Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE) - Full Text View

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 (belimumab), administered in addition to standard therapy, in subjects with active SLE disease.

Condition	Intervention	Phase
Lupus Erythematosus, Systemic	Biological: belimumab Other: Placebo	Phase II

Human Genome Sciences has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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:

MedlinePlus related topics: Lupus

Drug Information available for: Immunoglobulins Belimumab Globulin, Immune

U.S. FDA Resources

Further study details as provided by Human Genome Sciences:

Primary Outcome Measures:

To evaluate the safety and tolerability of LymphoStat-B (belimumab) in subjects with SLE. [ Time Frame: February 2006 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the efficacy of LymphoStat-B™ (belimumab) in subjects with SLE. [ Time Frame: Februrary 2006 ] [ Designated as safety issue: No ]

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
Experimental: Belimumab 1 mg/kg 1mg/kg, IV on Days 0, 14, 28, and every 28 days through 52 weeks	Biological: belimumab 1mg/kg, IV on Days 0, 14, 28, and every 28 days through 52 weeks Other Names: LymphoStat-B BENLYSTA
Experimental: Belimumab 4 mg/kg 4mg/kg, IV on Days 0, 14, 28, and every 28 days through 52 weeks	Biological: belimumab 4mg/kg, IV on Days 0, 14, 28, and every 28 days through 52 weeks Other Name: LymphoStat-B
Experimental: Belimumab 10 mg/kg 10mg/kg, IV on Days 0, 14, 28, and every 28 days through 52 weeks	Biological: belimumab 10mg/kg, IV on Days 0, 14, 28, and every 28 days through 52 weeks Other Name: LymphoStat-B
Placebo Comparator: Placebo Placebo Comparator	Other: 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 (belimumab), 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 ClinicalTrials.gov Identifier (NCT Number):

Jacobi AM, Huang W, Wang T, Freimuth W, Sanz I, Furie R, Mackay M, Aranow C, Diamond B, Davidson A. Effect of long-term belimumab treatment on B cells in systemic lupus erythematosus: extension of a phase II, double-blind, placebo-controlled, dose-ranging study. Arthritis Rheum. 2010 Jan;62(1):201-10.

Furie RA, Petri MA, Wallace DJ, Ginzler EM, Merrill JT, Stohl W, Chatham WW, Strand V, Weinstein A, Chevrier MR, Zhong ZJ, Freimuth WW. Novel evidence-based systemic lupus erythematosus responder index. Arthritis Rheum. 2009 Sep 15;61(9):1143-51.

Wallace DJ, Stohl W, Furie RA, Lisse JR, McKay JD, Merrill JT, Petri MA, Ginzler EM, Chatham WW, McCune WJ, Fernandez V, Chevrier MR, Zhong ZJ, Freimuth WW. A phase II, randomized, double-blind, placebo-controlled, dose-ranging study of belimumab in patients with active systemic lupus erythematosus. Arthritis Rheum. 2009 Sep 15;61(9):1168-78.

Responsible Party:	William Freimuth, MD, PhD, Vice President of Clinical Research, Immunology, Rheumatology and Infectious Diseases, Human Genome Sciences, Inc.
ClinicalTrials.gov Identifier:	NCT00071487 History of Changes
Other Study ID Numbers:	LBSL02
Study First Received:	October 24, 2003
Last Updated:	July 20, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Human Genome Sciences:

SLE

Additional relevant MeSH terms:

Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012