Comparison of Medical RESCUE Strategies for Patients With Steroid-refractory Acute Severe Ulcerative Colitis

NCT06660693 | Recruiting Phase 3 DMC

• 1 other identifier: RESCUE-UC
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to examine patients with acute severe UC who are refractory to intravenous corticosteroids and determine whether a strategy of using upadacitinib first followed by infliximab in upadacitinib non-responders is non-inferior to conventional management with infliximab only.

Conditions

Colitis, Ulcerative

Outcome Measures

Primary Outcomes (1)

• Measure treatment success of upadacitinib vs standard care.

  The primary objective of this study is to evaluate whether treatment success in ASUC patients in patients treated with strategy U is non-inferior to strategy C after 16 weeks of initiating therapeutic management.

  16 weeks

Study Arms (2)

Upadacitinib (treatment arm)

ACTIVE COMPARATOR

Participants will receive Upadacitinib 45mg daily, once a day, for at least five days.

Drug: Upadacitinib Oral Product

Infliximab (standard care)

NO INTERVENTION

Participants will receive standard care, which is Infliximab.

Interventions

Upadacitinib Oral Product DRUG

Upadacitinib oral 45mg once daily.

Upadacitinib (treatment arm)

Eligibility Criteria

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

You may qualify if:

• Confirmed diagnosis of UC, based on conventional clinical, endoscopic, and/or histologic criteria
• Admitted to hospital with acute severe flare and refractory to three days of intravenous steroids (at minimum of 40mg methylprednisolone, or equivalent, daily). Refractory is defined using the Oxford criteria at day 3 of steroid therapy: presence of \> 8 stools/day or CRP \> 45 mg/L
• Will undergo or has already undergone a baseline colonoscopy or flexible sigmoidoscopy while in hospital or in the 4 weeks preceding trial entry, with a baseline MES ≥2 based on locally evaluated endoscopy
• Provided written informed consent
• Subject is willing and able to adhere to study procedures, and describe in the procedures that screening and safety monitoring procedures will be applied as per upadacitinib and infliximab Canadian product monographs

You may not qualify if:

• Contraindications to receiving either infliximab or upadacitinib (as per current Canadian product monograph)
• Previously used infliximab or a JAK inhibitor for UC
• Patients \> 65 years of age
• Pregnant or breastfeeding
• Women of reproductive potential who are unwilling to agree to using effective contraception during treatment and 4 weeks following the final dose of upadacitinib
• Concurrent Clostridium difficile, other gastrointestinal infection, or other active systemic or localized infection which would preclude treatment with systemically acting biologic or small molecule therapy
• Patients with symptoms of thrombosis, or confirmed venous or arterial thromboembolism
• Active TB (patients should be tested for TB prior to upadacitinib or infliximab treatment)
• HBV/HCV positive
• Untreated malignancy or ongoing treatment for malignancy
• Concomitant treatment with strong CYP3A4 inhibitors or inducers
• Severe hepatic impairment
• Severe renal impairment (CrCl \< 30 ml/min)
• Patients who have received live vaccines in the 28 days prior to study entry.
• Patients with moderate or severe (NYHA Class III/IV) congestive heart failure.

Sponsors & Collaborators

• McMaster University: lead
• AbbVie: collaborator

Study Sites (1)

Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Neeraj Narula

CONTACT

905-521-2011; neeraj.narula@medportal.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Open-label, pragmatic, multi-centre, randomized control trial.

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 28, 2024
• Study Start: April 16, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

CA (1)