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
1 other identifier
interventional
9
2 countries
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2011
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 11, 2011
CompletedFirst Posted
Study publicly available on registry
January 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedMarch 27, 2013
March 1, 2013
1.2 years
August 11, 2011
March 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Study Arms (2)
PLACEBO
PLACEBO COMPARATORAMG 811
EXPERIMENTALInterventions
Single dose subcutaneous administration of AMG 811 or placebo to adult subjects with psoriasis.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (4)
Research Site
Herston, Queensland, 4006, Australia
Research Site
Nedlands, Western Australia, 6009, Australia
Research Site
Christchurch, 8011, New Zealand
Research Site
Grafton, Auckland, 1010, New Zealand
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2011
First Posted
January 18, 2012
Study Start
August 1, 2011
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
March 27, 2013
Record last verified: 2013-03