summary: The purpose of this study is to evaluate the efficacy of aticaprant compared with placebo as adjunctive therapy to an antidepressant in improving depressive symptoms in adult participants with major depressive disorder (MDD) with moderate to severe anhedonia (ANH+) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).

location_facility: Diagnostic Consulting Center Mladost - M Varna

location_facility: Premier Psychiatric Research Institute, LLC

location_facility: Beijing Anding Hospital of Capital Medical University

location_facility: Wexner Medical Center at the Ohio State University

location_facility: CHU de Brest - Hôpital de la Cavale Blanche

location_facility: Cabinet Medical des Drs Prizac-Desbonnet Scottez

location_facility: CHU Clermont-Ferrand - Hopital Gabriel Montpied

location_facility: Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu

location_facility: Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach

location_facility: INSA Instituto de Neurociencias San Agustín

location_facility: Psychiatricka ambulance, MUDr. Marta Holanova

location_facility: Psychiatricka Ambulancia Psycholine S.R.O.

location_facility: DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD

location_facility: Clinica Privada de Salud Mental Santa Teresa de Ávila

location_facility: Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales

location_facility: Filip Rybakowski Specjalistyczna Praktyka Lekarska

location_facility: CHRU de Tours Clinique Psychiatrique Universitaire

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda

location_facility: CEN-Consultorios Especializados en Neurociencias

title: A Randomized, Double-blind, Multicenter, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Aticaprant 10 mg as Adjunctive Therapy in Adult Participants With Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy

location_country:
Poland
Slovakia
United Kingdom
Argentina
United States
China
Korea, Republic of
South Africa
Taiwan
Czechia
Bulgaria
Canada
France


title: Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis

acronym: PACIFIC

summary: This phase 2 trial will evaluate the effects of EP547 in subjects with cholestatic pruritus due to Primary Biliary Cholangitis (PBC) or Primary Sclerosing Cholangitis (PSC)

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Escient Pharmaceuticals, Inc

location_country:
France
United Kingdom
Netherlands
Belgium
United States
Spain
Canada
Israel

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: University Hospitals Cleveland Medical Center

location_facility: Toronto Centre for Liver Disease Toronto General Hospital

location_facility: NYU Grossman School of Medicine Gastroenterology and Hepatology

location_facility: La Fe University and Polytechnic Hospital

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust

location_facility: Rambam Medical Center- Keriat Eliezer Family Health Center

location_facility: The Liver Institute at Methodist Dallas Medical Center

location_facility: Institute of Cellular Medicine, Newcastle University

location_facility: Tulane University Health Sciences Center

location_facility: University of Nottingham - Nottingham Digestive Diseases Centre Biomedical Research Unit

location_facility: Centre hospitalier de l'Université de Montréal (CHUM)

location_facility: King's College Hospital NHS Foundation Trust

location_facility: University of Miami - Schiff Center for Liver Diseases

location_facility: University of Alabama Birmingham Hospital

location_facility: Campus Hospital Universitario Virgen del Rocio

location_facility: Academic Medical Center- University of Amsterdam

location_facility: University Hospitals Plymouth NHS Trust - Derriford Hospital

location_facility: Dignity Health Center for Clinical Research at St. Joseph Hospital

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


type: EudraCT Number

type: Other Identifier

type: Registry Identifier

title: A Phase 2, Open-Label, Parallel Cohort Study of Subcutaneous Amivantamab in Multiple Regimens in Patients With Advanced or Metastatic Solid Tumors Including EGFR-mutated Non-Small Cell Lung Cancer

summary: The purpose of this study is to assess the anti-tumor activity and safety of amivantamab which will be administered as a co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) (subcutaneous co-formulation [SC-CF]) in combination treatment (all cohorts except Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4).

design_allocation: Non-Randomized

ipd_sharing: Yes

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

lead_sponsor: Janssen Research & Development, LLC

location_country:
Germany
Italy
Israel
United Kingdom
Japan
Brazil
United States
China
Korea, Republic of
Spain
Malaysia
France

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Tianjin Medical University General Hospital

location_facility: The First Affiliated Hospital Zhejiang University College of Medicine

location_facility: H. Lee Moffitt Cancer & Research Institute

location_facility: Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital

location_facility: Impar Servicos Hospitalares SA - Hospital Nove de Julho

location_facility: National Hospital Organization Himeji Medical Center

location_facility: Fundacao Antonio Prudente - A.C. Camargo Cancer Center

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Klinikum Würzburg Mitte gGmbH Standort Missioklinik

location_facility: Policlinico Hospital San Martino- IRCCS for Oncology

location_facility: Azienda Ospedaliera Specialistica dei Colli

location_facility: Seoul National University Bundang Hospital

location_facility: Washington University School of Medicine

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

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

location_facility: Instituto do Cancer de Londrina - Hospital do Cancer de Londrina

location_facility: PERSONAL - Oncologia de Precisão e Personalizada

location_facility: Rambam Medical Center Department of Pediatric Pulmonology Meyer Childern's Hospital

location_facility: Harbin medical university cancer hospital

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

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

location_facility: General University Hospital of Alicantet


title: A Single-Arm, Open-Label, Multicenter Phase 1/2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BCL2 Inhibitor BGB-11417 in Patients With Relapsed or Refractory Mantle Cell Lymphoma

summary: The study consists of two parts. Part 1 determines the safety and tolerability of BGB-11417 (sonrotoclax) monotherapy, the maximum tolerated dose, and the recommended Phase 2 dose of BGB-11417 monotherapy for relapsed or refractory mantle cell lymphoma. Part 2 evaluates efficacy of BGB-11417 monotherapy at the recommended Phase 2 dose with recommended ramp-up schedule from Part 1.

lead_sponsor: BeiGene

location_country:
Germany
Italy
Poland
Israel
Argentina
United Kingdom
Brazil
Belgium
United States
China
Spain
Turkey
Canada
France

location_facility: Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

location_facility: Affiliated Cancer Hospital of Xinjiang Medical University

location_facility: Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp

location_facility: Churchill Hospital Oxford University Hospital Nhs Trust

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr W Lublinie

location_facility: Guangdong Provincial Peoples Hospital Huifu Branch

location_facility: The Affiliated Hospital of Qingdao University Branch West Coast

location_facility: Instituto Dor de Pesquisa E Ensino Sao Paulo

location_facility: Universitatsklinikum Koln, Innere Medizin I

location_facility: Des Moines Oncology Research Association

location_facility: The Tumor Hospital Affiliated to Guangxi Medical University

location_facility: Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular

location_facility: Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital

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

location_facility: Institute of Hematology and Hospital of Blood Disease

location_facility: University of Alabama At Birmingham Hospital

location_facility: Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy

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

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst

location_facility: The University of Texas Md Anderson Cancer Center

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Affiliated Hospital of Nantong University

location_facility: Chu Tours Hopital Bretonneau Service Pneumologie

location_facility: Beijing Friendship Hospital, Capital Medical University(Tongzhou)

location_facility: Centre Hospitalier Universitaire Nantes Hotel Dieu

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: The Affiliated Hospital of Xuzhou Medical University

location_facility: Cancer Hospital of Guizhou Medical University

location_facility: Hopital Pitie Salpetriere Service Hematologie

location_facility: Hospital Beneficencia Portuguesa de Sao Paulo

location_facility: General Hospital of Ningxia Medical University

location_facility: The First Affiliated Hospital of Nanchang University Branch Donghu


title: A Phase Ib, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple-Ascending Doses of RO7303509 in Participants With Systemic Sclerosis

summary: The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of RO7303509 treatment in participants with systemic sclerosis (SSc) during a multiple-ascending-dose (MAD) portion of the trial. In the MAD phase, increasing doses of study drug will be tested sequentially. For each dose tested, the MAD stage will consist of a treatment period of 12 weeks followed by either a safety follow-up period of 13 weeks or continued treatment in an optional open-label safety extension (OSE) stage of 52 weeks to assess the long-term safety. All patients in the OSE stage will receive RO7303509 and no patient will receive placebo.

ipd_sharing_description: Qualified researchers may request access to individual participant 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: Genentech, Inc.

location_country:
Germany
Poland
Portugal
Israel
Argentina
United Kingdom
Belgium
United States
Spain
Puerto Rico
France

location_facility: Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy; Klinika Reumatologii

location_facility: Mayo Clinic - Cancer Center - Rochester - PPDS

location_facility: Hospital de Alta Complejidad en Red ?El Cruce? Dr. Néstor Kirchner ? S.A.M.I.C.

location_facility: Centro Hospitalar E Universitário de Coimbra EPE

location_facility: Szpital Specjalistyczny im. Jozefa Dietla w Krakowie

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: The Alliance Medical Sciences Campus; University Hospital

location_facility: Centre Hospitalier Universitaire de Grenoble - Albert Michallon

location_facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher


title: A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy and Safety of Multiple Treatment Combinations in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck (Morpheus-Head and Neck Cancer)

summary: This is a Phase Ib/II, open-label, multicenter, randomized, umbrella study in participants with locally advanced squamous cell carcinoma of the head and neck (SCCHN). The study will enroll treatment-naive participants with resectable Stage III-IVA human papillomavirus (HPV)-negative, programmed death-ligand 1 (PD-L1)-positive SCCHN with measurable disease, as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) who have not received systemic treatment for their disease.

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

lead_sponsor: Hoffmann-La Roche

location_country:
France
United Kingdom
Australia
Switzerland
United States
Korea, Republic of
Spain
Israel

location_facility: Severance Hospital - Yonsei Cancer Center

location_facility: Hadassah University Hospital - Ein Kerem; Oncology

location_facility: INSTITUT CURIE_SITE PARIS - Service d'Oncologie Médicale.

location_facility: UCLA Jonsson Comprehensive Cancer Center

location_facility: Sir Charles Gairdner Hospital; Medical Oncology

location_facility: Hospital Clínico San Carlos; Oncology Service

location_facility: Centre Georges François Leclerc; Service Pharmacie, Bp 77980

location_facility: Vall d?Hebron Institute of Oncology (VHIO), Barcelona; Servicio de Farmacia. Semi-sótano USIFO

location_facility: Hospital Clinico Universitario de Valencia

location_facility: University of Michigan Comprehensive Cancer Center


title: SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor

acronym: ACSPIRE

summary: This will be a study with SPI-62 to evaluate the efficacy, safety, and pharmacological effect of SPI-62 in subjects with hypercortisolism related to a benign adrenal tumor. Each subject will receive 2mg of SPI-62 daily.

lead_sponsor: Sparrow Pharmaceuticals

location_country:
United States
Romania
United Kingdom
France

location_facility: Mayo Clinic Cancer Center (MCCC) - Rochester

location_facility: Spitalul Clinic Judeţean de Urgenţe "Sf. Spiridon"

location_facility: Manchester University NHS Foundation Trust - Wythenshawe Hospital

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

location_facility: IU Simon Cancer Center - Indiana University

location_facility: Washington University School of Medicine - Center for Advanced Medicine (CAM) - Diabetes Center

location_facility: Eastern Virginia Medical School - Strelitz Diabetes Center

location_facility: Universitatea de Medicina si Farmacie Targu Mures - Spitalul Clinic Judetean de Urgenta Targu Mures


title: Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Mocravimod as Adjunctive and Maintenance Treatment in Adult AML Patients Undergoing Allogeneic HCT

acronym: MO-TRANS

summary: This is a multi-center, randomized, double-blinded, placebo controlled trial.

lead_sponsor: Priothera SAS

location_country:
Germany
Italy
France
Poland
United Kingdom
Romania
Japan
Switzerland
United States
Spain
Taiwan
Israel

location_facility: Stony Brook University (SBU) - Cancer Center

location_facility: Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)

location_facility: University of Maryland Medical Center (UMMC)

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria

location_facility: National Taiwan University Hospital (NTUH)

location_facility: University of Cincinnati Medical Center (University Hospital)

location_facility: Ochsner Medical Center (OMC) - New Orleans

location_facility: Centre de Lutte Contre le Cancer (CLCC) - Institut Gustave-Roussy

location_facility: Centre Hospitalier Universitaire (CHU) Angers

location_facility: Azienda Sanitaria Locale 13 - Ospedale "C. e G. Mazzoni"- Ascoli Piceno

location_facility: Slaski Uniwersytet Medyczny (SUM) w Katowicach - Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego (SPSKM) - Slaskie Centrum Hematologii I Transplantacji Szpiku

location_facility: Universita degli Studi di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC) LAB TMO

location_facility: University of Pennsylvania - Abramson Cancer Center

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Casa Sollievo della Sofferenza (CSS)

location_facility: University of Alabama Hospital (UAB Hospital)

location_facility: Centre Hospitalier Regional Universitaire (CHRU) de Lille - Hopital Claude Huriez -

location_facility: Institut Catala d'Oncologia (ICO) - Hospital Universitari Germans Trias i Pujol (HUGTP) Location

location_facility: University of California Los Angeles (UCLA) - David Geffen School of Medicine

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Emory University - Winship Cancer Institute (WCI)

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Spectrum Health Medical Group (SHMG) - Blood & Marrow Transplant - Adult (BMT)

location_facility: Hospital Universitario de Gran Canaria ""

location_facility: Universitaetsklinikum Jena - Klinik fuer Innere Medizin II

location_facility: Oregon Health & Science University (OHSU) - Knight Cancer Institute

location_facility: Institutul Regional de Oncologie Iasi, - Haematology Department

location_facility: The Ohio State University Comprehensive Cancer Center (OSUCCC)

location_facility: Hospital Clinico Universitario - Universidad de Salamanca


title: A Randomized, Double-blind, Placebo-controlled, Phase 2 Study Evaluating Efficacy and Safety of Inupadenant in Combination With Carboplatin and Pemetrexed in Adults With Nonsquamous Non-small Cell Lung Cancer Who Have Progressed on Immunotherapy

summary: Part 1 of the study determines the optimal dose of inupadenant to be given in combination with carboplatin and pemetrexed to patients that progressed after receiving specific first line treatments for Stage 3 or metastatic non-small cell lung cancer. Part 2 compares the efficacy of inupadenant to placebo when both are combined with carboplatin and pemetrexed for patients that progressed after receiving the same first line treatments for Stage 3 or metastatic non-small cell lung cancer.

lead_sponsor: iTeos Belgium SA

location_country:
Italy
Poland
Switzerland
Belgium
United States
Spain
Czechia
Canada
France

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Complejo Hospitalario Universitario de Ourense

location_facility: Hospital Quiron Barcelona - Instituto Oncologico Baselga

location_facility: Mid-Florida Hematology & Oncology Centers, PA

location_facility: Uniwersytet Medyczny w Lodzi Klinika Pulmonologii Ogolnej i Onkologicznej

location_facility: Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie

location_facility: Hospital General Universitario de Alicante

location_facility: Innovative Clinical Research Institute (ICRI)

location_facility: Oncologia Casa Di Cura Polispecialistica Dott Pederzoli

location_facility: Gruppo Humanitas - Istituto Clinico Humanitas

location_facility: Consorcio Hospitalario Provincial de Castellon

location_facility: Carolina Institute for Clinical Research

location_facility: Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

location_facility: Fondazione Irccs Ca Granda Ospedale Maggiore Policlinico

location_facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o


title: A Randomized, Double-blind, Placebo Controlled, 3-arm Multicenter Phase 3 Study to Assess the Efficacy and Safety of Ianalumab in Patients With Active Sjogren's Syndrome (NEPTUNUS-2)

summary: A randomized, double-blind, placebo controlled, 3-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjogren's syndrome (NEPTUNUS-2)

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Chile
Canada
France
Colombia
Slovakia
Hungary
United States
India
Romania
Lebanon
China
Italy
United Kingdom
Sweden
Mexico
Spain
Greece
South Africa
Taiwan
Bulgaria
Israel

intervention_type: Other


title: A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Bemarituzumab Monotherapy and Combination With Other Anti-Cancer Therapy in Subjects With Squamous-Cell Non-Small-Cell Lung Cancer (FORTITUDE-201)

summary: The primary objectives of this study are to evaluate the safety and tolerability of bemarituzumab monotherapy and combination with other anti-cancer therapies, and to determine the recommended phase 3 dose of bemarituzumab in combination with other anti-cancer therapies.

status: Active, not recruiting

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

lead_sponsor: Amgen

location_country:
Poland
Japan
Belgium
United States
Korea, Republic of
Spain
Taiwan
France

location_facility: Hospital Regional Universitario de Malaga

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Complexo Hospitalario Universitario A Coruña Hospital Teresa Herrera

location_facility: Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie

location_facility: Centrum Medyczne Hope Clinic Sebastian Szklener

location_facility: Hospital Clinic i Provincial de Barcelona

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

location_facility: Institut Catala d Oncologia Hospitalet. Hospital Duran i Reynals

location_facility: Seoul National University Bundang Hospital

location_facility: Przychodnia Lekarska Komed Roman Karaszewski

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

location_facility: Severance Hospital Yonsei University Health System

location_facility: University of Pittsburgh, Cancer Institute

location_facility: Montefiore Einstein Center for Cancer Care

location_facility: Instytut Genetyki i Immunologii GENIM Spzoo


title: A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Once Weekly Semaglutide, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With a GLP 1 Receptor Agonist. COMBINE 2

acronym: COMBINE 2

summary:
This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to semaglutide taken once a week in people with type 2 diabetes.

The study will look at how well IcoSema controls blood sugar level in people with type 2 diabetes compared to semaglutide.

Participants will either get IcoSema or semaglutide. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe semaglutide in many countries.

Participants will get IcoSema or semaglutide, which they must inject once a week with a pen, which has a small needle, in a skin fold in the thigh, upper arm, or stomach.

The study will last for about 1 year and 1 month. Participants will have 18 clinic visits, 34 phone/video calls with the study doctor, and 4 contacts with the site that can either be clinic visits or phone/video calls.

At 11 clinic visits participants will have blood samples taken. At 7 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit.

Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

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

lead_sponsor: Novo Nordisk A/S

location_country:
Slovakia
Hungary
Israel
Japan
Brazil
Sweden
Switzerland
United States
China
Greece
Taiwan
Canada
Russian Federation
France


title: A Phase 3 Study of Relacorilant in Combination With Nab-Paclitaxel Versus Nab-Paclitaxel Monotherapy in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer (ROSELLA)

summary: The primary objective of this study is to evaluate progression-free survival (PFS) by blinded independent central review (BICR) in patients treated with intermittent regimen of relacorilant in combination with nab-paclitaxel compared with patients treated with nab-paclitaxel monotherapy.

lead_sponsor: Corcept Therapeutics

sponsor_collaborators:
Corcept Therapeutics
Gynecologic Oncology Group

location_country:
Italy
Poland
Hungary
Argentina
Israel
Australia
Brazil
United Kingdom
Belgium
United States
Korea, Republic of
Spain
Canada
France

location_facility:
Site 415
Site 127
Site 344
Site 281
Site 289
Site 395
Site 321
Site 383
Site 310
Site 341
Site 276
Site 049
Site 391
Site 398
Site 346
Site 392
Site 316
Site 229
Site 389
Site 297
Site 109
Site 124
Site 397
Site 320
Site 280
Site 382
Site 409
Site 042
Site 122
Site 403
Site 339
Site 121
Site 032
Site 334
Site 328
Site 412
Site 311
Site 366
Site 314
Site 347
Site 330
Site 301
Site 327
Site 312
Site 277
Site 396
Site 273
Site 317
Site 080
Site 331
Site 279
Site 278
Site 337
Site 291
Site 293
Site 272
Site 001
Site 335
Site 401
Site 298
Site 203
Site 399
Site 306
Site 117
Site 200
Site 380
Site 376
Site 325
Site 292
Site 424
Site 322
Site 381
Site 307
Site 384
Site 374
Site 348
Site 290
Site 400
Site 413
Site 304
Site 404
Site 323
Site 421
Site 364
Site 393
Site 349
Site 315
Site 295
Site 351
Site 009
Site 390
Site 318
Site 329
Site 309
Site 402
Site 345
Site 150
Site 365
Site 055
Site 372
Site 350
Site 300
Site 414
Site 275
Site 367
Site 368
Site 288
Site 319
Site 161
Site 108
Site 014
Site 326


title: A Parallel-group Treatment, Phase 2, Double-blind, Three-arm Study to Assess Efficacy and Safety of Finerenone Plus Empagliflozin Compared With Either Finerenone or Empagliflozin Alone in Participants With Chronic Kidney Disease and Type 2 Diabetes.

acronym: CONFIDENCE

summary:
Finerenone works by blocking a group of proteins, called mineralocorticoid receptor. An increased stimulation of mineralocorticoid receptor is known to trigger injury and inflammation in the kidney and is therefore thought to play a role in CKD.

Empagliflozin lowers blood sugar levels by increasing the excretion of glucose from the blood into the urine.

In this study, the researchers want to learn how well the combination of finerenone and empagliflozin helps to slow down the worsening of the participants' kidney function compared to either treatment alone. For this, the level of protein in the urine will be measured. The investigators also want to know how safe the combination is compared to either treatment alone.

Depending on the treatment group, the participants will either take the combination of finerenone and empagliflozin, or finerenone together with a placebo, or empagliflozin together with a placebo, once a day as tablets by mouth. A placebo looks like a treatment but does not have any medicine in it. Importantly, the participants will also continue to take their other current medicine for CKD and T2D.

The participants will be in the study for up to 7.5 months and will take the study treatments for 6 months. During the study, participants will visit the study site 7 times.

The study team will:

collect blood and urine samples
check the participants' vital signs
do a physical examination including height and weight
check the participants' heart health by using an electrocardiogram (ECG)
monitor the participants' blood pressure
ask the participants questions about how they are feeling and what adverse events they may be having An adverse event is any problem that happens during the trial. Doctors keep track of all events that happen in trials, even if they do not think the events might be related to the study treatments.

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

lead_sponsor: Bayer

location_country:
Germany
Italy
India
Israel
Denmark
Japan
Netherlands
Belgium
United States
Korea, Republic of
Spain
Taiwan
Canada
France

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital Universitario Puerta de Hierro Majadahonda | Clinical Pharmacology Department

location_facility: Onze-Lieve-Vrouwziekenhuis (OLVZ) - Campus Aalst

location_facility: West Orange Endocrinology & Clinical Research

location_facility: Centre Hospitalier de l'Université de Montréal (CHUM)

location_facility: Steno Diabetes Center Copenhagen | Herlev - Clinical and Translational Research Department

location_facility: Regionaal ZH Jan Yperman Campus Mariaziekenhuis

location_facility: Diabetologische Schwerpunkt Praxis Dortmund

location_facility: Institute of Post-Graduate Medical Education and Research

location_facility: Clalit Health Services through HaEmek Medical Center

location_facility: Carolina Clinical Research & Consulting at Triad Internal Medicine

location_facility: Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition

location_facility: Seth Gordhandas Sunderdas Medical College (GSMC) - King Edward Memorial (KEM) Hospital

location_facility: Soon Chun Hyang University Cheonan Hospital

location_facility: Taipei Medical University - Shuang Ho Hospital

location_facility: Hallym University Kangnam Sacred Heart Hospital

location_facility: MultiCare Rockwood Clinic Diabetes & Endocrinology Center

location_facility: University of North Carolina Kidney Center

location_facility: Regionshospitalet Godstrup | Nephrology Department

location_facility: Health Corporation of Galilee Medical Center

location_facility: Hadassah University Medical Center (HUMC)

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

location_facility: Grant Medical Foundation - Ruby Hall Clinic (RHC)

location_facility: Thyroid, Endocrinology, and Diabetes (TED) PA

location_facility: Yonsei University Wonju Christian Hospital

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: North Texas Kidney Disease Associates, PLLC

location_facility: Far Eastern Memorial Hospital | Nephrology Department

location_facility: Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión Arterial

location_facility: Hospital Vithas Sevilla | Endocrinology Department

location_facility: Universidad Autonoma de Madrid (UAM) - Facultad de Medicina - Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD)

location_facility: Vinaya Hospital and Research Centre (A Unit of KIMS)

location_facility: University of Tennessee Health Science Center

location_facility: Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital

location_facility: Universita Degli Studi "Gabriele d'Annunzio" - Chieti - Centro Scienze dell'Invecchiamento (Centro Studi Sull'Invecchiamento

location_facility: Health Corporation of the Ziv Medical Center (R.A.)

location_facility: Ciutat Sanitaria i Universitaria de la Vall d'Hebron

location_facility: Washington University School of Medicine

location_facility: Centricity Research Mirabel Multispecialty

location_facility: Asian Kidney Hospital and Medical Centre

location_facility: Eastern Nephrology Associates / Greenville NC

location_facility: Government Medical College and Hospital (GMCH) Nagpur

location_facility: Government Kilpauk Medical College Hospital

location_facility: Kyung Hee University Hospital at Gangdong

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Bangalore Medical College & Research Institute

location_facility: KLES Dr. Prabhakar Kore Hospital & Medical Research Centre

location_facility: Max Super Speciality Hospital (MSSH) - Saket

location_facility: Hospital Universitario Virgen de la Victoria | Unidad de Investigacion Clinica - Endocrinology Department

location_facility: Jiyugaoka Yamada Internal Medicine Clinic

location_facility: William Osler Health centre, Sakuara Medical

location_facility: Zentrum für Diabetologie und Ernährungsmedizin

location_facility: Public Central Hospital of Matto Ishikawa

location_facility: University of Texas Health Science Center

location_facility: Hospital Quironsalud Barcelona | Internal Medicine Department

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: East Coast Institute for Research, Inc. - Jacksonville

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Clalit Health Services Rabin Medical Center-Beilinson Campus

location_facility: Sriram Chandra Bhanj Medical College & Hospital

location_facility: Santa Rosa Medical Centers of Nevada / CCT Research

location_facility: Nizam's Institute of Medical Sciences (NIMS)


acronym: HIMALAYA

lead_sponsor: Sanofi

summary:
This is a parallel treatment, Phase 2, randomized, double-blind study to assess the efficacy, safety, tolerability, PK, and PD of twice daily (BID) oral SAR443820 compared with placebo in male and female participants,18 to 80 years of age with ALS followed by an open label, longterm extension period.

Study ACT16970 consists of 2 parts (A and B) as follows:

Part A is a 24week, double blind, placebo controlled part, preceded by a screening period of up to 4 weeks before Day 1.

On Day 1 of Part A, participants will be randomized in a 2:1 ratio to the SAR443820 treatment arm or matching placebo arm as listed below:

Treatment arm: SAR443820, BID

Placebo arm: Placebo, BID

Randomization will be stratified by the geographic region of the study site, region of ALS onset (bulbar vs other areas), use of riluzole (yes vs no), use of edaravone (yes vs no) and use of the combination of sodium phenylbutyrate and taurursodiol (named Relyvrio in the United States of America [USA] and Albrioza in Canada) (yes vs no). Participants will attend in clinic study assessments at baseline (Day 1), Week 2, Week 4, Week 8, Week 16, and Week 24, and will receive a phone call at Week 12 and Week 20. All ongoing participants in Part A will rollover to part B. The Week 24 Visit is the end of Part A and the beginning of Part B.

Part B is an open label, longterm extension period that starts from the end of Part A (Week 24) and continues up to Week 106. The objectives of Part B are to further determine the safety and efficacy of longterm SAR443820 treatment. The treatment assignment of participants in Part A will remain blinded to Investigators, participants, and site personnel until the end of Part B. Every participant, except those who discontinued Investigational Medicinal Product (IMP) treatment permanently in Part A , will receive BID oral tablets of SAR443820 in Part B.

location_facility: University of Colorado Site Number : 8400025

location_facility: University of Pennsylvania Site Number : 8400021

location_facility: Froedtert Hospital & Medical College of Wisconsin Site Number : 8400010

location_facility: Georgetown University Medical Center Site Number : 8400020

location_facility: Johns Hopkins University Site Number : 8400028

location_facility: Thomas Jefferson University Hospital Site Number : 8400014

location_facility: Massachusetts General Hospital Site Number : 8400001

location_facility: Northwestern Medical Group, Department of Neurology Site Number : 8400003

location_facility: AdventHealth Medical Group - Neurology at Winter Park Site Number : 8400006

location_facility: University of California Irvine Site Number : 8400012

location_facility: University of Utah Site Number : 8400009

location_facility: UC San Diego Health Site Number : 8400022

location_facility: California Pacific Medical Center Site Number : 8400015

location_facility: Penn State Milton S. Hershey Medical Center Site Number : 8400004

location_facility: Mount Sinai Beth Israel Medical Center Site Number : 8400002

title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SAR443820 in Adult Participants With Amyotrophic Lateral Sclerosis, Followed by an Open-label Extension

source: euctr

enrollment_type: Actual

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

location_country:
Germany
Italy
Poland
United Kingdom
Japan
Sweden
Netherlands
Belgium
United States
China
Spain
Canada
France


title: A Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With the Sodium-glucose Transport Protein 2 (SGLT2) Inhibitor EmpaGliflozin in patiEnts With Non-alcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)

acronym: LEGEND

summary: The study in the T2DM population is intended to confirm the lanifibranor effect versus placebo on glycemic control and assess a positive effect of the combination of lanifibranor with an SGLT2 inhibitor on glycemic control.

lead_sponsor: Inventiva Pharma

location_country:
United Kingdom
Netherlands
Belgium
United States
France

location_facility: Institute for Liver Health dba Arizona Liver Health

location_facility: Diabetes & Glandular Disease Clinic, P.A.

location_facility: Digestive Health Research of North Texas

location_facility: Tandem Clinical Research - New Orleans Area Site

location_facility: Digestive Health Research of Southern California


title: A PHASE 2, RANDOMIZED, OPEN-LABEL STUDY OF ENCORAFENIB AND CETUXIMAB PLUS PEMBROLIZUMAB VERSUS PEMBROLIZUMAB ALONE IN PARTICIPANTS WITH PREVIOUSLY UNTREATED BRAF V600E-MUTANT, MSI H/DMMR METASTATIC COLORECTAL CANCER

acronym: SEAMARK

summary:
The purpose of this study is to learn about the effects of three study medicines (encorafenib, cetuximab, and pembrolizumab) given together for the treatment of colorectal cancer that:

is metastatic (spread to other parts of the body);
has the condition of genetic hypermutability (tendency to mutation) or impaired DNA mismatch repair (MMR)
has a certain type of abnormal gene called "BRAF" and;
has not received prior treatment.

All participants in this study will receive pembrolizumab at the study clinic as an intravenous (IV) infusion (given directly into a vein) at the study clinic.

In addition, half of the participants will take encorafenib by mouth at home every day and cetuximab by IV infusion at the study clinic.

The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.

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

lead_sponsor: Pfizer

sponsor_collaborators:
Pfizer
Merck Sharp & Dohme LLC
Merck KGaA, Darmstadt, Germany
Eli Lilly and Company

location_country:
Germany
Italy
Poland
Slovakia
Norway
United Kingdom
Denmark
Australia
Sweden
Netherlands
Belgium
United States
Spain
Czechia
Canada
France

location_facility: Hospital General Universitario Gregorio Marañon

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

location_facility: Institut für Klinisch Onkologische Forschung

location_facility: Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie

location_facility: Mayo Clinic Cancer Center Outpatient Pharmacy

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: USC/Norris Comprehensive Cancer Center / Investigational Drug Services

location_facility: Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica

location_facility: Centre Hospitalier Universitaire Estaing

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Copernicus Podmiot Leczniczy Sp. z o.o. Wojewodzkie Centrum Onkologii

location_facility: Institut Català d'Oncologia - L'Hospitalet

location_facility: Hospital General Universitario de Valencia

location_facility: Azienda USL Toscana Nord Ovest_Ospedale Civile di Livorno

location_facility: Azienda Ospedaliera Universitaria dell'Università "Luigi Vanvitelli" Piazza Luigi Miraglia, 2 Napol

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza

location_facility: Vychodoslovensky onkologicky ustav, a.s.

location_facility: Radomskie Centrum Onkologii im. Bohaterow Radomskiego Czerwca 76

location_facility: Fondazione Poliambulanza Istituto Ospedaliero

location_facility: Institut Regional du Cancer de Montpellier - ICM Val d'Aurelle

location_facility: Sunnybrook Health Sciences - Odette Cancer Centre

location_facility: University of Miami Hospital and Clinics, Sylvester Cancer Center

location_facility: SPZOZ Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu

location_facility: The West Clinic, PLLC dba West Cancer Center

location_facility: Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia


title: A Phase 1/2 Dose-Escalation and Dose-Expansion Study of ZN-c3 in Combination With Niraparib in Subjects With Platinum-Resistant Ovarian Cancer

summary: This is a Phase 1/2 study to evaluate the safety, clinical activity, pharmacokinetics (PK), and pharmacodynamics (PD) of ZN-c3 in combination with niraparib in subjects with platinum-resistant ovarian cancer.

lead_sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

location_country:
United States
France

location_facility: ICANS - Institut de cancérologie Strasbourg Europe

location_facility: Optimum Clinical Research Group- Women's Oncology

location_facility: Arizona Oncology Associates (Wilmot HOPE) - USOR

location_facility: Women and Infants Hospital of Rhode Island

location_facility: The Blavatnik Family - Chelsea Medical Center at Mount Sinai

location_facility: Willamette Valley Cancer Institute and Research Center


title: A Phase 3, Prospective, Randomized, Open-label, Adaptive Group Sequential, Multicenter Trial With Blinded Endpoint Assessment to Evaluate the Efficacy and Safety of TAK-330 for the Reversal of Direct Oral Factor Xa Inhibitor-induced Anticoagulation in Patients Requiring Urgent Surgery/Invasive Procedure

summary:
The aim of this study is to find out the effects of TAK-330 compared with four-factor prothrombin complex concentrate (4F-PCC) as part of standard treatment other than Prothromplex Total for anticoagulation reversal in participants treated with Factor Xa inhibitors who require urgent surgery/invasive procedure.

The participant will be assigned by chance to either TAK-330 or SOC 4F-PCC as part of standard treatment before surgery.

Patients participating in this study will need to be hospitalized. They will also be contacted (via telehealth/phone call) 30 days after the surgery.

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Takeda

collaborators: Takeda Development Center Americas, Inc.

location_country:
Netherlands
Belgium
United States
Spain
France

location_facility: CHU Clermont Ferrand - Hopital Gabriel Montpied

location_facility: Maastricht University Medical Center , Department of Anesthesiology & Pain Management

location_facility: Hospital Universitari i Politecnic La Fe

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

location_facility: Service d'Accueil des Urgences, Hôpital Lariboisière

location_facility: Ohio State University Wexner Medical Center

location_facility: UC Davis Health Dept of Orthopaedic Surgery


title: A Randomized, Double-blind, Parallel Group, Placebo-controlled, Multicenter Phase 3 Trial to Evaluate Efficacy, Safety and Tolerability of Ianalumab on Top of Standard-of-care Therapy in Participants With Active Lupus Nephritis (SIRIUS-LN).

acronym: SIRIUS-LN

summary: This trial will evaluate efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN

location_country:
Germany
Argentina
Brazil
Thailand
Vietnam
Chile
Czechia
Canada
France
Lithuania
Colombia
Hungary
Hong Kong
United States
India
Romania
China
Malaysia
Estonia
Italy
Guatemala
United Kingdom
Singapore
Mexico
Korea, Republic of
Spain
Taiwan


title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ISIS 678354 Administered Subcutaneously to Patients With Severe Hypertriglyceridemia

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

lead_sponsor: Ionis Pharmaceuticals, Inc.

location_country:
Finland
Germany
Poland
New Zealand
Australia
Turkey
Czechia
Canada
France
Portugal
Slovakia
Hungary
Denmark
United States
Italy
Norway
United Kingdom
Sweden
Netherlands
Spain
South Africa
Bulgaria
Israel

location_facility: UMHAT Prof. Dr. Stoyan Kirkovich AD, Clinic of Cardiology

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Stoffwechselcentrum Charite Campus Virchow

location_facility: Dr. Heart Pty Ltd at Cholesterol Care Australia

location_facility: Centro Hospitalar do Baixo Vouga Hospital Infante D. Pedro

location_facility: Hospital Egas Moniz - Centro Hospitalar de Lisboa Ocidental

location_facility: Nemocnica arm. generala L. Svobodu Svidnik,

location_facility: IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di SantOrsola

location_facility: Oak Tree Surgery and Pensilva Health Centre

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Debreceni Egyetem Klinikai Kozpont Belgyogyaszat A epulet

location_facility: Diabetes/Lipid Management & Research Center

location_facility: Clinique des Maladies Lipidiques de Quebec Inc.

location_facility: University of California, San Diego (UCSD)

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: University of Michigan Hospital and Health Systems/ Dept. of Pharmacy-Research Pharmacy

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

location_facility: Medispektrum s.r.o., diabetologicka a metabolicka ambulancia

location_facility: Academic Medical Center - Department of Vascular Medicine

location_facility: Centro Hospitalar Universitário de São João Consultas Externas de Endocrinologia K13

location_facility: TREAD Research - Department of Cardiology

location_facility: Novant Health Cancer Institute Elizabeth Investigational Drug Services

location_facility: Circuit Clinical (Crystal Run Healthcare)

location_facility: Észak-Pesti Centrumkórház - Honvédkórház; II. Belgyógyászati Osztály

location_facility: Washington University School of Medicine

location_facility: Semmelweis Egyetem Kardiológiai Rehabilitacio

location_facility: Instytut Centrum Zdrowia Matki Polki Klinika

location_facility: Medical Center Smolyan Clinical Research OOD

location_facility: Institut d'Investigació i Innovació Parc Taulí (I3PT) Departament Medicina Universitat

location_facility: Manchester University NHS Foundation Trust (MFT)

location_facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Vychodoslovensky Ustav srdcovych a cievnych chorob a.s.

location_facility: Hudson County Clinical Trials Research Center

location_facility: Hospital Universitari Sant Joan de Reus.

location_facility: West Virginia University Heart and Vascular Institute

location_facility: A.O. Policlinico Universitario P. Giaccone

location_facility: Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: Institut de recherches cliniques de Montréal (IRCM)

location_facility: Hospital Virgen del Rocio Edificio Centro de Diagnostico y Tratamiento (CDT)

location_facility: Necmettin Erbakan University Meram Medical Faculty


title: A Randomized, Double-Blind, Active-Controlled, Phase 3 Study of Chronocort Compared With Immediate-Release Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia

acronym: CONnECT

summary: This study is a randomized, double-blind, active-controlled, phase III study of Chronocort® compared with immediate-release hydrocortisone replacement therapy in participants aged 16 years and over with Congenital Adrenal Hyperplasia.

lead_sponsor: Diurnal Limited

location_country:
United States
Japan
France

location_facility: Diurnal Investigational Site in Michigan

location_facility: Diurnal Investigational Site in Toulouse (Children's Hospital)

location_facility: Diurnal Investigational Site in Maryland

location_facility: Diurnal Investigational Site in Milwaukee

location_facility: Diurnal Investigational Site in Jacksonville

location_facility: Diurnal Investigational Site in Los Angeles

location_facility: Diurnal Investigational Site in Rochester

location_facility: Diurnal Investigational Site in Asahi-ku


title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients With Primary Biliary Cholangitis

acronym: VANTAGE

summary: The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression of PBC.

lead_sponsor: Mirum Pharmaceuticals, Inc.

location_country:
Germany
Italy
France
United Kingdom
United States
Israel

location_facility: CHI Health Clinic (Alegent Creighton Clinic)- Gastroenterology-Bergan

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Hadassah Medical Center - Ein Karem, Liver Institute Kiryat Hadassah POB 12000

location_facility: Bon Secours Richmond Community Hospital LLC d/b/a Bon Secours Liver Institute of Richmond

location_facility: Bon Secours Liver Institute of Hampton Roads Mary Immaculate Hospital

location_facility: Belfast Health & Social Care Trust (BHSCT) Royal Victoria Hospital

location_facility: Loyola University Health System - Loyola Outpatient Center

location_facility: University Hospital Tübingen Medical clinic

location_facility: Einstein Healthcare Network - Einstein Medical Center

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Hopital Claude Huriez-Digestive system disease clinic


title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of Remibrutinib (LOU064) to Investigate the Efficacy, Safety and Tolerability for 52 Weeks in Adult Chronic Spontaneous Urticaria (CSU) Patients Inadequately Controlled by H1-antihistamines

summary: The purpose of this study is to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) in adult participants suffering from chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines in comparison to placebo.

location_country:
Argentina
Australia
Japan
Turkey
Czechia
France
Colombia
Hungary
United States
India
Puerto Rico
Italy
Singapore
Mexico
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation

location_facility: Hospital General Universitario de Alicante, Edifico Consultas Externas

location_facility: Hospital Universitario Gran Canaria Doctor Negrin


title: A Phase 1 Study of Oral LOXO-338, a Selective BCL-2 Inhibitor, in Patients With Advanced Hematologic Malignancies

summary: The purpose of this study is to find out whether the study drug, LOXO-338, is safe and effective in patients with advanced blood cancer. Patients must have already received standard therapy. The study may last up to approximately 3 years.

lead_sponsor: Eli Lilly and Company

sponsor_collaborators:
Eli Lilly and Company
Loxo Oncology, Inc.

location_country:
United States
Italy
Poland
France

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

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

location_facility: Centre hospitalier universitaire de Haut Leveque

location_facility: University of California San Francisco, Medical Center at Paranassus

location_facility: L'Institut Universitaire du Cancer de Toulouse Oncopole

location_facility: Indiana Blood & Marrow Transplantation (IBMT)


title: A Multicenter, Open-label, Phase 2 Basket Study of MK-7684A, a Co-formation of Vibostolimab (MK-7684) With Pembrolizumab (MK-3475), With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors

summary: The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of pembrolizumab/vibostolimab co-formulation (MK-7684A) with or without other anticancer therapies in participants with selected advanced solid tumors. The primary hypothesis is that pembrolizumab/vibostolimab co-formulation is superior to pembrolizumab alone in terms of objective response rate or progression-free survival in participants with cervical cancer.

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Germany
Italy
Poland
Colombia
Israel
Japan
Netherlands
United States
Korea, Republic of
Spain
Turkey
Chile
Taiwan
Canada
France

location_facility: Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative (

location_facility: Ankara City Hospital-Medical Oncology ( Site 1202)

location_facility: Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 1172)

location_facility: Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1051)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Sperimentazioni Cliniche ( Site 1134)

location_facility: Acibadem Universitesi Atakent Hastanesi ( Site 1208)

location_facility: Gustave Roussy-medicine departement ( Site 1153)

location_facility: Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 1103)

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1204)

location_facility: Clinica Universidad de Navarra-Medical Oncology ( Site 1118)

location_facility: Hadassah Medical Center-Oncology ( Site 1142)

location_facility: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1117)

location_facility: Centre Georges François Leclerc ( Site 1155)

location_facility: Trakya University-Medical Oncology ( Site 1207)

location_facility: HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1114)

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 1136)

location_facility: National Cancer Center Hospital East ( Site 1321)

location_facility: National Cancer Center Hospital ( Site 1322)

location_facility: City of Hope Comprehensive Cancer Center ( Site 1001)

location_facility: National Taiwan University Hospital-Oncology ( Site 1301)

location_facility: Instituto Catalan de Oncologia - Hospital Duran i Reynals-Medical Oncology ( Site 1113)

location_facility: Memorial Sloan Kettering - Westchester ( Site 1020)

location_facility: Universitaetsklinikum Heidelberg-Nationales Centrum für Tumorerkrankungen ( Site 1180)

location_facility: Chang Gung Medical Foundation-Linkou Branch ( Site 1304)

location_facility: CENTRE LEON BERARD-Medical oncology ( Site 1151)

location_facility: Fundación Cardiovascular de Colombia ( Site 1423)

location_facility: Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1201)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 1101

location_facility: Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1104)

location_facility: University of California, Irvine (UCI) Health - UC Irvine Me-Chao Family Comprehensive Cancer Cente

location_facility: Ospedale San Raffaele-Oncologia Medica ( Site 1135)

location_facility: James Lind Centro de Investigación del Cáncer ( Site 1404)

location_facility: Memorial Sloan Kettering - Basking Ridge ( Site 1023)

location_facility: Erasmus Medisch Centrum-Medical Oncology ( Site 1122)

location_facility: Aichi Cancer Center Hospital ( Site 1324)

location_facility: Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 1171)

location_facility: Hacettepe Universitesi-oncology hospital ( Site 1209)

location_facility: Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1311)

location_facility: Sheba Medical Center-ONCOLOGY ( Site 1144)

location_facility: Instituto Nacional de Cancerología-Clinical Oncology ( Site 1425)

location_facility: Universitaetsklinikum Tuebingen-Department of Internal Medicine VIII - Medical Oncology, ECTU, Pne

location_facility: Seoul National University Hospital-Internal Medicine ( Site 1312)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 1002)

location_facility: Institut Régional du Cancer Montpellier ( Site 1157)

location_facility: Sanford Cancer Center-Gynecologic Oncology ( Site 1015)

location_facility: Fundación Colombiana de Cancerología Clínica Vida ( Site 1422)

location_facility: Sourasky Medical Center-Oncology ( Site 1143)

location_facility: Rambam Health Care Campus-Oncology ( Site 1141)

location_facility: Klinikum der Universität München Großhadern ( Site 1176)

location_facility: Osaka International Cancer Institute ( Site 1323)

location_facility: Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1111)

location_facility: Sainte Catherine Institut du Cancer Avignon Provence-Oncologie médicale ( Site 1156)

location_facility: Istanbul Universitesi Cerrahpasa ( Site 1203)

location_facility: Princess Margaret Cancer Centre ( Site 1056)

location_facility: Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) ( Site 1121)

location_facility: NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 1302)

location_facility: Memorial Sloan Kettering - Monmouth ( Site 1022)

location_facility: Memorial Sloan Kettering- Commack ( Site 1021)

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1024)


title: A Phase 2/3 Study of Evorpacept (ALX148) in Patients With Advanced HER2-Overexpressing Gastric/Gastroesophageal Junction Adenocarcinoma (ASPEN-06)

summary: A Phase 2/3 Study of Evorpacept (ALX148) in Combination With Trastuzumab, Ramucirumab, and Paclitaxel in Patients With Advanced HER2-overexpressing gastric/GEJ adenocarcinoma.

lead_sponsor: ALX Oncology Inc.

sponsor_collaborators:
ALX Oncology Inc.
Eli Lilly and Company

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

location_facility: The Catholic University of Korea Saint Vincent's Hospital

location_facility: Fondazione IRCCS - Istituto Nazionale dei Tumori

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

location_facility: The Oncology Institute of Hope & Innovation

location_facility: Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: Policlinico Universitario Campus Bio-Medico

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Azienda Sanitaria Universitaria Friuli Centrale - P.O. Santa Maria della Misericordia

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine

location_facility: Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-Minjoz


title: A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy With PRA023 in Subjects With Moderately to Severely Active Ulcerative Colitis

acronym: ARTEMIS-UC

summary:
The purpose of this study is to assess the safety and efficacy of PRA023 in participants with moderately to severely active Ulcerative Colitis.

The purpose of Cohort 2 of the study is to assess the safety and efficacy of PRA023 in participants with moderately to severely active ulcerative colitis who are companion diagnostic positive.

After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for another 38 weeks.

lead_sponsor: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

location_country:
Italy
Poland
Hungary
Israel
United Kingdom
Australia
Belgium
United States
Czechia
Canada
Georgia
France

location_facility:
Prometheus Biosciences Selected Site
Prometheus Biosciences Selected Sites
Prometheus Biosciences Selected Center
Prometheus Biosciences Selected Site #2


title: EMBER-3: A Phase 3, Randomized, Open-Label Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Patients With Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With Endocrine Therapy

summary: The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have breast cancer that is advanced or has spread to another part of the body. Study participation could last up to 5 years.

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

location_country:
Germany
Argentina
Australia
Brazil
Japan
Turkey
France
United States
India
Belgium
China
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation

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

location_facility: Texas Oncology - San Antonio Medical Center

location_facility: Institut de Cancérologie de Lorraine Alexis Vautrin

location_facility: Banner MD Anderson Cancer Center at North Colorado Medical Center

location_facility: Instituto de Investigaciones Clínicas Mar del Plata

location_facility: Institut de cancérologie Strasbourg Europe (ICANS)

location_facility: Icesp - Instituto Do Câncer Do Estado de São Paulo

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

location_facility: Centro de Investigación Clínica de Alta Especialidad

location_facility: The University of Vermont Medical Center Inc.

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: Centre de Cancérologie du Grand Montpellier

location_facility: Deenanath Mangeshkar Hospital & Research Centre

location_facility: Kaiser Permanente Moanalua Medical Center

location_facility: Mid Florida Hematology and Oncology Center

location_facility: Baskent University Dr. Turgut Noyan Research and Training Center

location_facility: Willamette Valley Cancer Institute & Research Ctr.

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Clínica de Pesquisa e Centro de Estudos em Ginecologia Oncológica e Mamária LTDA

location_facility: Onkologische Schwerpunktpraxis Heidelberg, Dr. med. Andreas Karcher, Dr. med. Daniel Debatin, Dr. med. Stefan Fuxius

location_facility: Fundación Cenit Para La Investigación En Neurociencias

location_facility: Texas Oncology - Methodist Charlton Cancer Center

location_facility: Regional Cancer Centre - Thiruvananthapuram

location_facility: University of Florida College of Medicine

location_facility: Volgograd Regional Clinical Cancer Clinic No.1

location_facility: Uniklinikum Salzburg, Universitaetsklinik für Innere Medizin III der PMU

location_facility: Banner MD Anderson Cancer Center at McKee Medical Center

location_facility: Texas Oncology - Dallas Presbyterian Hospital

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Instituto Argentino de Diagnóstico y Tratamiento (IADT)

location_facility: Mercy Health - St. Vincent Medical Center

location_facility: General Oncology Hospital of Kifissia "Agioi Anargiroi"

location_facility: Gynäkologisch-Onkologische Praxis am Pelikanplatz

location_facility: University of California Davis (UC Davis) Comprehensive Cancer Center

location_facility: Jining Medical University - Affiliated Hospital

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: N.N.Petrov Research Institute of Oncology

location_facility: Kyungpook National University Chilgok Hospital


title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment

acronym: AIM-PMR

summary:
Polymyalgia rheumatica (PMR) is an inflammatory disease causing shoulder, hip, and neck pain and stiffness, in adults aged 50 years or older. This study evaluates how safe and effective ABBV-154 is in participants with glucocorticoid-dependent PMR. Adverse events and change in disease activity will be assessed.

ABBV-154 is an investigational drug being evaluated for the treatment of PMR. Participants will be randomized into 1 of 4 treatment groups or arms, each arm receiving a different treatment. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 160 participants, of at least 50 years of age, with PMR will be enrolled in the study at approximately 95 sites worldwide.

The study is compromised of a 52 week double-blind, placebo-controlled period and a follow-up visit 70 days after the last dose of the study drug. All participants will receive a glucocorticoid taper along with the assigned dose of ABBV-154 or placebo, subcutaneously (SC) every other week (eow).

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

status: Terminated

study_completion_date_type: Actual

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

lead_sponsor: AbbVie

location_country:
Germany
Italy
Poland
New Zealand
Hungary
United Kingdom
Australia
Japan
Netherlands
Austria
United States
Korea, Republic of
Spain
Canada
France

location_facility: Royal Prince Alfred Hospital /ID# 244888

location_facility: Obudai Egeszsegugyi Centrum Kft. /ID# 231121

location_facility: Vital Medical Center Orvosi es Fogaszati Kozpont (Vital Medicina Kft.) /ID# 229674

location_facility: Azienda Ospedaliero-Universitaria di Modena /ID# 228825

location_facility: Tokyo Medical And Dental University Hospital /ID# 232206

location_facility: Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 228860

location_facility: Kyushu University Beppu Hospital /ID# 232250

location_facility: ASL 3 Genovese - Ospedale la Colletta /ID# 229282

location_facility: Japanese Red Cross Okayama Hospital /ID# 230857

location_facility: Wellington Regional Hospital /ID# 229490

location_facility: Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 232238

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o /ID# 228357

location_facility: Hospital Clínico Universitario de Santiago-CHUS /ID# 244868

location_facility: Hospital Universitario Canarias /ID# 229451

location_facility: International Medical Research /ID# 228765

location_facility: Paramount Medical Research Con /ID# 228839

location_facility: Hospital General Universitario Gregorio Maranon /ID# 229302

location_facility: Nova Reuma Domyslawska I Rusilowicz - Spolka Partnerska Lekarza Reumatologa I Fi /Id# 228466

location_facility: Rheumatology Research Associates /ID# 230363

location_facility: Fondazione IRCCS Policlinico /ID# 245274

location_facility: Clinical Research Source, Inc. /ID# 231903

location_facility: Toyama Prefectural Central Hospital /ID# 230616

location_facility: Portsmouth Hospitals University NHS Trust /ID# 245291

location_facility: Obudai Egeszsegugyi Centrum Kft. Zalaegerszeg /ID# 229759

location_facility: Matsuyama Red Cross Hospital /ID# 230458

location_facility: West Tennessee Research Institute /ID# 228854

location_facility: CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 230065

location_facility: The Royal Free London NHS Foundation Trust /ID# 231707

location_facility: Timaru Medical Specialists Ltd /ID# 229098

location_facility: DM Clinical Research - Tomball /ID# 245512

location_facility: Liverpool University Hospitals NHS Foundation Trust /ID# 245296

location_facility: Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 228353

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 241674

location_facility: Dartmouth-Hitchcock Medical Center /ID# 229557

location_facility: Rheuma-Zentrum Wien-Oberlaa GmbH /ID# 229436

location_facility: Kyungpook National University Hospital /ID# 228716

location_facility: Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 244866

location_facility: Hospital Unversitario Marques de Valdecilla /ID# 229297

location_facility: The Queen Elizabeth Hospital /ID# 229049

location_facility: Rinku Hashimoto Rheumatology Orthopaedics /ID# 246532

location_facility: Providence Medical Foundation /ID# 228681

location_facility: Four Rivers Clinical Research /ID# 228858

location_facility: Arthritis and Rheumatism Associates /ID# 232089

location_facility: Universitair Medisch Centrum Groningen /ID# 227727

location_facility: Hopital de la Cavale Blanche /ID# 228348

location_facility: University of Rochester Medical Center /ID# 232554

location_facility: Hospital for Special Surgery /ID# 228577

location_facility: Osaka Medical and Pharmaceutical University Hospital /ID# 246530

location_facility: Rheumatology Care Center PLLC /ID# 232306

location_facility: Centre de Recherche Musculo-Squelettique /ID# 228392

location_facility: Arthritis & Rheumatic Disease Specialties /ID# 245448

location_facility: CHU Montpellier - Hôpital Lapeyronie /ID# 228347

location_facility: CISSSBSL -Hopital regional de Rimouski /ID# 228394

location_facility: AI Centrum Medyczne Sp. z o.o. sp.k. /ID# 228951

location_facility: Care Access Research, Huntington Beach /ID# 228677

location_facility: Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 228815

location_facility: National Hospital Organization Shimoshizu National Hospital /ID# 230500

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 229758

location_facility: Hospital Clinico Universitario San Carlos /ID# 229296

location_facility: Hanyang University Seoul Hospital /ID# 228719

location_facility: Inland Rheum & Osteo Med Grp /ID# 228679

location_facility: MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 228658

location_facility: Cardiff & Vale University Health Board /ID# 245297

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 231966

location_facility: Hans Richard Barthel, M.D., Inc /ID# 231902

location_facility: North West Anglia NHS Foundation Trust /ID# 230866

location_facility: Azienda Ospedaliero-Universitaria Senese-Ospedale Santa Maria delle Scotte /ID# 245273

location_facility: Arthritis & Osteo Medical Ctr /ID# 228680

location_facility: CHRU Tours - Hopital Trousseau /ID# 228349

location_facility: Maastricht Universitair Medisch Centrum /ID# 227779

location_facility: Pest Megyei Flor Ferenc Korhaz /ID# 229676

location_facility: A.O.U. Citta della Salute e della Scienza di Torino /ID# 229080

location_facility: Hospital Clinic de Barcelona /ID# 229295

location_facility: CHU de Besancon - Jean Minjoz /ID# 244897

location_facility: Purushotham & Akther Kotha MD, Inc /ID# 245391

location_facility: Rheumatology Consultants - Clinical Research /ID# 232137

location_facility: Csongrad-Csanad Megyei Dr. Bugyi Istvan Korhaz /ID# 229793

location_facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 228661

location_facility: Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 228314

status_simplified: Unknown


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

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

lead_sponsor: Hoffmann-La Roche

sponsor_collaborators:
Hoffmann-La Roche
Chugai Pharmaceutical

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Tianjin Medical University General Hospital

location_facility: Universitätsklinikum Essen (AöR); Klinik für Neurologie

location_facility: St. Josef-Hospital, Klinik für Neurologie

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

location_facility: Hospital Universitario la Fe; Servicio de Neurologia

location_facility: Hopital Timone Adultes; Neurologie Mal Neuro Musculaires

location_facility: Box Hill Hospital; Department of Neurology

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

location_facility: Clinica Universitaria Navarra; Servicio Neurologia

location_facility: Xiangya Hospital Central South University

location_facility: Hospital de Donostia Unidad Demencias; Consultas de Neurología

location_facility: Samara Regional Clinical Hospital named after V.D. Seredavina

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

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

location_facility: Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie

location_facility: Karadeniz Tecnical Uni. Med. Fac.; Neurology

location_facility: Tokyo Women's Medical University Hospital; Neurology

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

location_facility: Beijing Tiantan Hospital,Capital Medical University

location_facility: Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY

location_facility: The First Affiliated Hospital of Wenzhou Medical University

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

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

location_facility: Research Center of Neurology; Neurology Department #5

location_facility: National Center of Social Significant Disease

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

location_facility: University of California Irvine - Manchester Pavilion

location_facility: The Ohio State University Wexner Medical Center; Department of Neurology

location_facility: Sapporo Medical University Hospital; Neurology

location_facility: Hacettepe University Medical Faculty; Neurology

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

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

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Neurologia

location_facility: Osaka Toneyama Medical Center; Neurology

location_facility: Chang Gung Medical Foundation Linkou Branch

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

location_facility: The First Affiliated Hospital Of Shandong First Medical University

location_facility: Nagasaki Kawatana Medical Center; Neurology

location_facility: The Affiliated Hospital of Guizhou Medical University

location_facility: Klinika Neurologii Doros?ych, Uniwersyteckie Centrum Kliniczne

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

location_facility: Clinica Universitaria de Navarra; Servicio de Neurología

location_facility: Pusan National University Yangsan Hospital

location_facility: Dokkyo Medical University Saitama Medical Center; Neurology

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

location_facility: West China Hospital - Sichuan University

location_facility: Washington University School of Medicine; Department of Neurology

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

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

location_facility: Azienda Ospedaliera A. Cardarelli; Dipartimento medico polispecialistico

location_facility: Univeristätsklinikum Leipzig; Klinik und Poliklinik für Neurologie

location_facility: Hospital Universitario Infanta Sofia; Servicio de Neurologia

location_facility: Novosibirsk State Regional Clinical Hospital

location_facility: Kocaeli University Hospital; Department of Neurology

location_facility: University at Buffalo / SUNY; UBMD Neurology

location_facility: Fundación Scherbovsky; General Department

location_facility: Rigshospitalet; Klinik for Nerve- og Muskelsygdomme

location_facility: MUCH - Montreal Neurological Institute & Hospital

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

location_facility: Taipei Veterans General Hospital-Neurology

location_facility: Aarhus Universitetshospital; Neurologisk Klinik

location_facility: Hospital Universitari de Bellvitge; Servicio de Neurologia

location_facility: Kyungpook National University Chilgok Hospital


title: A Two-part, Randomized, Placebo Controlled, Double Blind, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Linerixibat for the Treatment of Cholestatic Pruritus in Participants With Primary Biliary Cholangitis (PBC)

summary: This is a 2-part study in PBC participants with cholestatic pruritus and will evaluate the efficacy, safety and impact on health-related quality of life of linerixibat compared with placebo.

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

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Poland
Argentina
Japan
Brazil
Czechia
Canada
France
Switzerland
United States
Belgium
China
Italy
United Kingdom
Mexico
Spain
Greece
Bulgaria
Russian Federation
Israel


title: A Phase 2, Multicenter, Multi Arm, Study to Evaluate MK-1308A (Co-formulated Quavonlimab (MK-1308)/Pembrolizumab) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer: (MK-1308A-008)

summary: The purpose of this study is to assess the efficacy and safety of co-formulated pembrolizumab/quavonlimab versus other treatments in participants with MSI-H or dMMR Metastatic Stage IV Colorectal Cancer.

location_country:
Germany
Poland
Costa Rica
Turkey
Canada
France
Lithuania
Colombia
Hungary
Denmark
United States
Romania
Belgium
Estonia
Italy
Guatemala
United Kingdom
Netherlands
Korea, Republic of
Spain
Greece
Russian Federation

location_facility: HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1206)

location_facility: Fundación Colombiana de Cancerología Clínica Vida ( Site 1606)

location_facility: Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1104)

location_facility: Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) ( Site 2901)

location_facility: Icahn School of Medicine at Mount Sinai ( Site 1528)

location_facility: Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0604)

location_facility: Samsung Medical Center-Division of Hematology/Oncology ( Site 1102)

location_facility: Universitätsklinikum Marburg ( Site 0610)

location_facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 2001)

location_facility: Hopital Claude Huriez - CHU de Lille ( Site 0510)

location_facility: Otto-von-Guericke-Universität Magdeburg-Klinik für Gastroenterologie, Hepatologie und Infektiologie

location_facility: Fundación Instituto Valenciano de Oncología ( Site 1209)

location_facility: Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 2704)

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 0601)

location_facility: Rostov Cancer Research Institute ( Site 1014)

location_facility: Sunnybrook Research Institute - Odette Cancer Centre ( Site 0316)

location_facility: University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 2703)

location_facility: COMPLEJO HOSPITALARIO DE NAVARRA-oncologia médica ( Site 1210)

location_facility: Hospital Universitario Central de Asturias-Medical Oncology ( Site 1203)

location_facility: Centro Medico Integral De Cancerología (CEMIC) ( Site 2203)

location_facility: Seoul National University Hospital-Internal Medicine ( Site 1101)

location_facility: University Cancer & Blood Center, LLC ( Site 1521)

location_facility: Mediservis del Tolima IPS S.A.S ( Site 1609)

location_facility: Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1302)

location_facility: Hôpital Saint Antoine-Oncologie médicale ( Site 0508)

location_facility: Aalborg Universitetshospital, Syd ( Site 1903)

location_facility: Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1601)

location_facility: Hospital Metropolitano - Sede Lindora-Metropolitano Research Institute Sede Lindora ( Site 2102)

location_facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2005)

location_facility: H.R.U Málaga - Hospital General ( Site 1207)

location_facility: Fundeni Clinical Institute-Medical Oncology ( Site 2603)

location_facility: Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 0611)

location_facility: The Catholic Univ. of Korea Seoul St. Mary's Hospital-Medical Oncology ( Site 1106)

location_facility: Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 1611)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale-Department of Abdominal Oncology ( Site 0803)

location_facility: The Moncton Hospital-Oncology ( Site 0307)

location_facility: Hospital Clinico San Carlos-Oncology Department ( Site 1204)

location_facility: University of Chicago Medical Center-Medicine - Section of Hematology/Oncology - Gastrointestinal P

location_facility: Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0102)

location_facility: Centre Georges François Leclerc ( Site 0506)

location_facility: Semmelweis Egyetem-Belgyógyászati és Hematológiai Klinika ( Site 2002)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Onkologii i Radioterapii ( Site

location_facility: Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center ( Site 1509)

location_facility: Baylor Scott & White Medical Center - Temple-Division of Hematology/Oncology ( Site 1549)

location_facility: The West Clinic, PLLC dba West Cancer Center ( Site 1576)

location_facility: INTEGRA Cancer Institute-Oncology ( Site 2201)

location_facility: Hospital of Lithuanian University of Health Sciences Kauno klinikos ( Site 2402)

location_facility: DOLNOSLASKIE CENTRUM ONKOLOGII PULMONOLOGII I HEMATOLOGII ( Site 0920)

location_facility: Korea University Anam Hospital ( Site 1107)

location_facility: McGill University Health Centre-CIM - Oncology ( Site 0306)

location_facility: First Moscow State Medical University I.M. Sechenov-Interhospital Institution Health Management Cl

location_facility: Hacettepe Universitesi-oncology hospital ( Site 1301)

location_facility: Northwest Medical Specialties, PLLC ( Site 1546)

location_facility: Odense Universitetshospital ( Site 1902)

location_facility: Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology-Clinical Pharmacology and Chemotherapy

location_facility: VILNIUS UNIVERSITY HOSPITAL SANTAROS KLINIKOS ( Site 2403)

location_facility: Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0903)

location_facility: Centro Regional de Sub Especialidades Médicas SA ( Site 2204)

location_facility: Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2604)

location_facility: Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1303)

location_facility: Ankara City Hospital-Medical Oncology ( Site 1306)

location_facility: Asan Medical Center-Department of Oncology ( Site 1105)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0802)

location_facility: UCLH-Cancer Clinical Trials Unit ( Site 1402)

location_facility: Luxmed Onkologia sp. z o. o. ( Site 0915)

location_facility: Hospital Universitari Vall d'Hebron ( Site 1201)

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1305)

location_facility: Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 1001)

location_facility: Kyungpook National University Chilgok Hospital-Hematology/oncology ( Site 1103)

location_facility: Hematology Oncology Associates of Rockland ( Site 1525)

location_facility: UT Southwestern Medical Center ( Site 1551)

location_facility: Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie ( Site 0612)

location_facility: Assistance Publique Hôpitaux de Marseille - Hôpital de la Ti-Service d'Hepato-Gastro-Enterologie et

location_facility: University Hospital Coventry & Warwickshire ( Site 1406)

location_facility: Centre Hospitalier Universitaire de Poitiers ( Site 0511)

location_facility: Velindre Cancer Centre-Research and Development ( Site 1415)

location_facility: Beatson West of Scotland Cancer Centre-Clinical Trials Unit ( Site 1401)

location_facility: European Interbalkan Medical Center-Oncology Department ( Site 2701)

location_facility: Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 2008)

location_facility: CHU Rangueil-Digestive oncology department ( Site 0502)

location_facility: Istituto Oncologico Veneto IRCCS ( Site 0804)

location_facility: Republican Clinical Oncology Dispensary-Chemotherapy #3 ( Site 1006)

location_facility: Cliniques universitaires Saint-Luc-Medical Oncology ( Site 0104)

location_facility: Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 2010)

location_facility: North Estonia Medical Centre Foundation-Chemotherapy ( Site 2301)

location_facility: Hospital Universitario Marqués de Valdecilla ( Site 1202)

intervention_type: Biological


title: BEAMION-Lung 1: An Open Label, Phase I Dose Escalation Trial, With Dose Confirmation and Expansion, of BI 1810631 as Monotherapy in Patients With Advanced or Metastatic Solid Tumors With HER2 Aberrations

summary:
The study has 2 parts. The first part is open to adults with different types of advanced cancer (solid tumours with changes in the HER2 gene) for whom previous treatment was not successful. The second part is open to people with non-small cell lung cancer with a specific mutation in the HER2 gene.

The purpose of the first study part is to find the highest dose of a medicine called BI 1810631 the participants can tolerate. Once this dose is found, it will be used in the second study part to tests whether BI 1810631 can make tumours shrink.

In this study, BI 1810631 is given to people for the first time. Participants take BI 1810631 as tablets once a day or twice a day.

The participants are in the study for as long as they benefit from and can tolerate treatment. Study doctors regularly check the participants' health and monitor the tumours. The doctors also take note of any unwanted effects that could have been caused by BI 1810631.

ipd_sharing_description:
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

studies in products where Boehringer Ingelheim is not the license holder;
studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datasharing

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
Italy
Portugal
Israel
Hong Kong
Singapore
Australia
Japan
Netherlands
Austria
Belgium
Sweden
United States
China
Korea, Republic of
Spain
United Kingdom
France

location_facility: Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T

location_facility: Istituto Nazionale IRCCS Tumori Fondazione Pascale

location_facility: First Affiliated Hospital of Xiamen University

location_facility: The Affiliated Cancer Hospital, Guangxi Medical University

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

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Harbin Medical University cancer hospital

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: The Chaim Sheba Medical Center Tel HaShomer

location_facility: Leids Universitair Medisch Centrum (LUMC)

location_facility: The First Affiliated Hospital of Zhengzhou Unviersity


title: A Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of AXA1125 in Subjects With Non Cirrhotic, Non Alcoholic Steatohepatitis and Fibrosis (EMMPACT)

summary: This study will compare the effects of AXA1125, an orally active mixture of amino acids, compared to placebo, on improving fat and inflammation (steatohepatitis) as well as fibrosis in subjects with non alcoholic steatohepatitis (NASH). as well as the safety and tolerability of AXA1125. Subjects will take one of two different doses of AXA1125 or a placebo twice daily, and a liver biopsy will be done at the beginning and end of the 48-week study.

lead_sponsor: Axcella Health, Inc

location_country:
Poland
United Kingdom
Australia
United States
Canada
Puerto Rico
France

location_facility: Velocity - Advanced Clinical Research - Salt Lake City of Gastroenterolog

location_facility: Lucas Research - Diabetes & Endocrinology Consultants, PC

location_facility: Indiana University (IU) School of Medicine

location_facility: ENCORE Borland Groover Clinical Research

location_facility: The National Diabetes & Obesity Research Institute

location_facility: Virginia Commonwealth University Medical College of Virginia


lead_sponsor: Bristol-Myers Squibb

summary: The purpose of this study is to evaluate the benefits and risks of conversion of existing adolescent kidney allograft recipients aged 12 to less than 18 years of age to a belatacept-based immunosuppressive regimen as compared to continuation of a calcineurin inhibitor-based regimen and their adherence to immunosuppressive medications.

location_facility: Cincinnati Children's Hospital Medical Center-Nephrology

location_facility: Oregon Health and Science University-Pediatric Nephrology

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

location_facility: UCLA Clinical & Translational Research Center (CTRC)-Pediatrics

location_facility: Boston Children's Hospital-Division of Nephrology

location_facility: Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita

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

location_facility: Hospices Civils de Lyon - Hôpital Femme Mère Enfant-néphrologie pédiatrique

location_facility: Cleveland Clinic-Children's Hospital Pediatric Research Institute

location_facility: Johns Hopkins Hospital-Pediatric Nephrology

location_facility: University of Alabama at Birmingham - School of Medicine

location_facility: Bordeaux University Hospital - Pellegrin-Pediatrics

title: A Prospective, Open-label, Multicenter, Randomized Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Renal Allograft Recipients Aged 12 to Less Than 18 Years of Age to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications

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