Status:
RECRUITING
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
Lead Sponsor:
AbbVie
Conditions:
Crohn's Disease
Eligibility:
All Genders
2-17 years
Phase:
PHASE3
Brief Summary
Crohn's Disease (CD) is a gastrointestinal disease that can cause chronic diarrhea with or without gross bleeding, abdominal pain, weight loss, and fever. This study will assess the pharmacokinetics, ...
Eligibility Criteria
Inclusion
- 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
- 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:
- Current diagnosis of ulcerative colitis, indeterminate colitis, or monogenic IBD.
- A diagnosis of CD prior to 2 years of age.
- A diagnosis or suspected diagnosis of a primary immunodeficiency.
- 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.
- Ostomy or ileoanal pouch.
- Diagnosis of short gut or short bowel syndrome.
- 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.
Key Trial Info
Start Date :
December 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT05995353
Start Date
December 11 2023
End Date
April 1 2029
Last Update
October 1 2025
Active Locations (85)
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1
Phoenix Children's Hospital /ID# 255766
Phoenix, Arizona, United States, 85016-7710
2
Arkansas Children's Hospital /ID# 255762
Little Rock, Arkansas, United States, 72202
3
UCSF Benioff Children's Hospital - Oakland /ID# 258327
Oakland, California, United States, 94609
4
Childrens Hospital Colorado - Aurora /ID# 255764
Aurora, Colorado, United States, 80045