Human Genome Sciences and GlaxoSmithKline Initiate Phase 3 Trial of Belimumab (BENLYSTA®)
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“Initiation of this new trial investigating a subcutaneous formulation of BENLYSTA represents an important step in our ongoing clinical development program,” said H. Thomas Watkins, President and Chief Executive Officer, Human Genome Sciences (HGS).
About the Design of BLISS-SC
BLISS-SC is a Phase 3, multi-center, international, randomized, double-blind, placebo-controlled, 52-week study to investigate use of belimumab administered subcutaneously once-weekly in autoantibody-positive adult subjects with active SLE.
Approximately 816 SLE subjects will be randomized to one of two arms, with a target of 544 subjects receiving belimumab 200 mg weekly plus standard of care (SOC) and 272 subjects receiving placebo plus SOC. Subjects completing the 52-week double-blind period can enter a 6-month open-label extension in which all subjects will receive belimumab 200 mg SC weekly.
The primary efficacy endpoint of BLISS-SC is response rate at Week 52, as measured by the SLE Responder Index (SRI) defined as:
• A reduction from baseline of at least 4 points on the SELENA-SLEDAI; and
• No worsening (increase of <0.30 points from baseline) in Physician's Global Assessment (PGA); and
• No new BILAG A organ domain score (which would indicate a severe flare of lupus disease activity) or 2 new BILAG B organ domain scores (which would indicate a moderate flare of disease activity) compared with baseline at the time of assessment.
BLISS-SC is being conducted at over 200 sites globally. Initial results from the trial are anticipated in the second half of 2014. Data from this study will be subject to evaluation and approval by regulatory authorities before belimumab could be made available in a subcutaneous formulation.
