Safety and Efficacy of a STOPping Strategy Versus Classical Maintenance Dose of JAK Inhibitors in Deep Remission Patients With Ulcerative Colitis
Phase 4 · Testing treatment withdrawal · 22 sites · Assistance Publique Hopitaux De Marseille
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing treatment withdrawal (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis in Remission.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 11 more requirement(s). There are also 19 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 224 participants are expected to take part.
- Start date: 2027-01 (planned).
- Main results expected around 2030-01 (estimate from the record).
- 22 study sites listed in France.
Main thing being measured
- The primary endpoint of this study will be a composite criterion of treatment safety, efficacy, and patient satisfaction during the first 52 weeks of the follow-up. (1 year)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis in Remission |
| Lead sponsor | Assistance Publique Hopitaux De Marseille |
| Enrollment | 224 (estimated) |
| Start date | 2027-01 |
| Primary completion (est.) | 2030-01 |
| First posted | 2026-07-22 |
| Last updated | 2026-07-22 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT07718529 |
Interventions
- treatment withdrawal (Drug)
the patients will stop their treatment, as long as possible until symptom reappearance, if any
Full eligibility criteria (from the record)
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
Locations (22)
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Amiens-Picardie | Amiens | France | |
| Centre Hospitalier d'Avignon | Avignon | France | |
| CHRU Besançon | Besançon | France | |
| CHU Bordeaux | Bordeaux | France | |
| CHU Clermont Ferrand | Clermont-Ferrand | France | |
| Chu Lille | Lille | France | |
| HCL | Lyon | France | |
| AP-HM hopital Nord | Marseille | France | |
| CHU Montpellier | Montpellier | France | |
| CHRU Nancy | Nancy | France | |
| CHU Nantes | Nantes | France | |
| CHU Nice | Nice | France | |
| CHU Nîmes | Nîmes | France | |
| Hôpital Beaujon | Paris | France | |
| Hôpital Bicêtre | Paris | France | |
| Hôpital Henri-Mondor | Paris | France | |
| Institut des MICI | Paris | France | |
| Chu Rennes | Rennes | France | |
| CHU Rouen | Rouen | France | |
| CHU St Etienne | Saint-Etienne | France | |
| Chits Toulon | Toulon | France | |
| CHU Toulouse | Toulouse | France |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.