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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01510951

Enrollment

Registered

2012-01-18

Start date

2011-08-31

Completion date

2012-10-31

Last updated

2013-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

AMGEN, PSORIASIS, SAFETY

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.

Interventions

DRUGAMG 811 or Placebo

Single dose subcutaneous administration of AMG 811 or placebo to adult subjects with psoriasis.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Australia, New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026