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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. juli 2026 oppdatert av: 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

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

224

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: velferdstandard
Eksperimentell: STOP, treatment withdrawal
Legemiddel: treatment withdrawal
the patients will stop their treatment, as long as possible until symptom reappearance, if any

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 1 year
patient satisfaction during the first 52 weeks of the follow-up.
1 year

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Assistance Publique Hopitaux De Marseille

Etterforskere

  • Hovedetterforsker: Lucas GUILLO, DR, AP-HM

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. januar 2027

Primær fullføring (Antatt)

1. januar 2030

Studiet fullført (Antatt)

1. januar 2031

Datoer for studieregistrering

Først innsendt

10. juli 2026

Først innsendt som oppfylte QC-kriteriene

17. juli 2026

Først lagt ut (Faktiske)

22. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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