Cure8 trial brief
This registry entry describes a completed Phase 2 study of a new IV drug (tulisokibart) for moderate–severe ulcerative colitis, including safety endpoints and a companion diagnostic — information patients may want when following emerging treatment options or trials.
Adults with moderate to severe UC, patients who have tried biologics or JAK inhibitors, clinicians following IBD drug development, and researchers interested in companion diagnostics and new biologic therapies. This is a clinicaltrials.gov trial record (trial‑design and endpoints).
The registry entry summarizes study design, dosing, cohorts, and planned outcomes but does not present
Adults with moderate–severe UC; patients who failed or are intolerant to biologics/JAK inhibitors; clinicians and researchers tracking new UC therapies and companion diagnostics.
This is a completed Phase 2 interventional trial (NCT04996797) testing tulisokibart (MK-7240/PRA023) given by IV infusion for moderately to severely active ulcerative colitis. The trial included a 12‑week induction period with an open‑label extension option up to ~170 weeks and used a companion diagnostic (PRA023 CDx genotyping assay) to define some cohorts.
Primary outcomes reported on the registry include clinical remission by a 3‑component Modified Mayo Score and several safety endpoints (AEs, discontinuations, serious AEs) through ~14 weeks.
The record lists inclusion criteria typical for UC trials (adult participants with moderate–severe disease and prior inadequate response or intolerance to corticosteroids, immunosuppressants, or approved biologics/JAK inhibitors). Dosing described: 1000 mg IV Day 1 then 500 mg IV on Weeks 2, 6, and 10 for induction; placebo arms were included.
The listing reports planned enrollment and outcome definitions but does not provide trial results on this registry page. If you are tracking new therapies, this trial is relevant as a Phase 2 evaluation of a novel agent with a companion diagnostic; the registry describes design and safety/outcome measures but not efficacy or safety results on this page.
This classification is based on the trial registry record (trial design, interventions, cohorts, and registered outcomes). The registry lists endpoints and safety reporting but does not include detailed efficacy or safety results on the page; look for linked publications or sponsor press releases for 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.
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