A Study to Test Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Crohn's Disease

A Phase 3, Randomized, Double-Blind, Multicenter Study Including an Active Reference Arm to Evaluate Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol in Children and Adolescents (6 to 17 Years of Age) With Moderately to Severely Active Crohn's Disease

The purpose of the study is to assess efficacy, safety and tolerability of 2 dose regimens of certolizumab pegol

Inclusion Criteria:

• Participant must be 6 to 17 years, inclusive, at the time of signing informed consent/assent
• Participant has been diagnosed with active Crohn's disease (CD) as confirmed by endoscopic examination with/without histological confirmation ≤12 weeks before the Screening Visit
• Participant has moderately to severely active disease despite current treatment
• Participant has an inadequate response or intolerance to conventional therapy
• Participants are certolizumab pegol (CZP) and adalimumab (ADA) naïve

Exclusion Criteria:

• Participant has had an extensive colonic resection, subtotal or total colectomy, diagnosis of short bowel syndrome or a history of >3 small bowel resections
• Participant has had a primary failure (ie, lack of response within the first 12 weeks of treatment) to any anti-Tumor necrosis factor-α agent for treatment of Crohn's disease