LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorEli Lilly and Company

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

Qualifiers

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

Treatments tested in this trial

  • LY4268989
  • Placebo

Treatment groups

1,431 Participants
are divided into 3 treatment groups

Sponsors and collaborators