Crohn Disease study: Ustekinumab
Official title De-escalation of Ustekinumab Therapy in Patients With Crohn's Disease and Ulcerative Colitis
ClinicalTrials.gov ID: NCT07303686
What this study is testing
What is Ustekinumab 90 mg SC q8w?
Ustekinumab 90 mg SC q8w is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for crohn disease (cd).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if reducing the dose of ustekinumab, from every 4 weeks to every 8 weeks, or from every 8 weeks to every 12 weeks, keeps patients in remission.
- Who it's for
- Adults with Crohn’s disease or ulcerative colitis who are already in deep remission while on ustekinumab.
- What's involved
- Participants will change their ustekinumab injection schedule and visit the clinic every 12 weeks for check‑ups and tests to monitor drug levels and inflammation.
- Time commitment
- The study lasts until the next scheduled visit, with clinic visits every 12 weeks to track progress.
- Phase 4: studies an already-approved treatment
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Clinical remission
- Biochemical remission
- Endoscopy remission
- Not on corticosteroid
- A woman must be ;
You likely can't join 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Montreal, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.