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NCT01649765 · ClinicalTrials.gov registry record · Phase 2
Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy
A Phase 2 study of Systemic Lupus Erythematosus, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 93
- Enrollment target
- 20
- Study locations
NCT01649765 is a Phase 2 study of Systemic Lupus Erythematosus that has completed, run by GlaxoSmithKline. The registered enrollment target is 93 participants, below the 379-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (75% lower). The trial reports 20 study locations across 7 states.
The verdict
NCT01649765, a Phase 2 study of Systemic Lupus Erythematosus, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 93 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- OTHER placebo
- DRUG belimumab 10mg/kg
Study Locations (20)
Other
- GSK Investigational Site - Rosario
- GSK Investigational Site - Santa Fe
- GSK Investigational Site - San Luis Potosí City
- GSK Investigational Site - Lima
- GSK Investigational Site - Lima
- GSK Investigational Site - Surco
- GSK Investigational Site - Saint Petersburg
- GSK Investigational Site - Espluges de Llobregat
- GSK Investigational Site - Madrid
- GSK Investigational Site - Valencia
- GSK Investigational Site - Bristol
- GSK Investigational Site - Liverpool
- GSK Investigational Site - London
New York
- GSK Investigational Site - New York
- GSK Investigational Site - The Bronx
Arizona
- GSK Investigational Site - Phoenix
District of Columbia
- GSK Investigational Site - Washington D.C.
Georgia
- GSK Investigational Site - Augusta
Missouri
- GSK Investigational Site - St Louis
Ohio
- GSK Investigational Site - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2012-09-07 |
| Est. Completion | 2025-09-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01649765
The ClinicalTrials.gov registry entry for NCT01649765 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 379-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (75% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT01649765 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Other, New York, Arizona.
Frequently Asked Questions
What is clinical trial NCT01649765 about?
NCT01649765 is a clinical study titled "Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy". 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
What is the current status of trial NCT01649765?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 93 participants. The study started on 2012-09-07. Estimated completion is 2025-09-30.
What conditions does trial NCT01649765 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus.
What interventions are being tested in trial NCT01649765?
The interventions under investigation include: placebo (OTHER), belimumab 10mg/kg (DRUG).
Who is sponsoring clinical trial NCT01649765?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01649765 being conducted?
This trial has 20 study locations across Arizona, District of Columbia, Georgia, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.