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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 de julio de 2026 actualizado por: 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

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

224

Fase

  • Fase 4

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: estándar de cuidado
Experimental: STOP, treatment withdrawal
Droga: treatment withdrawal
the patients will stop their treatment, as long as possible until symptom reappearance, if any

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 1 year
patient satisfaction during the first 52 weeks of the follow-up.
1 year

Medidas de resultado secundarias

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Assistance Publique Hopitaux De Marseille

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de enero de 2027

Finalización primaria (Estimado)

1 de enero de 2030

Finalización del estudio (Estimado)

1 de enero de 2031

Fechas de registro del estudio

Enviado por primera vez

10 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

17 de julio de 2026

Publicado por primera vez (Actual)

22 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

17 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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