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

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Phase 4

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

224 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

1. Diagnosis of UC from at least 6 months according to clinical, endoscopic, histological and/or radiological criteria.
2. Male or female age ≥ 18 years
3. Currently treated by JAK inhibitor (tofacitinib, upadacitinib or filgotinib) for more than 12 months.
4. 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.
5. 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).
6. Endoscopic steroid free remission for at inclusion, defined by a Mayo endoscopic subscore = 0 (annex 1).
7. Fecal calprotectin ≤ 150μg/g.
8. Without known risk factors for venous thromboembolism (VTE).
9. Without known risk factors for major adverse cardiovascular events (MACE).
10. Without known risk factors for malignancy.
11. 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.
12. Patients able to understand information provide to them and to give written informed consent for study.
13. Affiliation to a social security scheme.
14. Good general health according to history and clinical examination.

Exclusion Criteria:

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

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (22)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

22 locations

Study team and timeline

Lead sponsor

Assistance Publique Hopitaux De Marseille

Study start

2027-01 Estimated

Primary completion

2030-01 Estimated

Study completion

2031-01 Estimated

First posted

Jul 22, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts