LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis

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

  • Ulcerative Colitis (UC)
  • Ulcerative Colitis, Active Moderate
  • Ulcerative Colitis, Active Severe

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
    Other names:
    • MORF-057
    • zotemtegrast
Experimental
LY4268989 Study Dose 2 		LY4268989 administered orally
  • Drug: LY4268989
    Administered orally
    Other names:
    • MORF-057
    • zotemtegrast
Placebo Comparator
Placebo Study Dose 		Placebo administered orally
  • Drug: Placebo
    Administered orally

Recruiting Locations

Clinnova Research
Anaheim, California 92805

GMC Clinical Research
Folsom, California 95630

Om Research LLC
Temple City, California 91780
Contact:
661-388-2239

Om Research LLC
Victorville, California 92395
Contact:
661-388-2239

Peak Gastroenterology Associates
Colorado Springs, Colorado 80907
Contact:
719-310-6719

Rocky Mountain Gastroenterology Associates - Lakewood
Lakewood, Colorado 80228

K2 Medical Research - Daytona Beach
Daytona Beach, Florida 32114

Clinical Research of Osceola
Kissimmee, Florida 34741
Contact:
407-954-4016

Florida Research Institute
Lakewood Rch, Florida 34211
Contact:
941-727-7772

Grand Teton Research Group
Idaho Falls, Idaho 83404
Contact:
208-528-4256

Midwest Digestive Health & Nutrition
Des Plaines, Illinois 60016
Contact:
312-767-3244

Springfield Clinic - First
Springfield, Illinois 62702
Contact:
217-528-7541

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

Gastroenterology Health Partners
Louisville, Kentucky 40218
Contact:
502-888-1988

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

Digestive Disease Specialists - Las Vegas - Crimson Canyon Drive
Las Vegas, Nevada 89128

Carolina Digestive Diseases and Endoscopy Center
Greenville, North Carolina 27834
Contact:
252-758-8181

Wilmington Health, PLLC
Wilmington, North Carolina 28401

GI Alliance - Fort Worth
Fort Worth, Texas 76104
Contact:
817-612-5575

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

Integrity Advanced Therapeutics
Houston, Texas 77090
Contact:
281-453-2005

GI Alliance: Mansfield
Mansfield, Texas 76063
Contact:
817-417-9664

Southern Star Research Institute
San Antonio, Texas 78229
Contact:
210-581-2812

GI Alliance - San Marcos
San Marcos, Texas 78666
Contact:
512-878-1100

Tyler Research Institute
Tyler, Texas 75701
Contact:
903-630-6211

Eximia Research-VA, LLC
Norfolk, Virginia 23502

Washington Gastroenterology - Tacoma
Tacoma, Washington 98405
Contact:
253-272-5127

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