RecruitingPhase 4NCT07303686

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

Pilot Study to Assess 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

Enrollment

115 participants

Start Date

Oct 8, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • 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

Exclusion Criteria5

  • 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

Interventions

BIOLOGICALUstekinumab 90 mg SC q8w

Sub-group switching from Q4w to Q8w

BIOLOGICALUstekinumab 90 mg SC q12w

Sub-group switching from Q8w to Q12w


Locations(1)

MUHC - Montreal General Hospital

Montreal, Quebec, Canada

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NCT07303686


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