Colitis, Ulcerative study: Upadacitinib Oral Product
Official title Comparison of Medical RESCUE Strategies for Patients With Steroid-refractory Acute Severe Ulcerative Colitis
ClinicalTrials.gov ID: NCT06660693
What this study is testing
What is Upadacitinib Oral Product?
An investigational oral medicine being studied as a potential treatment for acute severe ulcerative colitis. It is designed to inhibit Janus kinase (JAK) signaling pathways, which helps reduce inflammation.
Also referred to as upadacitinib.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if starting with upadacitinib and switching to infliximab for non‑responders is not worse than giving infliximab right away.
- Who it's for
- Adults with acute severe ulcerative colitis who have not improved after intravenous corticosteroids.
- What's involved
- Participants will receive upadacitinib; those who do not respond will then receive infliximab. Another group will receive infliximab from the start. The trial includes regular clinic visits and standard safety tests.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join 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...
- Will undergo or has already undergone a baseline colonoscopy or flexible sigmoidoscopy while in hospital or in the 4 weeks preceding trial entry...
- 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...
You likely can't join 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...
- Concurrent Clostridium difficile, other gastrointestinal infection, or other active systemic or localized infection which would preclude treatment...
See the full eligibility criteria
- 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).
- 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
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Hamilton, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Hamilton, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.