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Not yet recruitingNCT07718529STOPUpdated Jul 22, 2026

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

A Phase 4 interventional study of treatment withdrawal in Ulcerative Colitis in Remission, sponsored by Assistance Publique Hopitaux De Marseille. Not yet recruiting at 22 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.

Sponsored by Assistance Publique Hopitaux De Marseille · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
224
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

Background:

Janus kinase (JAK) inhibitors are effective oral therapies for moderate-to-severe ulcerative colitis (UC). Their lack of immunogenicity provides a unique opportunity to evaluate treatment withdrawal and intermittent treatment strategies. However, safety concerns raised by regulatory agencies, including increased risks of infections, venous thromboembolism, major adverse cardiovascular events, and malignancies, support the investigation of strategies aiming to reduce long-term exposure to JAK inhibitors while maintaining disease control.

Objective:

To demonstrate the superiority of a JAK inhibitor stopping strategy compared with standard maintenance therapy in terms of treatment safety, efficacy, and patient satisfaction in adults with ulcerative colitis in deep remission.

Study Design:

This is a phase IV, prospective, multicenter, open-label, randomized controlled trial. Adult patients with ulcerative colitis receiving a stable dose of tofacitinib, upadacitinib, or filgotinib for at least 12 months and achieving sustained steroid-free clinical, biological, and endoscopic remission for at least 6 months will be randomized to either treatment discontinuation or continuation of standard maintenance therapy. A total of 224 participants will be enrolled and followed for 104 weeks.

Primary Endpoint:

The primary endpoint is a composite outcome assessing treatment safety, efficacy, and patient satisfaction during the first 52 weeks after randomization. Patient satisfaction will be evaluated using the Treatment Satisfaction Questionnaire for Medication (TSQM 1.4).

Secondary Endpoints:

Secondary outcomes include adverse events and serious adverse events, maintenance of remission, treatment satisfaction, quality of life, JAK inhibitor exposure, endoscopic outcomes, relapse rates, treatment success at Weeks 52 and 104, and identification of predictors of successful treatment discontinuation.

Expected Benefits:

Reducing exposure to JAK inhibitors may improve the overall safety profile by decreasing treatment-related adverse events while reducing treatment burden for patients with ulcerative colitis. This strategy could support a more individualized and potentially safer long-term management approach for patients in sustained deep remission.

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Conditions studied

  • Ulcerative Colitis in Remission

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Keywords

  • ulcerative colitis
  • treatment removal
03

In context

Colitis, Ulcerative

1,492 studies on the registry are indexed under Colitis, Ulcerative; 400 are open to participants now.

This study's planned enrollment of 224 is above the median of 71 across 1,042 interventional studies indexed under Colitis, Ulcerative.

Browse Colitis, Ulcerative studies →

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
224 participants (estimated)

Study arms

  • No intervention
    standard of care
  • Experimental
    STOP, treatment withdrawal

    Drug: treatment withdrawal

Interventions

  • Drugtreatment withdrawal

    the patients will stop their treatment, as long as possible until symptom reappearance, if any

06

What researchers measure

Primary outcomes

  1. 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.

    treatment safety, during the first 52 weeks of the follow-up.

    Time frame: 1 year

  2. 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.

    treatment efficacy, during the first 52 weeks of the follow-up.

    Time frame: 1 year

  3. 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.

    patient satisfaction during the first 52 weeks of the follow-up.

    Time frame: 1 year

Secondary outcomes

  1. Safety: occurrence of herpes zoster, infection, cardiovascular event, biochemical parameter, malignancies, adverse event leading to discontinuation, and all adverse events (serious or not) during the whole follow-up.

    Time frame: 2 years

  2. Remission rate at the end the first 52 weeks of the follow-up

    Time frame: 1 year

  3. Assess the treatment success of this innovative therapeutic strategy at the end of the first 52 weeks of the follow-up and after 104 weeks of follow-up.

    Time frame: 2 years

  4. Partial Mayo score at each visit of the entire follow-up

    Time frame: 2 years

  5. Number of days under treatment and cumulative dose of treatment per patient between randomization and primary endpoint

    Time frame: 1 year

  6. Number of days under induction dose of JAK inhibitor at the end the first 52 weeks of the follow-up.

    Time frame: 1 year

  7. Mayo endoscopic subscore at week 52 and week 104

    Time frame: 2 years

  8. Proportion of patients relapsing for each arm

    Time frame: 2 years

07

Study locations

22 sites
  • 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
    • Adrien Nicolau · Contact · nicolau.a@chu-nice.fr · +330492036168
    • Adrien NICOLAU · Principal investigator
  • CHU Nîmes
    Nîmes, France
  • Hôpital Beaujon
    Paris, France
  • Hôpital Bicêtre
    Paris, France
    • Aurélien Amiot · Contact · aurelien.amiot@aphp.fr · +330145213726
    • Aurélien AMIOT · Principal investigator
  • Hôpital Henri-Mondor
    Paris, France
    • Mathieu Uzzan · Contact · mathieu.uzzan@aphp.fr · +330149812362
    • Mathieu UZZAN · Principal investigator
  • 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
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07718529
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Jul 22, 2026
Start date
Jan 2027 (estimated)
Primary completion
Jan 2030 (estimated)
Completion
Jan 2031 (estimated)
Last update
Jul 22, 2026

Study contacts

Amandine ROLLAND-BRUN
Contact
amandine.rolland@ap-hm.fr
+33 04 91 38 12 45 ext. +33
Lucas GUILLO, DR
principal investigator · AP-HM

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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