Overview

This trial is active, not recruiting.

Condition plaque psoriasis
Treatments ixekizumab auto-injector, ixekizumab prefilled syringe
Phase phase 3
Sponsor Eli Lilly and Company
Start date March 2013
End date May 2014
Trial size 180 participants
Trial identifier NCT01777191, 14728, I1F-MC-RHBL

Summary

The purpose of this study is to evaluate the serum concentration of ixekizumab after administration using either prefilled syringe or auto-injector in participants with moderate to severe plaque psoriasis. Treatment period is followed by 40 weeks optional safety extension.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Ixekizumab administered by two 80 milligram (mg) subcutaneous (SC) injections at Week 0, then one 80 mg SC injection thereafter.
ixekizumab auto-injector LY2439821
Administered SC by auto-injector
(Experimental)
Ixekizumab administered by two 80 mg SC injections at Week 0, then one 80 mg SC injection thereafter.
ixekizumab prefilled syringe LY2439821
Administered SC by prefilled syringe

Primary Outcomes

Measure
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Ixekizumab After Starting Dose
time frame: Day 2 to Day 14
PK: Area Under the Concentration Time Curve from Time 0 to 14 Days (AUC 0-14) of Ixekizumab
time frame: Day 2 to Day 14

Secondary Outcomes

Measure
Efficacy of Ixekizumab in Participants with Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index (PASI)
time frame: Week 12
Efficacy of Ixekizumab in Participants with Moderate to Severe Plaque Psoriasis. Measure: static Physician Global Assessment (sPGA)
time frame: Week 12
Number of Device Operation Failures
time frame: Baseline through Week 12
Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)
time frame: Baseline, Week 8

Eligibility Criteria

Male or female participants at least 18 years old.

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 Exclusion Criteria: - Pustular, erythrodermic, and/or guttate forms of psoriasis - History of drug-induced psoriasis - Clinically significant flare of psoriasis during the 12 weeks prior to randomization - Concurrent or recent use of any biologic agent - Received systemic psoriasis therapy [such as psoralen and ultraviolet A (PUVA) light therapy] or phototherapy 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 Pharmacokinetic Evaluations of Ixekizumab Following Subcutaneous Administration Using Prefilled Syringe or Auto-Injector in Patients With Moderate-to-Severe Plaque Psoriasis
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.