RecruitingPhase 3ACTRN12607000327482

A Study of Belimumab, a Fully Human Monoclonal Anit-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE)

Sponsor

Kendle R&D Pty Limited

Enrollment

810 participants

Start Date

Jun 1, 2007

Study Type

Interventional

Conditions

Systemic Lupus Erythematosus (SLE)

Summary

The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of 2 different doses of belimumab administered in addition to standard therapy in subjects with active SLE disease.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a medicine called belimumab for adults with systemic lupus erythematosus (SLE), also known as lupus. Lupus is an autoimmune disease where the body's immune system attacks its own healthy tissues, causing symptoms like joint pain, rashes, fatigue, and kidney problems. Belimumab works by reducing the number of a type of immune cell (B cells) that drives this attack. Participants will receive belimumab at one of two doses in addition to their regular lupus treatments, and the study will assess whether their symptoms improve and whether the treatment is safe. You may be eligible if: - You are 18 years of age or older - You have a confirmed diagnosis of lupus (SLE) - You have active lupus disease - You are on a stable lupus treatment regimen You may NOT be eligible if: - You are pregnant or breastfeeding - You have previously received B cell-targeted therapy - You have received a biological investigational drug in the past year - You received IV cyclophosphamide within the past 180 days - You have severe lupus kidney disease or active CNS (brain) lupus - You have had an active infection requiring treatment in the past 60 days - You have current drug or alcohol problems - You have tested positive for HIV, hepatitis B, or hepatitis C Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, 52-week study to evaluate the efficacy and safety of belimumab in subjects with active SLE. In addition to stable standard therapy, subjects will be randomized to 1 of 3 treatment groups in a 1:1:1 ratio: 1 mg/kg belimumab, 10 mg/kg belimumab or placebo. At randomization, subjects will be stratified by their screening SELENA SLEDAI score (6-9 vs >= 10), screening proteinuria level (< 2 g/24 hour vs >= 2 g/24 hour equivalent) and race (African descent or indigenous-American descent vs other). Subjects will be dosed with study agent on Days 0, 14, and 28, then every 28 days through 48 weeks, with a final evaluation at Week 52 (4 weeks after the last dose). Study agent will be administered intravenously over 1 hour. Approximately 810 SLE subjects will be randomized at approximately 150 sites, with a target of about 270 subjects per treatment group. All subjects will continue the stable standard therapy they were receiving during the screening period. All subjects, including withdrawals, will return for an Exit (final evaluation) visit approximately 4 weeks after their last dose of study agent. Subjects who withdraw or do not enter the continuation protocol after 48 weeks of treatment will be required to return for an additional follow-up visit approximately 8 weeks after their last dose of study agent.