Moderate to severe plaque psoriasis MedDRA version: 18.1 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy of ixekizumab vs. etanercept and placebo in subjects with moderate to severe chronic plaque psoriasis based on sPGA and PASI at week 12 ;Secondary Objective: -Efficacy of ixekizumab in subjects with moderate to severe chronic plaque psoriasis based on sPGA and PASI at week 12 -Quality of life assessments based on patient reported outcomes at week 12 ;Primary end point(s): Static Physician Global Assessment (sPGA) and Psoriasis Area and Severity Index (PASI);Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PASI and sPGA Quality-of-Life Assessments;Timepoint(s) of evaluation of this end point: At week 12 | — |
Countries
Bulgaria, Canada, Germany, Hungary, India, Italy, Mexico, Poland, Russian Federation, United States
Contacts
Public ContactClinical Trial Information
Eli Lilly and Company
Outcome results
None listed