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

NCT07718529 | Not Yet Recruiting Phase 4 DMC

• 2 other identifiers: RCAPHM24_0353 - STOP2026-525643-32-00
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 22

Brief 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

Conditions

Ulcerative Colitis in Remission

Keywords

ulcerative colitis; treatment removal

Outcome Measures

Primary Outcomes (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.

  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.

  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.

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

  1 year

Secondary Outcomes (8)

• 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.

  2 years

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

  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.

  2 years

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

  2 years

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

  1 year

Study Arms (2)

standard of care

NO INTERVENTION

STOP, treatment withdrawal

EXPERIMENTAL

Drug: treatment withdrawal

Interventions

treatment withdrawal DRUG

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

STOP, treatment withdrawal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of UC from at least 6 months according to clinical, endoscopic, histological and/or radiological criteria.
• Male or female age ≥ 18 years
• Currently treated by JAK inhibitor (tofacitinib, upadacitinib or filgotinib) for more than 12 months.
• 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.
• 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).
• Fecal calprotectin ≤ 150μg/g.
• Without known risk factors for venous thromboembolism (VTE).
• Without known risk factors for major adverse cardiovascular events (MACE).
• Without known risk factors for malignancy.
• 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.
• Patients able to understand information provide to them and to give written informed consent for study.
• Affiliation to a social security scheme.
• Good general health according to history and clinical examination.

You may not qualify if:

• Steroid use ≤ 6 months prior to enrolment.
• Currently treated by steroid, immunosuppressive agents or biologics.
• Pregnancy or planned pregnancy during the study.
• Breastfeeding.
• Non-compliant subject or inability to follow study protocol.
• Intolerance of JAK inhibitors (excipients included) or severe adverse event.
• Contraindications to using a JAK inhibitor (excipients included).
• Known risk factors for VTE.
• Known risk factors for MACE.
• Active neoplasia or history of malignant tumours less than 5 years old.
• Participation to another interventional study protocol (except for RIPH3 studies)
• Severe hepatic insufficiency.
• Severe to end-stage renal insufficiency.
• Active tuberculosis, serious infections such as septicemia or opportunistic infections.
• Absence or refusal of informed consent.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (22)

CHU Amiens-Picardie

Amiens, France

Location

Centre Hospitalier d'Avignon

Avignon, France

Location

CHRU Besançon

Besançon, France

Location

CHU Bordeaux

Bordeaux, France

Location

CHU Clermont Ferrand

Clermont-Ferrand, France

Location

Chu Lille

Lille, France

Location

HCL

Lyon, France

Location

AP-HM hopital Nord

Marseille, France

Location

CHU Montpellier

Montpellier, France

Location

CHRU Nancy

Nancy, France

Location

CHU Nantes

Nantes, France

Location

CHU Nice

Nice, France

Location

CHU Nîmes

Nîmes, France

Location

Hôpital Beaujon

Paris, France

Location

Hôpital Bicêtre

Paris, France

Location

Hôpital Henri-Mondor

Paris, France

Location

Institut des MICI

Paris, France

Location

Chu Rennes

Rennes, France

Location

CHU Rouen

Rouen, France

Location

CHU St Etienne

Saint-Etienne, France

Location

Chits Toulon

Toulon, France

Location

CHU Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Lucas GUILLO, DR

  AP-HM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amandine ROLLAND-BRUN

CONTACT

+33 04 91 38 12 45; amandine.rolland@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 22, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2031
• Last Updated: July 22, 2026

Record last verified: 2026-07

Locations

FR (22)