Bliss-76 Study
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What is the BLISS-76 Study?
BLISS-76 is a phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76-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).
The purpose of this study is to determine whether belimumab, the agent under investigation, is safe and effective in treating SLE. Belimumab is a monoclonal antibody (an antibody that recognizes only one form of BLyS™ [a protein pronounced “bliss”]), which is intended to stop or inhibit the activity of BLyS™. BLyS™ (which stands for B-Lymphocyte Stimulator) is a protein that is naturally found in the body. It acts as a B-cell growth factor and extends the life of B-cells. B-cells are a type of white blood cell in your blood. B-cells are important because they produce antibodies. Antibodies help protect the body against various diseases. However, B-cells sometimes make antibodies that fight against normal human cells and this may play a part in autoimmune diseases. SLE is an autoimmune disease.
What did we learn?
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Research is designed to benefit society by gaining new knowledge. You may or may not experience improvement in some of your symptoms of SLE. It is not yet known if belimumab is effective in treating SLE.
Who is Participating?
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This study will include approximately 810 subjects with SLE at approximately 150 study centers around the world. To qualify for this study, you must be at least 18 years of age, have a clinical diagnosis of active SLE disease and be on a stable medication regimen for at least 30 days
What is Involved?
The duration of the study is up to 80 weeks, which includes 72 weeks of treatment, and an evaluation visit 4 weeks later (Week 76) and a follow-up visit 8 weeks after your last dose of study agent (Week 80).
First, you will have a screening visit to determine if you are able to take part in this study. Once it has been determined that you may participate in the study, visits will occur on study Day 0 (the first day of your study agent treatment) and weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72 and the evaluation and follow-up visits at weeks 76 and 80. It is very important that you go to all scheduled visits for safety reasons.
If you agree to take part in the study, you will receive treatment with belimumab or placebo by an intravenous infusion. Intravenous means injected into a vein (blood vessel) through a plastic tube and needle. Although the infusion will be given over 1 hour, the length of each visit will vary depending upon the number of study-related assessments required at the visit. Most visits will last approximately 3-4 hours and will take place at the General Clinical Research Center at UNC Hospitals.
How will participants benefit?
There may be no direct benefit to you from your participation in this study. Your participation, however, may benefit future patients with SLE.
Contact Information
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Principal Investigator: Dr. Mary Anne Dooley
Lupus Clinical Trials Coordinator: Brenda Meier, RN (919-843-6619)