A Phase 3 Study in Participants With Moderate to Severe Psoriasis (UNCOVER-2)



Status:Active, not recruiting
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:2/9/2019
Start Date:May 18, 2012
End Date:July 10, 2019

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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients With Moderate-to-Severe Plaque Psoriasis

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.


Inclusion Criteria:

- Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic plaque
psoriasis for at least 6 months prior to first dose of study drug

- At least 10% Body Surface Area (BSA) of psoriasis at screening and at first dose of
study drug

- 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 first dose of study
drug

- 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
We found this trial at
41
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Wilmington, North Carolina 28401
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Worcester, MA
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