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

Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Study ID
NCT07700446
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Ulcerative Colitis (UC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Upadacitinib — DRUG
    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.

Study Details

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.

Key Dates

First listed
Jul 14, 2026
Start date
Nov 15, 2026
Status verified
Jul 2026
Primary completion
Nov 30, 2029
Completion
Apr 30, 2030

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Upadacitinib re-induction strategy
    Patients with moderate to severe active UC who have had a loss of response to upadacitinib 30 mg maintenance dose will receive receive higher dose of upadacitinib for a specified period. Followed by a 52-week maintenance phase with upadacitinib 30 mg QD.

Primary Outcome Measure

To determine the rate of re-capture of clinical response in subjects with moderate to severe active ulcerative colitis who had a loss of response to upadacitinib 30 mg QD maintenance dose prior to the study entry. [ Time Frame: from baseline to Wk8 ]

Central Contacts

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