Clinical Trials

Date: 2011-12-15

Type of information: Initiation of the trial

phase: 3

Announcement: initiation

Company: GSK (UK) Human Genome Sciences (USA)

Product: Benlysta® (belimumab)

Action mechanism:

monoclonal antibody. Belimumab is the first inhibitor designed to target B-lymphocyte stimulator (BLyS) protein, which may reduce the number of abnormal B cells thought to be a problem in lupus.

Disease: systemic lupus erythematosus (SLE)

Therapeutic area: Autoimmune diseases

Country:

Trial details:

BLISS-SC is a Phase III, multi-centre, international, randomised, 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 randomised 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.

Latest news:

GSK and Human Genome Sciences, have announced that dosing has been initiated in BLISS-SC, a new Phase III trial to evaluate the efficacy, safety and tolerability of BENLYSTA® (belimumab) administered subcutaneously (SC) once-weekly to autoantibody-positive adults with active systemic lupus erythematosus (SLE).