NCT06298188 Risankizumab in Children With Crohn's Disease (RisaKids)
| NCT ID | NCT06298188 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shaare Zedek Medical Center |
| Condition | Crohn Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-10-31 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2024-10-31 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. The investigators will record clinical manifestations, blood markers and fecal calprotectin, with monitoring for safety signals including infusion and injection site reactions, pyrexia and infections at various intervals as outlined below. The investigators will also include calprotectin monitoring and fecal sample collection for microbiome and serum samples for drug levels. According to available budget, the investigators will also collect fecal and serum samples for metabolome. Samples collection is optional, thus failure of bio-samples collection will not exclude patients from the study.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06298188 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 18 Years, studying Crohn Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06298188 currently recruiting?
Yes, NCT06298188 is actively recruiting participants. Contact the research team at natalyk@szmc.org.il for enrollment information.
Where is the NCT06298188 trial being conducted?
This trial is being conducted at Jerusalem, Israel.
Who is sponsoring the NCT06298188 clinical trial?
NCT06298188 is sponsored by Shaare Zedek Medical Center. The trial plans to enroll 90 participants.