genital psoriasis
Conditions
Interventions
The Blinded Treatment Period (Period 2) involves a comparison of ixekizumab 80
mg Q2W (starting dose of 160 mg) and placebo Q2W. All doses are administered
via SC injection.
All patients assigned t
Genital Psoriasis
Ixekizumab (LY2439821)
Sponsors
Eli Lilly
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Are male or female patients of 18 years or older Present with chronic plaque psoriasis based on a diagnosis of chronic plaque psoriasis for at least 6 months before baseline Have moderate-to-severe psoriasis in the genital area Have failed to respond to, or are intolerant of, at least 1 topical therapy (corticosteroids, calcineurin inhibitors and/or vitamin D analogs) used for treatment of psoriasis affecting the genital area Must agree to use reliable method of birth control
Exclusion criteria
Exclusion criteria: Pustular, erythrodermic, and/or guttate forms of psoriasis Have a history of drug-induced psoriasis Have recently received certain treatments with ixekizumab, secukinumab, or brodalumab, or another drug with similar mode of action Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to baseline and during the study Are currently enrolled in any other clinical trial involving an investigational product Serious disorder or illness other than plaque psoriasis Had a live vaccination within 12 weeks prior to baseline (Week 0, Visit 2), intend to have a live vaccination during the course of the study or within 12 weeks of completing treatment in this study Had a vaccination with Bacillus Calmette-Guérin (BCG) within 12 months prior to baseline Are women who are lactating or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients achieving sPGA of Genitalia (0,1) at Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline in the genital psoriasis itch NRS item within the GPSS at Week 12 | — |
Countries
Australia, Austria, Belgium, Canada, Netherlands, Turkey, United States of America
Outcome results
None listed