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

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Ixekizumab

Criteria

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