Risankizumab in Children With Crohn's Disease (RisaKids)

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06298188
• Other study ID #: RisaKids
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: October 2026

Study information

• Verified date: February 2024
• Source: Shaare Zedek Medical Center
• Contact: Chen Shubeli
• Phone: 97225645254
• Email: chenn[@]szmc.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: October 2026
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• Risankizumab
Risankizumab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Co-primary outcomes: Complete remission at end of remission (weeks 12 and week 54)	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)	Through study completion, approximately 3 years