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
  Purpose

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.


Condition Intervention Phase
Psoriasis
Drug: AMG 811 or Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 9
Study Start Date: August 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: PLACEBO Drug: AMG 811 or Placebo
Single dose subcutaneous administration of AMG 811 or placebo to adult subjects with psoriasis.
Experimental: AMG 811 Drug: AMG 811 or Placebo
Single dose subcutaneous administration of AMG 811 or placebo to adult subjects with psoriasis.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01510951

Locations
Australia, Queensland
Research Site
Herston, Queensland, Australia, 4006
Australia, Western Australia
Research Site
Nedlands, Western Australia, Australia, 6009
New Zealand
Research Site
Christchurch, New Zealand, 8011
Research Site
Grafton, Auckland, New Zealand, 1010
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01510951     History of Changes
Other Study ID Numbers: 20101147
Study First Received: August 11, 2011
Last Updated: March 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
AMGEN
PSORIASIS
SAFETY

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on July 22, 2014