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Efficacy of Upadacitinib Re-induction Therapy in Patients With Ulcerative Colitis Who Lost Response to 30 mg Maintenance Dose

NCT07700446 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-07-31

No results posted yet for this study

Summary

ReCOUP is a multicenter clinical study designed to evaluate the efficacy of upadacitinib (Rinvoq®) in patients with ulcerative colitis whose disease has become active again despite maintenance treatment with upadacitinib 30 mg.

This study involves adult patients aged 18 to 64 years with active ulcerative colitis, who are being treated with upadacitinib and are not participating in another interventional clinical trial.

Participation in this study will depend on the patients' response to treatment during the 52-week maintenance period.

Several follow-up visits will be scheduled throughout the study according to a timetable defined by the protocol, and additional visits may be arranged if necessary depending on patients' health status.

Conditions

  • Ulcerative Colitis (UC)

Interventions

DRUG

Upadacitinib

Upadacitinib is a selective JAK1 inhibitor. In this study, patients receive higher dose of upadacitinib as re-induction strategy. in the first timepoint, patients are managed according to disease response : patients without clinical response continue on higher updacatinib dose , patients with clinical response undergo endoscopy : patients with a positive endoscopy continue higher upadacitinib dose and patients with a negative endoscopy transition to the maintenance dose.

Sponsors & Collaborators

  • Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

    lead OTHER

Principal Investigators

  • Lucine Vuitton · CHU de Besançon, FRANCE

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-15
Primary Completion
2029-11-30
Completion
2030-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07700446 on ClinicalTrials.gov