De-escalation of Ustekinumab Therapy in Patients With Crohn's Disease and Ulcerative Colitis
Key facts
- Where
- Montreal, CanadaSee the site
- Phase
- Phase 4
Where in Canada
- MUHC- Montreal General HospitalMontreal, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Trial code
- NCT07303686
- Record updated
- 26 December 2025
- Original description
The goal of this clinical trial is to evaluate whether disease remission can be maintained when biologic therapy is reduced in patients with Crohn"s disease (CD) and ulcerative colitis (UC) taking ustekinumab (UST).Read full original descriptionShow less
Pilot Study to Assess De-escalation of Ustekinumab Therapy in Patients With Crohn's Disease and Ulcerative Colitis
The goal of this clinical trial is to evaluate whether disease remission can be maintained when biologic therapy is reduced in patients with Crohn"s disease (CD) and ulcerative colitis (UC) taking ustekinumab (UST).
The main question it aims to answer is:
Can we de-escalate UST subcutaneous dose either from every 4 weeks (Q4) to every 8 weeks (Q8) or every 8 weeks (Q8) to every 12 weeks (Q12) in CD or UC patients in deep remission without loosing their response? Researchers will follow UST blood levels, inflammation markers and intestinal mucosa integrity and to see if UST dose can be reduced while maintaining clinical remission.
Participants will:
Change UST dosing from Q4 to Q8 or from Q8 to Q12. Visit the clinic once every 12 weeks for checkups and tests.
Inclusion: Clinical remission; Biochemical remission; Endoscopy remission; Not on corticosteroid; A woman must be ; not of childbearing potential; of childbearing potential and practicing a medically accepted method of contraception; Able t provide informed consent.
Exclusion: On more than one biologics drug; Use of oral or topical steroids within 6months of study entry; Any issue that could lead to non-compliance, as alcohol, drug use; pregnancy; Unable to provide consent or t comply with follw-up visit.