A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus

March 27, 2015 updated by: Amgen

Randomized, Multicenter, Double-Blind, Placebo-Controlled, Rising Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus

This is a multicenter, randomized, double-blind, placebo-controlled, sequential rising single-dose study in which approximately 56 subjects with SLE will be enrolled in 7 dosing cohorts

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, NW10 7NS
        • Research Site
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Research Site
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Research Site
    • California
      • Los Angeles, California, United States, 90048
        • Research Site
      • Los Angeles, California, United States, 90033
        • Research Site
    • Indiana
      • Michigan City, Indiana, United States, 46360
        • Research Site
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Research Site
    • New York
      • Manhasset, New York, United States, 11030
        • Research Site
      • New York, New York, United States, 10003
        • Research Site
      • Rochester, New York, United States, 14642
        • Research Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Research Site
      • Dallas, Texas, United States, 75247
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of SLE with positive ANA
  • Stable disease with no change in SLE therapy within the previous 30 days
  • BMI from 18 to 38 kg/m2

Exclusion Criteria:

  • Have had signs or symptoms of a viral, bacterial or fungal infection within 30 days of study randomization
  • Evidence of renal disease or liver disease
  • Any history of granulomatous disease including autoimmune granulomatous vasculitis and sarcoidosis
  • Prior administration of any other biologic that primarily targets the immune system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
No active drug
Drug: Placebo
contains no active drug
Experimental: AMG 557
AMG 557 administered as subcutaneous and intravenous doses.
Drug: AMG 557
AMG 557 is for the treatment of sybjects with systemic lupus erythematosus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability
Time Frame: From 29 days to 169 days
Subject incidence of treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory safety tests, and ECGs
From 29 days to 169 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic profile of AMG 557 including Tmax, AUClast and Cmax
Time Frame: From 29 days to 169 days
Serum concentration and derived PK parameters including Tmax, AUClast and Cmax
From 29 days to 169 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

January 6, 2015

First Submitted That Met QC Criteria

March 11, 2015

First Posted (Estimate)

March 18, 2015

Study Record Updates

Last Update Posted (Estimate)

March 30, 2015

Last Update Submitted That Met QC Criteria

March 27, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20060132

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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