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
- Conditions
- Crohn's Disease
- Registration Number
- NCT05995353
- Lead Sponsor
- AbbVie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Pediatric individuals, 2 to < 18 years old<br><br> - Must have moderately to severely active CD, as defined by the PCDAI score > 30<br> assessed at Baseline<br><br> - Must have endoscopic evidence of mucosal inflammation as documented by the SES-CD of<br> = 6 for ileocolonic or colonic disease (or SES-CD of = 4 for isolated ileal disease)<br><br> - Demonstrated intolerance or inadequate response to one or more of the following<br> categories of drugs: aminosalicylates (This drug class is not sufficient for<br> eligibility for subjects in France, Italy, Netherlands, Spain, and Sweden), oral<br> locally acting corticosteroids, systemic steroids (prednisone or equivalent), IMMs,<br> and/or biologic therapies<br><br>Exclusion Criteria:<br><br> - History of hereditary fructose intolerance (a rare genetic condition) or an allergic<br> reaction or significant sensitivity to constituents of the study drug (and its<br> excipients) and/or other products in the same class<br><br> - Any of the following medical disorders:<br><br> 1. Current diagnosis of ulcerative colitis, indeterminate colitis, or monogenic<br> IBD.<br><br> 2. A diagnosis of CD prior to 2 years of age.<br><br> 3. A diagnosis or suspected diagnosis of a primary immunodeficiency.<br><br> 4. Currently known complications of CD such as:<br><br> - Active abscess (abdominal or perianal);<br><br> - Symptomatic bowel strictures;<br><br> - > 2 missing segments of the following 5 segments: terminal ileum, right<br> colon, transverse colon, sigmoid and left colon, and rectum;<br><br> - Fulminant colitis;<br><br> - Toxic megacolon;<br><br> - Or any other manifestation that might require surgery while enrolled in<br> the study.<br><br> 5. Ostomy or ileoanal pouch.<br><br> 6. Diagnosis of short gut or short bowel syndrome.<br><br> 7. Surgical bowel resection within the past 3 months prior to Baseline (excluding<br> gastrointestinal surgeries which are not bowel resections such as appendectomy<br> or ostomy closure), or a history of >3 bowel resections.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cohort 3 (Substudy 2): Percentage of Participants Achieving Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission;Cohort 3 (Substudy 2): Percentage of Participants Achieving Endoscopic Response per Simple Endoscopic Score for Crohn's Disease (SES-CD);Cohorts 1 & 2: Maximum Observed Serum Concentration (Cmax) of Risankizumab;Cohorts 1 & 2: Time to Cmax (Tmax) of Risankizumab;Cohorts 1 & 2: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau) of Risankizumab
- Secondary Outcome Measures
Name Time Method