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

• Status: Withdrawn
• Trial end date: 2026-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Biopharma SRL
• Treatments: Adalimumab; Certolizumab Pegol

Criteria

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