Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of AMG 811 in Subjects With Psoriasis

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety, tolerability, immunogenicity, and clinical effects of AMG 811 following single subcutaneous dose administration in subjects with moderate to severe psoriasis.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of AMG 811 in Subjects With Moderate to Severe Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: AMG 811 or Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 - 55 years old inclusive at Screening Active but clinically stable, plaque psoriasis Psoriasis involving ≥ 10% of the body surface area A minimum PASI score of ≥ 10 obtained during the screening period Additional inclusion criteria apply Exclusion Criteria: Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit Evidence of skin conditions other than psoriasis (eg, eczema) at the time of the screening visit or between the screening visit and study drug initiation that would interfere with evaluations of the effect of investigational product on psoriasis Any condition that, in the judgment of the investigator, might cause this study to be detrimental to the subject Additional exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: PLACEBO<br> | Drug: AMG 811 or Placebo<br>* Single dose subcutaneous administration of AMG 811 or placebo to adult subjects with psoriasis.<br>|
| Experimental: AMG 811<br> | Drug: AMG 811 or Placebo<br>* Single dose subcutaneous administration of AMG 811 or placebo to adult subjects with psoriasis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the number of adverse events per subject, including clinically significant changes in physical examinations, safety lab tests, ECG, vital signs, or immunogenicity to AMG 811 |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the efficacy of AMG 811 as measured by the following: the proportion of subjects with a PASI 50, 75 and 90 |  | 16 weeks | 
| Measure the area under the serum concentration curve versus time of AMG 811 after a single dose administration in subjects with moderate to severe psoriasis |  | 16 weeks | 
| Measure the peak serum concentration (Cmax) of AMG 811 after a single dose administration in subjects with moderate to severe psoriasis |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMGEN, PSORIASIS, SAFETY