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Assessing the effects of risankizumab in children with Crohn's Disease

A Phase 3, Multi-Center Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Risankizumab With Open-Label Induction, Randomized Double-Blind Maintenance, and Long-Term Extension Periods in Pediatric Subjects (2 to < 18 Years of Age) With Moderately to Severely Active Crohn's Disease

Phase 3 Interventional AbbVie · NCT05995353

This study is testing a new medication called risankizumab to see if it helps children with Crohn's Disease who haven't gotten better with other treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment110 (estimated)
Ages2 Years to 17 Years
SexAll
SponsorAbbVie Industry-sponsored
Drugs / interventionsprednisone, risankizumab
Locations85 sites (Phoenix, Arizona and 84 other locations)
Trial IDNCT05995353 on ClinicalTrials.gov

What this trial studies

This study evaluates the pharmacokinetics, efficacy, and safety of risankizumab in pediatric patients aged 2 to less than 18 years with moderately to severely active Crohn's Disease who have not responded adequately to other treatments. Participants will be divided into three cohorts based on age, and will receive a weight-based induction regimen of risankizumab during an open-label induction period, followed by a double-blind main study. The study aims to gather data on adverse events and changes in disease activity to better understand how the drug works in this population.

Who should consider this trial

Good fit: Ideal candidates are pediatric individuals aged 2 to less than 18 years with moderately to severely active Crohn's Disease who have shown intolerance or inadequate response to previous therapies.

Not a fit: Patients with hereditary fructose intolerance or significant sensitivity to the study drug or its components may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for children suffering from Crohn's Disease.

How similar studies have performed: Other studies have shown success with similar biologic therapies in treating Crohn's Disease, indicating potential for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Pediatric individuals, 2 to \< 18 years old
* Must have moderately to severely active CD, as defined by the PCDAI score \> 30 assessed at Baseline
* Must have endoscopic evidence of mucosal inflammation as documented by the SES-CD of ≥ 6 for ileocolonic or colonic disease (or SES-CD of ≥ 4 for isolated ileal disease)
* Demonstrated intolerance or inadequate response to one or more of the following categories of drugs: aminosalicylates (This drug class is not sufficient for eligibility for subjects in France, Italy, Netherlands, Spain, and Sweden), oral locally acting corticosteroids, systemic steroids (prednisone or equivalent), IMMs, and/or biologic therapies

Exclusion Criteria:

* History of hereditary fructose intolerance (a rare genetic condition) or an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class
* Any of the following medical disorders:

  1. Current diagnosis of ulcerative colitis, indeterminate colitis, or monogenic IBD.
  2. A diagnosis of CD prior to 2 years of age.
  3. A diagnosis or suspected diagnosis of a primary immunodeficiency.
  4. Currently known complications of CD such as:

     * Active abscess (abdominal or perianal);
     * Symptomatic bowel strictures;
     * \> 2 missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum;
     * Fulminant colitis;
     * Toxic megacolon;
     * Or any other manifestation that might require surgery while enrolled in the study.
  5. Ostomy or ileoanal pouch.
  6. Diagnosis of short gut or short bowel syndrome.
  7. Surgical bowel resection within the past 3 months prior to Baseline (excluding gastrointestinal surgeries which are not bowel resections such as appendectomy or ostomy closure), or a history of \>3 bowel resections.

Where this trial is running

Phoenix, Arizona and 84 other locations

+35 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Crohn's DiseaseRisankizumabSkyriziPediatrics
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.