CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 559 enrolled
Drug / intervention
Certolizumab Pegol +2 morebiological
Likely dose
Certolizumab Pegol 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02346240
NCT02346240Phase 3Completed

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

UCB Biopharma S.P.R.L.·interventional·Posted Jan 26, 2015·Updated Jul 16, 2021

In Brief

A Phase 3 clinical trial evaluating Certolizumab Pegol, Etanercept, and 1 other intervention for Psoriasis and Plaque Psoriasis. Completed, enrolled 559 participants across 70 sites in 9 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBulgaria, Czechia, France, Germany, Hungary, Netherlands, Poland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 26, 2015
Enrollment StartFeb 11, 2015
Primary CompletionMar 22, 2016
Study CompletionDec 17, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 11.4 years ago

Interventions

Certolizumab Pegolbiological

* Active Substance: Certolizumab Pegol * Pharmaceutical Form: Solution for injection in pre-filled syringe * Concentration: 200 mg/ mL * Route of Administration: Subcutaneous use

Etanerceptbiological

* Active Substance: Etanercept * Pharmaceutical Form: Solution for injection in pre-filled syringe * Concentration: 50 mg / mL * Route of Administration: Subcutaneous use

Placeboother

* Active Substance: Placebo * Pharmaceutical Form: Solution for injection in pre-filled syringe * Concentration: 0.9 % saline * Route of Administration: Subcutaneous use