A study of LY4268989 in participants with Moderately to Severely Active Ulcerative Colitis (EMERALD-3)
Key facts
- Where
- Budapest III, Budapest VIII, Gyongyos és Tatabánya, MagyarországSee the 4 sites
- Phase
- 2. fázis
Where in Magyarország
- Obudai Egeszseguegyi Centrum Kft.Budapest III, MagyarországTaking people
- Semmelweis UniversityBudapest VIII, MagyarországTaking people
- Clinexpert Gyoengyoes Kft.Gyongyos, MagyarországTaking people
- Komarom-Esztergom Varmegyei Szent Borbala KorhazTatabánya, MagyarországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly & Co.
- Trial code
- EU 2025-524404-29-00
- Record updated
- 2026. október 21.
- Original description
-To evaluate if the 10-week induction efficacy of LY4268989 is superior to placebo as assessed by clinical remission in participants with moderately to severely active UC -To evaluate if the maintenance efficacy of LY4268989 is superior to placebo at Week 52 (Visit 208) as assessed by clinical remission among participants who achieve clinical response with LY4268989 at Week 10Read full original descriptionShow less
J6E-MC-KWAM: 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)
-To evaluate if the 10-week induction efficacy of LY4268989 is superior to placebo as assessed by clinical remission in participants with moderately to severely active UC -To evaluate if the maintenance efficacy of LY4268989 is superior to placebo at Week 52 (Visit 208) as assessed by clinical remission among participants who achieve clinical response with LY4268989 at Week 10
Inclusion: 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: Have had or will need bowel resection or intestinal or intra-abdominal surgery; Have any prior or current evidence of cancer of the the gastrointestinal (GI) tract, or specified lesions with increased risk of GI malignancie; 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 a diagnosis or history of malignant disease within 5 years prior to randomization; 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 symptomat.