De-escalation of Ustekinumab Therapy in Patients With Crohn's Disease and Ulcerative Colitis

NCT07303686 · tracked via the Priya Life Science Canada tracker

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Phase

Phase 4

Started

2025-10-08

Last updated

2025-12-26

Condition(s) studied

Crohn Disease (CD)Ulcerative Colitis (UC)

Investigational drug(s) / intervention(s)

Ustekinumab 90 mg SC q8w →Ustekinumab 90 mg SC q12w →

Ustekinumab 90 mg SC q8w: Sub-group switching from Q4w to Q8w

Ustekinumab 90 mg SC q12w: Sub-group switching from Q8w to Q12w

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Loss of clinical remission — From treatment switch to end of participation (12 months)
Proportion of patients experiencing loss of remission

Trial sites (1)

Facility	City	Region	Status
MUHC - Montreal General Hospital	Montreal	Quebec	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07303686 on ClinicalTrials.gov ↗ ← All trials in Canada