Efficacy of Upadacitinib Re-induction Therapy in Patients With Ulcerative Colitis Who Lost Respon… (NCT07700446) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Efficacy of Upadacitinib Re-induction Therapy in Patients With Ulcerative Colitis Who Lost Response to 30 mg Maintenance Dose
100 participantsStarted 2026-11-15
Plain-language 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.
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects must voluntarily sign and date an informed consent, approved by an IEC/IRB, prior to the initiation of any screening or study-specific procedures.
. Individuals at least 18 years old and less than 65 years.
. Laboratory values meeting the following criteria within the screening period prior to the first dose of study drug:
. Are willing and able to comply with procedures required in this protocol.
. Subjects must not be incarcerated and must be freely willing and able to provide informed consent. Examples of subjects unable to freely provide informed consent may include some adults under legal protection measures (e.g., under guardianship/curatorship) or unable to express their consent and select adults under psychiatric care. Investigator's discretion should be applied.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: from baseline to Wk8
Trial details
NCT IDNCT07700446
SponsorGroupe d'Etude Therapeutique des Affections Inflammatoires Digestives
. Diagnosis of moderate to severe active ulcerative colitis with a documented initial response to upadacitinib treatment (defined as adapted Mayo score of 5-9) and subsequent documented loss of response to upadacitinib 30 mg QD dose. This should be within 8 weeks of screening. This will allow for short term non-UC related flares to self-resolve, while at the same time allowing for adequate time interval between appointments.
. Subject has documented diagnosis of moderate to severe active UC with a modified Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 at the time of screening.
. Pregnancy testing in females of childbearing potential/individuals of childbearing potential; Contraception Recommendations of this protocol :
Exclusion criteria
. Subject with current diagnosis of Crohn's Disease or diagnosis of indeterminate colitis.
. Current diagnosis of fulminant colitis and/or toxic megacolon.
. History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
. Conditions that could interfere with drug absorption including but not limited to short bowel syndrome.
. History of colectomy (total or subtotal), ileoanal pouch, Kock pouch, or ileostomy or is planning bowel surgery.
. Subject has active TB or latent TB.
. Subject who received fecal microbial transplantation within 30 days prior to Baseline.
. Subject with new or chronic systemic use of known strong cytochrome P450 (CYP)3A inhibitors or strong CYP3A inducers while on UPA therapy should be evaluated by caring physician as to possibility of this medication being responsible for the loss of response to UPA. Herbal therapies and other traditional medicines are defined as any herbal formulation that is intended to treat or prevent health problems and may include supplements based on herbs which the subject is taking.