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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join 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 be able to join 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 this trial is running

• MUHC - Montreal General Hospital, Montreal, Quebec, Canada

Who to contact

Waqqas Afif, MD · 514-934-1943 · waqqas.afif@mcgill.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07303686.