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

NCT07700446 | Not Yet Recruiting Phase 4

• 2 other identifiers: GETAID-2026-012026-526174-16-00
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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)

Keywords

ulcerative colitis; upadacitinib; re-induction

Outcome Measures

Primary Outcomes (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.

  from baseline to Wk8

Secondary Outcomes (4)

• To determine the proportion of subjects achieving clinical response

  From baseline to Wk8

• To determine the proportion of subjects achieving clinical response

  Frome baseline to Wk16

• To determine the rate of clinical remission

  Frome baseline to wk8 and wk16

• To determine the proportion of subjects achieving clinical remission

  Frome basline to 52-week maintenance period.

Study Arms (1)

Upadacitinib re-induction strategy

EXPERIMENTAL

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.

Drug: Upadacitinib

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.

Upadacitinib re-induction strategy

Eligibility Criteria

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

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives: lead

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

upadacitinib

Condition Hierarchy (Ancestors)

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

Study Officials

• Lucine Vuitton

  CHU de Besançon, FRANCE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Project Director Getaid

CONTACT

+33 (0)9 72 57 61 60; jmussot@getaid.org

Study Design

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

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start (Estimated): November 15, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): April 1, 2030
• Last Updated: July 31, 2026

Record last verified: 2026-07