A Study in Participants With Moderate to Severe Psoriasis (UNCOVER-3)

• Status: Completed
• Trial end date: 2019-07-22
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the safety and efficacy of ixekizumab (LY2439821), compared to etanercept and placebo in participants with moderate to severe chronic plaque psoriasis.

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

Details

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

Criteria

Inclusion Criteria:

• Presents with chronic plaque psoriasis based on a confirmed diagnosis of chronic psoriasis 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 or remain abstinent during the study

• Women must agree to use reliable 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

• Prior use of etanercept

• Clinically significant flare of psoriasis during the 12 weeks prior to randomization

• Concurrent or recent use of any biologic agent

• Received non-biologic systemic psoriasis therapy or phototherapy (including psoralens and ultraviolet A [PUVA], ultraviolet B [UVB]) 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