LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis
A Randomized, Multicenter, Double-Blind, Placebo-Controlled Development Program to Evaluate the Efficacy and Safety of LY4268989 (MORF-057) for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis (EMERALD-3)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 80 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how safe LY4268989 is and how well it works compared with a placebo, which has no active drug. It is for adults with moderately to severely active ulcerative colitis (UC), a disease that causes swelling and sores in the large bowel. The study drug is taken by mouth, and the study lasts up to about 108 weeks, not counting screening.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have had UC for at least 3 months, confirmed by a scope exam of the bowel.
- Have moderately to severely active UC, with required scores on bowel exams and symptom checks, including rectal bleeding.
- Have UC that reaches beyond the rectum, the last part of the large bowel.
- If you have had UC symptoms for more than 8 years, have a recorded colonoscopy within the past year or as local rules require. This scope exam checks for growths, abnormal cells, or cancer.
- Have tried at least one standard or advanced UC medicine that did not work well, stopped working, or caused side effects you could not tolerate.
- Meet the study's birth control rules.
Who can't join
- Have had an inadequate response to vedolizumab, a UC medicine.
- Have Crohn's disease, bowel inflammation that cannot be clearly classified, or primary sclerosing cholangitis, a disease that scars bile ducts.
- Have an inherited immune system disorder or a known single-gene cause of bowel swelling that looks like UC.
- Have had or will need surgery to remove part of the bowel, other bowel surgery, or surgery inside the belly.
- Have severe swelling of the large bowel, a pocket of infection inside the belly, or a narrowed bowel that causes symptoms or blocks passage of a colonoscope.
- Have or have ever had cancer in the digestive tract, or certain abnormal areas that raise the risk of digestive tract cancer.
- Have had cancer within the 5 years before assignment to a study group.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (52)
AZ
- Valleywise Health Medical Center · Phoenix, AZ 85008 · Study contact · 602-344-5194Indu Srinivasan · Principal investigatorMore trials in Phoenix
- One of a Kind Clinical Research Center · Scottsdale, AZ 85258 · Study contact · 602-820-6906Florin Gaidici · Principal investigatorMore trials in Scottsdale
CA
- Clinnova Research · Anaheim, CA 92805Amit Bhanvadia · Principal investigatorMore trials in Anaheim
- GMC Clinical Research · Folsom, CA 95630Nazir Rahim · Principal investigatorMore trials in Folsom
- Om Research LLC · Temple City, CA 91780 · Study contact · 661-388-2239Ken Nguyen · Principal investigatorMore trials in Temple City
- Om Research LLC · Victorville, CA 92395 · Study contact · 661-388-2239Nikhil Gupta · Principal investigatorMore trials in Victorville
CO
- Peak Gastroenterology Associates · Colorado Springs, CO 80907 · Study contact · 719-310-6719Bhaktasharan Patel · Principal investigatorMore trials in Colorado Springs
- Advanced Research Institute - Denver · Denver, CO 80218More trials in Denver
- Rocky Mountain Gastroenterology Associates - Lakewood · Lakewood, CO 80228Rajesh Jain · Principal investigatorMore trials in Lakewood
CT
- Medical Research Center of Connecticut · Hamden, CT 06518Paul Feuerstadt · Principal investigatorMore trials in Hamden
FL
- K2 Medical Research - Daytona Beach · Daytona Beach, FL 32114Esteban Olivera · Principal investigatorMore trials in Daytona Beach
- Clinical Research of Osceola · Kissimmee, FL 34741 · Study contact · 407-954-4016Basher Atiquzzaman · Principal investigatorMore trials in Kissimmee
- Florida Research Institute · Lakewood Rch, FL 34211 · Study contact · 941-727-7772Manuel Rodriguez · Principal investigatorMore trials in Lakewood Rch
- AdventHealth Orlando · Orlando, FL 32803 · Study contact · 407-303-9921Jennifer Seminerio Diehl · Principal investigatorMore trials in Orlando
ID
- Treasure Valley Medical Research · Boise, ID 83706 · Study contact · 208-813-6505Neetu Talreja · Principal investigatorMore trials in Boise
- Grand Teton Research Group · Idaho Falls, ID 83404 · Study contact · 208-528-4256Todd Williams · Principal investigatorMore trials in Idaho Falls
IL
- Northwestern University · Chicago, IL 60611 · Study contact · 312-695-4077Keith Summa · Principal investigatorMore trials in Chicago
- Rush University Medical Center · Chicago, IL 60612Atsushi Sakuraba · Principal investigatorMore trials in Chicago
- Midwest Digestive Health & Nutrition · Des Plaines, IL 60016 · Study contact · 312-767-3244Amar Naik · Principal investigatorMore trials in Des Plaines
- Springfield Clinic - First · Springfield, IL 62702 · Study contact · 217-528-7541Rajan Kochar · Principal investigatorMore trials in Springfield
IN
- Gastroenterology Health Partners · New Albany, IN 47150 · Study contact · 812-206-1702Jonathan Obert · Principal investigatorMore trials in New Albany
KY
- Gastroenterology Health Partners · Louisville, KY 40218 · Study contact · 502-888-1988Michael Krease · Principal investigatorMore trials in Louisville
LA
- GI Alliance - Gastro Group and Endocenter - Mandeville · Mandeville, LA 70471 · Study contact · 985-323-4003Brandon Brousse · Principal investigatorMore trials in Mandeville
MI
- Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center · Wyoming, MI 49519Allan Coates · Principal investigatorMore trials in Wyoming
MN
- Mayo Clinic in Rochester, Minnesota · Rochester, MN 55905Amanda Johnson · Principal investigatorMore trials in Rochester
MO
- KAD Clinical Research · St Louis, MO 63123 · Study contact · 314-254-3168Adrian Di Bisceglie · Principal investigatorMore trials in St Louis
- Specialists in Gastroenterology · St Louis, MO 63141Benjamin Root · Principal investigatorMore trials in St Louis
NC
- Carolina Digestive Diseases and Endoscopy Center · Greenville, NC 27834 · Study contact · 252-758-8181Phillip Goldstein · Principal investigatorMore trials in Greenville
- Wilmington Health, PLLC · Wilmington, NC 28401Ashok Shiani · Principal investigatorMore trials in Wilmington
NJ
- Virtua Health & Wellness Center - Moorestown · Moorestown, NJ 08057Sanket Patel · Principal investigatorMore trials in Moorestown
- Saint Peter's University Hospital · New Brunswick, NJ 08901Arkady Broder · Principal investigatorMore trials in New Brunswick
NV
- Digestive Disease Specialists - Las Vegas - Crimson Canyon Drive · Las Vegas, NV 89128Michael Zimmerman · Principal investigatorMore trials in Las Vegas
NY
- Stony Brook University · Stony Brook, NY 11794Lasha Gogokhia · Principal investigatorMore trials in Stony Brook
OH
- Ohio State University · Hilliard, OH 43026Jacob Skeans · Principal investigatorMore trials in Hilliard
- DSI Research, LLC d/b/a ObjectiveHealth Clinical Research - Springboro · Springboro, OH 45066Anjali Morey · Principal investigatorMore trials in Springboro
- Gastro Intestinal Research Institute of Northern Ohio, LLC · Westlake, OH 44145 · Study contact · 440-250-7630Mohamed Naem · Principal investigatorMore trials in Westlake
OR
- The Oregon Clinic · Portland, OR 97220Phillip Kiyasu · Principal investigatorMore trials in Portland
SC
- Medical University of South Carolina · Charleston, SC 29425 · Study contact · 843-792-3710Erin Forster · Principal investigatorMore trials in Charleston
SD
- Sanford USD Medical Center · Sioux Falls, SD 57105Ahmed Kurdi · Principal investigatorMore trials in Sioux Falls
TN
- Skyline Gastroenterology of West Tennessee · Jackson, TN 38301 · Study contact · 731-280-0157Brittain Little · Principal investigatorMore trials in Jackson
TX
- GI Alliance - Fort Worth · Fort Worth, TX 76104 · Study contact · 817-612-5575Kumar Gutta · Principal investigatorMore trials in Fort Worth
- GI Alliance - Garland · Garland, TX 75044 · Study contact · 972-265-8201Harry Sarles · Principal investigatorMore trials in Garland
- Integrity Advanced Therapeutics · Houston, TX 77090 · Study contact · 281-453-2005Howard Hamat · Principal investigatorMore trials in Houston
- GI Alliance: Mansfield · Mansfield, TX 76063 · Study contact · 817-417-9664MOUSTAFA YOUSSEF · Principal investigatorMore trials in Mansfield
- Southern Star Research Institute · San Antonio, TX 78229 · Study contact · 210-581-2812Jeff Bullock · Principal investigatorMore trials in San Antonio
- GI Alliance - San Marcos · San Marcos, TX 78666 · Study contact · 512-878-1100Thomas Kepczyk · Principal investigatorMore trials in San Marcos
- Tyler Research Institute · Tyler, TX 75701 · Study contact · 903-630-6211George DuVall · Principal investigatorMore trials in Tyler
VA
- Eximia Research-VA, LLC · Norfolk, VA 23502John Smith · Principal investigatorMore trials in Norfolk
WA
- Swedish Medical Center · Seattle, WA 98104Jason Harper · Principal investigatorMore trials in Seattle
- Principle Research Solutions · Spokane, WA 99202 · Study contact · 590-474-1107Harold Preiksaitis · Principal investigatorMore trials in Spokane
- Providence Sacred Heart Medical Center & Children's Hospital · Spokane, WA 99208 · Study contact · 509-489-2600Eashen Liu · Principal investigatorMore trials in Spokane
- Washington Gastroenterology - Tacoma · Tacoma, WA 98405 · Study contact · 253-272-5127William Holderman · Principal investigatorMore trials in Tacoma