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COMPLETED
NCT01649765
PHASE2

Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This is a multi-center study to evaluate the safety, pharmacokinetics, and efficacy of belimumab intravenous (IV) in pediatric patients 5 to 17 years of age with active systemic lupus erythematosus

Official title: A Multi-center, Randomized, Placebo-Controlled Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients With Systemic Lupus Erythematosus

Key Details

Gender

All

Age Range

5 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

93

Start Date

2012-09-07

Completion Date

2025-09-30

Last Updated

2026-04-20

Healthy Volunteers

No

Interventions

DRUG

Belimumab 10 mg/kg

Belimumab was administered.

OTHER

Placebo

Placebo was administered

Locations (32)

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Washington D.C., District of Columbia, United States

GSK Investigational Site

Augusta, Georgia, United States

GSK Investigational Site

St Louis, Missouri, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

The Bronx, New York, United States

GSK Investigational Site

Cincinnati, Ohio, United States

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Rosario, Argentina

GSK Investigational Site

Santa Fe, Argentina

GSK Investigational Site

Calgary, Alberta, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Aichi, Japan

GSK Investigational Site

Kagoshima, Japan

GSK Investigational Site

Miyagi, Japan

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

San Luis Potosí City, Mexico

GSK Investigational Site

Lima, Peru

GSK Investigational Site

Lima, Peru

GSK Investigational Site

Surco, Peru

GSK Investigational Site

Lodz, Poland

GSK Investigational Site

Warsaw, Poland

GSK Investigational Site

Moscow, Russia

GSK Investigational Site

Saint Petersburg, Russia

GSK Investigational Site

Tolyatti, Russia

GSK Investigational Site

Espluges de Llobregat, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Valencia, Spain

GSK Investigational Site

Bristol, United Kingdom

GSK Investigational Site

Liverpool, United Kingdom

GSK Investigational Site

London, United Kingdom

GSK Investigational Site

London, United Kingdom