About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Have a current diagnosis of
Crohn's disease
Inflammatory Bowel Disease (IBD unclassified) (formerly known as indeterminate colitis), or
primary sclerosing cholangitis
Trial design
Parallel
Treatments tested in this trial
LY4268989
DrugAdministered orally
Placebo
DrugAdministered orally
Treatment groups
Trial outcomes
Primary outcomes
Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS)
Percentage of Participants Who Achieve Clinical Remission with mMS Among Participants Who Achieved Clinical Response with LY4268989 at Week 10
Secondary outcomes
Percentage of Participants Who Achieve Clinical Response with mMS
Percentage of Participants Who Achieve Clinical Response with mMS Among Participants Who Achieved Clinical Response with LY4268989 at Week 10
Percentage of Participants Who Achieve Symptomatic Response
Percentage of Participants Who Achieve Symptomatic Response Among Participants Who Achieved Clinical Response with LY4268989 at Week 10
Sponsors and contacts
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