Safety and Efficacy of a STOPping Strategy Versus Classical Maintenance Dose of JAK Inhibitors in Deep Remission Patients With Ulcerative Colitis

This phase IV, multicenter, open-label randomized controlled trial will evaluate whether a JAK inhibitor discontinuation strategy is superior to standard maintenance therapy in adult patients with ulcerative colitis who are in sustained deep remission. A total of 224 patients treated with tofacitinib, upadacitinib, or filgotinib will be randomized to either treatment withdrawal or continuation of maintenance therapy and followed for 104 weeks. The primary objective is to compare safety, efficacy, and patient satisfaction at Week 52, while secondary objectives include assessment of remission maintenance, quality of life, treatment exposure, endoscopic outcomes, and relapse rates

NCT Number	NCT07718529
Lead Sponsor	Assistance Publique Hopitaux De Marseille
Conditions	Ulcerative Colitis in Remission
Enrollment	224 participants
Start Date	2027-01
Primary Completion	2030-01 (estimated)
Study Completion	2031-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-22