MedTrace Logo

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

NCT07303686 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2025-12-26

No results posted yet for this study

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)

Interventions

BIOLOGICAL

Ustekinumab 90 mg SC q8w

Sub-group switching from Q4w to Q8w

BIOLOGICAL

Ustekinumab 90 mg SC q12w

Sub-group switching from Q8w to Q12w

Sponsors & Collaborators

  • Janssen Inc.

    collaborator INDUSTRY

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

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-08
Primary Completion
2027-04-15
Completion
2027-10-15

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07303686 on ClinicalTrials.gov