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



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:1/10/2019
Start Date:February 11, 2015
End Date:December 17, 2018

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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

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.

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)

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

- Other protocol-defined inclusion criteria may apply

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

- Other protocol-defined exclusion criteria may apply
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Portland, Oregon
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Beverly Hills, California
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Dallas, Texas
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Dupnitsa, Kyustendil
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Henderson, Nevada
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Henderson, NV
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Houston, Texas
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Indianapolis, Indiana
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Indianapolis, IN
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Johnston, Rhode Island
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Johnston, RI
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Little Rock, Arkansas
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Little Rock, AR
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708 South Barrington Avenue
Los Angeles, California 90049
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Mobile, Alabama
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Mobile, AL
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San Antonio, Texas
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San Diego, California
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Springfield, Illinois
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Verona, New Jersey
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Verona, NJ
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Washington, District of Columbia
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Washington,
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Webster, Texas
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Webster, TX
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West Dundee, Illinois
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West Dundee, IL
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West Palm Beach, Florida
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