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

Recruiting now · Phase 4

Conditions studied: Crohn Disease (CD), Ulcerative Colitis (UC)

In brief

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.

Key facts

Study ID

NCT07303686

Run by

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

People needed

115

Starts

2025-10-08

Expected to finish

2027-10-15

Last updated by the study team

2025-12-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• MUHC - Montreal General Hospital — Montreal, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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