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Safety and Efficacy Study of LymphoStat-B in Subjects With Systemic Lupus Erythematosus (SLE)
This study has been completed.
First Received: October 24, 2003   Last Updated: February 19, 2009   History of Changes
Sponsor: Human Genome Sciences
Information provided by: Human Genome Sciences
ClinicalTrials.gov Identifier: NCT00071487
  Purpose

The purpose of this study is to evaluate the safety and efficacy of 3 different doses of LymphoStat-B, administered in addition to standard therapy, in subjects with active SLE disease.


Condition Intervention Phase
Lupus Erythematosus, Systemic
Drug: belimumab
Drug: Placebo
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study
Official Title: A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE)

Resource links provided by NLM:


Further study details as provided by Human Genome Sciences:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of LymphoStat-B™ in subjects with SLE. [ Time Frame: February 2006 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the efficacy of LymphoStat-B™ in subjects with SLE. [ Time Frame: Februrary 2006 ] [ Designated as safety issue: Yes ]

Enrollment: 449
Study Start Date: October 2003
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
1mg/kg, IV on Days 0, 14, 28, and every 28 days through 52 weeks
Drug: belimumab
1mg/kg, IV on Days 0, 14, 28, and every 28 days through 52 weeks
2: Experimental
4mg/kg, IV on Days 0, 14, 28, and every 28 days through 52 weeks
Drug: belimumab
4mg/kg, IV on Days 0, 14, 28, and every 28 days through 52 weeks
3: Experimental
10mg/kg, IV on Days 0, 14, 28, and every 28 days through 52 weeks
Drug: belimumab
10mg/kg, IV on Days 0, 14, 28, and every 28 days through 52 weeks
4: Placebo Comparator
Placebo Comparator
Drug: Placebo
IV on Days 0, 14, 28, and every 28 days through 52 weeks

Detailed Description:

The purpose of this study is to evaluate the safety and efficacy of three different doses of LymphoStat-B, administered in addition to standard therapy, in subjects with active SLE disease.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Primary Inclusion Criteria

  • Clinical diagnosis of SLE
  • "Active" SLE disease
  • On a stable SLE treatment regimen
  • History of measurable autoantibodies

Primary Exclusion Criteria

  • Received a non-FDA approved investigational agent within last 28 days
  • Cyclosporin, IVIG or plasmapheresis within last 90 days
  • Active lupus nephritis requiring hemodialysis, cyclophosphamide (Cytoxan™), or high-dose prednisone (> 100 mg/day) within last 90 days
  • Active CNS lupus requiring therapeutic intervention within last 60 days
  • History of renal transplant
  • History of chronic infection that has been active within last 6 months, herpes zoster within last 90 days or any infection requiring hospitalization or intravenous medication within last 60 days
  • History of hypogammaglobulinemia or IgA deficiency
  • HIV, Hepatitis B, Hepatitis C
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00071487

  Show 62 Study Locations
Sponsors and Collaborators
Human Genome Sciences
Investigators
Study Director: William Freimuth, MD, PhD Human Genome Sciences, Inc.
  More Information

No publications provided by Human Genome Sciences

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Responsible Party: Human Genome Sciences, Inc. ( William Freimuth, MD, PhD, Vice President of Clinical Research, Immunology, Rheumatology and Infectious Diseases )
Study ID Numbers: LBSL02
Study First Received: October 24, 2003
Last Updated: February 19, 2009
ClinicalTrials.gov Identifier: NCT00071487     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Human Genome Sciences:
SLE

Additional relevant MeSH terms:
Autoimmune Diseases
Immune System Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases

ClinicalTrials.gov processed this record on November 11, 2009