NCT07303686RecruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 26 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 115 (estimated)
- First submitted
- 2 Oct 2025
- Start date
- 8 Oct 2025
- Primary completion date
- 15 Apr 2027
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT07303686
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 115
- From 8 Oct 2025 to the primary completion date, 15 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- On more than one biologics drug
- Use of oral or topical steroids within 6months of study entry
- Any issue that could lead to non-compliance, as alcohol, drug use
Other
- pregnancy
- Unable to provide consent or t comply with follw-up visit
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| MUHC- Montreal General Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.