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

NCT07303686 | Recruiting Phase 4

• 1 other identifier: 2020-5567
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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)

Keywords

CD; UC; ustekinumab; UST

Outcome Measures

Primary Outcomes (1)

• Loss of clinical remission

  Proportion of patients experiencing loss of remission

  From treatment switch to end of participation (12 months)

Secondary Outcomes (5)

• 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.

  12 months

• Change from Baseline in the calprotectin level at loss of remission.

  12 months

• Disease duration before loss of remission.

  Up to 50 years.

• Change in drug concentration before loss of remission.

  12 months

Study Arms (2)

Ustekinumab Q4w

OTHER

Biological: Ustekinumab 90 mg SC q8w

Ustekinumab Q8w

OTHER

Biological: Ustekinumab 90 mg SC q12w

Interventions

Ustekinumab 90 mg SC q8w BIOLOGICAL

Sub-group switching from Q4w to Q8w

Ustekinumab Q4w

Ustekinumab 90 mg SC q12w BIOLOGICAL

Sub-group switching from Q8w to Q12w

Ustekinumab Q8w

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Inc.: collaborator
• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

MUHC - Montreal General Hospital

Montreal, Quebec, H3G1A4, Canada

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Waqqas Afif, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: December 26, 2025
• Study Start: October 8, 2025
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): October 15, 2027
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

CA (1)