Evaluation of Ixekizumab Using Auto-Injector or Prefilled Syringe in Participants With Moderate to Severe Plaque Psoriasis

Pharmacokinetic Evaluations of Ixekizumab Following Subcutaneous Administration Using Prefilled Syringe or Auto-Injector in Patients With Moderate-to-Severe Plaque Psoriasis

The purpose of this study is to evaluate the serum concentration of ixekizumab after administration using either prefilled syringe or auto-injector in participants with moderate to severe plaque psoriasis. Treatment period is followed by 40 weeks optional safety extension.

Inclusion Criteria:

• Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to randomization
• At least 10% Body Surface Area (BSA) of Psoriasis at screening and at randomization
• Static Physician Global Assessment (sPGA) score of at least 3 AND Psoriasis Area and Severity Index (PASI) score of at least 12 at screening and at randomization
• Candidate for phototherapy and/or systemic therapy
• Men must agree to use a reliable method of birth control during the study
• Women must agree to use birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment

Exclusion Criteria:

• Pustular, erythrodermic, and/or guttate forms of psoriasis
• History of drug-induced psoriasis
• Clinically significant flare of psoriasis during the 12 weeks prior to randomization
• Concurrent or recent use of any biologic agent
• Received systemic psoriasis therapy [such as psoralen and ultraviolet A (PUVA) light therapy] or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization
• Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to randomization and during the study
• Have participated in any study with interleukin-17 (IL-17) antagonists, including Ixekizumab
• Serious disorder or illness other than plaque psoriasis
• Serious infection within the last 3 months
• Breastfeeding or nursing (lactating) women