Recruiting

Ustekinumab

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT07303686

Conditions

Crohn Disease (CD)

Ulcerative Colitis (UC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ustekinumab 90 mg SC q8w

Ustekinumab 90 mg SC q12w

Study Details

Brief 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.

Conditions

Crohn Disease (CD)

Ulcerative Colitis (UC)

Study ID

NCT07303686

Start date

Oct 8, 2025

Status verified date

Dec, 2025

Completion date

Oct 15, 2027

Anticipated

Primary completion date

Apr 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

115 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Ustekinumab Q4w

other: Ustekinumab Q8w

Interventions

Ustekinumab 90 mg SC q8w

Sub-group switching from Q4w to Q8w

Ustekinumab 90 mg SC q12w

Sub-group switching from Q8w to Q12w

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Waqqas Afif, MD

514-934-1943waqqas.afif@mcgill.ca

Locations

MUHC - Montreal General Hospital

Recruiting

Montreal, Quebec, Canada, H3G1A4

Contacts

Waqqas Afif, MD

514-934-1934miirecherche.ibdresearch@muhc.mcgill.ca

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Dec 26, 2025

Last verified

Dec, 2025

Keywords

  • CD
  • UC
  • ustekinumab
  • UST

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2025-12-26.