Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07303686 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07303686
Lead Sponsor McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators: Janssen Inc.
Conditions
(from sponsor)		 Crohn Disease (CD), Ulcerative Colitis (UC)
Related terms Colitis, Ulcerative, Crohn Disease
Enrollment 115 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov