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Предстои набиране Фаза 2 NCT07483099

A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Crohn Disease

Спонсор: Eli Lilly and Company

Налично на: БГ
Обобщение
The main purpose of this study is to see how the safety and efficacy of a farnesoid X receptor (FXR) agonist (LY4395089), given together with mirikizumab compares with mirikizumab (alone) in adults with moderately to severely active Crohn's disease (CD). This study is part of the IIBD master protocol and will last approximately 62 weeks.
Кой може да участва
Inclusion Criteria: Participants must meet all the inclusion criteria in the IIBD master protocol, except the UC-specific criteria. In addition, they must meet the criteria below: * Participants taking glucagon-like peptide-1 (GLP-1) receptor agonists (RAs), GLP-1/glucose-dependent insulinotropic polypeptide (GIP) RAs, GLP-1/glucagon (Gcg) RAs, GLP-1/GIP/Gcg RAs, or similar medications for approved indications will be permitted to enroll provided they are on a stable dose at the time of screening Exclusion Criteria: Participants are excluded from the study if any of the exclusion criteria in the IIBD master protocol, except the UC-specific criteria apply, or if any of the following criteria apply: * Must not have a hepatic disease * Must not have a history of any other bone disease that affects bone metabolism * Must not have had any of the following within the past 180 days before screening: * acute myocardial infarction * cerebrovascular incident * hospitalization for unstable angina * hospitalization due to congestive heart failure, or * coronary revascularization * Must not have received or will need any other prohibited medications as specified in the protocol
Интервенции
LY4395089
DRUG
Mirikizumab - Intravenous (IV)
DRUG
Mirikizumab - Subcutaneous (SC)
DRUG
Места на провеждане 72
Белгия (4)
AZ Maria Middelares
Ghent
UZ Gent
Ghent
UZ Leuven
Leuven
AZ Delta vzw
Roeselare
Бразилия (10)
Loema Instituto de Pesquisa Clinica
Campinas
Fundação Universidade de Caxias do Sul (FUCS)
Caxias do Sul
Centro Digestivo de Curitiba
Curitiba
Centro de Pesquisa Clínica de Marília - CPCLIM
Marília
CPHosp Medicina, Ensino e Pesquisa (CPQuali)
São Paulo
CPCLIN
São Paulo
BR Trials - Ensaios Clinicos e Consultoria
São Paulo
Solare Trials
São Paulo
Clínica Hepatogastro JK
São Paulo
CEDOES
Vitória
Канада (2)
London Digestive Disease Institute
London
Tdda Inc.
Vaughan
Китай (9)
The Second Xiangya Hospital of Central South University
Changsha
Changzhou Second People's Hospital
Changzhou
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou
The Second Affiliated hospital of Zhejiang University school of medicine
Hangzhou
Huizhou Central People's Hospital
Huizhou
The Second Affiliated Hospital of Soochow University
Suzhou
The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university
Wenzhou
Zhongshan Hospital Affiliated to Xiamen University
Xiamen
Affiliated Hospital of Jiangsu University
Zhenjiang
Германия (5)
Charité Universitaetsmedizin Berlin - Campus Mitte
Berlin
Studienzentrum MVZ Dachau
Dachau
Studiengesellschaft BSF Unternehmergesellschaft
Halle
St. Marien- und St. Annastiftskrankenhaus
Ludwigshafen
Universitaetsklinikum Ulm
Ulm
Унгария (4)
Óbudai Egészségügyi Centrum
Budapest
Geomedical Egészségügyi Központ
Budapest
Semmelweis Egyetem
Budapest
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Tatabánya
Израел (7)
Assuta Ashdod Medical Center
Ashdod
Rambam Health Care Campus
Haifa
Shaare Zedek Medical Center
Jerusalem
Hadassah Medical Center
Jerusalem
Rabin Medical Center
Petah Tikva
Sheba Medical Center
Ramat Gan
Yitzhak Shamir Medical Center
Ẕerifin
Италия (6)
Azienda Ospedaliera Universitaria Careggi
Florence
Ospedale San Raffaele
Milan
Fondazione IRCCS San Gerardo dei Tintori
Monza
Ospedale Sacro Cuore Don G. Calabria
Negrar
Fondazione Policlinico Universitario Agostino Gemelli
Roma
Humanitas
Rozzano
Полша (10)
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero
Katowice
Oslomed Centrum Medyczne
Krakow
Medrise Sp. z o.o.
Lublin
Twoja Przychodnia PCM
Poznan
ETG Siedlce
Siedlce
Twoja Przychodnia SCM
Szczecin
Sonomed Sp. z o. o.
Szczecin
WSD MEDI
Warsaw
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warsaw
ETG Zamość
Zamość
САЩ (15)
Atlanta Gastroenterology Associates - Peachtree Dunwoody
Atlanta , Georgia
Rush University Medical Center
Chicago , Illinois
South Denver Gastroenterology
Englewood , Colorado
One of a Kind Clinical Research Center - Kingwood
Kingwood , Texas
Vector Clinical Trials
Las Vegas , Nevada
Biopharma Informatic, LLC
Los Angeles , California
Gastro Health Research - Miami
Miami , Florida
Ezy Medical Research
Miami Lakes , Florida
Om Research LLC
Oxnard , California
Southern Star Research Institute
San Antonio , Texas
Mayo Clinic in Arizona - Scottsdale
Scottsdale , Arizona
KAD Clinical Research
St Louis , Missouri
Cotton O'Neil Digestive Health Center
Topeka , Kansas
Innovo Research - Wilmington Gastroenterology Associates
Wilmington , North Carolina
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
Wyoming , Michigan
Технически детайли
Статус
Предстои набиране
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
80 Years
Здрави доброволци
Не
Начална дата
01.04.2026
Крайна дата
01.03.2028
Регистрационен номер
NCT07483099
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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