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

Phase 1

Completed

• Conditions: Psoriasis
• Interventions: Drug: AMG 811 or Placebo

• Registration Number: NCT01510951
• Lead Sponsor: Amgen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-11
• Study First Submitted QC: 2012-01-12
• Study First Posted: 2012-01-18
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-25
• Last Update Posted: 2013-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PLACEBO	AMG 811 or Placebo	-
AMG 811	AMG 811 or Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇳🇿 Grafton, Auckland, New Zealand