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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 julho de 2026 atualizado 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

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

224

Estágio

  • Fase 4

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: padrão de atendimento
Experimental: STOP, treatment withdrawal
Medicamento: treatment withdrawal
the patients will stop their treatment, as long as possible until symptom reappearance, if any

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
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.
Prazo: 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.
Prazo: 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.
Prazo: 1 year
patient satisfaction during the first 52 weeks of the follow-up.
1 year

Medidas de resultados secundários

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Assistance Publique Hopitaux De Marseille

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de janeiro de 2027

Conclusão Primária (Estimado)

1 de janeiro de 2030

Conclusão do estudo (Estimado)

1 de janeiro de 2031

Datas de inscrição no estudo

Enviado pela primeira vez

10 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de julho de 2026

Primeira postagem (Real)

22 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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