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

17 juillet 2026 mis à jour par: Assistance Publique Hopitaux De Marseille

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

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

224

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • France
      • Amiens, France
        • CHU Amiens-Picardie
        • Chercheur principal:
          • MAthurin FUMERY
        • Contact:
      • Avignon, France
        • Centre Hospitalier d'Avignon
        • Contact:
        • Chercheur principal:
          • Alban BENEZECH
      • Besançon, France
        • CHRU Besançon
        • Chercheur principal:
          • Lucine VUITTON
        • Contact:
      • Bordeaux, France
        • CHU Bordeaux
        • Chercheur principal:
          • Pauline RIVIERE
        • Contact:
      • Clermont-Ferrand, France
        • Chu Clermont Ferrand
        • Chercheur principal:
          • Anthony Buisson
        • Contact:
      • Lille, France
        • CHU Lille
        • Chercheur principal:
          • Maria NACHURY
        • Contact:
      • Lyon, France
        • HCL
      • Marseille, France
        • AP-HM Hôpital Nord
        • Chercheur principal:
          • Lucas GUILLO
        • Contact:
      • Montpellier, France
        • CHU Montpellier
        • Chercheur principal:
          • Romain ALTWEGG
        • Contact:
      • Nancy, France
        • CHRU NANCY
        • Chercheur principal:
          • Benedicte Caron
        • Contact:
      • Nantes, France
        • CHU Nantes
        • Contact:
        • Chercheur principal:
          • Arnaud BOUREILLE
      • Nice, France
        • CHU NICE
        • Chercheur principal:
          • Adrien Nicolau
        • Contact:
      • Nîmes, France
        • CHU Nîmes
        • Chercheur principal:
          • Ludovic CAILLO
        • Contact:
      • Paris, France
        • Hôpital Bicêtre
        • Chercheur principal:
          • Aurelien Amiot
        • Contact:
      • Paris, France
        • Hopital Beaujon
        • Contact:
        • Chercheur principal:
          • Alexandre NUZZO
      • Paris, France
        • Hôpital Henri-Mondor
        • Chercheur principal:
          • Mathieu Uzzan
        • Contact:
      • Paris, France
      • Rennes, France
        • Chu Rennes
        • Chercheur principal:
          • Guillaume BOUGUEN
        • Contact:
      • Rouen, France
        • CHU Rouen
        • Chercheur principal:
          • Nicolas RICHARD
        • Contact:
      • Saint-Etienne, France
      • Toulon, France
      • Toulouse, France
        • CHU Toulouse
        • Contact:
        • Chercheur principal:
          • Cyrielle GILETTA

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: norme de soins
Expérimental: STOP, treatment withdrawal
Médicament: treatment withdrawal
the patients will stop their treatment, as long as possible until symptom reappearance, if any

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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.
Délai: 1 year
treatment safety, during the first 52 weeks of the follow-up.
1 year
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.
Délai: 1 year
treatment efficacy, during the first 52 weeks of the follow-up.
1 year
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.
Délai: 1 year
patient satisfaction during the first 52 weeks of the follow-up.
1 year

Mesures de résultats secondaires

Mesure des résultats
Délai
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.
Délai: 2 years
2 years
Remission rate at the end the first 52 weeks of the follow-up
Délai: 1 year
1 year
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.
Délai: 2 years
2 years
Partial Mayo score at each visit of the entire follow-up
Délai: 2 years
2 years
Number of days under treatment and cumulative dose of treatment per patient between randomization and primary endpoint
Délai: 1 year
1 year
Number of days under induction dose of JAK inhibitor at the end the first 52 weeks of the follow-up.
Délai: 1 year
1 year
Mayo endoscopic subscore at week 52 and week 104
Délai: 2 years
2 years
Proportion of patients relapsing for each arm
Délai: 2 years
2 years

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Assistance Publique Hopitaux De Marseille

Les enquêteurs

  • Chercheur principal: Lucas GUILLO, DR, AP-HM

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 janvier 2027

Achèvement primaire (Estimé)

1 janvier 2030

Achèvement de l'étude (Estimé)

1 janvier 2031

Dates d'inscription aux études

Première soumission

10 juillet 2026

Première soumission répondant aux critères de contrôle qualité

17 juillet 2026

Première publication (Réel)

22 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • RCAPHM24_0353 - STOP
  • 2026-525643-32-00 (Ctis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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