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://www.clinicalstudydatarequest.com/

lead_sponsor: Sanofi

location_country:
Italy
France
Greece
Norway
Australia
Puerto Rico
United States

location_facility:
Investigational Site Number :3000002
Investigational Site Number :8400007
Investigational Site Number :0360006
Investigational Site Number :0360003
Investigational Site Number :2500001
Investigational Site Number :3000001
Investigational Site Number :5780001
Investigational Site Number :0360001
Investigational Site Number :2500002
Investigational Site Number :0360002
Investigational Site Number :8400001
Investigational Site Number :3800002
Investigational Site Number :3800001
Investigational Site Number :2500004
Investigational Site Number :0360005
Investigational Site Number :8400005
Investigational 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

summary:
Primary Objectives:

Part 1 (dose finding, experimental substudies):

To determine or confirm the recommended dose of novel agents when combined with isatuximab with or without dexamethasone in participants with RRMM.
Part 2 (expansion, experimental substudies):
To demonstrate the clinical benefit of novel agents combined with isatuximab with or without dexamethasone in terms of rate of very good partial response (VGPR) or better.

Secondary Objectives:

To assess the overall response rate (ORR) in each treatment arm.
To assess the clinical benefit rate (CBR) in each treatment arm.
To assess the duration of response (DOR) in each treatment arm.
To assess the time to first response (TT1R) in each treatment arm.
To assess the time to best response (TTBR) in each treatment arm.
To assess safety and tolerability in each treatment arm.
To assess progression free survival (PFS) in each treatment arm.
To assess overall survival (OS) in each treatment arm.
To evaluate the potential immunogenicity of isatuximab and novel agents when applicable.
To characterize the PK of isatuximab and novel agents.

To assess disease and treatment related symptoms, cancer and disease specific health-related quality of life, global impact of side effects and confirm/establish clinically meaningful change scores for clinical outcome assessments (COAs)/domain scores.

-Substudy 1 (Control Arm):

To assess clinical outcomes assessments (COAs).
To assess the incidence of skeletal related events (SREs).
To assess the time to first occurrence of SRE.

To assess health care resource utilization related with SREs.

-Substudy 2:

To assess pain intensity related to skeletal related events (SREs).
To assess the incidence of SREs.
To assess the time to first occurrence of SRE.

To assess health care resource utilization related with SREs.

-Substudy 3:

To assess patient-reported visual functioning


title: A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd) for the Treatment of Unresectable and/or Metastatic Solid Tumors Harboring HER2 Activating Mutations Regardless of Tumor Histology

summary: This is an open-label, multi-center, single arm, Phase II study to evaluate the efficacy and safety of T-DXd for the treatment of unresectable and/or metastatic solid tumors harboring specific HER2 activating mutations regardless of tumor histology. The target population are patients who have progressed following prior treatment or who have no satisfactory alternative treatment options, including approved second line therapies in the specific tumor type. Pre-specified HER2 mutations will be locally assessed using NGS tests or alternative methods. Prior HER2 targeting therapy is permitted

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

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

lead_sponsor: AstraZeneca

location_country:
Italy
United States
France
Japan
Belgium
Spain
Denmark
Canada
Korea, Republic of

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination With Systemic Corticosteroids in Ambulatory Subjects With Duchenne Muscular Dystrophy (DMD)

summary: To evaluate the efficacy and safety of pamrevlumab versus placebo in combination with systemic corticosteroids administered every two weeks in ambulatory subjects with Duchenne muscular dystrophy (age 6 to <12 years).

design_allocation: Randomized

ipd_sharing: Undecided

lead_sponsor: FibroGen

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

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: University of California Davis Children's Hospital

location_facility: Sheffield Children's NHS Foundation Trust

location_facility: Washington University School of Medicine in St. Louis

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

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

location_facility: Alder Hey Children's NHS Foundation Trust

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Spectrum Health Hospitals Helen DeVos Children's Hospital

location_facility: Penn State Health Milton S. Hershey Medical Center

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: University of Iowa Hospitals and Clinics

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico Eugenio Medea - Lombardia

location_facility: Centre Hospitalier Universitaire Nantes - Hôtel Dieu

location_facility: The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

location_facility: University of Florida Health Shands Hospital

location_facility: University of Kansas Medical Center Research Institute

location_facility: Children's Hospital of The King's Daughters

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Ospedale Pediatrico Bambino Gesù - Roma - Gianicolo

location_facility: University of Massachusetts Memorial Center

location_facility: Centre Hospitalier Régional de la Citadelle


lead_sponsor: Pharvaris Netherlands B.V.

location_country:
Italy
Netherlands
Germany
France
Czechia
Bulgaria
Israel
Poland
Hungary
Spain
United States
United Kingdom
Canada

ipd_sharing: No

type: EudraCT Number

source: euctr

title: A Phase II, Double-blind, Placebo-controlled, Randomized, Cross-over, Dose-ranging Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema Due to C1-inhibitor Deficiency Type I and II

summary: This study evaluates the efficacy of orally administered PHA-022121 for the acute treatment of attacks in patients with hereditary angioedema (HAE). Eligible subjects are randomized to one of three single doses of PHA-022121 and placebo. The study will compare symptom relief (skin pain, skin swelling, abdominal pain) during HAE attacks and safety of each dose of PHA-022121 with placebo.


title: A Phase 1b, Multicenter, 2-Part, Open-Label Study of Datopotamab Deruxtecan (Data-DXd) in Combination With Durvalumab With or Without Platinum Chemotherapy in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-Lung04)

summary: This study will assess safety, tolerability, and treatment activity of datopotamab deruxtecan (Dato-DXd) in combination with durvalumab in participants with advanced or metastatic non-small cell lung cancer (NSCLC).

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

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
United States
France
Japan

location_facility: University of Chicago Comprehensive Cancer Center

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

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: University Hospitals Cleveland Medical Center

location_facility: Hôpital Nord (Hôpitaux Universitaires de Marseille)


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

location_facility:
Investigator site 87 - US0010084
Investigator site 97 - RO0400013
Investigator site 14 - UA3800020
Investigator site 76 - US0010096
Investigator site 25 - IT-0390005
Investigator site 40 - RU0070035
Investigator site 2 - BG3590010
Investigator site 59 - ES0340034
Investigator site 51 - FR0330026
Investigator site 27 - PL0480027
Investigator site 38 - IT0390031
Investigator site 20 - DE0490002
Investigator site 98 - RO0400015
Investigator site 7 - ES0340029
Investigator site 37 - GR030006
Investigator site 66 - JP0810042
Investigator site 49 - RU0070030
Investigator site 90 - US0010117
Investigator site 83 - UK0440022
Investigator site 19 - DE0490025
Investigator site 61 - IT0390040
Investigator site 85 - IL9720002
Investigator site 43 - UA3800021
Investigator site 84 - US0010089
Investigator site 50 - RU0070034
Investigator site 81 - IT0390030
Investigator site 28 - PL0480025
Investigator site 72 - JP0810045
Investigator site 33 - DE0490024
Investigator site 64 - TR0900020
Investigator site 69 - JP0810050
Investigator site 12 - IT0390006
Investigator site 92 - AU0610013
Investigator site 68 - JP0810040
Investigator site 89 - US0010091
Investigator site 91 - US0010109
Investigator site 79 - IN0910004
Investigator site 45 - DE0490029
Investigator site 10 - US0010088
Investigator site 60 - FR0330027
Investigator site 88 - US0010114
Investigator site 86 - PL0480036
Investigator site 48 - RU0070029
Investigator site 63 - TR0900012
Investigator site 41 - RU0070033
Investigator 96 - RO0400014
Investigator site 80 - IN0910003
Investigator site 70 - JP0810041
Investigator site 56 - PL0480032
Investigator site 18 - BG3590013
Investigator site 23 - GR030005
Investigator site 55 - IT0390038
Investigator site 34 - DE0490030
Investigator site 24 - HU0360002
Investigator site 57 - ES0340027
Investigator site 5 - HU0360001
Investigator site 46 - RU0070031
Investigator site 82 - JP0810046
Investigator site 77 - FR0330028
Investigator site 53 - DE0490023
Investigator site 15 - AU0610006
Investigator site 17 - BG3590012
Investigator site 94 - IN0910001
Investigator site 6 - HU0360003
Investigator site 36 - GR0300002
Investigator site 62 - ES0340026
Investigator site 42 - ES0340025
Investigator site 8 - UA3800019
Investigator site 35 - DE0490028
Investigator site 54 - GR0300001
Investigator site 78 - GE9950014
Investigator site 65 - IN0910002
Investigator site 67 - JP0810043
Investigator site 73 - JP0810047
Investigator site 44 - US0010106
Investigator site 3 - BG3590011
Investigator site 21 - GR030004
Investigator site 11 - AU0610007
Investigator site 30 - US0010094
Investigator site 22 - GR030003
Investigator site 52 - DE0490001
Investigator site 32 - GE9950013
Investigator site 58 - ES0340028
Investigator site 26 - PL0480028
Investigator site 4 - DE0490026
Investigator site 74 - TR0900011
Investigator site 31 - GE9950015
Investigator site 95 - IT0390039
Investigator site 93 - DE0490027
Investigator site 29 - UA3800023
Investigator site 47 - RU0070028
Investigator site 9 - UA3800018
Investigator site 75 - UA3800017
Investigator site 13 - ES0340032
Investigator site 39 - RU0070032
Investigator site 71 - JP0810049
Investigator site 1 - US0010087


type: Registry Identifier

title: A Phase II, Multicenter, Open-Label, Single Arm Study to Evaluate the Pharmacodynamic Effects of Once Weekly Administration of Gantenerumab in Participants With Early (Prodromal to Mild) Alzheimer's Disease

summary: This is a Phase II, multicenter, open-label, single arm, PD study in participants with early (prodromal to mild) AD to evaluate the effect of a once weekly (Q1W) dosing regimen of gantenerumab on deposited amyloid as measured by change from baseline to Week 104 in brain amyloid positron emission tomography (PET). The administration of gantenerumab as a single injection of Q1W will be investigated in this study, to simplify the dosing regimen for participants.

status: Active, not recruiting

enrollment_type: Actual

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

lead_sponsor: Hoffmann-La Roche

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

location_facility: Alzheimer's Research and Treatment Center

location_facility: Fondazione San Raffaele Del Monte Tabor; Dipartimento Di Neurologia

location_facility: Ambulates Gesundheitszentrum der Charité GmbH; MVZ Neurologie Campus Benjamin Franklin

location_facility: Policlínica Guipuzcoa; Servicio de Neurología

location_facility: ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic

location_facility: Abington Neurological Associates Willow Grove

location_facility: Groupement Hospitalier Est - Hôpital Neurologique; Neurologie A (U502)

location_facility: Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

location_facility: Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie

location_facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia

location_facility: Center for Advanced Research & Education

location_facility: Surrey and Borders NHS Foundation Trust; Brain Science Research Unit

location_facility: Charing Cross Hospital; Imperial Memory Unit, Level 10 West

location_facility: Gerontopole; Centre de Recherche clinique

location_facility: Hospital Universitari i Politecnic La Fe; Servicio de Neurología

location_facility: Ospedale San Giovanni Calibita Fatebenefratell;Neurologia

location_facility: Hospital Quiron de Madrid; Servicio de Neurologia

location_facility: Hospital Universitario de la Princesa; Servicio de Neurologia

location_facility: Senior Sp. Z O.O. Poradnia Psychogeriatryczna

location_facility: Ospedale Cardinale Panico; Dip.Ricerca Clinica in Neurologia - UO Malattie Neurodegenerative


title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase III Study to Evaluate the Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients

acronym: APPLAUSE-IgAN

summary: The study is designed as a multicenter, randomized, double-blind, placebo controlled study to demonstrate the superiority of LNP023 at a dose of 200 mg b.i.d. compared to placebo on top of maximally tolerated ACEi or ARB on reduction of proteinuria and slowing renal disease progression in primary IgA Nephropathy patients.

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Finland
Malaysia
Belgium
Australia
Russian Federation
Denmark
Taiwan
India
France
Japan
Thailand
Norway
Argentina
Canada
Korea, Republic of
Colombia
Sweden
Netherlands
Vietnam
Singapore
Hungary
China
Germany
United States
United Kingdom
Italy
Brazil
Czechia
Israel
Spain
Turkey


title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of AKCEA-APOCIII-LRx Administered Subcutaneously to Patients With Familial Chylomicronemia Syndrome (FCS)

acronym: BALANCE

summary: The purpose of the study is to evaluate the efficacy of AKCEA-APOCIII-LRx as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.

lead_sponsor: Ionis Pharmaceuticals, Inc.

location_country:
Italy
Sweden
Netherlands
Spain
France
Slovakia
Norway
Portugal
United States
United Kingdom
Canada

location_facility: Azienda Ospedaliero Universitaria Policlinico Umberto I


title: HORIZON: A Phase II, Open-label, Outcomes-assessor Masked, Multicentre, Randomised, Controlled Study to Evaluate the Safety and Efficacy of Two Doses of GT005 Administered as a Single Subretinal Injection in Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration

summary: The purpose of this clinical study is to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with geographic atrophy secondary to age-related macular degeneration (AMD).

lead_sponsor: Gyroscope Therapeutics Limited

location_country:
United States
France
Australia
Spain
Germany
United Kingdom

location_facility: Hospital Universitari General de Catalunya

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Lübeck

location_facility: Retina Vitreous Associates Medical Group

location_facility: The University of Melbourne - The Centre for Eye Research Australia (CERA)


title: The LEADLESS II IDE Study (Phase II)

summary: prospective, non-randomized, multi-center, international clinical study is designed to confirm the safety and effectiveness of the Aveir LP System in a subject population indicated for a VVI(R) pacemaker.

lead_sponsor: Abbott Medical Devices

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

location_facility: Institut de Cardiologie de Quebec (Hospital Laval)

location_facility: Institut de Cardiologie de Montreal (Montreal Heart Inst.)

location_facility: University Hospital - University of Alabama at Birmingham (UAB)

location_facility: New York Presbyterian Hospital/Cornell University

location_facility: University Hospitals Cleveland Medical Center

location_facility: St. Elizabeth Medical Center - South Unit

location_facility: Kansas City Cardiac Arrhythmia Research Foundation

intervention_type: Device


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Arm, Multicenter Study Evaluating the Efficacy and Safety of Pridopidine in Patients With Early Stage of Huntington Disease

summary: This study will evaluate the efficacy and safety of pridopidine 45mg twice daily (BID) in patients with early stage manifest Huntington Disease (HD).

lead_sponsor: Prilenia

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

location_facility: Prilenia Investigational Site (Site 393)

location_facility: Prilenia Investigational Site (Site 119)

location_facility: Prilenia Investigational Site (Site 249)

location_facility: Prilenia Investigational Site (Site 017)

location_facility: Prilenia Investigational Site (Site 002)

location_facility: Prilenia Investigational Site (Site 083)

location_facility: Prilenia Investigational Site (Site 006)

location_facility: Prilenia Investigational Site (Site 246)

location_facility: Prilenia Investigational Site (Site 234)

location_facility: Prilenia Investigational Site (Site 030)

location_facility: Prilenia Investigational Site (Site 089)

location_facility: Prilenia Investigational Site (Site 019)

location_facility: Prilenia Investigational Site (Site 384)

location_facility: Prilenia Investigational Site (Site 388)

location_facility: Prilenia Investigational Site (Site 377)

location_facility: Prilenia Investigational Site (Site 390)

location_facility: Prilenia Investigational Site (Site 382)

location_facility: Prilenia Investigational Site (Site 199)

location_facility: Prilenia Investigational Site (Site 378)

location_facility: Prilenia Investigational Site (Site 037)

location_facility: Prilenia Investigational Site (Site 027)

location_facility: Prilenia Investigational Site (Site 239)

location_facility: Prilenia Investigational Site (Site 044)

location_facility: Prilenia Investigational Site (Site 061)

location_facility: Prilenia Investigational Site (Site 018)

location_facility: Prilenia Investigational Site (Site 394)

location_facility: Prilenia Investigational Site (Site 051)

location_facility: Prilenia Investigational Site (Site 386)

location_facility: Prilenia Investigational Site (Site 029)

location_facility: Prilenia Investigational Site (Site 380)

location_facility: Prilenia Investigational Site (Site 031)

location_facility: Prilenia Investigational Site (Site 032)

location_facility: Prilenia Investigational Site (Site 392)

location_facility: Prilenia Investigational Site (Site 175)

location_facility: Prilenia Investigational Site (Site 379)

location_facility: Prilenia Investigational Site (Site 098)

location_facility: Prilenia Investigational Site (Site 333)

location_facility: Prilenia Investigational Site (Site 076)

location_facility: Prilenia Investigational Site (Site 387)

location_facility: Prilenia Investigational site (Site 292)

location_facility: Prilenia Investigational Site (Site 020)

location_facility: Prilenia Investigational Site (Site 385)

location_facility: Prilenia Investigational Site (Site 160)

location_facility: Prilenia Investigational Site (Site 232)

location_facility: Prilenia Investigational Site (Site 087)

location_facility: Prilenia Investigational Site (Site 381)

location_facility: Prilenia Investigational Site (Site 228)

location_facility: Prilenia Investigational Site (Site 096)

location_facility: Prilenia Investigational Site (Site 088)

location_facility: Prilenia Investigational Site (Site 326)

location_facility: Prilenia Investigational Site (Site 376)

location_facility: Prilenia Investigational Site (Site 176)

location_facility: Prilenia Investigational site (Site 291)

location_facility: Prilenia Investigational Site (Site 343)

location_facility: Prilenia Investigational Site (Site 048)

location_facility: Prilenia Investigational Site (Site 244)

location_facility: Prilenia Investigational Site (Site 180)

location_facility: Prilenia Investigational Site (Site 028)


design_allocation: Non-Randomized

intervention_type: Biological

lead_sponsor: Atara Biotherapeutics

location_country:
Italy
Austria
France
Belgium
Spain
United States

location_facility: Hospital Universitari Vall d'Hebrón (Adults and Pediatrics)

location_facility: Medizinische Universität Graz (Adults only)

location_facility: Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan (Adults only)

location_facility: Ospedale Pediatrico Bambino Gesù (Adults and Pediatrics)

location_facility: Medical University of South Carolina (Adults and Pediatrics)

location_facility: Emory University/Winship Cancer Institute (Adults [>= 16 years])

location_facility: Hôpital Saint-Eloi (Adults and Pediatrics)

location_facility: University of Texas Southwestern Medical Center (Pediatrics only)

location_facility: Hospital Universitario Viegen del Rocio (Adults and Pediatrics)

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago (Pediatrics only)

location_facility: Algemeen Ziekenhuis Delta - Campus Rumbeke (Adults only)

location_facility: Medizinische Universität Wien (Adults only)

location_facility: University of Michigan Rogel Cancer Center (Adults and Pediatrics)

location_facility: Columbia University Irving Medical Center (Adults only)

location_facility: University of Maryland Medical Center (Adults only)

location_facility: Hôpital Necker-Enfants Malades (Adults and Pediatrics)

location_facility: Ospedale Infantile Regina Margherita (Pediatrics only)

location_facility: Children's Hospital of Orange County (Pediatrics [up to 25 years old])

location_facility: Dana Farber Cancer Institute (DFCI) (Adults and Pediatrics)

location_facility: University of California Davis Comprehensive Cancer Center (Adults and Pediatrics)

location_facility: Cleveland Clinic Taussig Cancer Center (Adults and Pediatrics)

location_facility: Hospital Universitario Ramón y Cajal (Adults only)

location_facility: Hôpital Universitaire Pitié Salpêtrière (Adults only)

location_facility: Uniklinikum Salzburg Landeskrankenhaus (Adults only)

location_facility: Washington University in St. Louis (Adults only)

location_facility: The Children's Hospital at Montefiore (Adults and Pediatrics)

title: An Open-label, Single-arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects With Epstein-Barr Virus-associated Diseases

summary: The purpose of this study is to assess the efficacy and safety of tabelecleucel in participants with Epstein-Barr virus (EBV) associated diseases.


title: Neoadjuvant Study of Targeting ROS1 in Combination With Endocrine Therapy in Invasive Lobular Carcinoma of the Breast

acronym: ROSALINE

summary: Despite different clinical characteristics including the response to treatment and the patterns of metastatic relapse, invasive lobular breast carcinoma (ILBC) is treated like invasive ductal breast carcinoma (IDBC) carcinoma both in the clinics and in clinical trials. A large majority of ILBC are ER+/HER2- and almost 90% have loss of E-cadherin (CDH1) expression. A non-clinical study of CDH1 synthetic lethality interactions has identified ROS1 as a potential target. In vivo, ROS1 inhibitors produced profound antitumor effects in multiple models of E-cadherin-defective breast cancer, providing the preclinical rationale for assessing ROS1 inhibitors in this setting. Endocrine therapy being the mainstay of therapy for ER+/HER2- ILBC and the pre-operative setting offering a platform for rapid drug evaluation and biomarker research, the ROSALINE phase 2 study will evaluate the efficacy of Entrectinib (a potent inhibitor of ROS1 among other targets) in combination with letrozole (+ goserelin in premenopausal women) in the early setting of ILBC (stages 1 to 3). The neoadjuvant therapy will last 4 months and post-operative therapy will follow local practice. Biomarker research will include RNA sequencing of initial biopsis and surgical specimens, as well as liquid biopsies.

lead_sponsor: Jules Bordet Institute

location_country: Belgium France

location_facility:
UZ Brussel
UCL Saint-Luc
Institut Jules Bordet
UZ Gent
CHU Namur - Sainte Elisabeth
Institut Curie
Institut Bergonié
Institut Gustave Roussy
Grand Hôpital de Charleroi


type: Other Identifier

title: A Phase 1, First-in-Human, Dose Escalation Study of the JNJ-75348780 Bispecific Antibody Targeting CD3 and CD22 in Participants With NHL and CLL

summary: The purpose of this study is to characterize safety and to determine the putative recommended Phase 2 dose(s) (RP2D[s]) and optimal dosing schedule(s) of JNJ-75348780 in participants with relapsed/ refractory B-cell Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) in Part A and to further characterize the safety at the RP2D(s) in Part B.

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinicaltrials/ 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:
France
Israel
Australia
Spain
United States
United Kingdom
Korea, Republic of
Taiwan

location_facility: Severance Hospital, Yonsei University Health System

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

location_facility: University of Oklahoma Stephenson Cancer Center

location_facility: The University of Texas MD Anderson Cancer Center


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

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

location_country:
Italy
Brazil
Sweden
Spain
Germany
France
Japan
Australia
Russian Federation
New Zealand
China
Turkey
United States
United Kingdom
Taiwan

acronym: REEF-D

location_facility: Cepem - Centro de Pesquisa Em Medicina Tropical

location_facility: North East Federal University n.a. M.K.Amosov

location_facility: St George's, University of London and St George's University Hospitals NHS Foundation Trust

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: The First Bethune Hospital of Jilin University

location_facility: Beijing Ditan Hospital Capical Medical University

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH

location_facility: Karadeniz Teknik University Medical Faculty

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Ege University Medical of Faculty, Department of Gastroenterology

location_facility: Ospedale Molinette, AO Città della Salute e della Scienza di

location_facility: Republic Clinical Infectious Hospital n.a. AF Agafonov

location_facility: Universita degli Studi di Roma 'La Sapienza' - Umberto I Policlinico di Roma

location_facility: Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1

location_facility: Harvard Medical School - Massachusetts General Hospital

location_facility: The Second Affiliated Hospital of Chongqing Medical University

location_facility: Tokyo Medical and Dental University Medical Hospital

location_facility: Johns Hopkins University School of Medicine

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: St. Petersburg City Center for AIDS and Infectious Diseases Treatment and Prophylaxis

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

location_facility: Fundação De Medicina Tropical Doutor Heitor Vieira Dourado

location_facility: Krasnoyarsk Regional Center For AIDS And Infectious Diseases Treatment And Prophylaxis

location_facility: Guangzhou Eighth People's Hospital, Guangzhou Medical University

title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled Study With Deferred Active Treatment to Investigate the Efficacy, Safety, and Pharmacokinetics of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus

summary: The purpose of the study is to evaluate on-treatment efficacy against hepatitis D virus (HDV) of JNJ-73763989 + nucleos(t)ide analog (NA) regimen compared to NA alone.


title: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With Intrahepatic Cholangiocarcinoma (ICC) and Other Advanced Solid Tumors

summary: This is an open-label, FIH study designed to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary antineoplastic activity of RLY-4008, a potent and highly selective fibroblast growth factor receptor 2 (FGFR2) inhibitor administered orally patients with unresectable or metastatic ICC and other unresectable or metastatic solid tumors. This study consists of 2 parts, a dose escalation (Part 1) and a dose expansion (Part 2).

lead_sponsor: Relay Therapeutics, Inc.

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

location_facility: Taussig Cancer Institute Cleveland Clinic

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Hospital Universitario Fundación Jiménez Díaz- START MADRID

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: Hospital Universitario HM Sanchinarro-START MADRID-CIOCC

location_facility: Huntsman Cancer Institute, University of Utah

location_facility: The University of Texas M.D. Anderson Cancer Center


title: A Randomized, Double-blind, Multicenter, Placebo-controlled Phase 3 Study With Open-label Period to Evaluate the Efficacy and Safety of Inebilizumab in Adults With Myasthenia Gravis

acronym: MINT

summary: Randomized, double-blind, placebo-controlled, Phase 3, parallel-group study with optional open-label extension.

lead_sponsor: Viela Bio

location_country:
Italy
India
Spain
France
Japan
Korea, Republic of
Belarus
Russian Federation
China
Denmark
United States
Canada
Taiwan
Ukraine

location_facility:
Viela Bio Investigative Site - 5601
Viela Bio investigative Site - 4605
Viela Bio Investigative Site - 1006
Viela Bio Investigative Site - 3402
Viela Bio Investigative Site - 5202
Viela Bio Investigative Site - 4606
Viela Bio Investigative Site - 1018
Viela Bio Investigative Site - 1003
Viela Bio Investigative Site - 1014
Viela Bio Investigative Site - 1019
Viela Bio Investigative Site - 1005
Viela Bio Investigative Site - 4103
Viela Bio Investigative Site - 4601
Viela Bio Investigative Site - 4202
Viela Bio Investigative Site - 3204
Viela Bio Investigative Site - 4401
Viela Bio Investigative Site - 3203
Viela Bio Investigative Site - 5602
Viela Bio Investigative Site - 4603
Viela Bio Investigative Site - 1010
Viela Bio Investigative Site - 3003
Viela Bio Investigative Site - 1017
Viela Bio Investigative Site - 4203
Viela Bio Investigative Site - 3401
Viela Bio Investigative Site - 4004
Viela Bio Investigative Site - 5201
Viela Bio Investigative Site - 1012
Viela Bio Investigative Site - 5106
Viela Bio Investigative Site - 1013
Viela Bio Investigative Site - 3001
Viela Bio Investigative Site - 5104
Viela Bio Investigative Site - 3404
Viela Bio Investigative Site - 5101
Viela Bio Investigative Site - 1016
Viela Bio Investigative Site - 1002
Viela Bio Investigative Site - 1104
Viela Bio investigative Site - 4105
Viela Bio Investigative Site - 5105
Viela Bio Investigative Site - 5203
Viela Bio Investigative Site - 5204
Viela Bio Investigative Site - 4104
Viela Bio Investigative Site - 3002
Viela Bio Investigative Site - 1008
Viela Bio Investigative Site - 4102
Viela Bio Investigative Site - 5305
Viela Bio Investigative Site - 4604
Viela Bio Investigative Site - 1004
Viela Bio Investigative Site - 4107
Viela Bio Investigative Site - 1009
Viela Bio Investigative Site - 4101
Viela Bio Investigative Site - 4201
Viela Bio Investigative Site - 4602
Viela Bio Investigative Site - 4006
Viela Bio Investigative Site - 5103
Viela Bio Investigative Site - 1020
Viela Bio Investigative Site - 4109
Viela Bio Investigative Site - 1001
Viela Bio Investigative Site - 1015
Viela Bio Investigative Site - 3403
Viela Bio Investigative Site - 4108


title: A Phase I First-in-Human Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AZD8701 Administered Intravenously as Monotherapy and in Combination With Durvaluamb (MEDI4736) in Participants With Advanced Solid Tumours.

summary: The purpose of this study is to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Antitumor Activity of AZD8701 Alone and in Combination with Durvalumab (MEDI4736) in Adult Subjects with Select Advanced Solid Tumors

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
United States
Canada
France
Spain


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.

lead_sponsor: Boehringer Ingelheim

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

location_facility: The Guenther Dermatology Research Centre

location_facility: Markusovszky University Teaching Hospital

location_facility: Shiga University of Medical Science Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: Dermatovenereological Dispensary #10, St. Petersburg

location_facility: Tokyo Dental College Ichikawa General Hospital

location_facility: The Psoriasis Treatment Center of Central New Jersey

location_facility: SimcoDerm Medical and Surgical Dermatology Centre

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: Total Skin and Beauty Dermatology Center, PC

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

title: An Open-label, Long Term Safety Trial of Spesolimab Treatment in Patients With Palmoplantar Pustulosis (PPP) Who Have Completed Previous BI Spesolimab Trials

summary:
This study is open to people with palmoplantar pustulosis who took part in previous clinical studies of a medicine called spesolimab. Participants who benefited from spesolimab treatment in the previous studies can join this study.

The purpose of this study is to find out how safe spesolimab is and whether it helps people with palmoplantar pustulosis in the long-term. Participants are in this study for up to 5 years. During this time they visit the study site every month to get spesolimab injections under the skin.

At study visits, doctors check the severity of participants' palmoplantar pustulosis and collect information on any health problems of the participants.


title: A Multi-Center, Open-Label, Phase 2 Study to Evaluate Safety and Efficacy of U3-1402 in Subjects With Advanced or Metastatic Colorectal Cancer (CRC)

summary: This study is designed to primarily evaluate the safety and efficacy of U3-1402 in participants with advanced or metastatic colorectal cancer (CRC) who have received at least 2 prior lines of therapy and will explore clinical benefit according to human epidermal growth factor receptor 3 (HER3) tumor expression level in otherwise refractory tumors.

status: Terminated

study_completion_date_type: Actual

location_country:
Italy
France
Japan
Poland
Belgium
Spain
United States
United Kingdom

location_facility: M Sklodowska Curie Memorial Cancer Center

location_facility: City of Hope Comprehensive Cancer Center

location_facility: MD Anderson Cancer Center University of Texas

location_facility: Hospital Universitario HM Sanchinarro, CIOCC

location_facility: Consorci Corporació Sanitària Parc Taulí de Sabadell

location_facility: VHIO Valle de Hebron Instituto de Oncologia

location_facility: Hospital del Mar - Institut Hospital del Mar d'Investigacions Mediques IMIM

location_facility: Asst Grande Ospedale Metropolitano Niguarda

location_facility: National Hospital Organization - Osaka National Hospital (ONH)

location_facility: Szpital Kliniczny Przemienienia Pańskiego.University Hospital, Chemotherapy Department

location_facility: Northwestern Medical Faculty Foundation NMFF Hematology Oncology

location_facility: John Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: University of Texas Southwestern Medical Center

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

status_simplified: Unknown


title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)

summary: The primary objective for this trial is to determine the effect of GB002 (seralutinib) on improving pulmonary hemodynamics in subjects with World Health Organization (WHO) Group 1 PAH who are Functional Class (FC) II and III. The secondary objective for this trial is to determine the effect of GB002 (seralutinib) on improving exercise capacity in this population.

lead_sponsor: GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

location_country:
Austria
United States
Serbia
Germany
France
Israel
Australia
Belgium
Spain
Canada
United Kingdom

location_facility: LKH - Univ. Klinikum Graz - Universitatsklinik fur Innere Medizin

location_facility: Universitatsklinikum des Saarlandes Klinik fur lnnere Medizin V

location_facility: The Lundquist Institute of Biomedical Innovation at Harbor-UCLA Medical Center

location_facility: Universitatsklinikum Hamburg-Eppendorf Zentrum fur Onkologie

location_facility: The University of California San Francisco

location_facility: Washington University School of Medicine

location_facility: University of New Mexico Health Sciences Center

location_facility: CHU de Montpellier - Hopital Arnaud de Villeneuve

location_facility: New York Presbyterian Hospital - Weill Cornell Medicine

location_facility: Institute for Pulmonary Diseases of Vojvodina

location_facility: Imperial College Healthcare NHS Trust - Hammersmith Medicines Research Limited

location_facility: The Ohio State University Wexner Medical Center

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Dept of Veterans Affairs Greater Los Angeles Healthcare System

location_facility: Zentrum fur Pulmonale Hypertonie Thoraxklinik-Heidelberg gGmbH

location_facility: Medizinische Universitat Wien - Universitatsklinik fur Innere Medizin II

location_facility: Sir Mortimer B Davis Jewish General Hospital

location_facility: London Health Sciences Centre - Victoria Hospital


title: A Phase 1/2 Open-Label, Multicenter Study of INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders

summary: This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy or in combination with ruxolitinib in participants with MF who are transfusion-dependent or presenting with symptomatic anemia. This study will consist of 2 parts: dose escalation and expansion.

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:
Italy
United States
France

location_facility: Comitato Di Bioetica Della Fondazione IRCCS

location_facility: Emory University - Winship Cancer Institute

location_facility: Azienda Ospedaliero-Universitaria Careggi (Aouc)

location_facility: S Orsolas University Hospital Seragnoli Institute of Hematology


title: EXPLORE: A Phase II, Outcomes Assessor-masked, Multicentre, Randomised Study to Evaluate the Safety and Efficacy of Two Doses of GT005 Administered as a Single Subretinal Injection in Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration

acronym: EXPLORE

location_facility: Hospital Universitari General de Catalunya

location_facility: Clinica Universidad de Navarra - Pamplona

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Lübeck

location_facility: The University of Melbourne - The Centre for Eye Research Australia (CERA)


location_country:
Malaysia
Greece
Belgium
Australia
Taiwan
France
Japan
Lithuania
Poland
Thailand
Argentina
Korea, Republic of
Turkey
South Africa
Sweden
Hong Kong
Netherlands
Singapore
Hungary
China
Portugal
Germany
United States
Italy
Mexico
Spain
Estonia

acronym: COMMODORE 2

location_facility: Chang Gung Medical Foundation - Kaohsiung; Oncology

location_facility: Centro Hospitalar de Lisboa Central - Hospital D. Estefânia; Pediatrics

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Hacettepe University Medical Faculty; Neurology

location_facility: Affiliated Hospital of Nantong University; Nephrology

location_facility: ICO Badalona - Hospital Universitari Germans Trias i Pujol; Hematologia Clinica

location_facility: Severance Hospital, Yonsei University Health System

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: Vilnius University Hospital Santariskiu Clinics, Public Institution; Cardiology

location_facility: Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele

location_facility: Hospital Universitario de Gran Canaria Doctor Negrín; Servicio de Hematología

location_facility: Ege University Medical Faculty; Hematology

location_facility: Charlotte Maxeke Johannesburg Academic Hospital

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Singapore General Hospital; Department of Haematology

location_facility: Hospital Universitario Central de Asturias

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: National Taiwan Universtiy Hospital; Division of Hematology

location_facility: Global Trial Research Center S.A. de C.V.

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii

location_facility: Hospital Universitari i Politecnic La Fe; Unidad Hemostasis y Trombosis

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

location_facility: The Chinese University of Hong Kong; Department of Medicine & Therapeutics

location_facility: Organizacion Medica de Investigacion (OMI)

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1

location_facility: University General Hospital of Alexandroupolis; Haemotology

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: MacKay Memorial Hospital; Hematology and oncology

location_facility: Pusat Perubatan Universiti Kebangsaan Malaysia

location_facility: Szpital Uniwersytecki nr2 im. dr J. Biziela

location_facility: General Hospital of Thessaloniki G. Papanikolaou

location_facility: Hospital Universitario de Canarias;servicio de Hematologia

title: A Phase III, Randomized, Open-Label, Active-Controlled, Multicenter Study Evaluating The Efficacy And Safety Of Crovalimab Versus Eculizumab In Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors.

summary: A study designed to evaluate the non-inferiority of crovalimab compared with eculizumab in participants with PNH who have not been previously treated with complement inhibitor therapy. This study will enroll approximately 200 participants.


location_country:
Greece
Belgium
Australia
Taiwan
France
Japan
Poland
Canada
Korea, Republic of
Turkey
Sweden
Hong Kong
Netherlands
Singapore
Hungary
United States
Germany
Italy
Brazil
Czechia
Spain
Estonia

acronym: COMMODORE 1

location_facility: Kobe University Hospital; Medical Oncology and Hematology

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Institut Paoli Calmette; Service d'Hématologie Clinique

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Cliniques Universitaires Saint-Luc; Pharmacy

location_facility: Hacettepe University Medical Faculty; Neurology

location_facility: ICO Badalona - Hospital Universitari Germans Trias i Pujol; Hematologia Clinica

location_facility: Centro Integrado de Oncologia de Curitiba

location_facility: University General Hospital of Alexandroupolis

location_facility: *X*CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia

location_facility: Okinawa Tokushukai Takasago Seibu Hospital

location_facility: Instituto Joinvilense de Hematologia E Oncologia

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Ege University Medical Faculty; Hematology

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Hospital Universitario Central de Asturias

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Gaziantep University Medical Faculty Sahinbey Educational Research Hospital; Hematology

location_facility: Severance Hospital; Yonsei University Health System

location_facility: CHU Rennes - Hopital Pontchaillou; Service d'Hémostase Bioclinique

location_facility: Japanese Red Cross Society Suwa Hospital

location_facility: Nucleo de Pesquisa Clinica do Hospital da Crianca

location_facility: Hualien Tzu Chi Hospital; Hematology and oncology

title: A Phase III, Randomized, Open-Label, Active-Controlled, Multicenter Study Evaluating The Efficacy And Safety Of Crovalimab Versus Eculizumab In Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors.

summary: A study designed to evaluate the non-inferiority of crovalimab compared with eculizumab in participants with PNH currently treated with complement inhibitors. This study will enroll approximately 250 participants.


title: Randomized, Double Blind, Placebo Controlled Study to Evaluate the Effect of Dupilumab on Airway Inflammation Through Assessments of Lung Function, Mucus Plugging and Other Lung Imaging Parameters in Patients With Asthma

acronym: VESTIGE

summary:
Primary Objective:

o To assess the effect of dupilumab on lung function and related changes in airway volumes detectable by functional respiratory imaging

Secondary Objective:

To evaluate the effect of dupilumab at Week 24 on bronchodynamics, hyperinflation, airway resistance, airway wall thickness, ventilation defects and mucus plugging derived from high-resolution computed tomography (HRCT) scans, patient-reported outcomes, FeNO and spirometry.
To evaluate safety of dupilumab

lead_sponsor: Sanofi

location_country:
Italy
Sweden
Saudi Arabia
Spain
France
Bulgaria
Romania
Portugal
Denmark
United States
United Kingdom
Taiwan
Ukraine

location_facility:
Investigational Site Number :6420007
Investigational Site Number :8400007
Investigational Site Number :2500001
Investigational Site Number :1000007
Investigational Site Number :1580004
Investigational Site Number :7520001
Investigational Site Number :3800003
Investigational Site Number :6420006
Investigational Site Number :6820001
Investigational Site Number :1000004
Investigational Site Number :1000010
Investigational Site Number :6200005
Investigational Site Number :7240001
Investigational Site Number :7240004
Investigational Site Number :8040002
Investigational Site Number :8400002
Investigational Site Number :2080003
Investigational Site Number :6420003
Investigational Site Number :8260001
Investigational Site Number :8040001
Investigational Site Number :7240002
Investigational Site Number :1000013
Investigational Site Number :1000012
Investigational Site Number :2080006
Investigational Site Number :2080002
Investigational Site Number :6200006
Investigational Site Number :8400012
Investigational Site Number :6420008
Investigational Site Number :8040005
Investigational Site Number :8400014
Investigational Site Number :1000006
Investigational Site Number :6820008
Investigational Site Number :2080001
Investigational Site Number :1000008
Investigational Site Number :6200001
Investigational Site Number :8040007
Investigational Site Number :8260002
Investigational Site Number :8400004
Investigational Site Number :8400008
Investigational Site Number :2080005
Investigational Site Number :6420005
Investigational Site Number :1000003
Investigational Site Number :6820004
Investigational Site Number :1000011
Investigational Site Number :7240003
Investigational Site Number :1580001
Investigational Site Number :8040003
Investigational Site Number :2500003
Investigational Site Number :8400009
Investigational Site Number :1000015
Investigational Site Number :6820002
Investigational Site Number :6420001
Investigational Site Number :8040004
Investigational Site Number :8400011
Investigational Site Number :1000005
Investigational Site Number :6820010
Investigational Site Number :1000002
Investigational Site Number :1580002
Investigational Site Number :8400013
Investigational Site Number :2500002
Investigational Site Number :6820006
Investigational Site Number :6200004
Investigational Site Number :6200003
Investigational Site Number :1580003
Investigational Site Number :3800001
Investigational Site Number :2080004
Investigational Site Number :8400005
Investigational Site Number :8400010


title: A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene

summary: A phase 3 double blind, placebo controlled study evaluating the efficacy and safety of AL001 in participants at risk for or with frontotemporal dementia due to heterozygous mutations in the progranulin gene.

lead_sponsor: Alector Inc.

location_country:
Italy
United States
Sweden
Switzerland
Netherlands
Spain
Germany
France
Belgium
Australia
Portugal
Canada
United Kingdom

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: Karolinska Universitetssjukhuset Huddinge - PPDS

location_facility: Sunnybrook Research Institute - University of Toronto

location_facility: University of North Carolina at Chapel Hill

location_facility: Froedtert and The Medical College of Wisconsin

location_facility: IRCCS - Centro S. Giovanni di Dio Fatebenefratelli

location_facility: Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta

location_facility: Irving Institute for Clinical and Translational Research

location_facility: University Of Cincinnati Gardner Neuroscience institute

location_facility: Indiana University Health Neuroscience Center

location_facility: Perron Institute for Neurological and Translational Science

location_facility: University of Kansas Alzheimer's Disease Center

location_facility: Centro Hospitalar E Universitário de Coimbra EPE

location_facility: Johns Hopkins University School of Medicine

location_facility: Houston Methodist Institute for Academic Medicine

location_facility: Nuovo Ospedale Civile S. Agostino-Estense di Baggiovara


title: A Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination With Systemic Corticosteroids in Subjects With Non-ambulatory Duchenne Muscular Dystrophy (DMD)

summary: To evaluate the efficacy and safety of pamrevlumab versus placebo in combination with systemic corticosteroids in subjects with non-ambulatory Duchenne muscular dystrophy (age 12 years and older).

lead_sponsor: FibroGen

location_country:
Italy
Austria
United States
Switzerland
Netherlands
France
Czechia
Israel
Australia
Belgium
Spain
Canada
United Kingdom

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

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

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

location_facility: Carolinas HealthCare System Neurosciences Institute-Neurology - Charlotte

location_facility: Spectrum Health Hospitals Helen DeVos Children's Hospital

location_facility: Klinika dÄ>tské neurologie, Neuromuskulární centrum

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Children's Specialty Group - Medical Center Office

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Montreal Neurological Institute and Hospital

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Hospital General Universitario de Alicante

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico Eugenio Medea - Lombardia

location_facility: Fakultní Nemocnice Brno - Dětská Nemocnice

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: University of California Los Angeles Medical Center

location_facility: Washington University School of Medicine in Saint Louis

location_facility: Ospedale Pediatrico Bambino Gesù - Roma - Gianicolo

location_facility: Centre Hospitalier Régional de la Citadelle


title: A Phase 3 Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab Compared With Best Supportive Care in Patients With COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress Syndrome

summary: This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab administered in adult patients with Coronavirus Disease 2019 (COVID-19) severe pneumonia, acute lung injury, or acute respiratory distress syndrome. Patients will be randomly assigned to receive ravulizumab in addition to best supportive care (BSC) (2/3 of the patients) or BSC alone (1/3 of the patients). Best supportive care will consist of medical treatment and/or medical interventions per routine hospital practice.

ReferenceType: background

ReferenceCitation: WHO. Clinical management of severe acute respiratory infection when novel coronavirus (2019-nCoV) infection is suspected. Interim guidance, 28 January 2020.

ReferenceType: derived

ReferenceCitation: Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9:CD013825. doi: 10.1002/14651858.CD013825.pub2. Review.

name: Cochrane Haematology, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

family: Kreuzberger

full_name: Nina Kreuzberger

given: Nina

sequence: additional

family: Hirsch

full_name: Caroline Hirsch

given: Caroline

name: Transfusion Research Unit, School of Public Health and Preventive Medicine; Monash University; Melbourne Australia

family: Chai

full_name: Khai Li Chai

given: Khai Li

name: Population Health Sciences, Bristol Medical School; University of Bristol; Bristol UK

family: Tomlinson

full_name: Eve Tomlinson

given: Eve

family: Khosravi

full_name: Zahra Khosravi

given: Zahra

name: Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine; University Hospital Wuerzburg; Wuerzburg Germany

family: Popp

full_name: Maria Popp

given: Maria

family: Neidhardt

full_name: Miriam Neidhardt

given: Miriam

family: Piechotta

full_name: Vanessa Piechotta

given: Vanessa

name: Laboratory of Experimental Immunology, Institute of Virology; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

family: Salomon

full_name: Susanne Salomon

given: Susanne

name: Jon J van Rood Center for Clinical Transfusion Research; Sanquin/Leiden University Medical Center; Leiden Netherlands

family: Valk

full_name: Sarah J Valk

given: Sarah J

family: Monsef

full_name: Ina Monsef

given: Ina

name: Department of Nephrology; Technical University of Munich, School of Medicine, Klinikum rechts der Isar; Munich Germany

family: Schmaderer

full_name: Christoph Schmaderer

given: Christoph

family: Wood

full_name: Erica M Wood

given: Erica M

name: Erasmus Medical Centre; Rotterdam Netherlands

family: So-Osman

full_name: Cynthia So-Osman

given: Cynthia

name: Systematic Review Initiative; NHS Blood and Transplant; Oxford UK

family: Roberts

full_name: David J Roberts

given: David J

family: McQuilten

full_name: Zoe McQuilten

given: Zoe

name: Haematology/Transfusion Medicine; NHS Blood and Transplant; Oxford UK

family: Estcourt

full_name: Lise J Estcourt

given: Lise J

name: Cochrane Cancer, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

family: Skoetz

full_name: Nicole Skoetz

given: Nicole

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: McEneny-King AC, Monteleone JPR, Kazani SD, Ortiz SR. Pharmacokinetic and Pharmacodynamic Evaluation of Ravulizumab in Adults with Severe Coronavirus Disease 2019. Infect Dis Ther. 2021 Jun;10(2):1045-1054. doi: 10.1007/s40121-021-00425-7. Epub 2021 Apr 7.

family: McEneny-King

full_name: Alanna C. McEneny-King

given: Alanna C.

sequence: first

family: Monteleone

full_name: Jonathan P. R. Monteleone

given: Jonathan P. R.

family: Kazani

ReferenceCitation: Smith K, Pace A, Ortiz S, Kazani S, Rottinghaus S. A Phase 3 Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab Compared with Best Supportive Care in Patients with COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress Syndrome: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Jul 13;21(1):639. doi: 10.1186/s13063-020-04548-z.

ReferenceCitation: Java A, Apicelli AJ, Liszewski MK, Coler-Reilly A, Atkinson JP, Kim AH, Kulkarni HS. The complement system in COVID-19: friend and foe? JCI Insight. 2020 Aug 6;5(15). pii: 140711. doi: 10.1172/jci.insight.140711. Review.

evidence: oa repository (via OAI-PMH title and first author match)

publisher: American Society for Clinical Investigation

location_country:
France
Japan
Spain
United States
United Kingdom

location_facility: Central Arkansas Veterans Healthcare System

location_facility: Washington University School of Medicine

location_facility: Medical Hospital, Tokyo Medical and Dental University


intervention_type: Other

status: Completed

lead_sponsor: Karyopharm Therapeutics Inc

location_country:
Austria
France
Israel
Spain
United States
United Kingdom

acronym: Coronavirus

location_facility: Servicio de Medicina Interna, Hospital Universitario de Salamanca, Universidad de Salamanca

location_facility: Levine Cancer Institute-Atrium Health University City

location_facility: Miami Cancer Institute at Baptist Health

location_facility: MultiCare Institute for Research & Innovation (Puget Sound)

location_facility: Hospital Hietzing, 2. Medical department - Center for Diagnosis and Therapy of Rheumatic Diseases

title: A Phase 2 Randomized Single-Blind Study to Evaluate the Activity and Safety of Low Dose Oral Selinexor (KPT-330) in Patients With Severe COVID-19 Infection

summary: The main purpose of this study is to evaluate the activity of low dose oral selinexor (KPT-330) and to evaluate the clinical recovery, the viral load, length of hospitalization and the rate of morbidity and mortality in participants with severe COVID-19 compared to placebo. The study had 2 arms and evaluated selinexor 20 mg + standard of care (SoC) and placebo + SoC. As the treatment for COVID-19 is rapidly evolving, the SoC varied over time and across regions of the world.

status_simplified: Completed


title: An Exploratory Phase 1/2 Open-Label Multi-Arm Trial to Evaluate the Safety and Efficacy of CC-90009 Combinations in Subjects With Acute Myeloid Leukemia

summary: CC-90009-AML-002 is an exploratory Phase 1b open-label multi-arm trial to evaluate the safety and efficacy of CC-90009 in combination with anti-leukemia agents in subjects with acute myeloid leukemia (AML).

status: Suspended

ReferenceCitation: Surka C, Jin L, Mbong N, Lu CC, Jang IS, Rychak E, Mendy D, Clayton T, Tindall E, Hsu C, Fontanillo C, Tran E, Contreras A, Ng SWK, Matyskiela M, Wang K, Chamberlain P, Cathers B, Carmichael J, Hansen J, Wang JCY, Minden MD, Fan J, Pierce DW, Pourdehnad M, Rolfe M, Lopez-Girona A, Dick JE, Lu G. CC-90009, a novel cereblon E3 ligase modulator, targets acute myeloid leukemia blasts and leukemia stem cells. Blood. 2021 Feb 4;137(5):661-677. doi: 10.1182/blood.2020008676.

family: Surka

full_name: Christine Surka

given: Christine

name: Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada;

family: Jin

full_name: Liqing Jin

given: Liqing

family: Mbong

full_name: Nathan Mbong

given: Nathan

family: Lu

full_name: Chin-Chun Lu

given: Chin-Chun

family: Jang

full_name: In Sock Jang

given: In Sock

family: Rychak

full_name: Emily Rychak

given: Emily

family: Mendy

full_name: Derek Mendy

given: Derek

family: Clayton

full_name: Thomas Clayton

given: Thomas

family: Tindall

full_name: Elizabeth Tindall

given: Elizabeth

family: Hsu

full_name: Christy Hsu

given: Christy

family: Fontanillo

full_name: Celia Fontanillo

given: Celia

family: Tran

full_name: Eileen Tran

given: Eileen

family: Contreras

full_name: Adrian Contreras

given: Adrian

family: Ng

full_name: Stanley W. K. Ng

given: Stanley W. K.

family: Matyskiela

full_name: Mary Matyskiela

given: Mary

family: Wang

full_name: Kai Wang

given: Kai

family: Chamberlain

full_name: Philip Chamberlain

given: Philip

family: Cathers

full_name: Brian Cathers

given: Brian

family: Carmichael

full_name: James Carmichael

given: James

family: Hansen

full_name: Joshua Hansen

given: Joshua

name: Department of Medicine, University of Toronto, Toronto, ON, Canada;

name: Division of Medical Oncology and Hematology, University Health Network, Toronto, ON, Canada;

full_name: Jean C. Y. Wang

given: Jean C. Y.

family: Minden

full_name: Mark D. Minden

given: Mark D.

name: Bristol-Myers Squibb, San Francisco, CA; and

family: Fan

full_name: Jinhong Fan

name: Department of Molecular Genetics, University of Toronto, Toronto, ON, Canada

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/

location_country:
United States
United Kingdom
Canada
France

location_facility: Dana-Farber/Mass General Brigham Cancer Care, Inc

location_facility: The University of Texas - MD Anderson Cancer Center

location_facility: Institut Universitaire du Cancer de Toulouse (IUCT) - Oncopole


title: A Phase 3, Multicenter, Open-Label Extension Study of Patidegib Topical Gel, 2% in Subjects With Gorlin Syndrome (Basal Cell Nevus Syndrome)

summary: This is a multicenter, open label extension study evaluating the safety of Patidegib Topical Gel, 2%, applied topically twice daily to the face of adult subjects with Gorlin syndrome.

lead_sponsor: PellePharm, Inc.

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

location_facility: Penn State Health Milton S. Hershey Medical Center

location_facility: University of Utah, Midvalley Dermatology

location_facility: Columbia University Irving Medical Center


title: Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

acronym: ADHERE+

summary: This is the open-label extension study of phase II ARGX-113-1802 to evaluate the long-term safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP.

lead_sponsor: argenx

location_country:
Italy
Serbia
Netherlands
Germany
France
Czechia
Bulgaria
Israel
Georgia
Japan
Poland
Belgium
Russian Federation
Spain
Denmark
United States
Latvia
Ukraine

location_facility:
Investigator Site 5
Investigator site 1
Investigator site 8
Investigator site 55
Investigator site 57
Investigator site 15
Investigator site 38
Investigator site 61
Investigator site 52
Investigator site 42
Investigator site 56
Investigator site 14
Investigator site 2
Investigator site 21
Investigator site 11
Investigator site 59
Investigator Site 4
Investigator Site 7
Investigator site 47
Investigator site 9
Investigator site 50
Investigator site 54
Investigator site 32
Investigator site 20
Investigator site 22
Investigator Site 3
Investigator site 53
Investigator site 10
Investigator site 41
Investigator site 30
Investigator site 35
Investigator site 60
Investigator site 17
Investigator site 16
Investigator site 12
Investigator site 44
Investigator Site 6
Investigator site 19
Investigator site 37
Investigator site 25
Investigator site 26
Investigator site 51
Investigator site 28
Investigator site 33
Investigator site 29
Investigator site 40
Investigator site 34
Investigator site 31
Investigator site 46
Investigator site 39
Investigator site 43
Investigator site 24
Investigator site 45
Investigator site 48
Investigator site 27
Investigator site 58
Investigator site 18
Investigator site 49
Investigator site 23
Investigator site 13


title: Screening/Observational Protocol to Determine Patient Eligibility for Inclusion in AAV Gene Therapy Clinical Trials (ECLIPSE)

acronym: ECLIPSE

summary: Freeline is developing adeno-associated virus (AAV) vector based gene therapies for a number of diseases and is actively advancing a programme in Haemophilia B (HB). This study aims to collect prospective data to characterise bleeding events and Factor IX (FIX) concentrate consumption in HB patients that can be used as baseline for participants who elect to participate in a subsequent Freeline gene therapy study. The study will also screen participants for antibodies to a novel AAV vector to assess their suitability for inclusion in a Freeline gene therapy treatment study.

study_type: Observational

time_perspective: Other

lead_sponsor: Freeline Therapeutics

location_country:
Italy
Austria
United States
South Africa
Netherlands
Germany
France
Ireland
Australia
Turkey
Canada
United Kingdom

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

location_facility: Samsun Ondokuz Mayis University Medical Faculty

location_facility: Newcastle Hemophilia Comprehensive Care Centre

location_facility: Citta della Salute e della Scienza di Torino - Ospedale le Molinette

location_facility: Universitaetsklinikum des Saarlandes und Medizinische Fakultaet der Universitaet des Saarlandes

location_facility: University Hospitals Cleveland Medical Center

location_facility: University of Cape Town Clinical Research Center

location_facility: Indiana Hemophilia and Thrombosis Center

location_facility: Charlotte Maxeke Johannesburg Academic Hospital

location_facility: Lombardi Comprehensive Cancer Center at Georgetown University

location_facility: Universitaetsklinikum Frankfurt - Klinikum der Johann Wolfgang Goethe Universitaet


lead_sponsor: Celgene

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

acronym: TRANSCEND FL

location_facility: Perelman Center for Advanced Medicine - Abramson Cancer Center University of Pennsylvania

location_facility: CIUSSS de l'Est-de-l'Ile-de-Montreal - Installation Hopital Maisonneuve-Rosemont

location_facility: Providence Cancer Center - Earle A. Chiles Research Institute

location_facility: Allgemeinen Krankenhaus (AKH) Wien - Medizinische Universitaet Wien

location_facility: University College London Hospitals NHS Foundation Trust - University College Hospital

location_facility: Universitario de Salamanca - Hospital Clinico

location_facility: University of Maryland - Greenebaum Comprehensive Cancer Center

location_facility: Cleveland Clinic - Taussig Cancer Institute

location_facility: The University of Texas - MD Anderson Cancer Center

location_facility: Illinois Cancer Specialists - Arlington Heights

location_facility: Massachusetts General Hospital - Dana-Farber Cancer Institute (The Jon and JoAnn Hagler Center for Lymphoma)

location_facility: Northwestern University - Robert H. Lurie Comprehensive Cancer Center

location_facility: Novant Health Cancer Specialists Charlotte

location_facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale

location_facility: Yale New Haven Health - Smilow Cancer Hospita

title: A Phase 2, Open-label, Single Arm, Multicenter Trial to Evaluate the Safety and Efficacy of JCAR017 (Lisocabtagene Maraleucel) in Adult Subjects With High-risk, Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)

summary:
This is a global Phase 2, open-label, single-arm, multicohort, multicenter study to evaluate efficacy and safety of JCAR017 in adult subjects with r/r FL or MZL.

The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.

This study is divided into three periods:

Pretreatment, which consists of screening assessments, leukapheresis and the Pretreatment evaluation;
Treatment, which starts with the administration of lymphodepleting (LD) chemotherapy and continues through JCAR017 administration at Day 1 with follow-up through Day 29;
Posttreatment, which includes follow-up assessments for disease status and safety for 2 years.


title: A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Select Advanced Solid Tumors

summary: The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB099280 in participants with select solid tumors

ipd_sharing_description: There is no plan to share data

location_country:
Belgium
United States
Australia
France

location_facility: Universitaire Ziekenhuis Leuven - Gasthuisberg

location_facility: Institut de Cancerologie de L Ouest - Site Paul Papin


title: A Phase I, Open-label Multi-dose Pharmacokinetic and Safety Study of Oral Tazemetostat in Subjects With Moderate and Severe Hepatic Impairment With Advanced Malignancies

summary: This is a phase 1, 2-part, global, multicenter, open-label, PK, safety and tolerability study of oral tazemetostat in subjects with either advanced solid tumors, or hematological malignancies and normal hepatic function or moderate, or severe hepatic impairment.

lead_sponsor: Epizyme, Inc.

location_country:
France
Poland
Slovakia
Belgium
United States

location_facility: Oncology Consultants - Texas Medical Center

location_facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University


title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon in Early Parkinson's Disease (TEMPO-2 Trial)

summary: The purpose of this study is to assess the efficacy, safety, tolerability and pharmacokinetics (PK) of flexible doses of tavapadon in participants with Parkinson's Disease.

lead_sponsor: Cerevel Therapeutics, LLC

location_country:
Italy
United States
Serbia
France
Poland
Hungary
Australia
Spain
Germany
Ukraine

location_facility:
Fresno, California
Coral Springs, Florida
Syracuse, New York
San Sebastián
Winter Park, Florida
Kirkland, Washington
Gyor,
Cleveland, Ohio
Tatabanya
Belgrade
Port Charlotte, Florida
Kiev
Toulouse Cedex 9
Torino
Berlin
Kragujevac
Strasbourg
Szeged
Elk Grove Village, Illinois
Pamplona
West Bloomfield, Michigan
Ocala, Florida
Nantes CEDEX 1
Cassino
Albany, New York
Houston, Texas
Saint Louis, Missouri
Cincinnati, Ohio
Round Rock, Texas
Budapest
Memphis, Tennessee
Barcelona
Maitland, Florida
Zaporozhya
Dnipro
Krakow
Vinnitsa
Richmond, Virginia
Katowice
Kogarah, New South Wales
Muenchen
Milano
Rome
Belgrade,
Siemianowice Slaskie
Bochum
Rozzano Milano
Madrid
Pecs
Clayton VIC
Gera
München
Cracow
Lviv


intervention_type: Radiation

lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Peru
Guatemala
Greece
Australia
Belgium
Russian Federation
Taiwan
Ukraine
France
Japan
Thailand
Norway
Canada
Korea, Republic of
Colombia
Chile
Sweden
Hungary
Ireland
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Czechia
Israel
Spain
Turkey

location_facility: Xiangya Hospital Central-South University ( Site 1009)

location_facility: Sanford Bismarck Medical Center ( Site 0046)

location_facility: A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 0541)

location_facility: Linkou Chang Gung Memorial Hospital ( Site 1097)

location_facility: National Taiwan University Hospital ( Site 1095)

location_facility: Zhejiang Provincial People's Hospital ( Site 1021)

location_facility: Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 0290)

location_facility: Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 0876)

location_facility: Fondazione Giovanni Pascale Di Napoli ( Site 0544)

location_facility: IRCCS Ospedale San Raffaele ( Site 0539)

location_facility: Baskent Universitesi Ankara Hastanesi ( Site 0754)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 0227)

location_facility: Aichi Cancer Center Hospital ( Site 1155)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0729)

location_facility: Hospital das Clinicas de Ribeirão Preto - Unidade de Pesquisa Clinica-Unidade de Pesquisa Clínica (

location_facility: Keimyung University Dongsan Medical Center ( Site 1066)

location_facility: University of New Mexico Comprehensive Cancer Center-Clinical Research Office ( Site 0019)

location_facility: Srinagarind Hospital. Khon Kaen University ( Site 1132)

location_facility: McGill University Health Centre ( Site 0105)

location_facility: University of North Carolina at Chapel Hill ( Site 0025)

location_facility: Sanford Gynecology Oncology ( Site 0003)

location_facility: Royal Devon and Exeter Foundation Trust Hospital ( Site 0699)

location_facility: The First Affiliated Hospital of Xinjiang Medical University ( Site 1012)

location_facility: Istituto Nazionale Tumori Regina Elena ( Site 0540)

location_facility: Peking Union Medical College Hospital ( Site 1001)

location_facility: Fakultni nemocnice Kralovske Vinohrady ( Site 0913)

location_facility: Parkview Research Center at Parkview Regional Medical Center ( Site 0026)

location_facility: Princess Margaret Cancer Centre ( Site 0102)

location_facility: The First Affiliated Hospital of Xiamen University ( Site 1025)

location_facility: The First Affiliated Hospital.Sun Yat-sen University ( Site 1005)

location_facility: Karolinska Universitetssjukhuset ( Site 0784)

location_facility: Instituto Nacional de Cancerologia E.S.E ( Site 0228)

location_facility: Hospital Nacional Arzobispo Loayza ( Site 0292)

location_facility: Istituto di Candiolo - IRCCS ( Site 0546)

location_facility: Chelyabinsk Regional Clinical Center Oncology and Nuclear Medicine ( Site 0741)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 0845)

location_facility: Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 0734)

location_facility: Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 0287)

location_facility: Centro Medico Monte Carmelo ( Site 0289)

location_facility: Peter MacCallum Cancer Centre ( Site 0971)

location_facility: Texas Oncology-San Antonio Medical Center ( Site 8002)

location_facility: Our Lady of the Lake Regional Medical Center. ( Site 0031)

location_facility: Legacy Good Samaritan Medical Center ( Site 0013)

location_facility: Monash Health-Monash Medical Centre ( Site 0970)

location_facility: Hospital Clinico Universitario Lozano Blesa ( Site 0630)

location_facility: Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0321)

location_facility: Hadassah Medical Center. Ein Kerem ( Site 0816)

location_facility: Hospital Universitari Vall d Hebron ( Site 0634)

location_facility: Helse Bergen HF Haukeland Universitetssjukehus ( Site 0601)

location_facility: National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 0725)

location_facility: Charite Universitaetsmedizin Berlin ( Site 0442)

location_facility: Hospital das Clinicas da UFMG ( Site 0172)

location_facility: Liga Norte Riograndense Contra o Cancer ( Site 0170)

location_facility: MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 0722)

location_facility: Oslo Universitetssykehus Radiumhospitalet ( Site 0600)

location_facility: Klinikum der Universitaet in Muenchen ( Site 0446)

location_facility: Hoag Memorial Hospital Presbyterian ( Site 0038)

location_facility: Policlinico Universitario Gemelli ( Site 0538)

location_facility: Orszagos Onkologiai Intezet ( Site 0846)

location_facility: National Cancer Center Hospital ( Site 1172)

location_facility: Minnesota Oncology Hematology, PA ( Site 8007)

location_facility: Istituto Europeo di Oncologia ( Site 0536)

location_facility: ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 0701)

location_facility: Medizinische Universitat Graz ( Site 0569)

location_facility: Centro Investigación del Cáncer James Lind ( Site 0194)

location_facility: Iwate Medical University Hospital ( Site 1165)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 1167)

location_facility: Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0882)

location_facility: Instituto Nacional Do Cancer II ( Site 0173)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0542)

location_facility: IBCC - Instituto Brasileiro de Controle do Cancer ( Site 0166)

location_facility: Virginia Commonwealth University ( Site 0024)

location_facility: Japanese Foundation for Cancer Research-Gynecologic Oncology ( Site 1171)

location_facility: Texas Oncology-Fort Worth Cancer Center ( Site 8001)

location_facility: National Cancer Center Hospital East ( Site 1159)

location_facility: Centro Medico Integral De Cancerología (CEMIC) ( Site 0322)

location_facility: Hokkaido University Hospital ( Site 1163)

location_facility: St John of God Subiaco Hospital ( Site 0969)

location_facility: Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 1039)

location_facility: Complejo Hospitalario de Jaen ( Site 0632)

location_facility: A.O.U. Citta della Salute e della Scienza di Torino ( Site 0535)

location_facility: Hospital Nacional Daniel Alcides Carrion ( Site 0293)

location_facility: Centre Hospitalier Lyon Sud ( Site 0413)

location_facility: Royal Brisbane and Women s Hospital ( Site 0972)

location_facility: Medizinische Universitat Innsbruck ( Site 0566)

location_facility: Saitama Medical University International Medical Center ( Site 1168)

location_facility: Willamette Valley Cancer Institute and Research Center ( Site 8000)

location_facility: Affiliated Cancer Hospital of Guangxi Medical University ( Site 1036)

location_facility: Hospital Nacional Guillermo Almenara Irigoyen ( Site 0291)

location_facility: Allgemeines Krankenhaus der Stadt Wien ( Site 0567)

location_facility: University of Kentucky Markey Cancer Center ( Site 0015)

location_facility: Allegheny Health Network West Penn Hospital-Gynecologic Oncology ( Site 0030)

location_facility: Harbin Medical University Cancer Hospital ( Site 1013)

location_facility: Texas Oncology-Austin Central ( Site 8006)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 1162)

location_facility: Anhui Provincial Cancer Hospital ( Site 1007)

location_facility: Royal Marsden Hospital (Sutton)-Gynaecology Unit ( Site 0696)

location_facility: Ramathibodi Hospital, Mahidol University ( Site 1131)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0101)

location_facility: Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0453)

location_facility: CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0103)

location_facility: Fakultni Nemocnice Brno Bohunice ( Site 0912)

location_facility: UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0027)

location_facility: Fundacion Centro de Investigacion Clinica CIC ( Site 0231)

location_facility: Texas Oncology-The Woodlands ( Site 8003)

location_facility: Osaka International Cancer Institute ( Site 1161)

location_facility: C.I.U. Hopital Ambroise Pare ( Site 0353)

location_facility: Universitaetsklinik Leipzig ( Site 0456)

location_facility: Smilow Cancer Center at Yale-New Haven ( Site 0023)

location_facility: Universitaetsklinikum Carl Gustav Carus der Technischen Univ ( Site 0452)

location_facility: Maharaj Nakorn Chiang Mai Hospital ( Site 1133)

location_facility: I.U. Cerrahpasa Medical Faculty ( Site 0755)

location_facility: UZA University Hospital Antwerp ( Site 0351)

location_facility: UC Davis Comprehensive Cancer Center ( Site 0017)

location_facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 0445)

location_facility: University of the Ryukyus Hospital ( Site 1156)

location_facility: AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 0009)

location_facility: University of Colorado Health Sciences Center and Hospital ( Site 0028)

title: A Randomized, Phase 3, Double-Blind Study of Chemoradiotherapy With or Without Pembrolizumab for the Treatment of High-risk, Locally Advanced Cervical Cancer (KEYNOTE-A18/ENGOT-cx11/GOG-3047)

summary:
The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus concurrent chemoradiotherapy compared to placebo plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer.

The primary hypotheses are that pembrolizumab plus concurrent chemoradiotherapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival and overall survival.

Once the study objectives have been met or the study has ended, participants will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment.


title: SERENA-2: A Randomised, Open-Label, Parallel-Group, Multicentre Phase 2 Study Comparing the Efficacy and Safety of Oral AZD9833 Versus Fulvestrant in Women With Advanced ER-Positive HER2-Negative Breast Cancer

summary: This study is randomized, open-label, parallel-group, multicentre Phase 2 study aimed to compare the efficacy and safety of oral AZD9833 versus intramuscular (IM) fulvestrant in women with advanced breast cancer.

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

lead_sponsor: AstraZeneca

location_country:
Italy
United States
Spain
Germany
France
Poland
Israel
Georgia
Hungary
Belgium
Russian Federation
Portugal
Canada
United Kingdom
Korea, Republic of
Ukraine


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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.

lead_sponsor: Novartis Pharmaceuticals

location_country:
France
Belgium
Spain
China
United States

location_facility: University of Wisconsin Regulatory Contact

location_facility: Lurie Children's Hospital of Chicago Drug Shipment

location_facility: University of California at Los Angeles Reg-5

location_facility: Memorial Sloan Kettering Cancer Center Drug Ship - 2

location_facility: Texas Oncology Baylor Charles A Sammons Cancer Ctr

title: EPIK-B2: A Two Part, Phase III, Multicenter, Randomized (1:1), Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation

summary: The purpose of this two parts multicenter, randomized, double-blind, placebo-controlled, Phase III study is to evaluate the efficacy and safety of alpelisib compared to alpelisib matching-placebo in combination with trastuzumab and pertuzumab as maintenance treatment of patients with HER2-positive advanced breast cancer whose tumor harbors a PIK3CA mutation following induction therapy with a taxane in combination with trastuzumab and pertuzumab. Part 1 is the open-label, safety run-in part of the study, designed to confirm the recommended phase 3 dose (RP3D) dose of alpelisib in combination with trastuzumab and pertuzumab. Following Part 1, Part 2 will be initiated, which is the randomized, Phase III part of the study.


title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effect of Dupilumab on Exercise Capacity in Patients With Moderate-to-Severe Asthma

summary:
The primary objective of the study is to demonstrate that dupilumab treatment improves exercise capacity in patients with moderate-to-severe asthma.

The secondary objectives of the study are:

To demonstrate that dupilumab treatment increases physical activity of daily living in patients with moderate-to-severe asthma
To demonstrate that dupilumab treatment improves pre- and post-exercise lung function in patients with moderate-to-severe asthma

ipd_sharing_description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

lead_sponsor: Regeneron Pharmaceuticals

location_country:
United States
France
Poland
Spain
Germany


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

lead_sponsor: UCB Biopharma SRL

location_country:
Greece
Romania
Belgium
Russian Federation
Taiwan
Ukraine
Croatia
France
Japan
Poland
Moldova, Republic of
Korea, Republic of
Bulgaria
Hungary
United States
United Kingdom
Italy
Austria
Czechia
Georgia
Spain

title: A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)

summary: The purpose of this study is to demonstrate the clinical efficacy of rozanolixizumab in maintenance treatment and assess safety and tolerability of rozanolixizumab in adult study participants with primary immune thrombocytopenia (ITP).


title: A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Single Agent Belantamab Mafodotin Compared to Pomalidomide Plus Lowdose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM 3)

summary: This open-label, randomized study for evaluating the efficacy and safety of single agent belantamab mafodotin when compared to pom/dex in participants with RRMM. Participants will be randomized in a 2:1 ratio to receive either single agent belantamab mafodotin or pom/dex. Belantamab mafodotin will be administered intravenously at 2.5 milligram (mg)/kilogram (kg) on Day 1 (D1) of an every 3 weeks (Q3W) schedule. Pomalidomide will be administered orally at the approved starting dose of 4 mg daily on Days 1 to 21 of each 28-day cycle, with dexamethasone administered orally at a dose of 40 mg once weekly (Days 1, 8, 15, and 22). Participants in both arms will be treated until disease progression, death, unacceptable toxicity, withdrawal of consent, and lost to follow-up or end of study, whichever comes first. Approximately up to 380 participants will be randomized (320 + 60 to fulfill regional country requirements).

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

lead_sponsor: GlaxoSmithKline

location_country:
Italy
Brazil
Netherlands
Spain
Germany
France
Bulgaria
Greece
Japan
Korea, Republic of
Poland
Hungary
Belgium
Australia
Russian Federation
China
United States
United Kingdom
Canada