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Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy

NCT01649765 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2026-04-20

Study results available
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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

Conditions

Interventions

DRUG

Belimumab 10 mg/kg

Belimumab was administered.

OTHER

Placebo

Placebo was administered

Sponsors & Collaborators

  • Human Genome Sciences Inc., a GSK Company

    collaborator INDUSTRY

  • GlaxoSmithKline

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-07
Primary Completion
2018-01-24
Completion
2025-09-30

Countries

  • United States
  • Argentina
  • Canada
  • Japan
  • Mexico
  • Peru
  • Poland
  • Russia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT01649765 on ClinicalTrials.gov