Cure8 trial brief
This trial tests whether raising the upadacitinib dose to 45 mg can recapture clinical response in people with ulcerative colitis who lost response on the 30 mg maintenance dose. If effective and safe, the approach could provide a deliberate re-induction and rescue option for patients already on upadacitinib.
Adult UC patients currently or previously treated with upadacitinib who experienced loss of response, clinicians managing UC maintenance therapy, and clinical researchers interested in JAK1 inhibitor dosing strategies.
This is a registered Phase 4 (post-marketing) interventional trial testing an upadacitinib 45 mg re-induction strategy for adults with moderate–severe ulcerative colitis who have lost response while on upadacitinib 30 mg maintenance.
Participants receive 45 mg once daily for an initial 8-week re-induction; responders may step down to 30 mg QD for maintenance, while nonresponders can continue 45 mg to Week 16. A 52-week maintenance follow-up is planned with an option to temporarily increase to 45 mg if relapse occurs.
The study plans to enroll about 100 adults (ages 18–64) and is multicenter and open-label. The primary outcome is re-capture of clinical response per an adapted Mayo score at Week 8 or Week 16. Safety and discontinuation rules for lack of efficacy or significant adverse events are included.
This summary is grounded in the clinicaltrials.gov record (trial NCT07700446) and describes the registered trial design and procedures rather than results.
This record is a trial registration (Phase 4, not yet recruiting at time of record). It describes study design and planned outcomes; it does not report results. Upadacitinib (Rinvoq) is a JAK1 inhibitor used in UC; dose-escalation and re-induction strategies are being evaluated but safety and efficacy outcomes are pending publication of trial 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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