NCT04123795

A Study to Evaluate the Pharmacokinetics, Safety, and Effectiveness of Certolizumab Pegol in Children With Moderate to Severe Chronic Plaque Psoriasis

Multicenter, Open Label or Double-Blind, Placebo-Controlled Study to Evaluate the Pharmacokinetics, Safety, and Effectiveness of Certolizumab Pegol in Pediatric Study Participants With Moderate to Severe Chronic Plaque Psoriasis

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 49 (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 evaluate the pharmacokinetic (PK) of certolizumab pegol (CZP) in study participants aged 6 to 17 years with moderate to severe chronic plaque psoriasis (PSO) in order to support extrapolation of efficacy.

Conditions

• Moderate Chronic Plaque Psoriasis
• Severe Chronic Plaque Psoriasis
• Mixed Guttate/Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Certolizumab pegol	Certolizumab Pegol * Pharmaceutical Form: Solution for injection in pre-filled syringe * Route of Administration: Subcutaneous use
DRUG	Placebo	Placebo * Pharmaceutical Form: Solution for injection in pre-filled syringe * Route of Administration: Subcutaneous use

Timeline

• Start date: 2020-01-21
• Primary completion: 2026-04-09
• Completion: 2026-07-02
• First posted: 2019-10-11
• Last updated: 2026-04-13

Locations

19 sites across 3 countries: United States, Canada, Puerto Rico

Regulatory

• FDA-regulated drug study