Safety and Efficacy Study of LymphoStat-B 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, 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:

MedlinePlus related topics: Lupus

Drug Information available for: Belimumab

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™ 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):

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:	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