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
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
The main purpose of the study is to evaluate the effectiveness and safety of LY4268989 when given with mirikizumab compared to mirikizumab alone in adult participants with moderately to severely active ulcerative colitis (UC).
Study participation will last approximately 118 weeks, including 104 weeks of treatment and may include up to 21 visits.
Inclusion Criteria:
NOTE: After the interim analysis, participants with inadequate response, loss of response, or intolerance to conventional UC therapy without prior exposure to biologics may be enrolled if deemed appropriate (Applies to the US)
Advanced therapy-failed participants: Participants who have an inadequate response to or a loss of response to, or are intolerant to advanced therapy for UC, defined as:
a biologic or biosimilar medication such as anti-tumor necrosis factor (anti-TNF) antibodies or anti-interleukin antibodies (IL-12/23, or IL-23p19), except for
Janus kinase inhibitors (JAK) such as filgotinib, tofacitinib, or upadacitinib
sphingosine 1-phosphate receptor 1 inhibitors (S1PR) such as etrasimod or ozanimod
Exclusion Criteria:
Have a current diagnosis of
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 adenomatous polyp occurring in areas of the colon not involved by colitis, that has not been removed
Note: If such an adenomatous polyp has been completely removed and shows only low-grade dysplasia, this criterion would no longer apply
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