Denmark
Australia
Switzerland
United States
Canada
France

location_facility: University Heart and Vascular Center Hamburg

location_facility: Goethe-Universität - University Hospital Frankfurt

location_facility: Cedars-Sinai Medical Center, Los Angeles

location_facility: Rikshospitalet, Oslo University Hospital (OUS)

location_facility: Heart Center of the University Medical Center Mainz

lead_sponsor_type: academique


lead_sponsor: Takeda

summary:
Thrombotic thrombocytopenic purpura (or TTP for short) is a condition where blood clots form in small blood vessels throughout the body. The clots can limit or block the flow of oxygen-rich blood to the body's organs, such as the brain, kidneys, and heart. As a result, serious health problems can develop. The increased clotting that occurs in TTP uses up the cells that help the blood to clot, called platelets. With fewer platelets available in the blood, bleeding problems can also occur. People who have TTP may bleed underneath the skin forming purple bruises, or purpura. TTP also can cause anemia, a condition in which red blood cells break apart faster than the body can replace them, leading to fewer red blood cells than in normal.

TTP is caused by a lack of activity in the ADAMTS13 enzyme, a protein in the blood involved in controlling clotting of the blood. The ADAMTS13 enzyme breaks up another blood protein called von Willebrand factor that forms blood clots by clumping together with platelets. Some people are born with this condition, while others develop the condition during their life. Many people who are born with TTP experience frequent flare-ups that need to be treated right away. TAK-755 is a medicine that replaces ADAMTS13 and may prevent or control TTP flare-ups, called acute TTP events.

The main aim of the study is to check for side effects of long-term treatment with TAK-755. Treatment will be given in 2 ways:

TAK-755 treatment given either every week or every other week to prevent acute TTP events from happening (the "prophylactic" cohort).
TAK-755 treatment given to control an acute TTP event when it happens (the "on-demand" cohort).

Participants in the prophylactic cohort will receive treatment in the clinic or at home for up to approximately 3 years. They will visit the clinic at least every 12 weeks. Participants in the on-demand cohort will receive daily treatment for the acute TTP event until the flare-up has gotten better. They will have a follow-up visit at the clinic 4 weeks later.

sponsor_collaborators: Takeda Development Center Americas, Inc.

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)

location_facility: Institute of Hematology and Hospital of Blood Disease

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: Medical Hospital,Tokyo Medical and Dental University

location_facility: Tongji Hospital Affiliated to Tongji Medicine University

location_facility: Samodzielny Publiczny Dzieciecy Szpital Kliniczny

location_facility: University of Minnesota Health Clinical Research Unit

location_facility: Universitaetsklinikum Jena, Klinik fuerKinder-und Jugendmedizin

title: A Phase 3b, Prospective, Open-label, Multicenter, Single Treatment Arm, Continuation Study of the Safety and Efficacy of TAK-755 (rADAMTS13, Also Known as BAX 930/SHP655) in the Prophylactic and On-demand Treatment of Subjects With Severe Congenital Thrombotic Thrombocytopenic Purpura (cTTP; Upshaw-Schulman Syndrome, or Hereditary Thrombotic Thrombocytopenic Purpura)

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:
Germany
Italy
Poland
United Kingdom
Japan
Switzerland
Austria
United States
China
Spain
France


title: A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy

summary: The primary objective is to evaluate the efficacy and safety of efavaleukin alfa in subjects with active systemic lupus erythematosus.

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

lead_sponsor: Amgen

location_country:
Poland
Japan
Turkey
Chile
Canada
France
Colombia
Hong Kong
Switzerland
United States
Italy
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation

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

location_facility: Arizona Arthritis And Rheumatology Associates PC

location_facility: Feinstein Institute for Medical Research

location_facility: Integral Rheumatology and Immunology Specialists

location_facility: Azienda Ospedaliera Ordine Mauriziano di Torino

location_facility: University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD

location_facility: Institute for Clinical and Translation Research at Einstein and Montefiore Clinical Research Center

location_facility: Arizona Arthritis and Rheumatology Associates PC

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: New York University Langone Ambulatory Care Brooklyn Heights

location_facility: University of Alabama at Birmingham,Arthritis Clinical Intervention Program

location_facility: Azienda Ospedaliera Policlinico Umberto I

location_facility: National University Corporation Tohoku University Tohoku University Hospital

location_facility: Trinity Universal Research Associates, LLC

location_facility: Centre Hospitalier Universitaire de Montpellier Hopital Lapeyronie

location_facility: Sociedad de Prestaciones Medicas Intermedica Limitada

location_facility: I M Sechenov First Medical University of the MoH of RF

location_facility: Centre for Rheumatology Immunology and Arthritis

location_facility: Azienda Ospedaliero Universitaria Integrata Santa Maria della Misericordia

location_facility: National Hospital Organization Chibahigashi National Hospital

location_facility: University of Pittsburgh Medical Center Lupus Center of Excellence

location_facility: Centro Integral de Reumatología del Caribe Circaribe SAS

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil

location_facility: Centro de Investigacion en Reumatologia y Especialidades Medicas SAS

location_facility: Michigan Rheumatology Group, PC - Grand Blanc Office

location_facility: Centre Hospitalier Universitaire de Nancy - Hopital de Brabois

location_facility: Japan Community Healthcare Organization Chukyo Hospital

location_facility: FSBSI SRI of Rheumatology na V A Nasonova

location_facility: Cukurova Universitesi Balcali Hastanesi Saglik Uygulama ve Arastirma Merkezi

location_facility: Limited liability company Scientific Research Medical Complex Your Health

location_facility: Arthritis and Rheumatic Disease Specialties

location_facility: Phylasis Clínicas Research S. De R. L. De C. V.

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Centro de Investigacion Integral Medivest SC

location_facility: Investigacion y Terapias Reumatologicas Innovadoras LTDA - Interin LTDA

location_facility: Sociedad de prestaciones Medicas y Paramedicas Goecke Gatica y Compania Limitada - Prosalud

location_facility: Diagnostic-Consultative Center Sveti Georgi EOOD

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Estudios Clinicos Limitada - Centro de Estudios Reumatologicos

location_facility: Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil

location_facility: University of Texas Health Science Center at San Antonio Medical Arts Research Clinic Marc

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Hospital of the University of Occupational and Environmental Health Japan

location_facility: Saint-Petersburg State Budget Healthcare Institution Clinical Rheumatology Hospital 25

location_facility: University of North Carolina at Chapel Hill Thurston Arthritis Research Center

location_facility: Reumatop Grzegorz Rozumek, Karin Pistorius

location_facility: Università degli studi della Campania Luigi Vanvitelli

location_facility: Solano y Terront Servicios Medicos Ltda - Uniendo

location_facility: Centrum Badan Klinicznych Wojciech Brzezicki

location_facility: Center for medical consultations and research - practice

location_facility: Centro Integral en Reumatologia SA de CV

location_facility: Precision Comprehensive Clinical Research Solutions

location_facility: CITER SA de CV (Centro de Investigación y Tratamiento de las Enfermedades Reumáticas SA de CV)

location_facility: Daegu Catholic Universtiy Medcial Center

location_facility: Centro de Estudios de Investigacion Basica y Clinica, Sc

location_facility: Olympion Hospital-General Clinic of Patras AE

location_facility: Clinic of Robert Hozman, MD - Clinical Investigational Specialists, Inc

location_facility: State University of New York - Upstate Medical University

location_facility: Arthritis and Rheumatology Center of Oklahoma PLLC


acronym: ASSERT

lead_sponsor: Albireo

summary: Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in Patients with Alagille Syndrome.

location_facility: The Childrens Hospital at Montefiore Albert Einstein School of Medicine

location_facility: Antenne pédiatrique du CIC - Hopital Jeanne De Flandre

location_facility: Cliniques Universitaires Saint-Luc Bruxelles

location_facility: University of California - San Francisco

location_facility: Universitair Medisch Centrum Groningen (UMCG)

location_facility: Schneider Children's Medical Center of Israel

location_facility: Oregon Health Science University School of Medicine

location_facility: Istanbul University Medical Faculty Hospital

location_facility: Hacettepe Üniversitesi İhsan Doğramacı Çocuk Hastanesi

location_facility: Universitätsklinik für Kinder-und Jugendmedizin Tübingen

title: A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients With Alagille Syndrome (ASSERT)

location_country:
Germany
Italy
Poland
New Zealand
Israel
United Kingdom
Netherlands
Belgium
United States
Malaysia
Turkey
Canada
France


type: Other Identifier

title: A Phase IIIb, Global, Multicenter, Randomized, Visual Assessor-Masked Study Of The Efficacy, Safety, And Pharmacokinetics Of A 36-Week Refill Regimen For The Port Delivery System With Ranibizumab In Patients With Neovascular Age-Related Macular Degeneration (Velodrome)

summary: Study WR42221 is a Phase IIIb, global, multicenter, randomized, visual assessor-masked study designed to assess the efficacy, safety, and pharmacokinetics of the Port Delivery System with ranibizumab (PDS) 100 mg/mL delivered every 36 weeks (Q36W) compared with every 24 weeks (Q24W) in patients with neovascular age-related macular degeneration (nAMD).

location_country:
Germany
Italy
Israel
Argentina
Singapore
Australia
Brazil
Switzerland
Austria
Belgium
United Kingdom
Korea, Republic of
Spain
Turkey
Taiwan
France

location_facility: Universitätsklinikum Ulm, Augenklinik und Poliklinik

location_facility: Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

location_facility: Hospital dos de maig; servicio de oftalmologia

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik

location_facility: Städtisches Klinikum Dresden; Augenklinik

location_facility: Chang Gung Medical Foundation - Linkou; Ophthalmology

location_facility: Irccs Ospedale San Raffaele;U.O. Oculistica

location_facility: Ospedale Clinicizzato SS Annunziata; Clinica Oftalmologica

location_facility: Changhua Christian Hospital; Department of Ophthalmology

location_facility: Moorfields Eye Hospital NHS Foundation Trust

location_facility: Universitätsklinikum Freiburg, Klinik für Augenheilkunde

location_facility: Fondation Asile Des Aveugles ? Jules Gonin Eye Hospital

location_facility: Clinica Universitaria de Navarra; Servicio de Oftalmologia

location_facility: Hospital Universitario Rio Hortega; Servicio de Oftalmologia

location_facility: Hopital de la croix rousse; Ophtalmologie

location_facility: Kocaeli Üniversitesi T?p Fakültesi; Department of Ophthalmology

location_facility: Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia

location_facility: Knappschaftsklinikum Saar GmbH; Augenklinik Sulzbach

location_facility: Universitätsspital Basel Augenklinik Klinik

location_facility: Taipei Veterans General Hospital; Ophthalmology

location_facility: Ankara Ulucanlar Eye Research and Application Hospital; Ophthalmology

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: LMU Klinikum der Universität, Augenklinik

location_facility: Hospital Clinic de Barcelona; Consultas Externas Oftalmologia

location_facility: Seoul National University Bundang Hospital

location_facility: National Taiwan University Hospital; Ophthalmology

location_facility: Inselspital Bern Ophthalmologische Klinik

location_facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica

location_facility: Ospedale Classificato Equiparato Sacro Cuore ? Don Calabria; Dipartimento Oculistica

location_facility: Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica

location_facility: Tan Tock Seng Hospital; Ophthalmology Department

location_facility: Manchester University NHS Foundation Trust (MFT)

location_facility: Centro de Oftalmologia Barraquer; Servicio Oftalmologia

location_facility: National University Hospital; Ophthalmology Department

location_facility: Hull University Teaching Hospitals NHS Trust

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

location_facility: Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde

location_facility: Bristol Eye Hospital;Retinal Treatment and Research Unit

location_facility: Stadtspital Triemli Ophthalmologische Klinik


title: A Phase 1b, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-64264681 in Combination With JNJ-67856633 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

summary: The primary purpose of this study is to determine: the recommended Phase 2 doses (RP2Ds) of JNJ-64264681 and JNJ 67856633 when administered together in participants with B cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) (Part A - Dose Escalation); and the safety of the RP2Ds for this combination in different histologies/participant populations (Part B - Cohort Expansion).

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

lead_sponsor: Janssen Research & Development, LLC

location_country:
Poland
Israel
Australia
Netherlands
Belgium
United States
Korea, Republic of
Spain
Ukraine
Moldova, Republic of
Georgia
France

location_facility: Medical Center of Limited Liability Company Arensia Exploratory Medicine


lead_sponsor: Sanofi

summary: The purpose of this umbrella study is to evaluate isatuximab when combined with novel agents with or without dexamethasone in participants with relapsed or refractory myeloma. Substudies 02, 03, and 06 are controlled experimental substudies. Substudies 04 and 05 are independent experimental substudies.

location_facility: Puerto Rico Medical Research Center, LLC Site Number : 8400005

location_facility: University of Illinois Site Number : 8400007

location_facility: Roswell Park Cancer Institute Site Number : 8400008

location_facility: University of Michigan Site Number : 8400004

title: Phase 1-2 UMBRELLA Trial Evaluating Isatuximab With or Without Dexamethasone in Combination With Novel Agents Compared to Isatuximab With Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma (RRMM) - Master Protocol

location_country:
Italy
Portugal
Norway
Australia
United States
Greece
Puerto Rico
France


lead_sponsor: AstraZeneca

summary: This is a Phase III double-blind, placebo-controlled study of Durvalumab versus Placebo in patients with stage II-III NSCLC who are MRD-positive following curative intent therapy.

title: A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Study of Durvalumab for the Treatment of Stage II-III NSCLC Patients With Minimal Residual Disease Following Surgery and Curative Intent Therapy.

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:
Poland
Argentina
Australia
Brazil
Japan
Vietnam
Turkey
Czechia
Canada
France
Hungary
Hong Kong
United States
India
Belgium
Peru
Italy
Singapore
Netherlands
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel


title: A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter Combined Phase 2a/2b Study to Assess the Efficacy and Safety of BAY 1817080 in Patients With Diabetic Neuropathic Pain

summary:
People suffering from diabetes often have high blood sugar levels. Over time this can affect many organs including the nerves in hands and feet and can cause a nerve pain called diabetic neuropathic pain (DNP). There are treatments for DNP but in many patients they do not reach a good pain reduction and have unwanted side effects.

In this trial, the researchers will look at how BAY1817080 works and how safe it is. They will compare it to a placebo or another treatment for DNP called pregabalin. A placebo looks like a treatment but does not have any medicine in it. The researchers will use a placebo to learn if the participants' results are due to BAY1817080 or if the results could be due to chance. The researchers will also learn more about the right dose of BAY1817080 for these participants.

The trial will include participants who have DNP and either type 1 or type 2 diabetes. It will include about 440 men and women who are at least 18 years old.

This trial will have 2 parts. In Part 1, the participants will take either BAY1817080 or the placebo. These treatments will be taken as a tablet by mouth twice a day for 8 weeks. In Part 2, participants will take BAY 1817080, pregabalin, or a matching placebo of either treatment. BAY1817080 and a placebo will be taken as a tablet by mouth twice a day for 12 weeks. Pregabalin and a placebo will be taken as a capsule by mouth twice a day for 12 weeks.

The participants in Part 1 will visit their trial site 6 times. The participants in Part 2 will visit their trial site 7 times. At these visits, the doctors will ask the participants if they have any health problems, take blood samples, and do a physical exam. They will also ask the participants to complete questionnaires about their pain and other symptoms.

ReferenceType: derived

ReferenceCitation: Fletcher MC. Selectivity of the P2X3 receptor antagonist Eliapixant, and its potential use in the treatment of endometriosis. Purinergic Signal. 2022 Mar;18(1):1-3. doi: 10.1007/s11302-021-09831-5. Epub 2022 Jan 3. No abstract available.

oa_host_type: repository

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

version: publishedVersion

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Springer-Nature

ipd_sharing_description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

lead_sponsor: Bayer

location_country: Germany Finland Poland Slovakia Hungary Norway Denmark Sweden Czechia France

location_facility: Diamond Clinic Specjalistyczne Poradnie Lekarskie

location_facility: Diabetologicka a endokrinologicka ambulance, Milan Kvapil,

location_facility: Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu

location_facility: Tampereen yliopistollinen sairaala, keskussairaala


acronym: Substudy 03B: Phase 1b/2 Umbrella Study of Combination Therapies in RCC

lead_sponsor: Merck Sharp & Dohme LLC

summary:
Substudy 03B is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03).

The goal of substudy 03B is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced second line plus (2L+) clear cell renal cell carcinoma (ccRCC).

This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to demonstrate a tolerable safety profile for the combination of investigational agents. There will be no hypothesis testing in this study.

location_facility: Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 4301)

location_facility: Western Sydney Local Health District ( Site 3601)

location_facility: Yale-New Haven Hospital-Yale Cancer Center ( Site 3011)

location_facility: Sheba Medical Center - Oncology Division ( Site 3501)

location_facility: Hospital Universitari Vall d Hebron ( Site 3300)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 4200

location_facility: Laura and Isaac Perlmutter Cancer Center ( Site 3016)

location_facility: Hadassah Medical Center-Oncology ( Site 3504)

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 4201)

location_facility: Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 4202)

location_facility: University of California at San Francisco ( Site 3008)

location_facility: James Lind Centro de Investigación del Cáncer ( Site 4108)

location_facility: The Christie NHS Foundation Trust ( Site 3400)

location_facility: Princess Margaret Cancer Centre ( Site 3101)

location_facility: Vanderbilt University Medical Center ( Site 3004)

location_facility: Southampton General Hospital ( Site 3403)

location_facility: Rambam Health Care Campus-Oncology Division ( Site 3500)

location_facility: The Beatson West of Scotland Cancer Centre ( Site 3405)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 3002)

location_facility: Hospital Universitario Ramon y Cajal ( Site 3301)

location_facility: Institut de cancérologie Strasbourg Europe (ICANS) ( Site 3203)

location_facility: Velindre Cancer Centre Hospital ( Site 3407)

location_facility: Royal Brisbane and Women s Hospital ( Site 3603)

location_facility: Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)-medical oncology ( Site 4402)

location_facility: Institut De Cancerologie De Lorraine ( Site 3204)

location_facility: UPMC Cancer Center/Hillman Cancer Center ( Site 3017)

title: A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (U03): Substudy 03B

location_country:
Poland
New Zealand
Hungary
Israel
United Kingdom
Australia
Netherlands
United States
Korea, Republic of
Spain
Chile
Canada
France


acronym: Substudy 03A: Phase 1b/2 Umbrella Study of Combination Therapies in RCC

summary:
Substudy 03A is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03).

The goal of substudy 03A is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced first line (1L) clear cell renal cell carcinoma (ccRCC).

This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to demonstrate a tolerable safety profile for the combination of investigational agents. There will be no hypothesis testing in this study.

location_facility: Hadassah Medical Center-Oncology ( Site 1504)

location_facility: UPMC Cancer Center/Hillman Cancer Center ( Site 1017)

location_facility: Princess Margaret Cancer Centre ( Site 1101)

location_facility: James Lind Centro de Investigación del Cáncer ( Site 2108)

location_facility: The Christie NHS Foundation Trust ( Site 1400)

location_facility: Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 2202)

location_facility: Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 2301)

location_facility: Western Sydney Local Health District ( Site 1601)

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2201)

location_facility: Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)-medical oncology ( Site 2402)

location_facility: Velindre Cancer Centre Hospital ( Site 1407)

location_facility: Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1203)

location_facility: Southampton General Hospital ( Site 1403)

location_facility: Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 1900)

location_facility: Hospital Universitario Ramon y Cajal ( Site 1301)

location_facility: Yale-New Haven Hospital-Yale Cancer Center ( Site 1011)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 1002)

location_facility: Sheba Medical Center - Oncology Division ( Site 1501)

location_facility: Institut De Cancerologie De Lorraine ( Site 1204)

location_facility: University of California at San Francisco ( Site 1008)

location_facility: The Beatson West of Scotland Cancer Centre ( Site 1405)

location_facility: Hospital Universitari Vall d Hebron ( Site 1300)

location_facility: Royal Brisbane and Women s Hospital ( Site 1603)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 2200

location_facility: Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1905)

location_facility: Laura and Isaac Perlmutter Cancer Center ( Site 1016)

title: A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (U03): Substudy 03A

location_country:
Poland
Colombia
New Zealand
Hungary
Israel
United Kingdom
Australia
Netherlands
United States
Korea, Republic of
Spain
Chile
Canada
France


title: A Phase 2 Study of Avutometinib (VS-6766) (Dual RAF/MEK Inhibitor) Alone and In Combination With Defactinib (FAK Inhibitor) in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)

acronym: RAMP 201

summary: This study will assess the safety and efficacy of avutometinib (VS-6766) monotherapy and in combination with defactinib in subjects with recurrent Low-Grade Serous Ovarian Cancer (LGSOC)

lead_sponsor: Verastem, Inc.

collaborators: European Network of Gynaecological Oncological Trial Groups (ENGOT)

location_country:
Italy
United Kingdom
Belgium
United States
Spain
Canada
France

location_facility: U.O.C. Oncologia 2, Istituto Oncologico Veneto I.R.C.C.S.

location_facility: H. Lee Moffitt Cancer Center and Research Institute - Center for Women's Oncology

location_facility: Cleveland Clinic Women's Health Institute

location_facility: The Ohio State University Wexner Medical Center

location_facility: Washington University School of Medicine

location_facility: University of New Mexico Comprehensive Cancer Center

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: Texas Oncology- Dallas Presbyterian Hospital

location_facility: Centre de recherche di Centre Hospitalier de i'Universite de Montreal


lead_sponsor: Eli Lilly and Company

summary: The main purpose of this study is to evaluate the efficacy and safety of galcanezumab for the preventive treatment of chronic migraine in participants 12 to 17 years of age. The primary objective is to demonstrate the superiority of galcanezumab versus placebo in the reduction of monthly migraine headache days across the 3-month double-blind treatment period.

location_facility: University of Miami Don Suffer Clinical Research Building

location_facility: All India Institute of Medical Sciences (AIIMS) - Nagpur

location_facility: Centre Hospitalier Universitaire Estaing

location_facility: Centro de Investigacion Medica Aguascalientes

location_facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro

location_facility: PanAmerican Clinical Research - Guadalajara

location_facility: Barbara Diaz-Hernandez MD Research, Inc.

location_facility: Velocity Clinical Research at Raleigh Neurology

location_facility: P.D. Hinduja Hospital and Medical Research Centre

location_facility: Mangala Hospital & Mangala Kidney Foundation

location_facility: Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

location_facility: Hospital Infantil de Mexico Federico Gomez

location_facility: Orange County Research Institute - Ontario

location_facility: Miller Children's & Women's Hospital Long Beach

location_facility: Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

location_facility: Minneapolis Clinic of Neurology - Burnsville Office

location_facility: Cohen Children's Northwell Health Physician Partners - Pediatric Neurology

location_facility: G.B. Pant Institute of Postgraduate Medical Education & Research

location_facility: Clinica De Enfermedades Cronicas y Procedimientos Especiales

location_facility: University of Kentucky Chandler Medical Center

title: A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adolescent Patients 12 to 17 Years of Age With Chronic Migraine - the REBUILD-2 Study

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

location_country:
Germany
Italy
India
Denmark
Japan
Netherlands
Mexico
United States
Spain
Canada
Puerto Rico
France


title: foresiGHt: A Multicenter, Randomized, Parallel-arm, Placebo-controlled (Double- Blind) and Active-controlled (Open-label) Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone Deficiency

acronym: foresiGHt

summary: A 38 week dosing trial of lonapegsomatropin, a long-acting growth hormone product, administered once-a-week versus placebo-control. A daily somatropin product arm is also included to assist clinical judgement on the trial results. Approximately 240 adults (males and females) with growth hormone deficiency will be included. Randomization will occur in a 1:1:1 ratio (lonapegsomatropin : placebo : daily somatropin product). This is a global trial that will be conducted in, but not limited to, the United States, Europe, and Asia.

lead_sponsor: Ascendis Pharma Endocrinology Division A/S

location_country:
Germany
Poland
New Zealand
Australia
Japan
Armenia
Turkey
Canada
Serbia
France
Slovakia
Denmark
United States
Ukraine
Romania
Malaysia
Italy
United Kingdom
Netherlands
Korea, Republic of
Spain
Greece
Georgia
Israel


acronym: FJORD

summary: The purpose of this study is to investigate the use of benralizumab is effective in the treatment of patients symptomatic Bullous Pemphigoid (BP).

title: A Multinational, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab as a Treatment Option for Patients With Bullous Pemphigoid (FJORD)

location_country:
Germany
Italy
Israel
Australia
Japan
United States
China
Spain
Greece
Bulgaria
France


title: An Open-Label, Multicenter, Follow-up Trial of ARGX-113-1904 to Evaluate the Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients With Pemphigus

acronym: ADDRESS+

summary:
This is a prospective, multicenter, open label extension (OLE) trial on the efficacy, safety, patient outcome measures, tolerability, immunogenicity, PK and PD of efgartigimod PH20 SC in adult PV or PF participants, who participated in antecedent trial ARGX-113-1904. This trial provides extension of efgartigimod PH20 SC treatment and retreatment options for participants who have been randomized to efgartigimod PH20 SC treatment arm in the trial ARGX-113-1904, and the first treatment of efgartigimod PH20 SC and retreatment options for participants who had been randomized to placebo arm in trial ARGX-113-1904. Trial ARGX-113-1905 evaluates ability to (further) taper prednisone therapy and achieve Clinical Remission (CR) off therapy (CRoff), the ability to achieve CR and CR on minimal therapy (CRmin) for participants who had not yet achieved CRmin, and the ability to treat flare; and assess patient outcome measures and the safety, PD, PK and immunogenicity of efgartigimod PH20 SC over the duration of trial.

Study duration: Up to 60 weeks for participants who receive IMP administration up to 52 weeks and with a follow-up period of 8 weeks after the last IMP administration

lead_sponsor: argenx

location_country:
Germany
Poland
Australia
Japan
Turkey
Serbia
France
Hungary
United States
Ukraine
India
Romania
China
Italy
United Kingdom
Spain
Greece
Bulgaria
Georgia
Russian Federation
Israel

location_facility:
Investigator site 36 - GR0300002
Investigator site 64 - TR0900020
Investigator site 31 - GE9950015
Investigator site 115 - US0010086
Investigator site 98 - RO0400015
Investigator site 32 - GE9950013
Investigator site 65 - IN0910002
Investigator site 18 - BG3590013
Investigator site 59 - ES0340034
Investigator site 79 - IN0910004
Investigator site 46 - RU0070031
Investigator site 4 - DE0490026
Investigator site 3 - BG3590011
Investigator site 95 - IT0390039
Investigator site 68 - JP0810040
Investigator site 50 - RU0070034
Investigator site 82 - JP0810046
Investigator site 1 - US0010087
Investigator site 124 - US0010092
Investigator site 86 - PL0480036
Investigator site 24 - HU0360002
Investigator site 62 - ES0340026
Investigator site 33 - DE0490024
Investigator site 39 - RU0070032
Investigator site 92 - AU0610013
Investigator site 13 - ES0340032
Investigator site 99 - CN0860016
Investigator site 63 - TR0900012
Investigator site 100 - CN0860021
Investigator site 117 - CH0860026
Investigator site 41 - RU0070033
Investigator site 17 - BG3590012
Investigator site 69 - JP0810050
Investigator site 83 - UK0440022
Investigator site 9 - UA3800018
Investigator site 73 - JP0810047
Investigator site 90 - US0010117
Investigator site 8 - UA3800019
Investigator site 52 - DE0490001
Investigator site 40 - RU0070035
Investigator site 120 - CH0860023
Investigator site 67 - JP0810043
Investigator site 15 - AU0610006
Investigator site 43 - UA3800021
Investigator site 81 - IT0390030
Investigator site 126 - US0010090
Investigator site 80 - IN0910003
Investigator site 75 - UA3800017
Investigator site 110 - RS3810010
Investigator site 71 - JP0810049
Investigator site 22 - GR030003
Investigator site 114 - JP0810067
Investigator site 97 - RO0400013
Investigator site 57 - ES0340027
Investigator site 25 - IT-0390005
Investigator site 11 - AU0610007
Investigator site 29 - UA3800023
Investigator site 30 - US0010094
Investigator site 21 - GR030004
Investigator site 121 - CH0860025
Investigator site 125 - US0010107
Investigator site 61 - IT0390040
Investigator site 58 - ES0340028
Investigator site 5 - HU0360001
Investigator site 77 - FR0330028
Investigator site 122 - ES0340053
Investigator site 37 - GR030006
Investigator site 103 - US0010097
Investigator site 105 - RS3810012
Investigator site 60 - FR0330027
Investigator site 56 - PL0480032
Investigator site 55 - IT0390038
Investigator site 72 - JP0810045
Investigator site 76 - US0010096
Investigator site 7 - ES0340029
Investigator site 42 - ES0340025
Investigator site 38 - IT0390031
Investigator site 116 - CH0860053
Investigator site 19 - DE0490025
Investigator site 51 - FR0330026
Investigator site 70 - JP0810041
Investigator site 85 - IL9720002
Investigator site 127 - GE9950030
Investigator site 34 - DE0490030
Investigator site 26 - PL0480028
Investigator site 20 - DE0490002
Investigator site 10 - US0010088
Investigator site 66 - JP0810042
Investigator site 123 - UK0440037
Investigator site 28 - PL0480025
Investigator site 113 - CN0860024
Investigator site 88 - US0010114
Investigator site 47 - RU0070028
Investigator site 94 - IN0910001
Investigator site 106 - UK0440021
Investigator site 48 - RU0070029
Investigator site 102 - CN0860020
Investigator site 118 - CH0860027
Investigator site 16 - BG3590009
Investigator site 12 - IT0390006
Investigator site 74 - TR0900011
Investigator 96 - RO0400014
Investigator site 107 - CN0860018
Investigator site 6 - HU0360003
Investigator site 101 - CN0860017
Investigator site 49 - RU0070030
Investigator site 108 - FR0330029
Investigator site 87 - US0010084
Investigator site 53 - DE0490023
Investigator site 35 - DE0490028
Investigator site 89 - US0010091
Investigator site 23 - GR030005
Investigator site 104 - RS3810009
Investigator site 91 - US0010109
Investigator site 109 - RS3810011
Investigator site 14 - UA3800020
Investigator site 119 - CH0860022
Investigator site 112 - CN0860019
Investigator site 27 - PL0480027
Investigator site 45 - DE0490029
Investigator site 78 - GE9950014
Investigator site 84 - US0010089
Investigator site 93 - DE0490027
Investigator site 44 - US0010106
Investigator site 2 - BG3590010
Investigator site 54 - GR0300001
Investigator site 111 - US0010098


title: A Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Pemphigus (Vulgaris or Foliaceus)

acronym: ADDRESS

summary: This is a prospective, multicenter, randomized, double-blinded, placebo-controlled trial to investigate the efficacy, safety, patient outcome measures, tolerability, immunogenicity, PK, and PD of efgartigimod PH20 SC in adult participants aged from 18 years with PV or PF. The trial comprises a screening period of up to 3 weeks, a treatment period of up to 30 weeks, and an 8-week follow-up period for participants who do not enroll into the open-label extension (OLE) trial ARGX-113-1905. The primary objective of the ARGX-113-1904 trial is to demonstrate the efficacy of subcutaneous administration of efgartigimod co-formulated with recombinant human hyaluronidase PH20 (Efgartigimod PH20 SC) compared to placebo in the treatment of participants with Pemphigus Vulgaris (PV). Secondary objectives are to also demonstrate the efficacy of efgartigimod PH20 SC in the treatment of participants with Pemphigus Foliaceus (PF), and to demonstrate early onset of action and a prednisone-sparing effect. After confirmation of eligibility, participants will be randomized in a 2: 1 ratio to receive efgartigimod PH20 SC or placebo

location_facility:
Investigator site 117 - UK0440021
Investigator site 2 - BG3590009
Investigator site 111 - CN0860018
Investigator site 105 - RO0400014
Investigator site 109 - CN0860021
Investigator site 93 - JP0810041
Investigator site 2 - US0010087
Investigator site 39 - GR0300003
Investigator site 49 - DE0490024
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intervention_type: Other


title: Evaluation of the Safety and Efficacy of the reSept ASD Occluder to Treat Patients With Clinically Significant Secundum Atrial Septal Defect

acronym: ASCENT ASD

summary: Evaluation of the safety and efficacy of the reSept ASD Occluder to treat patients with clinically significant secundum atrial septal defect

lead_sponsor: atHeart Medical

location_country:
United States
France

location_facility: Joe DiMaggio Children's Hospital/Memorial Healthcare System

location_facility: Hôpital cardiologique Haut-Leveque (CHU Bordeaux)

location_facility: Washington University School of Medicine


lead_sponsor: Novartis Pharmaceuticals

summary: This is a prospective Phase II multi-center study with an upfront 16-week, randomized, double-blind, placebo-controlled period, and extension periods, to assess the efficacy, safety and pharmacokinetics of alpelisib in pediatric and adult participants with PIK3CA-related overgrowth spectrum (PROS).

ReferenceCitation: Madsen RR, Semple RK. PIK3CA-related overgrowth: silver bullets from the cancer arsenal? Trends Mol Med. 2022 Apr;28(4):255-257. doi: 10.1016/j.molmed.2022.02.009. Epub 2022 Mar 8.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

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

repository_institution: University of Edinburgh - Edinburgh Research Explorer

version: submittedVersion

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

location_facility: Children's Hospital and Regional Medical Center

location_facility: University of Texas Southwestern Medical Center .

location_facility: Cincinnati Children s Hospital Medical Center

location_facility: Washington University School of Medicine .

title: EPIK-P2: A Phase II Double-blind Study With an Upfront, 16-week Randomized, Placebo-controlled Period, to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (PROS)

location_country:
Germany
Italy
Norway
Hong Kong
United Kingdom
Netherlands
Switzerland
United States
China
Spain
Canada
France


lead_sponsor: Mitsubishi Tanabe Pharma America Inc.

summary: This is a Phase 3, international, multicenter, open-label, long-term extension study. The primary objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) for up to 96 weeks.

location_facility: Johns Hopkins University School of Medicine

location_facility: University of Colorado Anschutz Medical Campus

location_facility: Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca Granda - Centro Clinico Nemo (Neuro Muscular Omnicentre)

location_facility: Shiga University of Medical Science Hospital

location_facility: St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory W. Fulton ALS and Neuromuscular Disease Center

location_facility: Kansai Electric Power Hospital Recruiting

location_facility: University of Alberta - Walter C Mackenzie Health Sciences Centre (WCM)

location_facility: National Hospital Organization Iou National Hospital

location_facility: Tokyo Metropolitan Neurological Hospital

location_facility: Montreal Neurological Institute and Hospital

location_facility: National Hospital Organization Chibahigashi National Hospital

location_facility: Heritage Medical Research Clinic - University Of Calgary

location_facility: National Hospital Organization Toneyama Medical Center

location_facility: Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)

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

location_facility: Lewis Katz School of Medicine at Temple University

location_facility: National Hospital Organization Kumamoto Saishun Medical Center

location_facility: Wake Forest University Baptist Medical Center (WFUBMC) - The J. Paul Sticht Center on Aging and Rehabilitation

location_facility: Universita degli Studi di Torino - Centro Regionale Esperto Per La Sclerosi Laterale Amiotrofica (CRESLA)

location_facility: Niigata University Medical And Dental Hospital

location_facility: Centre Hospitalier Universitaire (CHU) de Bordeaux

location_facility: National Hospital Organization Hokkaido Medical Center

location_facility: Hopital Pierre Wertheimer - Hopital Neurologique

title: A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS)

location_country:
Germany
Italy
Japan
United States
Canada
France

ipd_sharing: Undecided


summary: The study is investigating efficacy, safety and tolerability of DNA-damage Response Agents (or Combinations), in participants with advanced/metastatic solid malignancies whose tumours contain molecular alterations

title: A Modular Phase 2a Multicentre Open-Label Study to Investigate DNA-damage Response Agents (or Combinations) in Patients With Advanced Cancer Whose Tumours Contain Molecular Alterations (PLANETTE)

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

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

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

location_country:
United States
Spain
France