NCT06298188

Risankizumab in Children With Crohn's Disease (RisaKids)

Risankizumab in Children With Crohn's Disease (RisaKids): A Multi-center PORTO Group Prospective Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Shaare Zedek Medical Center · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
DRUG	Risankizumab	Risankizumab

Timeline

• Start date: 2024-10-31
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2024-03-07
• Last updated: 2024-12-03

Locations

1 site across 1 country: Israel