A Phase 3 Study in Participants With Moderate to Severe Psoriasis
Status: | Completed |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/10/2019 |
Start Date: | November 16, 2011 |
End Date: | September 20, 2018 |
A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period and a Long- Term Extension Period to Evaluate the Efficacy and Safety of LY2439821 in Patients With Moderate-to-Severe Plaque Psoriasis
This study will assess the safety and efficacy of LY2439821 compared to placebo in
participants with moderate to severe, chronic plaque psoriasis.
participants with moderate to severe, chronic plaque psoriasis.
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 (IL)-17 antagonists, including
LY2439821
- 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
35
sites
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