Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of AMG 811 in Subjects With Psoriasis
Lead Sponsor:
Amgen
Conditions:
Psoriasis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01510951
Start Date
August 1 2011
End Date
October 1 2012
Last Update
March 27 2013
Active Locations (4)
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1
Research Site
Herston, Queensland, Australia, 4006
2
Research Site
Nedlands, Western Australia, Australia, 6009
3
Research Site
Christchurch, New Zealand, 8011
4
Research Site
Grafton, Auckland, New Zealand, 1010