Stopping JAK inhibitor medicines versus continuing them in ulcerative colitis remission

Trial details

Who runs it

Assistance Publique Hopitaux De Marseille

Trial code

NCT07718529EU 2026-525643-32-00

Record updated

10 November 2026

Original description

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 ratesRead full original descriptionShow less

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

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

Inclusion: Diagnosis of UC from at least 6 months according to clinical, endoscopic, histological and/or radiological criteria; Male or female age ≥ 18 years; Currently treated by JAK inhibitor (tofacitinib, upadacitinib or filgotinib) for more than 12 months; Currently at a stable dose of tofacitinib (5mg or 10mg twice a day), upadacitinib (15mg or 30mg per day) or filgotinib (200mg per day) for 6 months; Clinical steroid free remission for at least 6 months, defined by a partial Mayo Score < 2, with no subscore > 1 and rectal bleeding (RB) subscore of 0 (annex 1); Endoscopic steroid free remission for at inclusion, defined by a Mayo endoscopic subscore = 0 (annex 1); Fecal calprotectin ≤ 150μg/g; Without known risk factors for venous thromboembolism (VTE); Without known risk factors for major adverse cardiovascular events (MACE); Without known risk factors for malignancy; For women of child-bearing potential (WOCBP), and for men with partners who are WOCBP, willingness to use appropriate and efficient contraception, as recommended when using JAK inhibitor treatment (notably upadacitinib), during all the experimental treatment and until at least 4 weeks after the end of the experimental treatment, according to SmPC and CTFG (Clinical Trials Facilitation and Coordination Group) recommendations; Patients able to understand information provide to them and to give written informed consent for study; Affiliation to a social security scheme; Good general health according to history and clinical examination.

Exclusion: Steroid use ≤ 6 months prior to enrolment; Currently treated by steroid, immunosuppressive agents or biologics; Intolerance of JAK inhibitors (excipients included) or severe adverse event; Contraindications to using a JAK inhibitor (excipients included); People receiving psychiatric care; Severe hepatic insufficiency; Severe to end-stage renal insufficiency; Active tuberculosis, serious infections such as septicemia or opportunistic infections; People with difficulty understanding and/or cognitive disorder; Active neoplasia or history of malignant tumours less than 5 years old; Pregnancy or planned pregnancy during the study; Breastfeeding; Non-compliant subject or inability to follow study protocol; Known risk factors for VTE; Known risk factors for MACE; Participation to another interventional study protocol (except for RIPH3 studies); Absence or refusal of informed consent; People under guardianship, conservatorship, or judicial protection; People who have been deprived of their liberty by judicial or administrative order.

ClinicalTrials.gov NCT07718529 · EU CTIS 2026-525643-32-00