A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of Single Dose of AMG 623 in Subjects With Systemic Lupus Erythematosus

May 13, 2015 updated by: Amgen

A Randomized Double-blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 623 Following Single Dose Administration in Subjects With Systemic Lupus Erythematosus

This study is to evaluate the safety of AMG 623 in subjects with systemic lupus erythematosus. The study consists of a 21 day screening period followed by administration of the investigational product and up to 70 day follow up period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 1

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 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women, between the ages of 18 and 55
  • Diagnosis of SLE
  • Have had a disease duration of at least 1 year, as diagnosed by a physician

Exclusion Criteria:

  • Have a disorder (including psychiatric), condition or clinically significant disease (other than a diagnosis of SLE) that would interfere with the study evaluation, completion and/or procedures per the investigator's discretion
  • Have active vasculitis, active CNS lupus requiring therapy, active acute renal disease, uncontrolled hypertension, uncontrolled diabetes or active systemic infection
  • Have had signs or symptoms of viral or bacterial infection within 30 days of enrollment
  • Have received a daily dose of greater than 10 mg prednisone (or equivalent) in the prior 30 days

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: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AMG 623
Single dose of AMG 623 administered as subcutaneous and intravenous doses
Drug: AMG 623
Single dose of AMG 623 administered as subcutaneous and intravenous doses
Placebo Comparator: Placebo
Single dose of matching AMG 623 placebo administered as subcutaneous and intravenous doses
Drug: Placebo
Single dose of matching AMG 623 placebo administered as subcutaneous and intravenous doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of treatment emergent adverse events
Time Frame: up to 70 days
up to 70 days
Incidence of abnormal clinically significant vital signs
Time Frame: up to 70 days
up to 70 days
Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results
Time Frame: up to 70 days
up to 70 days
Incidence of abnormal clinically significant ECG results
Time Frame: up to 70 days
up to 70 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics profile of AMG 623 including Tmax, AUClast and Cmax
Time Frame: up to 70 days
up to 70 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

October 1, 2004

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

May 11, 2015

First Submitted That Met QC Criteria

May 13, 2015

First Posted (Estimate)

May 14, 2015

Study Record Updates

Last Update Posted (Estimate)

May 14, 2015

Last Update Submitted That Met QC Criteria

May 13, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20040147

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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