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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)
Masking Description
Non-responders at week 10 will receive Open Label LY4268989 in maintenance study

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
LY4268989 Study Dose 1 		LY4268989 administered orally
  • Drug: LY4268989
    Administered orally
Experimental
LY4268989 Study Dose 2 		LY4268989 administered orally
  • Drug: LY4268989
    Administered orally
Placebo Comparator
Placebo Study Dose 		Placebo administered orally
  • Drug: Placebo
    Administered orally

Recruiting Locations

Peak Gastroenterology Associates
Colorado Springs, Colorado 80907
Contact:
7193106719

Clinical Research of Osceola
Kissimmee, Florida 34741
Contact:
4079544016

Florida Research Institute
Lakewood Rch, Florida 34211
Contact:
9417277772

Springfield Clinic - First
Springfield, Illinois 62702
Contact:
2175287541

Gastroenterology Health Partners
New Albany, Indiana 47150
Contact:
812-206-1702

Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
Wyoming, Michigan 49519

Carolina Digestive Diseases and Endoscopy Center
Greenville, North Carolina 27834
Contact:
2527588181

GI Alliance - Garland
Garland, Texas 75044
Contact:
972-265-8201

Eximia Research-VA, LLC
Norfolk, Virginia 23502

Washington Gastroenterology - Tacoma
Tacoma, Washington 98405
Contact:
2532725127

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.