An Efficacy and Safety Study of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO)

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

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 when administered every 2 weeks.

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

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 Czech Republic and Germany) and within 3 months for all other countries. Male subjects who are planning a partner pregnancy during the study or within 10 weeks following the last dose of study drug
• 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