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RECRUITING
NCT07303686
PHASE4

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

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

115

Start Date

2025-10-08

Completion Date

2027-10-15

Last Updated

2025-12-26

Healthy Volunteers

No

Interventions

BIOLOGICAL

Ustekinumab 90 mg SC q8w

Sub-group switching from Q4w to Q8w

BIOLOGICAL

Ustekinumab 90 mg SC q12w

Sub-group switching from Q8w to Q12w

Locations (1)

MUHC - Montreal General Hospital

Montreal, Quebec, Canada