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

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	Phase II

MedlinePlus related topics:

Lupus

Drug Information available for:

Belimumab

U.S. FDA Resources

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)

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

Arms	Assigned Interventions
1: Active Comparator Subjects will received 1mg/kg (IV) of study agent on Days 0, 14, 28, and every 28 days through 72 weeks with a final evaluation at Week 76.	Drug: belimumab 1mg/kg, IV on Days 0, 14, 28, and every week with a final evaluation at Week 76. 10mg/kg, IV on Days 0, 14, 28, and every 72 weeks with a final evaluation at Week 76. Placebo
2: Active Comparator Subjects will received 10mg/kg (IV) of study agent on Days 0, 14, 28, and every 28 days through 72 weeks with a final evaluation of Week 76.	Drug: belimumab 1mg/kg, IV on Days 0, 14, 28, and every week with a final evaluation at Week 76. 10mg/kg, IV on Days 0, 14, 28, and every 72 weeks with a final evaluation at Week 76. Placebo
3: Placebo Comparator	Drug: belimumab 1mg/kg, IV on Days 0, 14, 28, and every week with a final evaluation at Week 76. 10mg/kg, IV on Days 0, 14, 28, and every 72 weeks with a final evaluation at Week 76. Placebo

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

Responsible Party:	Human Genome Sciences, Inc. ( William Freimuth, MD, PhD, Vice President of Clinical Research, Immunology, Rheumatology and Infectious Diseases )
Study ID Numbers:	LBSL02
First Received:	October 24, 2003
Last Updated:	April 9, 2008
ClinicalTrials.gov Identifier:	NCT00071487
Health Authority:	United States: Food and Drug Administration

Keywords provided by Human Genome Sciences:

SLE

Study placed in the following topic categories:

Antibodies

Autoimmune Diseases

Lupus Erythematosus, Systemic

Connective Tissue Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	Human Genome Sciences
Information provided by:	Human Genome Sciences
ClinicalTrials.gov Identifier:	NCT00071487