Tests LY4268989 as a treatment for moderate to severe ulcerative colitis
Tests LY4268989, compared with placebo, in adults with moderate to severe ulcerative colitis.
Key facts
- Who runs it
- Eli Lilly & Co.
- Where
- Milan, Rho, Rome, Rozzano, and San Donato Milanese, ItalySee the 7 sitesAlso in 10 other countries, 54 sites
- Trial code
- EU 2025-524404-29-00
- U1111-1333-7508
- Registry title
- A study of LY4268989 in participants with Moderately to Severely Active Ulcerative Colitis (EMERALD-3)
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 104 people, planned
- Started
- 24 Jun 2026
- Expected to end
- 31 Jul 2031
- Type of study
- Interventional
- Record updated
- 21 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with moderately to severely active ulcerative colitis who did not respond well to, lost response to, or could not tolerate earlier treatment.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Ulcerative colitis diagnosed at least 3 months ago, moderately to severely active (Modified Mayo Score 5 to 9, Endoscopic Score of at least 2, rectal bleeding of at least 1), reaching beyond the rectum.
- Earlier treatment
- Inadequate response, loss of response or intolerance to at least one conventional medicine (including corticosteroids) or one advanced therapy (biologics, JAK inhibitors or S1P immunomodulators). People with inadequate response to vedolizumab cannot join.
Main reasons for not taking part
- Crohn's disease, unclassified inflammatory bowel disease or primary sclerosing cholangitis
- Inherited immune deficiency or a known single-gene cause of colitis
- Bowel resection or intestinal or abdominal surgery, past or needed
- Toxic megacolon, abdominal abscess, or narrowing of the bowel
- Cancer of the digestive tract, or other cancer within 5 years before randomization
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Italy
Also in 10 other countries, 54 sites
- Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
- Azienda Socio Sanitaria Territoriale RhodenseRho, ItalyTaking people
- Azienda Ospedaliera Policlinico Universitario Tor VergataRome, ItalyTaking people
- Ospedale Isola Tiberina - Gemelli IsolaRome, ItalyTaking people
- San Camillo Forlanini HospitalRome, ItalyTaking people
- Humanitas Mirasole S.p.A.Rozzano, ItalyTaking people
- Policlinico San Donato S.p.A.San Donato Milanese, ItalyTaking people
About the trial
What the trial wants to find out
-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
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?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- 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)
- Plain-language title
- Tests LY4268989 as a treatment for moderate to severe ulcerative colitisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 21 October 2026