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

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

AMG 811 or Placebo

About this trial

This is an interventional basic science trial for Psoriasis focused on measuring AMGEN, PSORIASIS, SAFETY

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Research Site
Research Site
Research Site
Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

PLACEBO

AMG 811

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Evaluate the efficacy of AMG 811 as measured by the following: the proportion of subjects with a PASI 50, 75 and 90

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

Measure the peak serum concentration (Cmax) of AMG 811 after a single dose administration in subjects with moderate to severe psoriasis

Full Information

NCT ID

NCT01510951

First Posted

August 11, 2011

Last Updated

March 25, 2013

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT01510951

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

Keywords

AMGEN, PSORIASIS, SAFETY

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PLACEBO

Arm Type

Placebo Comparator

Arm Title

AMG 811

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

AMG 811 or Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Herston

State/Province

Queensland

ZIP/Postal Code

4006

Country

Australia

Facility Name

Research Site

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

Research Site

City

Christchurch

ZIP/Postal Code

8011

Country

New Zealand

Facility Name

Research Site

City

Grafton, Auckland

ZIP/Postal Code

1010

Country

New Zealand

12. IPD Sharing Statement

Links:

URL

http://www.amgentrials.com

Description

AmgenTrials clinical trials website

Learn more about this trial

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

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