Cure8 trial brief
This trial tests whether adding an investigational oral agent (LY4268989) to mirikizumab improves remission rates in people with moderately to severely active ulcerative colitis. If successful, it could expand treatment options for patients who have had inadequate responses to existing therapies.
Adults with moderately to severely active ulcerative colitis, clinicians caring for UC patients, clinical researchers, and people interested in new biologic or oral combination therapies for IBD.
This is a phase 2, randomized, interventional trial testing oral LY4268989 (investigational) co-administered with IV then SC mirikizumab versus mirikizumab with LY4268989 placebo in adults with moderately to severely active ulcerative colitis.
Planned participation is ~118 weeks with a 104-week treatment period; primary outcome is clinical remission by a modified Mayo Score at Week 12. Responders will be re-randomized into Study Period 2.
The study will enroll up to 252 participants and includes eligibility criteria about prior treatment failures (conventional therapies, biologics, JAK inhibitors, or S1PR modulators) and required baseline endoscopic confirmation of disease.
Key exclusions include Crohn's disease, indeterminate colitis, primary sclerosing cholangitis, recent major abdominal surgery, toxic megacolon, abscess, or non-traversable strictures.
This record is a recruiting ClinicalTrials.gov entry sponsored by Eli Lilly and Company and describes trial design, interventions, eligibility, and outcome measures rather than results.
This is a trial registry entry (phase 2) describing study design and planned outcomes; it does not report results. Mirikizumab is an IL-23–targeting biologic referenced in the protocol; LY4268989 is investigational. Eligibility and exclusion criteria are detailed and include prior therapy exposure limits and safety-related exclusions.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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