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
Study ID
NCT07303686
Phase
PHASE4
Status
Recruiting
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Conditions

  • Crohn Disease (CD)
  • Ulcerative Colitis (UC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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 Dates

Start date
Oct 8, 2025
Status verified
Dec 2025
Primary completion
Apr 15, 2027
Completion
Oct 15, 2027

Study Design

Enrollment
115 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Ustekinumab Q4w
  • Other: Ustekinumab Q8w

Primary Outcome Measure

Loss of clinical remission [ Time Frame: From treatment switch to end of participation (12 months) ]

Central Contacts

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