Evaluation of the Efficacy of Upadacitinib Re-induction Therapy in Patients With Ulcerative Colitis Who Lost Response to 30 mg Maintenance Dose

Summary

ReCOUP is a prospective, multicenter, open-label clinical study designed to evaluate the efficacy of upadacitinib (Rinvoq®) in patients with ulcerative colitis whose disease has become active again despite maintenance treatment with upadacitinib 30 mg. This study involves adult patients aged 18 to 64 years with active ulcerative colitis, who are being treated with upadacitinib and are not participating in another interventional clinical trial. The participation in this study will last approximately 60 to 68 weeks (1 year and 3 months), depending on patients' response to treatment. Approximately 100 patients will be enrolled across all participating centers. Several follow-up visits will be scheduled throughout the study according to a timetable defined by the protocol, and additional visits may be arranged if necessary depending on patients' health status. At the start of the study, patients will receive upadacitinib 45 mg from Visit 1 (Week 0) for an initial 8-week re-induction phase. Treatment response will be assessed at Week 8 (Visit 2). Depending on clinical response and endoscopic findings: * patients with sufficient improvement will switch to maintenance treatment with upadacitinib 30 mg and continue follow-up visits; * patients with persistent inflammation or insufficient clinical improvement may continue treatment with 45 mg for an additional 8 weeks until Visit 2bis (Week 16); * at Week 16, treatment continuation or discontinuation will be decided according to treatment response and inflammation control. During the maintenance phase with 30 mg, a temporary dose increase to 45 mg may be considered in case of disease relapse (rescue treatment). Treatment will be discontinued in case of lack of efficacy or significant treatment-related adverse effects.

Timeline

Start

2026-11-15

Primary completion

2029-11

Completion

2030-04

Drugs

Indications