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 |
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.
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
sites
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