De-escalation of Ustekinumab Therapy in Patients With Crohn's Disease and Ulcerative Colitis
NCT ID: NCT07303686
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
115 participants
INTERVENTIONAL
2025-10-08
2027-10-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ustekinumab Q4w
Ustekinumab 90 mg SC q8w
Sub-group switching from Q4w to Q8w
Ustekinumab Q8w
Ustekinumab 90 mg SC q12w
Sub-group switching from Q8w to Q12w
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ustekinumab 90 mg SC q8w
Sub-group switching from Q4w to Q8w
Ustekinumab 90 mg SC q12w
Sub-group switching from Q8w to Q12w
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Janssen Inc.
INDUSTRY
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
waqqas.afif
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
MUHC - Montreal General Hospital
Montreal, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Waqqas Afif, MD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020-5567
Identifier Type: -
Identifier Source: org_study_id