A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Versus Placebo in Patients with Moderate-to-Severe Genital Psoriasis
- Conditions
- genital psoriasis10014982
- Registration Number
- NL-OMON53160
- Lead Sponsor
- Eli Lilly
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 9
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The proportion of patients achieving sPGA of Genitalia (0,1) at Week 12</p><br>
- Secondary Outcome Measures
Name Time Method <p> Mean change from baseline in the genital psoriasis itch NRS item within the<br /><br>GPSS at Week 12</p><br>