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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Percentage of Participants with Crohn's Disease who Achieve Endoscopic Response
The percentage of participants who achieve endoscopic response at week 12 of Study Period 1.
Time frame: Baseline, Up to Week 12
Percentage of Participants who Achieve Clinical Remission
Time frame: Baseline, Up to Week 12
Percent Change from Baseline in Fecal Calprotectin
Time frame: Baseline, Up to Week 12
There may be multiple sites in this clinical trial. (Add "This 1-877-CTLILLY (1-877-285-4559) or
CONTACT
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Mayo Clinic in Arizona - Scottsdale
Scottsdale, Arizona, United States
SUSPENDEDBiopharma Informatic, LLC
Los Angeles, California, United States
NOT_YET_RECRUITINGOm Research LLC
Oxnard, California, United States
RECRUITINGSouth Denver Gastroenterology
Englewood, Colorado, United States
RECRUITINGGastro Health Research - Miami
Miami, Florida, United States
RECRUITINGEzy Medical Research
Miami Lakes, Florida, United States
RECRUITINGAtlanta Gastroenterology Associates - Peachtree Dunwoody
Atlanta, Georgia, United States
RECRUITINGRush University Medical Center
Chicago, Illinois, United States
NOT_YET_RECRUITINGCotton O'Neil Digestive Health Center
Topeka, Kansas, United States
RECRUITINGGastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
Wyoming, Michigan, United States
NOT_YET_RECRUITING...and 60 more locations