RecruitingPhase 2

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

CA

CO

CT

  • Medical Research Center of Connecticut · Hamden, CT 06518Paul Feuerstadt · Principal investigatorMore trials in Hamden

FL

ID

IL

IN

KY

LA

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

NC

NJ

NV

  • Digestive Disease Specialists - Las Vegas - Crimson Canyon Drive · Las Vegas, NV 89128Michael Zimmerman · Principal investigatorMore trials in Las Vegas

NY

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

SC

SD

TN

TX

VA

WA