Safety and Efficacy Study of Adalimumab in the Treatment of Plaque Psoriasis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Adalimumab (Humira®) in Chinese Subjects With Moderate to Severe Plaque Psoriasis

A study to evaluate the safety and efficacy of adalimumab in Chinese subjects with moderate to severe plaque psoriasis.

The purpose of this study is to evaluate the safety and efficacy of adalimumab and to determine how well it works in the treatment of adults with moderate to severe plaque psoriasis in the Chinese population. Psoriasis is a chronic immunologic disease characterized by marked inflammation and thickening of the epidermis that result in thick, scaly plaques involving the skin.

Inclusion Criteria:

• Clinical diagnosis of psoriasis for at least 6 months.
• Must have stable plaque psoriasis for at least 2 months before screening and baseline visits.
• Participant must have a Psoriasis Area Severity Index score greater than or equal to 10 at the baseline visit.
• Participant must have moderate to severe plaque Psoriasis, defined by Body Surface Area involvement greater than or equal to 10% at the baseline visit.
• Participant must have a Physicians Global Assessment of at least moderate disease at baseline visit.

Exclusion Criteria:

• Diagnosis of other active skin diseases or skin infections.
• Participant has known hypersensitivity to adalimumab or it excipients.
• Participant has chronic recurring infections or active tuberculosis.
• Participant has demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease.
• Participant is known to have immune deficiency or is immunocompromised.