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Clinical trial

A Study to Evaluate the Efficacy and Safety of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO) (CIMPASI-2)

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Last updated:15th Dec 2014
Identifier: NCT02326272

Brief 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.

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


Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 227 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date: December 15, 2014
Actual Primary Completion Date: January 5, 2016
Estimated Study Completion Date: August 31, 2018

Arm:
- Experimental:
CZP 200 mg
- Experimental: CZP 400 mg
- Placebo Comparator: Placebo

Category Value
Date last updated at source 2018-05-30
Study type(s) Interventional
Expected enrolment 227
Study start date 2014-12-15
Estimated primary completion date 2016-01-05

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