LY4268989 (MORF-057) Co-Administered with Mirikizumab in Adults with Moderately to Severely Active Ulcerative Colitis: A Phase 2 Study
Key facts
- Where
- Bekescsaba, Budapest III, Budapest VIII, Budapest XIII, Gyongyos, Tatabánya és Vac, MagyarországSee the 7 sites
- Phase
- 2. fázis
Where in Magyarország
- Bekes Varmegyei Koezponti KorhazBekescsaba, MagyarországTaking people
- Obudai Egeszseguegyi Centrum Kft.Budapest III, MagyarországTaking people
- Semmelweis UniversityBudapest VIII, MagyarországTaking people
- Pannonia Maganorvosi Centrum Kft.Budapest XIII, MagyarországTaking people
- Clinexpert Gyoengyoes Kft.Gyongyos, MagyarországTaking people
- Komarom-Esztergom Varmegyei Szent Borbala KorhazTatabánya, MagyarországTaking people
- Javorszky Oedoen KorhazVac, 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 2025-522338-30-00
- Record updated
- 2026. október 7.
- Original description
To evaluate the 12-week induction efficacy of LY4268989/mirikizumab co-administration compared with mirikizumab monotherapy in participants with moderately-to-severely active UCRead full original descriptionShow less
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
To evaluate the 12-week induction efficacy of LY4268989/mirikizumab co-administration compared with mirikizumab monotherapy in participants with moderately-to-severely active UC
Inclusion: 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.
Exclusion: 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.