Oral LY4268989 for adults with moderate to severe ulcerative colitis.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional study gives adult participants with centrally confirmed moderate-to-severe ulcerative colitis either LY4268989 or a matching placebo taken by mouth and follows them for up to about 108 weeks (excluding screening). Eligible participants must have had UC for at least 3 months, a Modified Mayo Score of 5–9 with endoscopic score ≥2 and rectal bleeding ≥1, and disease extending beyond the rectum. Participants must also have had an inadequate response, loss of response, or intolerance to at least one conventional or advanced therapy (with inadequate response to vedolizumab excluded). Endoscopic confirmation and routine surveillance colonoscopy history are required where applicable, and study visits occur at participating U.S. sites.

Why it matters

Who can join: the full rules

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 within small bowel or colon that cannot be traversed by a colonoscope or that are symptomatic
* Have any prior or current evidence of cancer gastrointestinal (GI) tract, or specified lesions with increased risk of GI malignancies
* Have a diagnosis or history of malignant disease within 5 years prior to randomization

Where it's running

• Valleywise Health Medical Center
  Phoenix, Arizona, United States Recruiting
• One of a Kind Clinical Research Center
  Scottsdale, Arizona, United States Recruiting
• Clinnova Research
  Anaheim, California, United States Recruiting
• GMC Clinical Research
  Folsom, California, United States Recruiting
• Om Research LLC
  Temple City, California, United States Recruiting
• Om Research LLC
  Victorville, California, United States Recruiting

+208 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.