LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis (NCT07415044) | Clinical Trial Compass
RecruitingPhase 2
LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis
United States1,431 participantsStarted 2026-03-26
Plain-language summary
The main purpose of this study is to evaluate the safety and effectiveness of LY4268989 when compared to placebo in adult participants with moderately to severely active ulcerative colitis (UC). The study drug will be administered orally.
The study will last up to approximately 108 weeks, excluding screening.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Have had an established diagnosis of ulcerative colitis (UC) for ≥3 months prior to randomization, which includes endoscopic evidence of UC
* Have moderately to severely active UC defined by a Modified Mayo Score (mMS) of 5 to 9 with an Endoscopic Score (ES)≥2 confirmed by central reader and rectal bleeding (RB)≥1
* Have evidence of UC extending proximal to the rectum
* Have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization, if the participant has a history of UC symptoms for more than 8 years
* Have an inadequate response to, loss of response to, or intolerance to at least one conventional medication (including corticosteroids) or one advanced therapy (including biologics, Janus Kinase (JAK) inhibitors, or sphingosine-1-phosphate (S1P) immunomodulators). Participants with inadequate response to vedolizumab are excluded
* Must meet contraception requirements
Exclusion Criteria:
* Have a current diagnosis of
* Crohn's disease
* Inflammatory Bowel Disease (IBD unclassified) (formerly known as indeterminate colitis), or
* primary sclerosing cholangitis
* Have an inherited immunodeficiency syndrome or known monogenic cause of UC-like colonic inflammation
* Have had or will need bowel resection or intestinal or intra-abdominal surgery
* Have evidence of toxic megacolon, intra-abdominal abscess, or stricture or stenosis…
What they're measuring
1
Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS)
Timeframe: Week 10
2
Percentage of Participants Who Achieve Clinical Remission with mMS Among Participants Who Achieved Clinical Response with LY4268989 at Week 10
Timeframe: Week 52
Trial details
NCT IDNCT07415044
SponsorEli Lilly and Company
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2030-06
Contact for this trial
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or