Reducing ustekinumab dosing for Crohn's disease and ulcerative colitis
Official title: Pilot Study to Assess De-escalation of Ustekinumab Therapy in Patients With Crohn's Disease and Ulcerative Colitis
Run by McGill University Health Centre/Research Institute of the McGill University Health Centre · NCT07303686 · Data updated 2026-11-12
This will try giving ustekinumab less often—changing from every 4 or 8 weeks to every 8 or 12 weeks—to see if people with Crohn's disease or ulcerative colitis in deep remission can stay well.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 115 (estimated) |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Drugs / interventions | ustekinumab |
| Locations | 1 site (Montreal, Quebec) |
| Status | Recruiting |
| Started | October 8, 2025 |
| Main results expected | April 15, 2027 |
| Study ends | October 15, 2027 |
| Registry record updated | December 26, 2025 |
| Trial ID | NCT07303686 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with Crohn's disease or ulcerative colitis in clinical, biochemical, and endoscopic remission on ustekinumab who are off corticosteroids and able to attend follow-up visits and provide informed consent.
✕Probably not a fit
Patients not in deep remission, those using corticosteroids or multiple biologics, pregnant individuals, or people unable to comply with visits or follow-up are unlikely to benefit from dose reduction.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with Crohn's disease or ulcerative colitis who are in deep remission on ustekinumab will switch from 90 mg subcutaneous injections every 4 weeks to every 8 weeks, or from every 8 weeks to every 12 weeks, and be followed for 12 months. Clinic visits are scheduled roughly every 12 weeks for blood tests, measurement of drug levels and inflammatory markers, and periodic endoscopic assessment of mucosal healing. Investigators will track clinical, biochemical, and endoscopic remission rates and monitor for disease relapse after dose reduction. The goal is to determine whether less frequent dosing maintains remission while reducing medication exposure.
Why it matters
Potential benefit: If successful, patients could remain in remission with fewer injections, which may reduce side effects, costs, and clinic visits.
How similar studies have gone: Dose de-escalation of biologic therapies has been explored in other IBD studies with mixed results, and there is limited specific evidence for ustekinumab, so this approach remains relatively under-tested for UST.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * On more than one biologics drug * Use of oral or topical steroids within 6months of study entry * pregnancy * Any issue that could lead to non-compliance, as alcohol, drug use * Unable to provide consent or t comply with follw-up visit
Where it's running
-
MUHC - Montreal General Hospital
Montreal, Quebec, Canada Recruiting
Study contacts
- Study coordinator: Waqqas Afif, MD
- Email: waqqas.afif@mcgill.ca
- Phone: 514-934-1943
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.