Cure8 trial brief
This trial tests a new oral drug for moderate-to-severe ulcerative colitis and could expand treatment options if later shown to be safe and effective. It also targets patients who have had inadequate response or intolerance to prior therapies.
Adults with moderately to severely active ulcerative colitis, clinicians who treat IBD, and researchers or trial investigators interested in UC drug development.
This is the clinicaltrials.gov record for a Phase 2, randomized, placebo-controlled study testing LY4268989 — an oral investigational medicine — in adults with moderately to severely active ulcerative colitis. The trial is recruiting, plans to enroll about 1,431 participants, and includes two dose arms and a placebo arm.
Primary outcomes focus on clinical remission (modified Mayo Score) at Week 10 and sustained remission among early responders at Week 52. The planned study duration is up to ~108 weeks excluding screening.
The record lists typical inclusion/exclusion rules for UC trials: adult participants with endoscopic confirmation of moderately to severely active UC, prior inadequate response or intolerance to at least one conventional or advanced therapy (with some exclusions such as prior vedolizumab failure), and requirements around surveillance colonoscopy and contraception.
No efficacy or safety results are reported in this registry entry; it describes trial design, eligibility, interventions, locations, and planned outcome timepoints. For decisions about care or access to treatment, clinicians and participants should rely on peer-reviewed results or regulatory guidance when available.
This is a trial registration record (Phase 2) and does not report study results. The entry describes planned outcomes and eligibility but not safety or efficacy findings. LY4268989 is investigational; enrollment and completion are required before results and regulatory decisions.
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.
The article explains how gut bacteria may contribute to IBD and summarizes common tests and treatments people are likely to encounter. It highlights emerging microbial therapies (probiotics and FMT) that some patients...
A long-term study that profiles immune cells, genes, diet, and the microbiome could help identify biomarkers that predict flares or response to therapy, which matters to people living with Crohn’s or ulcerative colitis.
This NIH natural-history study is collecting clinical, immune, and genetic samples from people with Crohn’s disease and ulcerative colitis to better understand immune pathways and molecular causes of IBD. Those findings...
