RecruitingPhase 4NCT07303686

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

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

Sponsor

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

Enrollment

115 participants

Start Date

Oct 8, 2025

Study Type

INTERVENTIONAL

Conditions

Ulcerative Colitis (UC)Crohn Disease (CD)

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether patients with Crohn's disease or ulcerative colitis who are in full remission can safely reduce (de-escalate) their dose of ustekinumab — a biologic medication used to control these inflammatory bowel conditions. The goal is to find out if reducing the dose maintains remission while potentially reducing side effects and costs. **You may be eligible if...** - You have Crohn's disease or ulcerative colitis - You are currently in complete remission — no symptoms, normal blood markers, and normal colonoscopy findings - You are not taking corticosteroids - You are using only ustekinumab (not in combination with another biologic) **You may NOT be eligible if...** - You are taking more than one biologic medication - You have used oral or topical steroids within the past 6 months - You are pregnant - You have drug or alcohol use issues that could affect compliance - You are unable to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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