NCT02346240

Efficacy and Safety Study of Certolizumab Pegol (CZP) Versus Active Comparator and Placebo in Subjects With Plaque Psoriasis (PSO)

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled Study Followed by a Placebo-Controlled Maintenance 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: 559 (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 compared to active comparator and placebo in adults with moderate to severe chronic plaque psoriasis.

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 Extension Treatment Period (96 weeks) * Safety Follow-Up (10 weeks)

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
BIOLOGICAL	Etanercept	* Active Substance: Etanercept * Pharmaceutical Form: Solution for injection in pre-filled syringe * Concentration: 50 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: 2015-02-11
• Primary completion: 2016-03-22
• Completion: 2018-12-17
• First posted: 2015-01-26
• Last updated: 2021-07-16
• Results posted: 2018-07-18

Locations

70 sites across 9 countries: United States, Bulgaria, Czechia, France, Germany, Hungary, Netherlands, Poland, United Kingdom

Regulatory

• FDA-regulated drug study