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CompletedNCT01510951Updated Mar 27, 2013

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

A Phase 1 interventional study of AMG 811 or Placebo in Psoriasis, sponsored by Amgen. Completed at 4 sites in 2 countries. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2013-03-27.

Sponsored by Amgen · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
9
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Psoriasis

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Keywords

  • AMGEN
  • PSORIASIS
  • SAFETY
03

In context

Psoriasis

1,928 studies on the registry are indexed under Psoriasis; 234 are open to participants now.

This study's enrollment of 9 is below the median of 70 across 1,472 interventional studies indexed under Psoriasis.

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Lead sponsor

Amgen is the lead sponsor of 1,044 studies on the registry; 51 are open to participants now.

Of its 246 completed or terminated interventional studies of FDA-regulated products, 164 (67%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
9 participants (actual)

Study arms

  • Placebo comparator
    PLACEBO

    Drug: AMG 811 or Placebo

  • Experimental
    AMG 811

    Drug: AMG 811 or Placebo

Interventions

  • DrugAMG 811 or Placebo

    Single dose subcutaneous administration of AMG 811 or placebo to adult subjects with psoriasis.

06

What researchers measure

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

    Time frame: 16 weeks

Secondary outcomes

  1. 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

  2. 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

  3. 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

07

Study locations

4 sites
  • 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
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2011, a primary completion of Oct 2012 and a completion of Oct 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2011
First posted
Jan 18, 2012
Start
Aug 2011
Primary completionActual
Oct 2012
CompletionActual
Oct 2012
Last update
Mar 27, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 27, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01510951
Lead sponsor
Amgen
Responsible party
Sponsor
First posted
Jan 18, 2012
Start date
Aug 2011
Primary completion
Oct 2012
Completion
Oct 2012
Last update
Mar 27, 2013

Study contacts

MD
study director · Amgen
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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