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

RecruitingPhase 4Ages 18 Years - anyAllMcGill University Health Centre/Research Institut…
NCT07303686 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Ustekinumab 90 mg SC q8w
  • Ustekinumab 90 mg SC q12w
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Where

1 site
MUHC - Montreal General Hospital
Montreal, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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