A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease
Phase 2 – studying effectiveness and dosage
Conditions:
Crohn Disease
Sponsor: Eli Lilly and Company
trial.available_in:
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Overview
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.
Who can participate
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
Interventions
LY4395089
DRUG
Mirikizumab - Intravenous (IV)
DRUG
Mirikizumab - Subcutaneous (SC)
DRUG
Locations
72
Belgium (4)
AZ Maria Middelares
Ghent
UZ Gent
Ghent
UZ Leuven
Leuven
AZ Delta vzw
Roeselare
Brazil (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
Canada (2)
London Digestive Disease Institute
London
Tdda Inc.
Vaughan
China (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
Germany (5)
Charité Universitaetsmedizin Berlin - Campus Mitte