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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Phoenix Children's Hospital /ID# 255766
  Phoenix, Arizona, United States Recruiting
• UCSF Benioff Children's Hospital - Oakland /ID# 258327
  Oakland, California, United States Recruiting
• Children's Hospital Colorado - Aurora /ID# 255764
  Aurora, Colorado, United States Recruiting
• Arnold Palmer Hospital for Children Center Digestive Health and Nutrition-Orland /ID# 255437
  Orlando, Florida, United States Recruiting
• Indiana University Health Riley Hospital for Children /ID# 256454
  Indianapolis, Indiana, United States Recruiting
• Massachusetts General Hospital - Mass General Waltham /ID# 255767
  Waltham, Massachusetts, United States Recruiting

+35 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• SL-325 in Crohn's Disease: a phase 2 test for adults with moderate to severe disease

  This phase 2 study tests SL-325 against placebo in adults with moderately to severely active Crohn's disease to see if it helps improve symptoms and disease activity.

  Recruiting Phase 2 Shattuck Labs, Inc. · Little Rock, Arkansas and 19 other locations · NCT07753850

• Advanced therapies for moderately to severely active Crohn's disease or ulcerative colitis in adults

  This study tests combinations of risankizumab with either trosunilimab or ABBV-701 in adults with moderately to severely active Crohn's disease or ulcerative colitis.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.