De-escalation of Ustekinumab Therapy in Patients With Crohn's Disease and Ulcerative Colitis
Phase 4 · Testing Ustekinumab 90 mg SC q8w and Ustekinumab 90 mg SC q12w · 1 site · McGill University Health Centre/Research Institute of the McGill University Health Centre
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Ustekinumab 90 mg SC q8w (a biologic) and Ustekinumab 90 mg SC q12w (a biologic) as a possible treatment. Condition(s) listed: Crohn Disease (CD) and Ulcerative Colitis (UC).
It is open-label: participants know what they are receiving.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Clinical remission
- Biochemical remission
- Endoscopy remission
Plus 5 more requirement(s). There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 115 participants are expected to take part.
- Start date: 2025-10-08.
- Main results expected around 2027-04-15 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Canada.
Main thing being measured
- Loss of clinical remission (From treatment switch to end of participation (12 months))
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Crohn Disease (CD); Ulcerative Colitis (UC) |
| Lead sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre |
| Collaborators | Janssen Inc. |
| Enrollment | 115 (estimated) |
| Start date | 2025-10-08 |
| Primary completion (est.) | 2027-04-15 |
| First posted | 2025-12-26 |
| Last updated | 2025-12-26 |
| Official title | Pilot Study to Assess De-escalation of Ustekinumab Therapy in Patients With Crohn's Disease and Ulcerative Colitis |
| ClinicalTrials.gov ID | NCT07303686 |
Interventions
- Ustekinumab 90 mg SC q8w (Biological)
Sub-group switching from Q4w to Q8w - Ustekinumab 90 mg SC q12w (Biological)
Sub-group switching from Q8w to Q12w
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| MUHC - Montreal General Hospital | Montreal, Quebec | Canada | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.