Crohn Disease
Conditions
Brief 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.
Interventions
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants who Achieve Clinical Remission | Baseline, Up to Week 12 |
| Percent Change from Baseline in Fecal Calprotectin | Baseline, Up to Week 12 |
Countries
Belgium, Brazil, Canada, China, Germany, Hungary, Israel, Italy, Poland, United States
Contacts
CONTACTThere may be multiple sites in this clinical trial. (Add "This 1-877-CTLILLY (1-877-285-4559) or
STUDY_DIRECTORContact Lilly at 1-877-CTLILLY (1-877-285-4559) or
Eli Lilly and Company
Outcome results
None listed