Clinical Trials in Israel / NCT07483099
Recruiting
Phase 2
A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease
NCT07483099 · tracked via the Priya Life Science Israel tracker
Condition(s) studied
Crohn Disease
Investigational drug(s) / intervention(s)
LY4395089: Administered orally
Mirikizumab - Intravenous (IV): Administered IV
Mirikizumab - Subcutaneous (SC): Administered SC
Study summary
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.
Eligibility
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
Primary outcome measure(s)
- Percentage of Participants with Crohn's Disease who Achieve Endoscopic Response — Baseline, Up to Week 12
The percentage of participants who achieve endoscopic response at week 12 of Study Period 1.
Trial sites (70)
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic in Arizona - Scottsdale | Scottsdale | Arizona | Suspended |
| Biopharma Informatic, LLC | Los Angeles | California | Not Yet Recruiting |
| Om Research LLC | Oxnard | California | Recruiting |
| South Denver Gastroenterology | Englewood | Colorado | Recruiting |
| Gastro Health Research - Miami | Miami | Florida | Recruiting |
| Ezy Medical Research | Miami Lakes | Florida | Recruiting |
| Atlanta Gastroenterology Associates - Peachtree Dunwoody | Atlanta | Georgia | Recruiting |
| Rush University Medical Center | Chicago | Illinois | Not Yet Recruiting |
| Cotton O'Neil Digestive Health Center | Topeka | Kansas | Recruiting |
| Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center | Wyoming | Michigan | Not Yet Recruiting |
| KAD Clinical Research | St Louis | Missouri | Recruiting |
| Vector Clinical Trials | Las Vegas | Nevada | Recruiting |
| One of a Kind Clinical Research Center - Kingwood | Kingwood | Texas | Recruiting |
| Southern Star Research Institute | San Antonio | Texas | Recruiting |
| AZ Maria Middelares | Ghent | Belgium | Not Yet Recruiting |
| UZ Gent | Ghent | Belgium | Not Yet Recruiting |
| UZ Leuven | Leuven | Belgium | Not Yet Recruiting |
| AZ Delta vzw | Roeselare | Belgium | Not Yet Recruiting |
| Loema Instituto de Pesquisa Clinica | Campinas | Brazil | Not Yet Recruiting |
| Fundação Universidade de Caxias do Sul (FUCS) | Caxias do Sul | Brazil | Recruiting |
| Centro Digestivo de Curitiba | Curitiba | Brazil | Not Yet Recruiting |
| Centro de Pesquisa Clínica de Marília - CPCLIM | Marília | Brazil | Recruiting |
| CPHosp Medicina, Ensino e Pesquisa (CPQuali) | São Paulo | Brazil | Recruiting |
| CPCLIN | São Paulo | Brazil | Not Yet Recruiting |
| BR Trials - Ensaios Clinicos e Consultoria | São Paulo | Brazil | Recruiting |
| Clínica Hepatogastro JK | São Paulo | Brazil | Recruiting |
| CEDOES | Vitória | Brazil | Recruiting |
| Prairie Institute of Liver and Luminal Advanced Research Ltd (PILLAR) | Lethbridge | Canada | Not Yet Recruiting |
| London Digestive Disease Institute | London | Canada | Not Yet Recruiting |
| Tdda Inc. | Vaughan | Canada | Recruiting |
| The Second Xiangya Hospital of Central South University | Changsha | China | Recruiting |
| Changzhou Second People's Hospital | Changzhou | China | Recruiting |
| The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | China | Recruiting |
| The Second Affiliated hospital of Zhejiang University school of medicine | Hangzhou | China | Recruiting |
| Huizhou Central People's Hospital | Huizhou | China | Recruiting |
| The Second Affiliated Hospital of Soochow University | Suzhou | China | Recruiting |
| The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university | Wenzhou | China | Recruiting |
| Zhongshan Hospital Affiliated to Xiamen University | Xiamen | China | Recruiting |
| Affiliated Hospital of Jiangsu University | Zhenjiang | China | Recruiting |
| Charité Universitaetsmedizin Berlin - Campus Mitte | Berlin | Germany | Not Yet Recruiting |
+ 30 more sites — see the full list on the official registry below.
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07483099 on ClinicalTrials.gov ↗ ← All trials in Israel