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Completed Phase 2 Interventional Results available

Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy

ClinicalTrials.gov ID: NCT01649765

Public ClinicalTrials.gov record NCT01649765. 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 24, 2026, 7:30 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 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

Brief summary

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

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

Study identification

NCT ID
NCT01649765
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
GlaxoSmithKline
Industry
Enrollment
93 participants

Conditions and interventions

Interventions

Drug · Other

Eligibility (public fields only)

Age range
5 Years to 17 Years
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
Sep 7, 2012 (Actual)
Primary completion
Jan 24, 2018 (Actual)
Completion
Sep 30, 2025 (Actual)
Last update posted
Apr 20, 2026

2012 – 2025

United States locations

U.S. sites
7
U.S. states
6
U.S. cities
7
Facility City State ZIP Site status
GSK Investigational Site Phoenix Arizona 85016 —
GSK Investigational Site Washington D.C. District of Columbia 20010 —
GSK Investigational Site Augusta Georgia 30912 —
GSK Investigational Site St Louis Missouri 63104 —
GSK Investigational Site New York New York 10032 —
GSK Investigational Site The Bronx New York 10467 —
GSK Investigational Site Cincinnati Ohio 45229 —

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

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 25 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01649765, 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 Apr 20, 2026 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01649765 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →