Recruiting
Phase 3

Upadacitinib & Infliximab

Sponsor:

McMaster University

Code:

NCT06660693

Conditions

Colitis, Ulcerative

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Upadacitinib Oral Product

Study Details

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

Study ID

NCT06660693

Start date

Apr 16, 2025

Status verified date

Jun, 2025

Completion date

Sep, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Inclusion Criteria: Adult (≥ 18 - 64 years) male or non-pregnant, non-lactating female patients with:

  • 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

Exclusion Criteria:

  • 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.
  • Patients with a history of hypersensitivity to infliximab, to other murine proteins, or to any of the excipients.
  • Patients who are hypersensitive to upadacitinib or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

Study Design

Enrollment

134 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Upadacitinib (treatment arm)

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

no intervention: Infliximab (standard care)

Participants will receive standard care, which is Infliximab.

Interventions

Upadacitinib Oral Product

Upadacitinib oral 45mg once daily.

Primary outcome measure

  • Measure treatment success of upadacitinib vs standard care. [ Time Frame: 16 weeks ]

Central Contacts and Locations

Central contacts

Neeraj Narula

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

Locations

Hamilton Health Sciences

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Contacts

Neeraj Narula, MD

905-521-2100neeraj.narula@medportal.ca

More Information

Sponsor

McMaster University

Last update posted

Jun 22, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by McMaster University on 2025-06-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.