CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 839 enrolled
Drug / intervention
Placebo +2 morebiological
Likely dose
Belimumab 200 mg SCfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01484496
NCT01484496Phase 3Completed
CompareCT.gov

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects With Systemic Lupus Erythematosus (SLE)

Human Genome Sciences Inc., a GSK Company·interventional·Posted Dec 2, 2011·Updated Jun 6, 2018

In Brief

A Phase 3 clinical trial evaluating Placebo, Belimumab 200 mg SC, and 1 other intervention for Systemic Lupus Erythematosus. Completed, enrolled 839 participants across 207 sites in 31 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (SC) to adult subjects with Systemic Lupus Erythematosus (SLE).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus
CountriesArgentina, Austria, Belgium, Brazil, Bulgaria, Chile, Colombia, Croatia, Czechia, Denmark, France, Germany, Hungary, Italy, Japan, Malaysia, Mexico, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Spain, Sweden, Taiwan, Thailand, Ukraine, United Kingdom, United States
CollaboratorsGlaxoSmithKline

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 2, 2011
Enrollment StartNov 16, 2011
Primary CompletionFeb 13, 2015
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 14.6 years ago

Interventions

Placebobiological

Placebo

Belimumab 200 mg SCbiological

Belimumab 200 mg SC

Standard therapydrug

Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; biologics and intravenous cyclophosphamide are not permitted.