NCT01510951
Completed
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- AMG 811 or Placebo
- Conditions
- Psoriasis
- Sponsor
- Amgen
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
PLACEBO
Intervention: AMG 811 or Placebo
AMG 811
Intervention: AMG 811 or Placebo
Outcomes
Primary Outcomes
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
Time Frame: 16 weeks
Secondary Outcomes
- 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)
Study Sites (1)
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