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

NCT00657007 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2013-08-02

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Human Genome Sciences Inc.

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-02-28
Primary Completion
2003-03-31
Completion
2003-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00657007 on ClinicalTrials.gov