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

NCT02346240 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 559

Last updated 2021-07-16

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • UCB Biopharma S.P.R.L.

    lead INDUSTRY

Principal Investigators

  • UCB Cares · +1 844 599 2273 (UCB)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-11
Primary Completion
2016-03-22
Completion
2018-12-17
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Czechia
  • France
  • Germany
  • Hungary
  • Netherlands
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02346240 on ClinicalTrials.gov