A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of AMG 557 in Subjects With Moderate to Severe Psoriasis

Amgen1 site in 1 country6 target enrollmentNovember 2011

ConditionsPsoriasis

InterventionsAMG 557 or PLACEBO

DrugsAMG 557 or PLACEBO

Overview

Phase: Phase 1
Intervention: AMG 557 or PLACEBO
Conditions: Psoriasis
Sponsor: Amgen
Enrollment: 6
Locations: 1
Primary Endpoint: 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 557
Status: Terminated
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to study the safety, tolerability and immunogenicity of AMG 557 following multiple subcutaneous dose administration in adults with moderate to severe psoriasis.

Registry

clinicaltrials.gov

Start Date

November 2011

End Date

June 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Amgen

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects must sign an Institutional Review Board (IRB)-approved informed consent form (ICF) before any study specific procedures.
•Diagnosis of moderate to severe plaque PsO for at least 6 months prior to screening as defined by:
•A minimum PASI score of ≥ 10 obtained at screening;
•Psoriasis involving ≥ 10% of the Body Surface Area (BSA) at screening.
•Received at least 1 previous phototherapy or systemic PsO therapy (but not within the 30 days before study drug administration), or has been a candidate to receive phototherapy or systemic PsO therapy in the opinion of the PI.
•Stable treatment without topical or systemic steroids, topical or systemic retinoids, vitamin D analogues (Dovenex), Psoralen Ultraviolet A (PUVA) therapy, Ultraviolet A (UVA) therapy or Ultraviolet B (UVB) therapy, methotrexate, or cyclosporine for at least 60 days prior to IP administration. Stable treatment of PsO involving scalp, axillae, or groin with topical corticosteroids of moderate strength will be allowed.
•Agrees to wear clothing that protects from sun exposure for the duration of the study.
•Agrees to use sunscreen (SPF of at least 30) on sun-exposed skin for the duration of the study.
•Male or female subjects between 18 and 55 years of age, inclusive at the time of screening.
•Body mass index (BMI) between 18 and 35 kg/m2, inclusive, at screening, unless considered by the PI and the Amgen Medical Monitor to be at an appropriate value in the context of other measured safety parameters.

Exclusion Criteria

•Diagnosis of guttate, pustular, or other non plaque forms of PsO.
•Evidence of skin conditions other than PsO (eg, eczema) during the screening period that would interfere with evaluations of the effect of IP on PsO.
•Previous receipt of any approved or investigational biologic agent for PsO or other medical conditions.
•Received PUVA therapy, UVA therapy or UVB therapy ≤ 30 days prior to IP administration.
•Treatment with any other systemic PsO therapy or oral or parenteral corticosteroids ≤ 30 days prior to IP administration.
•Use of high potency topical steroids, topical vitamin A or D analog preparations, or anthralin ≤ 30 days prior to IP administration (Note: stable doses \> 30 days of low or moderate strength topical steroids are permitted only on the scalp, axillae, and groin according to the package insert).
•Received topical cyclosporin or calcineurin inhibitors such as pimecrolimus (Elidel) and tacrolimus (Protopic) ≤ 30 days prior to IP administration.
•Received IV or oral calcineurin inhibitors such as tacrolimus (Prograf) ≤ 30 days prior to IP administration.
•Significant concurrent medical conditions at the time of screening or prior to randomization, including:
•Uncontrolled hypertension (defined as screening systolic blood pressure measurement of greater than 140 mm Hg or a screening diastolic blood pressure of greater than 90 mm Hg) confirmed by 2 separate measurements during the screening visit;

Arms & Interventions

PLACEBO

Intervention: AMG 557 or PLACEBO

AMG 557

Intervention: AMG 557 or PLACEBO

Outcomes

Primary Outcomes

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 557

Time Frame: 28 weeks

Secondary Outcomes

Measure the area under the serum concentration curve versus time of AMG 557 after multiple dose administration in subjects with moderate to severe psoriasis(28 weeks)
Evaluate the efficacy of AMG 557 as measured by the proportion of subjects with a PASI 50, 75 and 90 at week 28(28 weeks)
Measure the peak serum concentration (Cmax) of AMG 557 after multiple dose administration in subjects with moderate to severe psoriasis(28 weeks)