Risankizumab in Children With Crohn's Disease (RisaKids)
Not applicable · Testing Risankizumab · 1 site · Shaare Zedek Medical Center
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Risankizumab (a drug) as a possible treatment. Condition(s) listed: Crohn Disease.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 6 to 18
- Any sex
Some of the main requirements, copied from the record:
- Children under the age of 18 years,
- Patients diagnosed with CD.
- Patients commenced on risankizumab by treating physician (at least one dose), either alone or in combination with any other CD medications, at any stage of the disease.
There are also 1 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 90 participants are expected to take part.
- Start date: 2024-10-31.
- Main results expected around 2026-10 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Israel.
Main thing being measured
- Co-primary outcomes: Complete remission at end of remission (weeks 12 and week 54) (Through study completion, approximately 3 years)
In the researchers’ words
The goal of this observational study is to to prospectively explore the real life short (12 weeks) and longer term (54 weeks) clinical, biochemical and endoscopic outcomes of risankizumab in pediatric CD. This is a 1-year prospective multi-center cohort study of children commencing on risankizumab for pediatric CD with 2 years extension for long-term follow-up.
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 | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease |
| Lead sponsor | Shaare Zedek Medical Center |
| Enrollment | 90 (estimated) |
| Start date | 2024-10-31 |
| Primary completion (est.) | 2026-10 |
| First posted | 2024-03-07 |
| Last updated | 2024-12-03 |
| Official title | Risankizumab in Children With Crohn's Disease (RisaKids): A Multi-center PORTO Group Prospective Study |
| ClinicalTrials.gov ID | NCT06298188 |
Interventions
- Risankizumab (Drug)
Risankizumab
Full eligibility criteria (from the record)
Inclusion Criteria: * Children under the age of 18 years, * Patients diagnosed with CD. * Patients commenced on risankizumab by treating physician (at least one dose), either alone or in combination with any other CD medications, at any stage of the disease. Exclusion Criteria: * There will be no exclusion criteria to this study.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Shaare Zedek Medical Center | Jerusalem | Israel | 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.