Cure8 trial brief
This trial tests mirikizumab (an anti–IL-23p19 biologic) alone and with an oral agent in adults with moderate–severe UC or CD, which could expand treatment options if later-phase trials are successful.
Adults with moderately to severely active UC or Crohn's disease, particularly those who have had inadequate response to prior therapies; clinicians and researchers following biologic and combination therapy development.
The trial is interventional and currently recruiting adults (18–80) with moderately to severely active UC or CD who have had inadequate response, loss of response, or intolerance to prior therapies. Mirikizumab is being given IV in an initial study period with responders switching to subcutaneous dosing in a later period.
One arm involves co-administration of an oral agent (LY4395089) with IV mirikizumab during the first period, with the oral agent stopped for responders who continue on SC mirikizumab. The study is Phase 2 with an estimated enrollment of about 60 participants and planned follow-up of at least 62 weeks.
Key eligibility and endpoint assessments include centrally read endoscopy (mMS/ES for UC; SES-CD for CD) and standard clinical activity indices. The protocol excludes participants with certain complications (for example, significant strictures in CD) and those who previously failed anti–IL-23p19 therapy.
This is a Phase 2 master protocol record on clinicaltrials.gov sponsored by Eli Lilly; the registry entry describes design and eligibility but does not provide efficacy or safety results.
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.
These are multi‑year clinical results for a newly approved IL‑23p19 inhibitor (mirikizumab) showing sustained clinical and endoscopic benefit for many patients with moderate‑to‑severe Crohn’s disease, including some who...
An FDA approval means another biologic option is available for Crohn’s disease, which could affect treatment choices and insurance coverage. The approval also signals pharma competition and pipeline activity that may...
This trial tests whether adding an FXR agonist (LY4395089) to mirikizumab improves endoscopic response in people with moderate–severe Crohn's disease. Results could influence future combination treatment strategies and...
