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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-10-31

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.

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Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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PLACEBO

Group Type PLACEBO_COMPARATOR

AMG 811 or Placebo

Intervention Type DRUG

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

AMG 811

Group Type EXPERIMENTAL

AMG 811 or Placebo

Intervention Type DRUG

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

Interventions

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AMG 811 or Placebo

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

Intervention Type DRUG

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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No