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

COMPLETEDPHASE3

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

NCT02346240•UCB Biopharma S.P.R.L.

View on ClinicalTrials.gov

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)

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Provided informed consent
•Adult men or women \>= 18 years
•Chronic plaque psoriasis for at least 6 months
•Baseline psoriasis activity and severity index \>= 12 and body surface area \>= 10 % and Physician's Global Assessments score \>= 3
•Candidate for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy

Exclusion Criteria

•Erythrodermic, guttate, generalized pustular form of psoriasis
•History of current, chronic, or recurrent infections of viral, bacterial, or fungal origin as described in the protocol
•Congestive heart failure
•History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease
•Concurrent malignancy or a history of malignancy as described in the protocol
•History of, or suspected, demyelinating disease of the central nervous system (e.g., multiple sclerosis or optic neuritis)
•Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study or within 5 months following last dose of study drug in the UK, Czech Republic, Germany, and France, and within 3 months for all other countries. Male subjects who are planning a partner pregnancy during the study or within 5 months following the last dose in France and within 10 weeks in all other countries
•Any other condition which, in the Investigator's judgment, would make the subject unsuitable for participation in the study

Locations (70)

Ps0003 317

Mobile, Alabama, United States

Ps0003 306

Little Rock, Arkansas, United States

Ps0003 301

Beverly Hills, California, United States

Ps0003 307

Los Angeles, California, United States

Ps0003 405

San Diego, California, United States

Ps0003 316

Washington D.C., District of Columbia, United States

Ps0003 304

West Palm Beach, Florida, United States

Ps0003 302

Springfield, Illinois, United States

Ps0003 313

West Dundee, Illinois, United States

Ps0003 310

Indianapolis, Indiana, United States

Key Dates

Start Date

February 11, 2015

Primary Completion Date

March 22, 2016

Completion Date

December 17, 2018

Last Updated

July 16, 2021

Enrollment

559

ACTUAL participants

Conditions

PsoriasisPlaque Psoriasis

Interventions

Certolizumab Pegol

BIOLOGICAL

Etanercept

BIOLOGICAL

Placebo

OTHER

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

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Psoriasis

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RECRUITINGPHASE3

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

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RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 16, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments