Risankizumab in Children With Crohn's Disease (RisaKids)

Not Applicable

Recruiting

• Conditions: Crohn Disease
• Interventions: Drug: Risankizumab

• Registration Number: NCT06298188
• Lead Sponsor: Shaare Zedek Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-24
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-29
• Study First Posted: 2024-03-07
• Study Start: 2024-10-31
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-03
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Risankizumab	Risankizumab	Induction regimen: 0,4,8 IV and then every 8 weeks sc

Primary Outcome Measures

Name	Time	Method
Co-primary outcomes: Complete remission at end of remission (weeks 12 and week 54)	Through study completion, approximately 3 years	Co-primary outcomes: Complete remission at end of remission (weeks 12 and week 54) as defined by the fulfilment of all three criteria: i. Corticosteroids and enteral nutrition free; ii. Clinical remission (i.e. PCDAI\<10); iii. CRP lower than 1 mg/dl (may be substituted by ESR if CRP missing)

Trial Locations

Locations (1)

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel