Phase 3 N=865 Randomized Double-blind Treatment

A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus

Bottom Line

View on ClinicalTrials.gov: NCT00424476 ↗

Enrolled (actual)

865

Serious AEs

14.3%

Results posted

May 2011

Primary outcome: Primary: SLE Responder Index (SRI) Response Rate at Week 52 — 43.6; 51.4; 57.6 Percentage of participants — p=0.0006

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Placebo (Drug); Belimumab 1 mg/kg (Drug); Belimumab 10 mg/kg (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Human Genome Sciences Inc.
Primary completion: May 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY SLE Responder Index (SRI) Response Rate at Week 52	43.6; 51.4; 57.6	0.0006 sig
SECONDARY Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Wk 52.	46.0; 53.1; 58.3	0.0024 sig
SECONDARY Mean Change in Physician's Global Assessment (PGA) at Wk 24.	-0.39; -0.44; -0.54	0.0003 sig
SECONDARY Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Wk 24.	3.64; 3.65; 3.58	0.8870
SECONDARY Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 52	12.0; 20.6; 18.6	0.0526

Summary

The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) disease.

Eligibility Criteria

Key Inclusion Criteria

Clinical diagnosis of SLE by ACR criteria.
Active SLE disease.
Autoantibody-positive.
On stable SLE treatment regimen.

Key Exclusion Criteria

Pregnant or nursing
Have received treatment with any B cell targeted therapy.
Have received treatment with a biological investigational agent in the past year.
Have received IV cyclophosphamide within 180 days of Day 0.
Have severe lupus kidney disease.
Have active central nervous system (CNS) lupus.
Have required management of acute or chronic infections within the past 60 days.
Have current drug or alcohol abuse or dependence.
Have a historically positive test or test positive at screening for HIV, hepatitis B, or hepatitis C.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00424476). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.