Cure8 trial brief
Researchers are testing whether short-term dual therapy with vedolizumab plus tofacitinib can induce remission in people with moderate–severe UC who have failed prior TNF blockers. If effective and safe, this approach could offer an additional treatment strategy for difficult-to-treat UC.
Adults with moderate-to-severe ulcerative colitis, patients with prior TNF antagonist failure or intolerance, clinicians who treat IBD, and researchers interested in combination biologic/small-molecule strategies.
This is a ClinicalTrials.gov record for a Phase 4 interventional trial testing a short course of combined vedolizumab (IV) and tofacitinib (oral) for adults with moderate-to-severe ulcerative colitis who have had inadequate response or intolerance to up to two prior TNF antagonists.
All participants receive vedolizumab 300 mg IV at Weeks 0, 2, and 6 plus tofacitinib 10 mg twice daily through Week 8; those with a clinical response at Week 8 transition to vedolizumab monotherapy (300 mg IV every 8 weeks) through Week 46. The primary outcome is percentage achieving clinical remission at Week 8 by complete Mayo score.
The study plans to enroll ~65 participants across the U.S. and Canada, with total study duration up to 76 weeks and a 26-week post-treatment safety follow-up. Eligibility limits include ages 18–65 and prior exposure/failure to biologic therapy as specified in the protocol. This summary is grounded in the trial registry entry (ClinicalTrials.gov).
It summarizes the registered design, interventions, and primary outcome as listed; it does not report results or make clinical recommendations.
This is a Phase 4 trial record from ClinicalTrials.gov describing the study design and planned outcomes; no results are reported in the registry entry. The entry includes detailed inclusion/exclusion criteria and safety follow-up. Consult clinical teams for individual treatment 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.
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