Using risankizumab to treat children with Crohn's disease
Risankizumab in Children With Crohn's Disease (RisaKids): A Multi-center PORTO Group Prospective Study
This study is testing how well the medication risankizumab works and how safe it is for children with Crohn's disease over one year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Shaare Zedek Medical Center Academic / other |
| Drugs / interventions | risankizumab |
| Locations | 1 site (Jerusalem) |
| Trial ID | NCT06298188 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the short and long-term outcomes of risankizumab in children diagnosed with Crohn's disease. Over a period of one year, the study will monitor clinical manifestations, blood markers, and fecal calprotectin levels, while also assessing safety signals such as infusion reactions and infections. Participants will have their microbiome and drug levels analyzed through optional fecal and serum sample collections. The study will provide valuable insights into the effectiveness and safety of risankizumab in a pediatric population.
Who should consider this trial
Good fit: Ideal candidates for this study are children under 18 years old who have been diagnosed with Crohn's disease and have started treatment with risankizumab.
Not a fit: Patients who are not diagnosed with Crohn's disease or are over the age of 18 will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for children suffering from Crohn's disease.
How similar studies have performed: While this approach is being explored in a pediatric population, similar studies in adults have shown promising results with risankizumab.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Jerusalem
- Shaare Zedek Medical Center — Jerusalem, Israel (Recruiting)
Study contacts
- Study coordinator: Nataly Kawazba
- Email: natalyk@szmc.org.il
- Phone: 97225645254
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.