A Phase 3 Study in Moderate to Severe Psoriasis Patients
- Conditions
- Moderate to severe plaque psoriasisMedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2011-004368-31-BG
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 1225
-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
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 1175
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
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
within the previous 4 weeks; or had topical psoriasis treatment within
the previous 2 weeks prior to baseline
-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 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method