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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01510951
First received: August 11, 2011
Last updated: March 25, 2013
Last verified: March 2013
History of Changes

August 11, 2011
March 25, 2013
August 2011
October 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01510951 on ClinicalTrials.gov Archive Site
  • Evaluate the efficacy of AMG 811 as measured by the following: the proportion of subjects with a PASI 50, 75 and 90 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Measure the peak serum concentration (Cmax) of AMG 811 after a single dose administration in subjects with moderate to severe psoriasis [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Psoriasis
Drug: AMG 811 or Placebo
Single dose subcutaneous administration of AMG 811 or placebo to adult subjects with psoriasis.
  • Placebo Comparator: PLACEBO
    Intervention: Drug: AMG 811 or Placebo
  • Experimental: AMG 811
    Intervention: Drug: AMG 811 or Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia,   New Zealand
 
NCT01510951
20101147
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP