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LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis

RecruitingPhase 2

Sponsor: Eli Lilly and Company

Conditions: Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate, Ulcerative Colitis, Active Severe

Interventions: LY4268989, Placebo

Countries: United States, Argentina, Brazil, Canada, China, Colombia, Croatia, Czechia

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 overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (259)

Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Anaheim, California, United States
Folsom, California, United States
Temple City, California, United States
Victorville, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Lakewood, Colorado, United States
Hamden, Connecticut, United States
Daytona Beach, Florida, United States
Kissimmee, Florida, United States
Lakewood Rch, Florida, United States
Orlando, Florida, United States
Boise, Idaho, United States
Idaho Falls, Idaho, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Des Plaines, Illinois, United States
Springfield, Illinois, United States
New Albany, Indiana, United States
Louisville, Kentucky, United States
Mandeville, Louisiana, United States
Wyoming, Michigan, United States
Rochester, Minnesota, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
Moorestown, New Jersey, United States
New Brunswick, New Jersey, United States
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