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NCT06298188Not yet recruiting

Risankizumab in Children With Crohn's Disease (RisaKids)

Risankizumab in Children With Crohn's Disease (RisaKids): A Multi-center PORTO Group Prospective Study
Shaare Zedek Medical CenterClinicalTrials.govdrug
Study focus
Disease/Condition
Crohn Disease
Drug/Device/Intervention
Risankizumab
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Shaare Zedek Medical Center
Timeline & enrollment
Phase
N/A
Start date
Mar 01, 2024
End date
Oct 01, 2026
Enrollment
90 participants
Primary outcome

Co-primary outcomes: Complete remission at end of remission (weeks 12 and week 54)

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.

ICD-10 classifications
Crohn disease, unspecifiedOther Crohn diseaseCrohn disease of large intestineCrohn disease of small intestineCrohn disease [regional enteritis]
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06298188
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06298188 through Pure Global AI's free database. This phase not specified trial is sponsored by Shaare Zedek Medical Center and is currently Not yet recruiting. The study focuses on Crohn Disease. Target enrollment is 90 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.