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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01510951
• Other study ID #: 20101147
• Status: Completed
• Phase: Phase 1
• First received: August 11, 2011
• Last updated: March 25, 2013
• Start date: August 2011
• Est. completion date: October 2012

Study information

• Verified date: March 2013
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• AMG 811 or Placebo
Single dose subcutaneous administration of AMG 811 or placebo to adult subjects with psoriasis.

Locations

Country	Name	City	State
Australia	Research Site	Herston	Queensland
Australia	Research Site	Nedlands	Western Australia
New Zealand	Research Site	Christchurch
New Zealand	Research Site	Grafton, Auckland

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Evaluate the efficacy of AMG 811 as measured by the following: the proportion of subjects with a PASI 50, 75 and 90		16 weeks	No
Secondary	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	No
Secondary	Measure the peak serum concentration (Cmax) of AMG 811 after a single dose administration in subjects with moderate to severe psoriasis		16 weeks	No

External Links

•   AmgenTrials clinical trials website