Risankizumab in Children With Crohn's Disease (RisaKids)

Sponsor
Shaare Zedek Medical Center
Study ID
NCT06298188
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 31, 2024
Status verified
Feb 2024
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Risankizumab
    Induction regimen: 0,4,8 IV and then every 8 weeks sc

Primary Outcome Measure

Co-primary outcomes: Complete remission at end of remission (weeks 12 and week 54) [ Time Frame: Through study completion, approximately 3 years ]

Central Contacts

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