Status:
RECRUITING
LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:
Lead Sponsor:
Eli Lilly and Company
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 activ...
Eligibility Criteria
Inclusion
- Have had an established diagnosis of ulcerative colitis (UC) of ≥3 months in before baseline, which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC
- Have moderately to severely active UC as 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, with endoscopy performed within 21 days before baseline
- 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 per local society guidelines
- Have an inadequate response to, loss of response to, or intolerance to at least 1 of the medications:
- Conventional-failed participants: Participants who have had an inadequate response to or a loss of response to or are intolerant to at least 1 of the following medications: corticosteroids or immunomodulators (Does not apply to US)
- 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
- mirikizumab.
- Janus kinase inhibitors (JAK) such as filgotinib, tofacitinib, or upadacitinib
- sphingosine 1-phosphate receptor 1 inhibitors (S1PR) such as etrasimod or ozanimod
Exclusion
- Have a current diagnosis of
- Crohn's disease
- Inflammatory Bowel Disease (IBD) unclassified (formerly known as indeterminate colitis), or
- primary sclerosing cholangitis
- 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
- Have a current or recent acute, active infection
Key Trial Info
Start Date :
November 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT07186101
Start Date
November 11 2025
End Date
March 1 2029
Last Update
December 17 2025
Active Locations (149)
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1
Mayo Clinic in Arizona - Scottsdale
Scottsdale, Arizona, United States, 85259
2
Clinnova Research - Anaheim
Anaheim, California, United States, 92805
3
Om Research LLC
Lancaster, California, United States, 93534
4
Biopharma Informatic, LLC
Los Angeles, California, United States, 90035