Crohn's disease
Conditions
Interventions
PK Cohort 1: SS1
Cohort 1 will consist of 2 age groups (6 to < 12 years and 12 to < 18 years). SS1 is a 12-week induction period where participants will receive a weight-based dose of risankizumab. Al
Sponsors
Fujimura Kimino
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Pediatric individuals, 2 to 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, oral locally acting corticosteroids, systemic steroids (prednisone or equivalent), IMMs, and/or biologic therapies
Exclusion criteria
Exclusion criteria: - History of 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: a. Current diagnosis of ulcerative colitis, indeterminate colitis, or monogenic IBD. b. A diagnosis of CD prior to 2 years of age. c. A diagnosis or suspected diagnosis of a primary immunodeficiency. d. 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. e. Ostomy or ileoanal pouch. f. Diagnosis of short gut or short bowel syndrome. g. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK Cohort 1 and Cohort 2 - Cmax - Tmax - AUCtau Expansion Cohort 3 - Achievement of clinical remission per PCDAI at Week 64 (SS2) - Achievement of endoscopic response at Week 64 (SS2) | — |
Secondary
| Measure | Time frame |
|---|---|
| PK Cohort 1 and Cohort 2 - Achievement of clinical remission per PCDAI at Week 64 (SS2). - Achievement of endoscopic response at Week 64 (SS2). - Achievement of clinical remission per PCDAI at Week 12 (SS1). - Achievement of endoscopic response at Week 12 (SS1). - Achievement of endoscopic remission at Week 12 (SS1). - Achievement of endoscopic remission at Week 64 (SS2). - Achievement of corticosteroid-free clinical remission per PCDAI at Week 64 (SS2). Expansion Cohort 3 - Achievement of clinical remission per PCDAI at Week 12 (SS1). - Achievement of endoscopic response at Week 12 (SS1). - Achievement of endoscopic remission at Week 12 (SS1). - Achievement of endoscopic remission at Week 64 (SS2). - Achievement of corticosteroid-free clinical remission per PCDAI at Week 64 (SS2). | — |
Countries
Belgium, Bulgaria, Canada, China, Czechia, France, Germany, Israel, Italy, Japan, Netherlands, Poland, Puerto Rico, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States of America
Contacts
Public ContactContact for Patients and HCP
AbbVie G.K.
Outcome results
None listed