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

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.

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease (CD); Ulcerative Colitis (UC)
• Intervention / Treatment: Biological: Ustekinumab 90 mg SC q8w; Biological: Ustekinumab 90 mg SC q12w

Detailed Description

Participation in this research study will last 12 months and will include 4-6 visits.

• Study Type: Interventional
• Enrollment (Estimated): 115
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Waqqas Afif, MD; Phone Number: 36536 514-934-1943; Email: waqqas.afif@mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3G1A4
      • Recruiting
      • MUHC - Montreal General Hospital
      • Contact: Waqqas Afif, MD; Phone Number: 36536 514-934-1934; Email: miirecherche.ibdresearch@muhc.mcgill.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Ustekinumab Q4w	Biological: Ustekinumab 90 mg SC q8w; Sub-group switching from Q4w to Q8w
Other: Ustekinumab Q8w	Biological: Ustekinumab 90 mg SC q12w; Sub-group switching from Q8w to Q12w

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Loss of clinical remission	Proportion of patients experiencing loss of remission	From treatment switch to end of participation (12 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-to-loss of Remission		From treatment switch to end of participation (12 months)
Change from Baseline in the C-reactive protein (CRP) level at loss of remission.	To define if CRP level is a predictor of loss of remission.	12 months
Change from Baseline in the calprotectin level at loss of remission.	To define if calprotectin level is a predictor of loss of remission.	12 months
Disease duration before loss of remission.	Define if disease duration is a predictor of loss of remission.	Up to 50 years.
Change in drug concentration before loss of remission.	Define if drug concentration in blood is a predictor of loss of remission.	12 months

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborators: Janssen Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2025
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): October 15, 2027

Study Registration Dates

• First Submitted: October 2, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): December 26, 2025

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: CD; UC; ustekinumab; UST
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Crohn Disease; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Ustekinumab
• Other Study ID Numbers: 2020-5567

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No