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Taking people in DenmarkPhase 2

Tests LY4268989 with mirikizumab in adults with ulcerative colitis

Tests LY4268989 added to mirikizumab in adults with active ulcerative colitis.

Key facts

Who runs it
Eli Lilly & Co.
Where
Gistrup, Herlev, and Odense C, DenmarkSee the 3 sitesAlso in 8 other countries, 39 sites
Trial code
Registry title
LY4268989 (MORF-057) Co-Administered with Mirikizumab in Adults with Moderately to Severely Active Ulcerative Colitis: A Phase 2 Study
Status
Recruiting
Phase
Phase 2
People taking part
75 people, planned
Started
31 Mar 2026
Expected to end
1 Mar 2029
Type of study
Interventional
Record updated
7 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 do well on earlier treatment.

Age
18 years or older
Sex
Women and men can join.
Disease stage
Moderately to severely active ulcerative colitis, diagnosed at least 3 months before the start, with inflammation reaching beyond the rectum.
Earlier treatment
Inadequate response, loss of response or intolerance to conventional therapy, immunomodulators or advanced therapy.

Main reasons for not taking part

  • Crohn's disease, unclassified IBD or primary sclerosing cholangitis
  • Inherited immunodeficiency or a known single-gene cause of colitis
  • Bowel resection or intestinal or abdominal surgery, past or needed
  • Likely to need surgery for ulcerative colitis during the study
  • Toxic megacolon, abdominal abscess, or a narrowing in the bowel that a colonoscope cannot pass or that causes symptoms

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • Have had an established diagnosis of UC of ≥3 months in before baseline
  • Have moderately to severely active UC
  • Have evidence of UC extending proximal to the rectum
  • Participants with greater than 8 years of UC symptoms have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local country or regional medical guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization
  • Are up-to-date on colorectal cancer surveillance
  • Have an inadequate response to, loss of response to, or intolerance to Conventional therapy, Immunomodulators, Advanced therapy

Who cannot take part

  • Have had or will need bowel resection or intestinal or intra-abdominal surgery
  • Are likely to require surgery for the treatment of UC during the study
  • Have a current diagnosis of Crohn’s disease, IBD unclassified or primary sclerosing cholangitis
  • Have an inherited immunodeficiency syndrome or known monogenic cause of UC-like colonic inflammation
  • 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

Where in Denmark

Also in 8 other countries, 39 sites

  • Aalborg University HospitalGistrup, DenmarkTaking people
  • Herlev and Gentofte HospitalHerlev, DenmarkTaking people
  • Odense University HospitalOdense C, DenmarkTaking people

About the trial

What the trial wants to find out

To evaluate the 12-week induction efficacy of LY4268989/mirikizumab co-administration compared with mirikizumab monotherapy in participants with moderately-to-severely active UC

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
J6E-MC-KWAN: A Phase 2, Multicenter, Randomized, Double-Blind, Active-Controlled Study of LY4268989 (MORF-057) Co-Administered with Mirikizumab in Adults with Moderately to Severely Active Ulcerative Colitis
Plain-language title
Tests LY4268989 with mirikizumab in adults with 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
7 October 2026