Moderate-to-severe genital psoriasis MedDRA version: 18.1 Level: LLT Classification code 10063407 Term: Psoriasis genital System Organ Class: 100000004858
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Are male or female patients of 18 years or older Have 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 plaque psoriasis in a nongenital area at screening and baseline Have failed to respond to, or are intolerant of, at least 1 topical therapy used for treatment of psoriasis affecting the genital area Must agree to use reliable method of birth control, which could include abstinence, during the study and for at least 12 weeks following the last dose of study drug Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 131 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: Pustular, erythrodermic, and/or guttate forms of psoriasis History of drug-induced psoriasis Have recently received certain treatments for psoriasis (in particular, within the past 4 weeks but the restriction can go up to 12 months for some treatments) Have ever received treatment with ixekizumab, secukinumab, brodalumab, or another drug with a 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 Active or history of malignant disease within 5 years prior to baseline Serious infection with the last 3 months Have received a live vaccine within 3 months of baseline or plan to do so during the study Have received a vaccination with Bacillus Calmette-Guérin (BCG) within the past year Pregnant or breastfeeding (lactating) women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether ixekizumab is superior to placebo at Week 12 in the treatment of patients with moderate-to-severe genital psoriasis ;Secondary Objective: To assess whether ixekizumab is superior to placebo at week 12 in the treatment of patients with moderate-to-severe genital psoriasis as measured by change in itch;Primary end point(s): Static Physician Global Assessment(sPGA) of Genitalia;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Symptom and Quality of Life Assessments;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Countries
Australia, Austria, Belgium, Canada, Netherlands, Turkey, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed