Cure8 trial brief
This trial is testing risankizumab in children with moderate-to-severe Crohn’s disease to learn how the drug behaves in kids, whether it’s safe, and whether it reduces disease activity — information that could expand pediatric treatment options if results are positive.
Pediatric patients with Crohn’s disease and their caregivers; pediatric gastroenterologists; clinicians treating children with biologics; researchers studying IL‑23 therapies.
This ClinicalTrials.gov record describes a Phase 3 interventional study testing risankizumab (an IL-23–targeting biologic) in children aged 2–17 with moderately to severely active Crohn’s disease.
The trial’s main goals are to measure pharmacokinetics (how the drug moves through the body), safety/adverse events, and effects on disease activity over roughly 64 weeks, with endoscopic eligibility and response assessed by SES‑CD.
The study enrolls pediatric participants with prior inadequate response or intolerance to standard therapies (steroids, immunomodulators, biologics, or aminosalicylates where permitted) and excludes those with major complications requiring surgery, active abscesses, symptomatic strictures, recent bowel resection, ostomy/pouch, or primary immunodeficiency.
Locations listed are pediatric centers in the U.S.; the record is provided by the sponsor (AbbVie) and is currently recruiting. This is a trial-record summary of the registered study design and eligibility; it does not report trial results.
Registered on ClinicalTrials.gov as a Phase 3 interventional study sponsored by AbbVie; record describes study design, eligibility, pharmacokinetic and safety endpoints, and locations. It is a trial record and does not contain outcome data.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
Market and late-stage trial updates can indicate which new therapies may become available and influence treatment options, access, and research priorities for Crohn's disease over the coming years.
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