Cure8 trial brief
This Phase 2a trial tested a new investigational drug, tulisokibart, in people with moderately to severely active Crohn’s disease who have not done well on prior therapies — so patients and clinicians watching new treatment options will find it relevant.
Adults with moderately to severely active Crohn’s disease, patients with prior biologic or immunosuppressant treatment failure or intolerance, gastroenterologists, and IBD researchers.
This was a Phase 2, open-label induction study with a 12-week induction period of IV tulisokibart (1000 mg at Week 0, then 500 mg at Weeks 2, 6, and 10).
Eligible participants could enter an open-label extension (up to 170 weeks) randomized to IV 100 mg or 250 mg every 4 weeks, with investigator-directed titration from 100 mg to 250 mg if disease control was inadequate.
The study’s primary safety outcomes include treatment-emergent adverse events, serious adverse events, and adverse events leading to discontinuation. A key efficacy outcome listed is endoscopic improvement at Week 12 (SES-CD ≥ 50% decrease from baseline).
This is a clinicaltrials.gov trial record describing study design and endpoints; the record does not present outcomes or peer-reviewed results. The study is listed as completed — search for a results posting or publication for efficacy/safety data.
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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