NCT00657007

Phase 1 Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)

A Phase 1, Multi-Center, Double-Blind, Single and Double Dose-Escalation Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Human Genome Sciences Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of thie study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of belimumab (LymphoStat-B™)in subjects with SLE.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
BIOLOGICAL	belimumab	1. 1 mg/kg, IV (in the vein) once on Day 0, with a final evaluation at Day 84 (Cohort 1). 2. 1 mg/kg, IV (in the vein) on Days 0 and 21, with a final evaluation at Day 105 (Cohort 5).
BIOLOGICAL	belimumab	1. 4 mg/kg, IV (in the vein) once on Day 0, with a final evaluation at Day 84 (Cohort 2). 2. 4 mg/kg, IV (in the vein) on Days 0 and 21, with a final evaluation at Day 105 (Cohort 6).
BIOLOGICAL	belimumab	1. 10 mg/kg, IV (in the vein) once on Day 0, with a final evaluation at Day 84 (Cohort 3). 2. 10 mg/kg, IV (in the vein) on Days 0 and 21, with a final evaluation at Day 105 (Cohort 7).
BIOLOGICAL	belimumab	1. 20 mg/kg, IV (in the vein) once on Day 0, with a final evaluation at Day 84 (Cohort 4). 2. 20 mg/kg, IV (in the vein) on Days 0 and 21, with a final evaluation at Day 105 (Cohort 8).
BIOLOGICAL	Placebo	1. IV (in the vein) on Day 0 (Cohorts 1-4). 2. IV (in the vein) on Days 0 and 21 (Cohorts 5-8).

Timeline

• Start date: 2002-02-01
• Primary completion: 2003-03-01
• Completion: 2003-03-01
• First posted: 2008-04-14
• Last updated: 2013-08-02

Locations

18 sites across 1 country: United States