A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease

Launched by ABBVIE · Aug 10, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called risankizumab, which is designed to help children and teenagers with moderately to severely active Crohn's Disease (CD). Crohn's Disease can cause symptoms like stomach pain, diarrhea, and weight loss. The trial aims to understand how the drug works in the bodies of young participants aged 2 to less than 18 years who have not responded well to other treatments. Around 110 children will be involved in the study, which will take place at about 100 different sites worldwide.

To participate, children must have been diagnosed with Crohn's Disease and have a specific level of disease activity. They should also have tried other treatments without success. Participants will receive risankizumab in different ways during the study: first through an IV for 12 weeks, then as a shot under the skin for a year, and finally for an extended period based on how well they respond. Throughout the trial, children will have regular check-ups to monitor their health, and their responses to the treatment will be closely observed through tests and questionnaires. It's important to note that this trial may involve more doctor visits and treatments compared to standard care.

Gender

ALL

Eligibility 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.