A Phase 3 Study in Moderate to Severe Psoriasis Patients

Phase 1

Conditions: Moderate to severe plaque psoriasis
MedDRA version: 18.1Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2011-004368-31-HU

Lead Sponsor: Eli Lilly and Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1225

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

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
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<br>;Secondary Objective: -Efficacy of ixekizumab in subjects with moderate to severe chronic<br>plaque psoriasis based on sPGA and PASI at week 12<br>-Quality of life assessments based on patient reported outcomes at week<br>12<br>;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 Outcome Measures

Name	Time	Method
Secondary end point(s): PASI and sPGA<br>Quality-of-Life Assessments;Timepoint(s) of evaluation of this end point: At week 12

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