NCT04643483

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Certolizumab pegol	* Pharmaceutical form: Solution for injection * Route of administration: Subcutaneous Subjects will receive certolizumab pegol in a pre-specified sequence during the Treatment Periods.
DRUG	Adalimumab	* Pharmaceutical form: Solution for injection * Route of administration: Subcutaneous Subjects will receive adalimumab in a pre-specified sequence during the Treatment Periods.
DRUG	Placebo	* Pharmaceutical form: Solution for injection * Route of administration: Subcutaneous Subjects will receive placebo in a pre-specified sequence during the Treatment Periods.

Timeline

• Start date: 2021-06-01
• Primary completion: 2023-09-01
• Completion: 2026-04-01
• First posted: 2020-11-25
• Last updated: 2021-06-23

Regulatory

• FDA-regulated drug study