A Randomized, Double-blind, Placebo-controlled, Ascending, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus

Amgen1 site in 1 country58 target enrollmentDecember 2008

ConditionsSystemic Lupus Erythematosus

InterventionsAMG 557

DrugsAMG 557

Overview

Phase: Phase 1
Intervention: AMG 557
Conditions: Systemic Lupus Erythematosus
Sponsor: Amgen
Enrollment: 58
Locations: 1
Primary Endpoint: Subject incidence of treatment-emergent adverse events and the incidence of antibodies to AMG 557.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase 1, randomized, placebo-controlled, double-blind, dose-escalation study of repeat SC doses of AMG 557 in adults with Systemic Lupus Erythematosus.

Registry

clinicaltrials.gov

Start Date

December 2008

End Date

May 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Investigators

Sponsor

Amgen

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Before any study-specific procedure, the appropriate written informed consent must be obtained;
•Men and women, between the ages of 18 and 70 years old, inclusive, at the time of randomization;
•Diagnosis of SLE as defined by the most recent ACR criteria, including a positive ANA at screening or documented positive ANA (the titer should be at least 1:80) in the past.
•SLE duration of at least six months, as diagnosed by a physician;
•Stable disease, defined as no change in SLE therapy within the previous 30 days; and, in the opinion of the investigator, no anticipated need for a change in SLE therapy will be required while the subject is enrolled in the study;
•Normal or clinically acceptable ECG (12-lead reporting ventricular rate and PR, QRS, QT, QTc) at screening and Day -1 based on the opinion of the investigator;
•Body mass index from 18 to 40 kg/m2 at screening;
•Able and willing to complete entire study according to study schedule.
•Immunizations up to date, with a minimum of tetanus, diphtheria, pertussis (td/Tdap), pneumococcal (polysaccharide) and influenza (during flu season) vaccinations, as determined by the Principal Investigator.

Exclusion Criteria

•Positive serology for HIV antibodies, hepatitis B surface antigen or hepatitis C antibodies (confirmed by PCR or RIBA);
•Have had signs or symptoms of a viral, bacterial or fungal infection within 30 days of study randomization;
•Evidence of active or latent tuberculosis as assessed by PPD or Quantiferon testing at screening;
•Have donated blood or experienced a loss of blood \>500mL within 4 weeks of randomization;
•History of ethanol or drug abuse within the last one year prior to randomization;
•Evidence of significant renal insufficiency, defined by:
•The glomerular fitration rate \< 50 mL/min using the Cockroft and Gault equation;
•Evidence of liver disease (eg, serum ALT or AST \> 2x upper limit of normal);
•Total WBC \<3000 x 106/L;
•Neutrophil count \< 1500 x106/L