Phase 2 Study of Belimumab Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)

Last updated: August 1, 2013
Sponsor: Human Genome Sciences Inc.
Overall Status: Terminated

Phase

2

Condition

Musculoskeletal Diseases

Systemic Lupus Erythematosus

Lupus

Treatment

N/A

Clinical Study ID

NCT00732940
HGS1006-1070
112232
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to test the safety and tolerability of repeated subcutaneous (SC) doses of belimumab in subjects with SLE.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria

  • Active SLE disease

  • On stable SLE treatment regimen

Exclusion

Exclusion Criteria:

  • Pregnant or nursing

  • Have received treatment with an B cell targeted therapy

  • Have received treatment with a biologic investigational agent in the past year

  • Have received intravenous (IV) cyclophosphamide within 180 days of Day 0

  • Have severe lupus kidney disease

  • Have active central nervous system (CNS) lupus

  • Have required management of acute or chronic infections with the past 60 days

  • Have current drug or alcohol abuse or dependence or within the past year

  • Have a historically positive test or test positive at screening for humanimmunodeficiency virus (HIV), hepatitis B, or hepatitis C

  • Have a history of an allergic or anaphylactic reaction to drugs, food, or insectsrequiring medical intervention

Study Design

Total Participants: 56
Study Start date:
October 01, 2008
Estimated Completion Date:
March 31, 2012

Study Description

This clinical trial will evaluate the safety, pharmacokinetics (PK), and effect on biomarkers of repeated subcutaneous (SC) administration of belimumab in subjects with SLE. As data permit, an exploratory pharmacodynamic analysis will be performed to evaluate the correlation between belimumab serum exposure, PGA, SELENA SELDAI, and biomarker effects.

Connect with a study center

  • Hospital Central "Igancio Morones Prieto"

    San Lusi Potosi, 78240
    Mexico

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35249-7201
    United States

    Site Not Available

  • Valerious Medical Group Research Center

    Long Beach, California 90806
    United States

    Site Not Available

  • Tampa Medical Group, PA

    Tampa, Florida 33614
    United States

    Site Not Available

  • Fiechtner Research, Inc.

    Lansing, Michigan 48910
    United States

    Site Not Available

  • SUNY Downstate Medical Center

    Brooklyn, New York 11203
    United States

    Site Not Available

  • North Shore-LIJ Health System/Rheumatology, Allergy, Immunology

    Lake Success, New York 11042
    United States

    Site Not Available

  • Rheumatology Associates

    Smithtown, New York 11787
    United States

    Site Not Available

  • STAT Research, Inc.

    Dayton, Ohio 45408
    United States

    Site Not Available

  • Oklahoma Center for Arthritis Therapy & Research

    Tulsa, Oklahoma 74104
    United States

    Site Not Available

  • Houston Institute for Clinical Research

    Houston, Texas 77074
    United States

    Site Not Available

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