LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis
Recruiting · NCT07415044 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
LY4268989Placebo
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 is running
60 locations listed across 25 US states.
- Valleywise Health Medical Center - Phoenix, Arizona, United States
- One of a Kind Clinical Research Center - Scottsdale, Arizona, United States
- Clinnova Research - Anaheim, California, United States
- GMC Clinical Research - Folsom, California, United States
- Om Research LLC - Temple City, California, United States
- Om Research LLC - Victorville, California, United States
- Peak Gastroenterology Associates - Colorado Springs, Colorado, United States
- Advanced Research Institute - Denver - Denver, Colorado, United States
- Rocky Mountain Gastroenterology Associates - Lakewood - Lakewood, Colorado, United States
- Medical Research Center of Connecticut - Hamden, Connecticut, United States
- K2 Medical Research - Daytona Beach - Daytona Beach, Florida, United States
- Clinical Research of Osceola - Kissimmee, Florida, United States
- Florida Research Institute - Lakewood Rch, Florida, United States
- AdventHealth Orlando - Orlando, Florida, United States
- Treasure Valley Medical Research - Boise, Idaho, United States
- Grand Teton Research Group - Idaho Falls, Idaho, United States
- Northwestern University - Chicago, Illinois, United States
- Rush University Medical Center - Chicago, Illinois, United States
- Midwest Digestive Health & Nutrition - Des Plaines, Illinois, United States
- Springfield Clinic - First - Springfield, Illinois, United States
- Gastroenterology Health Partners - New Albany, Indiana, United States
- Gastroenterology Health Partners - Louisville, Kentucky, United States
- GI Alliance - Gastro Group and Endocenter - Mandeville - Mandeville, Louisiana, United States
- Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center - Wyoming, Michigan, United States
- Mayo Clinic in Rochester, Minnesota - Rochester, Minnesota, United States
- KAD Clinical Research - St Louis, Missouri, United States
- Specialists in Gastroenterology - St Louis, Missouri, United States
- Digestive Disease Specialists - Las Vegas - Crimson Canyon Drive - Las Vegas, Nevada, United States
- Virtua Health & Wellness Center - Moorestown - Moorestown, New Jersey, United States
- Saint Peter's University Hospital - New Brunswick, New Jersey, United States
- Stony Brook University - Stony Brook, New York, United States
- Carolina Digestive Diseases and Endoscopy Center - Greenville, North Carolina, United States
- Wilmington Health, PLLC - Wilmington, North Carolina, United States
- Ohio State University - Hilliard, Ohio, United States
- DSI Research, LLC d/b/a ObjectiveHealth Clinical Research - Springboro - Springboro, Ohio, United States
- Gastro Intestinal Research Institute of Northern Ohio, LLC - Westlake, Ohio, United States
- The Oregon Clinic - Portland, Oregon, United States
- Medical University of South Carolina - Charleston, South Carolina, United States
- Sanford USD Medical Center - Sioux Falls, South Dakota, United States
- Skyline Gastroenterology of West Tennessee - Jackson, Tennessee, United States
- GI Alliance - Fort Worth - Fort Worth, Texas, United States
- GI Alliance - Garland - Garland, Texas, United States
- Integrity Advanced Therapeutics - Houston, Texas, United States
- GI Alliance: Mansfield - Mansfield, Texas, United States
- Southern Star Research Institute - San Antonio, Texas, United States
- GI Alliance - San Marcos - San Marcos, Texas, United States
- Tyler Research Institute - Tyler, Texas, United States
- Eximia Research-VA, LLC - Norfolk, Virginia, United States
- Swedish Medical Center - Seattle, Washington, United States
- Principle Research Solutions - Spokane, Washington, United States
- Providence Sacred Heart Medical Center & Children's Hospital - Spokane, Washington, United States
- Washington Gastroenterology - Tacoma - Tacoma, Washington, United States
- Bakent University, Adana Clinic & Research Ctr. - Adana, Turkey (Türkiye)
- Motilal Nehru Medical College Hospital - Allahābād, India
- Hacettepe Universite Hastaneleri - Ankara, Turkey (Türkiye)
- Antalya Egitim ve Arastırma Hastanesi - Antalya, Turkey (Türkiye)
- Asahikawa Medical University Hospital - Asahikawa, Japan
- Assuta Ashdod Medical Center - Ashdod, Israel
- Barzilai Medical Center - Ashkelon, Israel
- Evangelismos General Hospital of Athens - Athens, Greece
Showing 60 of 259 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →