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Can ulcerative colitis patients in remission ditch their daily pill?

NCT ID NCT07718529

Disease control Sponsor: Assistance Publique Hopitaux De Marseille Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This trial asks whether adults with ulcerative colitis who are in deep remission can safely stop taking their JAK inhibitor medication (tofacitinib, upadacitinib, or filgotinib) instead of continuing daily maintenance therapy. Half of the 224 participants will stop treatment and be monitored for up to two years, while the other half continues as usual. The goal is to compare safety, effectiveness, and patient satisfaction between the two approaches.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
stopping JAK inhibitor treatment (tofacitinib, upadacitinib, or filgotinib)
What this could lead to
If successful, this could show that some patients with ulcerative colitis can safely stop their medication without relapse, reducing long-term drug exposure and side effects.
What could go wrong
This is a relatively small, open-label trial, and stopping treatment may lead to disease flares. Results may not apply to all patients or other JAK inhibitors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 224 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Jan 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ulcerative colitis in remission

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    22 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AP-HM hopital Nord

    Marseille, France

  • CHRU Besançon

    Besançon, France

  • CHRU Nancy

    Nancy, France

  • CHU Amiens-Picardie

    Amiens, France

  • CHU Bordeaux

    Bordeaux, France

  • CHU Clermont Ferrand

    Clermont-Ferrand, France

  • CHU Montpellier

    Montpellier, France

  • CHU Nantes

    Nantes, France

  • CHU Nice

    Nice, France

  • CHU Nîmes

    Nîmes, France

  • CHU Rouen

    Rouen, France

  • CHU St Etienne

    Saint-Etienne, France

  • CHU Toulouse

    Toulouse, France

  • Centre Hospitalier d'Avignon

    Avignon, France

  • Chits Toulon

    Toulon, France

  • Chu Lille

    Lille, France

  • Chu Rennes

    Rennes, France

  • HCL

    Lyon, France

  • Hôpital Beaujon

    Paris, France

  • Hôpital Bicêtre

    Paris, France

  • Hôpital Henri-Mondor

    Paris, France

  • Institut des MICI

    Paris, France