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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00071487
• Date of registration: 24/10/2003
• Prospective Registration: No
• Primary sponsor: Human Genome Sciences Inc.
• Public title: Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE)
• Scientific 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)
• Date of first enrolment: October 2003
• Target sample size: 449
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00071487
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Canada, United States

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion 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, intravenous immunoglobulin (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 central nervous system (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 immunoglobulin A (IgA) deficiency

- Human immunodeficiency virus (HIV), Hepatitis B, Hepatitis C



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lupus Erythematosus, Systemic

Intervention(s)

Drug: Belimumab 10 mg/kg

Drug: Belimumab 4 mg/kg

Drug: Belimumab 1 mg/kg

Drug: Placebo

Primary Outcome(s)

Percentage Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24. [Time Frame: Baseline, 24 weeks]

Time to First Mild/Moderate or Severe SLE Flare (SLE Flare Index) [Time Frame: 0 to 52 weeks]

Secondary Outcome(s)

Percentage Change From Baseline in SELENA SLEDAI Score at Week 52 [Time Frame: Baseline, 52 weeks]

Time to First Type A/B SLE Flare (as Defined Using BILAG) Over 52 Weeks [Time Frame: 0 to 52 weeks]

Percentage of Patients With a Reduction in Prednisone Dose [Time Frame: Baseline, weeks 40 to 52]

Percentage Change From Baseline in British Isles Lupus Activity Group (BILAG) Score at Week 52 [Time Frame: Baseline, 52 weeks]

Area Under the Curve (AUC) of BILAG Score at Week 52 [Time Frame: Baseline and every 4 to 8 weeks through Week 52]

Area Under the Curve (AUC) of SELENA SLEDAI Score at Week 52 [Time Frame: Baseline and every 4 to 8 weeks through Week 52]

Secondary ID(s)

LBSL02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 28/08/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00071487