NCT02326298

An Efficacy and Safety Study of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO)

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Study Followed by a Dose-Blind Period and Open-Label Follow-Up to Evaluate the Efficacy and Safety of Certolizumab Pegol in Subjects With Moderate to Severe Chronic Plaque Psoriasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 234 (actual)
• Sponsor: UCB Biopharma S.P.R.L. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the efficacy and safety of two dose levels of certolizumab pegol in adults with moderate to severe chronic plaque psoriasis when administered every 2 weeks.

Detailed description

This study consists of the following Periods: * Initial Treatment Period from Week 0 to Week 16 * Maintenance Treatment Period from Week 16 to Week 48 * Open-label Treatment Period from Week 48 to Week 144 * Safety Follow-Up Period from Week 144 to Week 152

Conditions

• Psoriasis
• Plaque Psoriasis

Interventions

Type	Name	Description
BIOLOGICAL	Certolizumab Pegol	* Active Substance: Certolizumab Pegol * Pharmaceutical Form: Solution for injection in pre-filled syringe * Concentration: 200 mg/mL * Route of Administration: Subcutaneous use
OTHER	Placebo	* Active Substance: Placebo * Pharmaceutical Form: Solution for injection in pre-filled syringe * Concentration: 0.9 % saline * Route of Administration: Subcutaneous use

Timeline

• Start date: 2014-12-16
• Primary completion: 2016-03-08
• Completion: 2018-10-24
• First posted: 2014-12-29
• Last updated: 2019-11-07
• Results posted: 2018-08-13

Locations

30 sites across 5 countries: United States, Canada, Czechia, Germany, Hungary

Regulatory

• FDA-regulated drug study