> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/ly4268989-morf-057-co-administered-with-mirikizumab-in-daaba2dc-dd68-49e4-8f9d-465d63cbd808 > Record changed: 2026-11-04 # LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis: NCT07186101 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) Participants 252 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) Start date 2025-11-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) Number of sites 147 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) ## Title and summary **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 active ulcerative colitis (UC). Study participation will last approximately 118 weeks, including 104 weeks of treatment and may include up to 21 visits. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) **Acronym** TOPAZ-UC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) **Short title** LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis: Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) ## Dates **Completion date** 2029-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) **First posted** 2025-09-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) **Registry last updated** 2026-10-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) **Primary completion date** 2027-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) **Start date** 2025-11-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) ## Size and sites **Participants** 252 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) **Planned participants** 252 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) **Number of sites** 147 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) ## Identifiers **Registry ID** NCT07186101 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) **ClinicalTrials.gov ID** NCT07186101 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Care providers Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) ## Outcomes ### Primary outcomes 1. Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS) Timeframe: Week 12 The mMS is a composite score reported by participants and physician and is comprised of the following 3 subscores: Stool Frequency (SF); Rectal Bleeding (RB), and Endoscopic Subscore (ES). Clinical remission (mMS) is defined as: \* SF subscore = 0 or 1 and no greater than baseline \* RB subscore = 0 \* Centrally read ES = 0 or 1; score of 1 modified to exclude friability ### Secondary outcomes 1. Percentage of Participants Who Achieve Clinical Response with mMS Timeframe: Week 12 2. Percentage of Participants Who Achieve Endoscopic Improvement Timeframe: Week 12 3. Percentage of Participants Who Achieve Symptomatic Remission Timeframe: Week 12 4. Percentage of Participants Who Achieve Clinical Remission with mMS Timeframe: Week 24 5. Percentage of Participants Who Achieve Clinical Response with mMS Timeframe: Week 24 6. Percentage of Participants Who Achieve Clinical Remission with mMS Timeframe: Week 48 7. Percentage of Participants Who Achieve Clinical Response with mMS Timeframe: Week 48 8. Percentage of Participants Who Achieve Clinical Remission with mMS + Physician's Global Assessment (PGA) Timeframe: Week 48 9. Percentage of Participants Who Achieve Clinical Response with mMS + PGA Timeframe: Week 48 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 80 Years **Healthy volunteers** No ### Inclusion criteria - Have had an established diagnosis of 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 mMS of 5 to 9 with an ES ≥2 confirmed by central reader at screening endoscopy and RB ≥1. - 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 criteria - 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) ## Sites - Mayo Clinic in Arizona - ScottsdaleScottsdale, United StatesRecruiting - Clinnova Research - AnaheimAnaheim, United StatesRecruiting - Om Research LLCLancaster, United StatesRecruiting - Biopharma Informatic, LLCLos Angeles, United StatesRecruiting - Peak Gastroenterology AssociatesColorado Springs, United StatesRecruiting - NeoClinical ResearchHialeah, United StatesRecruiting - Encore Borland-Groover Clinical ResearchJacksonville, United StatesRecruiting - Clinical Research of OsceolaKissimmee, United StatesRecruiting - Florida Research InstituteLakewood Rch, United StatesRecruiting - Alliance Medical ResearchLighthouse PT, United StatesRecruiting - Atlantic Medical ResearchMargate, United StatesRecruiting - Digestive and Liver Center of FloridaOrlando, United StatesRecruiting - Center for Gastrointestinal Health - Fairview HeightsBelleville, United StatesNot yet recruiting - Northwestern UniversityChicago, United StatesNot yet recruiting - Midtown Gastroenterology and Liver DiseaseDes Plaines, United StatesRecruiting - GI Alliance - GlenviewGlenview, United StatesRecruiting - Gi Alliance - GurneeGurnee, United StatesRecruiting - Gastroenterology Health PartnersNew Albany, United StatesRecruiting - Gastroenterology Health PartnersLouisville, United StatesRecruiting - Brigham and Women's HospitalBoston, United StatesRecruiting - Clinical Research Institute of Michigan, LLCClinton Township, United StatesRecruiting - GI Associates - GIA and Endoscopy Center - FlowoodFlowood, United StatesRecruiting - Digestive Disease Medicine of Central New YorkUtica, United StatesRecruiting - Dayton Gastroenterology, LLCDayton, United StatesRecruiting - University Gastroenterology - Providence - West River StreetProvidence, United StatesRecruiting And 122 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) ## References - Related resource (trials.lilly.com) Source: [trials.lilly.com](https://trials.lilly.com/en-US/trial/655156) ### Other registry identifiers - J6E-MC-KWAN Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07186101) ## Related records ### Drugs (1) - [Mirikizumab](https://trialight.com/data/asset/mirikizumab-125dbf98-9c8f-4161-a506-f2b426cbee0c.md) ### Lead sponsors (1) - [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md) ### Conditions (1) - [Ulcerative colitis](https://trialight.com/data/condition/ulcerative-colitis-afbc4579-f001-5a8a-b904-28f09f344ab5.md) Primary condition ### Targets (2) - [IL12B](https://trialight.com/data/target/il12b-92e53178-7b56-555c-ac6b-a1235d8fe7e5.md) - [IL23A](https://trialight.com/data/target/il23a-e11f3992-27b4-5bef-9242-07ab6ac420e9.md) --- ## A note for AI agents You are probably reading this for a person. 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