Colitis, UlcerativePhase 3RESCUE UCNCT06660693
Comparison of Medical RESCUE Strategies for Patients With Steroid-refractory Acute Severe Ulcerative Colitis
A Phase 3 study testing Upadacitinib Oral Product in people with Colitis, Ulcerative, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- Upadacitinib Oral Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteCanada
- Study dates
- 16 Apr 2025to Sep 2027
- Phase
- Phase 3
- 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
None listed.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2
Neeraj Narula, MD, 905-521-2100, neeraj.narula@medportal.ca
About this study
Official title: Comparison of Medical RESCUE Strategies for Patients With Steroid-refractory Acute Severe Ulcerative Colitis: an Open-label Randomized Controlled Trial (RESCUE-UC).
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.
Read the detailed description
In acute hospitalized severe, steroid refractory UC, only two medical rescue therapies have been found efficacious in controlled trials and recommended in management, infliximab and cyclosporine. Due to toxicity and nuance in using cyclosporine, infliximab is by far the most commonly used medical rescue therapy in this setting. There is emerging retrospective and prospective case series data suggesting JAK inhibitors, such as tofacitinib or upadacitinib, could also be used for this patient population. JAK inhibitors offer potential advantages including convenience of oral therapy, efficacy independent of serum albumin levels, and no concern for immunogenicity as is seen with anti-TNFs. They also offer a short half-life and are eliminated by humans within 48 hours of the last dose administered. This could be beneficial, as it may offer a chance to use a JAK inhibitor first and switch to infliximab in patients who do not respond to a JAK inhibitor, as theoretically cumulative immunosuppression should not be as high transitioning from a JAK inhibitor to infliximab, as compared to using JAK inhibitor after infliximab failure since there will still be lots of infliximab present owing to its long half-life. It is unclear how JAK inhibitors compare to our standard of care and where they should be positioned in acute severe UC. 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
- Being tested
- Upadacitinib Oral Product
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upadacitinib Oral ProductDrug
Upadacitinib oral 45mg once daily.
| Study group | Role | What they receive |
|---|---|---|
| Upadacitinib (treatment arm) | Active comparator | Participants will receive Upadacitinib 45mg daily, once a day, for at least five days. Receives: Drug: Upadacitinib Oral Product |
| Infliximab (standard care) | No intervention | Participants will receive standard care, which is Infliximab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start16 Apr 2025
- Primary completionMay 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, pragmatic, multi-centre, randomized control trial.
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie
- Responsible party
- Principal investigator, Neeraj Narula, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660693
- Sponsor's protocol ID
- RESCUE-UC
- Acronym
- RESCUE UC
- Status last verified
- Jun 2025
- First submitted
- 25 Oct 2024
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Medical RESCUE Strategies for Patients With Steroid-refractory Acute Severe Ulcerative Colitis: an Open-label Randomized Controlled Trial (RESCUE-UC).
- ClinicalTrials.gov ID
- NCT06660693
- Acronym / sponsor ID
- RESCUE UC / RESCUE-UC
- Conditions
- Colitis, Ulcerative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- AbbVie
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In acute hospitalized severe, steroid refractory UC, only two medical rescue therapies have been found efficacious in controlled trials and recommended in management, infliximab and cyclosporine. Due to toxicity and nuance in using cyclosporine, infliximab is by far the most commonly used medical rescue therapy in this setting. There is emerging retrospective and prospective case series data suggesting JAK inhibitors, such as tofacitinib or upadacitinib, could also be used for this patient population. JAK inhibitors offer potential advantages including convenience of oral therapy, efficacy independent of serum albumin levels, and no concern for immunogenicity as is seen with anti-TNFs. They also offer a short half-life and are eliminated by humans within 48 hours of the last dose administered. This could be beneficial, as it may offer a chance to use a JAK inhibitor first and switch to infliximab in patients who do not respond to a JAK inhibitor, as theoretically cumulative immunosuppression should not be as high transitioning from a JAK inhibitor to infliximab, as compared to using JAK inhibitor after infliximab failure since there will still be lots of infliximab present owing to its long half-life. It is unclear how JAK inhibitors compare to our standard of care and where they should be positioned in acute severe UC. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, pragmatic, multi-centre, randomized control trial.
| Arm | Type | Receives |
|---|---|---|
| Upadacitinib (treatment arm) | Active comparator | Drug: Upadacitinib Oral ProductParticipants will receive Upadacitinib 45mg daily, once a day, for at least five days. |
| Infliximab (standard care) | No intervention | –Participants will receive standard care, which is Infliximab. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upadacitinib Oral ProductUpadacitinib oral 45mg once daily. | Drug | Upadacitinib (treatment arm) |
Primary outcome
Measure treatment success of upadacitinib vs standard care.
Time frame: 16 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Upadacitinib Oral Product in people with Colitis, Ulcerative, run by McMaster University at 1 site in Canada.
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 0 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Neeraj Narula (905-521-2011, neeraj.narula@medportal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure treatment success of upadacitinib vs standard care. (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2025.