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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01510951




Registration number
NCT01510951
Ethics application status
Date submitted
11/08/2011
Date registered
18/01/2012
Date last updated
27/03/2013

Titles & IDs
Public title
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of AMG 811 in Subjects With Psoriasis
Scientific 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
Secondary ID [1] 0 0
20101147
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AMG 811 or Placebo

Placebo Comparator: PLACEBO -

Experimental: AMG 811 -


Treatment: Drugs: AMG 811 or Placebo
Single dose subcutaneous administration of AMG 811 or placebo to adult subjects with psoriasis.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
16 weeks
Secondary outcome [1] 0 0
Evaluate the efficacy of AMG 811 as measured by the following: the proportion of subjects with a PASI 50, 75 and 90
Timepoint [1] 0 0
16 weeks
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
16 weeks
Secondary outcome [3] 0 0
Measure the peak serum concentration (Cmax) of AMG 811 after a single dose administration in subjects with moderate to severe psoriasis
Timepoint [3] 0 0
16 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Basic Science
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2012
Sample size
Target
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
QLD,WA
Recruitment hospital [1] 0 0
Research Site - Herston
Recruitment hospital [2] 0 0
Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
4006 - Herston
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch
Country [2] 0 0
New Zealand
State/province [2] 0 0
Grafton, Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT01510951
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01510951