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Completed Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT00657007

Public ClinicalTrials.gov record NCT00657007. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 26, 2026, 7:01 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT00657007
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Human Genome Sciences Inc.
Industry
Enrollment
70 participants

Conditions and interventions

Interventions

Biological

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 2002 (Type not available)
Primary completion
Mar 2003 (Actual)
Completion
Mar 2003 (Actual)
Last update posted
Aug 2, 2013

2002 – 2003

United States locations

U.S. sites
18
U.S. states
11
U.S. cities
15
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35294 —
University of Southern California Los Angeles California 90033 —
University of California-Los Angeles Los Angeles California 90095 —
Washington Hospital Center Washington D.C. District of Columbia 20010 —
Northwestern University Medical School Chicago Illinois 60611 —
Rush-Presbyterian-St Luke's Medical Center Chicago Illinois 60612 —
The University of Chicago Hospital Chicago Illinois 60637 —
The University of Michigan Health System Ann Arbor Michigan 48109 —
SUNY Downstate Medical Center Brooklyn New York 11203 —
North Shore University Hospital Manhasset New York 11030 —
Hospital for Joint Diseases New York New York 10003 —
The University of North Carolina at Chapel Hill Chapel Hill North Carolina 27599 —
Duke University Durham North Carolina 27710 —
Wake Forest University School of Medicine Winston-Salem North Carolina 27157 —
Oklahoma Medical Research Foundation Oklahoma City Oklahoma 73104 —
University of Pittsburgh School of Medicine Pittsburgh Pennsylvania 15261 —
Medical University of South Carolina Charleston South Carolina 29425 —
University of Texas Southwestern Medical Center at Dallas Dallas Texas 75390 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00657007, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 2, 2013 · Synced Oct 26, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00657007 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →