LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:
Condition(s) studied
Investigational drug(s) / intervention(s)
LY4268989: Administered PO
Mirikizumab: Administered IV then SC
LY4268989 Placebo: Administered PO
Study summary
The main purpose of the study is to evaluate the effectiveness and safety of LY4268989 when given with mirikizumab compared to mirikizumab alone in adult participants with moderately to severely active ulcerative colitis (UC).
Study participation will last approximately 118 weeks, including 104 weeks of treatment and may include up to 21 visits.
Eligibility
Primary outcome measure(s)
- Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS) — Week 12
The mMS is a composite score reported by participants and physician and is comprised of the following 3 subscores: Stool Frequency (SF); Rectal Bleeding (RB), and Endoscopic Subscore (ES). Clinical remission (mMS) is defined as: * SF subscore = 0 or 1 and no greater than baseline * RB subscore = 0 * Centrally read ES = 0 or 1; score of 1 modified to exclude friability
Trial sites (147)
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic in Arizona - Scottsdale | Scottsdale | Arizona | Recruiting |
| Clinnova Research - Anaheim | Anaheim | California | Recruiting |
| Om Research LLC | Lancaster | California | Recruiting |
| Biopharma Informatic, LLC | Los Angeles | California | Recruiting |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | Recruiting |
| NeoClinical Research | Hialeah | Florida | Recruiting |
| Encore Borland-Groover Clinical Research | Jacksonville | Florida | Recruiting |
| Clinical Research of Osceola | Kissimmee | Florida | Recruiting |
| Florida Research Institute | Lakewood Rch | Florida | Recruiting |
| Alliance Medical Research | Lighthouse PT | Florida | Recruiting |
| Atlantic Medical Research | Margate | Florida | Recruiting |
| Digestive and Liver Center of Florida | Orlando | Florida | Recruiting |
| Center for Gastrointestinal Health - Fairview Heights | Belleville | Illinois | Not Yet Recruiting |
| Northwestern University | Chicago | Illinois | Not Yet Recruiting |
| Midtown Gastroenterology and Liver Disease | Des Plaines | Illinois | Recruiting |
| GI Alliance - Glenview | Glenview | Illinois | Recruiting |
| Gi Alliance - Gurnee | Gurnee | Illinois | Recruiting |
| Gastroenterology Health Partners | New Albany | Indiana | Recruiting |
| Gastroenterology Health Partners | Louisville | Kentucky | Recruiting |
| Brigham and Women's Hospital | Boston | Massachusetts | Recruiting |
| Clinical Research Institute of Michigan, LLC | Clinton Township | Michigan | Recruiting |
| GI Associates - GIA and Endoscopy Center - Flowood | Flowood | Mississippi | Recruiting |
| Digestive Disease Medicine of Central New York | Utica | New York | Recruiting |
| Dayton Gastroenterology, LLC | Dayton | Ohio | Recruiting |
| University Gastroenterology - Providence - West River Street | Providence | Rhode Island | Recruiting |
| Gastroenterology Associates, P.A. of Greenville | Greenville | South Carolina | Recruiting |
| Gastro One - Walnut Run Road | Cordova | Tennessee | Recruiting |
| Texas Digestive Disease Consultants - Cedar Park | Cedar Park | Texas | Recruiting |
| GI Alliance - Dallas - Gaston Avenue | Dallas | Texas | Not Yet Recruiting |
| GI Alliance - Fort Worth | Fort Worth | Texas | Recruiting |
| GI Alliance - Garland | Garland | Texas | Recruiting |
| GI Alliance - Lubbock | Lubbock | Texas | Recruiting |
| Southern Star Research Institute | San Antonio | Texas | Recruiting |
| Tyler Research Institute | Tyler | Texas | Recruiting |
| GI Alliance-Webster | Webster | Texas | Recruiting |
| Care Access - Ogden | Ogden | Utah | Recruiting |
| Clinical Research Partners, LLC | Richmond | Virginia | Recruiting |
| GI Alliance - Richmond | Richmond | Virginia | Recruiting |
| Carilion Clinic | Roanoke | Virginia | Recruiting |
| Washington Gastroenterology - Bellevue | Bellevue | Washington | Recruiting |
+ 107 more sites — see the full list on the official registry below.
On this site
📄 Omvoh (mirikizumab) drug profile →More Eli Lilly and Company trials in Italy
Other trials for the same condition
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 NCT07186101 on ClinicalTrials.gov ↗ ← All trials in Italy