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Ulcerative Colitis (UC)Phase 4ReCOUPNCT07700446

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

A Phase 4 study testing Upadacitinib in people with Ulcerative Colitis (UC), run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Ulcerative Colitis (UC)
What is being tested?
Upadacitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
15 Nov 2026to Apr 2030
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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:
  • Serum alanine transaminase (ALT) < 2 × ULN;
  • Serum aspartate aminotransferase (AST) < 2 x ULN;
  • Estimated glomerular filtration rate (GFR) by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula > 0 mL/min/1.73 m2;
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  • Total white blood cell (WBC) count > 2,500/μL;
  • Absolute neutrophil count (ANC) > 1,500/μL;
  • Platelet count > 100,000/μL;
  • Absolute lymphocyte count > 850/μL;
  • Hemoglobin > 10 g/dL.
  • 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.
  • 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 :
  • Females of childbearing potential/Individuals of childbearing potential must have a negative serum pregnancy test at the Screening Visit.
  • Female subjects of childbearing potential must practice at least 1 protocol-specified method of birth control, from Study Day 1 through at least 30 days after the last dose of study drug. Female subjects of nonchildbearing potential do not need to use birth control.

Who cannot join

  • 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.
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  • 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.
  • Subject currently receiving total parenteral nutrition (TPN) or plan to receive TPN at any time during study treatment.
  • Subject with positive C. difficile toxin stool assay during screening.
  • Infection(s) requiring treatment with intravenous anti-infectives within 30 days prior to the Baseline visit or oral/intramuscular anti-infectives within 14 days prior to the baseline visit.
  • Chronic recurring infection and/or active viral infection that, based on the investigator's clinical assessment, makes the subject an unsuitable candidate for the study
  • Subject has current or past history of recurrent or disseminated (even a single episode) herpes zoster
  • Subject has current or past history of disseminated (even a single episode) herpes simplex
  • Prior or current gastrointestinal (GI) dysplasia, other than completely removed dysplastic lesion in any biopsy performed during or before the screening endoscopy.
  • History of any malignancy, except for successfully treated nonmelanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix.
  • History of gastrointestinal (GI) perforation (other than due to appendicitis or mechanical injury), diverticulitis, or significantly increased risk of GI perforation per investigator's judgment.
  • History of an allergic reaction or significant sensitivity to constituents of upadacitinib (and its excipients)
  • Subject who previously received stem cell transplantation
  • Subject has been a previous recipient of an organ transplant which requires continued immunosuppression.
  • History of cerebrovascular accident, myocardial infarction, coronary stenting, or aortocoronary bypass stenting or retinal vein occlusion; however, if the investigator determines there are no suitable treatment alternatives available for a subject who has experienced one of these events more than 6 months prior to the Baseline visit, the investigator must document a favorable benefit-risk assessment to justify the subject's inclusion in the study.
  • In patients with known VTE risk factors other than cardiovascular or alignancy risk factors, participation in this clinical trial is considered the most suitable treatment option among treatment alternatives and the risks and benefits have been discussed with the subject.
  • A serious AE or AE that is identified or a possible risk of UPA during prior treatment with upadacitinib that is deemed to have a causal relationship with upadacitinib by Investigator
  • Subjects who have been treated with any investigational drug of chemical or biologic nature within 30 days or five half-lives (whichever is longer) prior to the first dose of study treatment or who are currently enrolled in another interventional clinical study.
  • Received treatment with rectal aminosalicylates or corticosteroids, other enemas/suppositories (other than required for endoscopy), within 7 days prior to the Screening endoscopy and during the remainder of the Screening Period.
  • Received cyclosporine, tacrolimus, mycophenolate mofetil or thalidomide within 30 days prior to Baseline.
  • Subjects who received azathioprine or 6-mercaptopurine within 10 days of Baseline.
  • Subjects who received intravenous corticosteroids within 14 days prior to screening or during the screening period.
  • Subjects who require corticosteroids to remain in the study
  • Subject who received non-steroidal anti-inflammatory drugs (NSAIDs) (except topicalNSAIDs and the useof low dose aspirin for cardiovascular [CV] protection) within 7 days prior to baseline

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Project Director Getaid contact

+33 (0)9 72 57 61 60

jmussot@getaid.org

About this study

Official title: A Single Arm, Multicenter Open-Label Interventional to Evaluate the Efficacy of Upadacitinib Re-induction Therapy in Patients With Ulcerative Colitis Who Lost Response to 30 mg Maintenance Dose

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.

Read more

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.

Being tested
Upadacitinib
Keywords
ulcerative colitis, upadacitinib, re-induction
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UpadacitinibDrug

    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 groups in NCT07700446
Study groupRoleWhat they receive
Upadacitinib re-induction strategyExperimentalPatients 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.
Receives: Drug: Upadacitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: from baseline to Wk8

Secondary outcomes (4)

  1. To determine the proportion of subjects achieving clinical response

    Measured: From baseline to Week 8

  2. To determine the proportion of subjects achieving clinical response

    Measured: Frome baseline to Week 16

  3. To determine the rate of clinical remission

    Measured: Frome baseline to week 8 and week 16

  4. To determine the proportion of subjects achieving clinical remission

    Measured: Frome basline to 52-week maintenance period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2026
  2. Study start15 Nov 2026 (estimated)
  3. Primary completionNov 2029 (estimated)
  4. Study completionApr 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07700446
Sponsor's protocol ID
GETAID-2026-01
Other IDs
2026-526174-16-00
Acronym
ReCOUP
Status last verified
Jul 2026
First submitted
8 Jul 2026
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Upadacitinib in people with Ulcerative Colitis (UC), run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Project Director Getaid (+33 (0)9 72 57 61 60, jmussot@getaid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07700446.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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