Clinical Trial

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

Study acronym: ReCOUP
Not Yet Recruiting Phase 4
View on ClinicalTrials.gov →
Summary
ReCOUP is a multicenter 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. Participation in this study will depend on the patients' response to treatment during the 52-week maintenance period. 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.
Protocol Amendment History 1 change
critical Primary endpoint(s) modified 2026-08-01
Trial Details
NCT Number NCT07700446
Lead Sponsor Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Conditions Ulcerative Colitis (UC)
Enrollment 100 participants
Start Date 2026-11-15
Primary Completion 2029-11 (estimated)
Study Completion 2030-04 (estimated)
Updated on ClinicalTrials.gov 2026-07-31