Overview

This trial is active, not recruiting.

Condition psoriasis
Treatments 80 mg ixekizumab, 50 mg etanercept, placebo
Phase phase 3
Sponsor Eli Lilly and Company
Start date July 2012
End date May 2014
Trial size 1225 participants
Trial identifier NCT01646177, 13685, I1F-MC-RHBC

Summary

This study will assess the safety and efficacy of ixekizumab (LY2439821), compared to etanercept and placebo in participants with moderate to severe chronic plaque psoriasis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Administered by two 80 milligram (mg) subcutaneous (SC) injections at Week 0, then one 80 mg SC injection per Dosing Regimen 1 until Week 12. At Week 12, arm is assigned to Dosing Regimen 2.
80 mg ixekizumab LY2439821
Administered SC
(Experimental)
Administered by two 80 mg SC injections at Week 0, then one 80 mg SC injection per Dosing Regimen 2 until Week 264.
80 mg ixekizumab LY2439821
Administered SC
(Active Comparator)
Administered by SC injections twice weekly starting at Week 0 up to Week 12. At Week 12, arm is assigned to Dosing Regimen 2.
50 mg etanercept
Administered SC
(Placebo Comparator)
Placebo for ixekizumab administered by two SC injections at Week 0, then one SC injection per Dosing Regimen 1 until Week 12. Placebo for etanercept administered by one SC injection twice weekly starting at Week 0 up to Week 12. At Week 12, arm is assigned to Dosing Regimen 2.
placebo
Administered SC

Primary Outcomes

Measure
Efficacy of ixekizumab in participants with moderate to severe chronic plaque psoriasis. Measure: static Physician Global Assessment (sPGA)
time frame: 12 Weeks
Efficacy of ixekizumab in participants with moderate to severe chronic plaque psoriasis. Measure: Psoriasis Area and Severity Index (PASI)
time frame: 12 Weeks

Secondary Outcomes

Measure
Efficacy of ixekizumab in participants with moderate to severe chronic plaque psoriasis. Measure: sPGA
time frame: Baseline through Week 12
Efficacy of ixekizumab in participants with moderate to severe chronic plaque psoriasis. Measure: PASI
time frame: Baseline through Week 12
Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)
time frame: Baseline through Week 12

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Presents with chronic plaque psoriasis based on a confirmed diagnosis of chronic psoriasis for at least 6 months prior to randomization - At least 10% Body Surface Area (BSA) of Psoriasis at screening and at randomization - sPGA score of at least 3 and 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 or remain abstinent during the study - Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment 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 (including psoralens and ultraviolet A [PUVA], ultraviolet B [UVB]) within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization - 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 interleukin 17 (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

Additional Information

Official title A 12-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients With Moderate to Severe Plaque Psoriasis With a Long-Term Extension Period
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.