Date: 2013-04-03
Type of
information: Initiation of the trial
phase: 3
Announcement: initiation of the study
Company: GSK (UK)
Product: Benlysta® (belimumab)
Action
mechanism: This monoclonal antibody is the first inhibitor designed to target B-lymphocyte stimulator (BLyS) protein, which may reduce the number of abnormal B
Disease: ANCA (Anti-neutrophil Cytoplasmic Antibodies) positive vasculitis
Therapeutic
area: Inflammatory diseases
Country:
Trial
details: The multi-centre, multi-national, randomised, double-blind study will evaluate the efficacy and safety of belimumab in combination with azathioprine for the maintenance of remission in patients with a particular type of vascultitic disease called ANCA associated Vasculitis (Granulomatosis with Polyangiitis (Wegener’s) or microscopic polyangiitis).
Latest
news:
- • On April 3, 2013, GSK has announced the start of a Phase III study to evaluate Benlysta® (belimumab) in patients with ANCA (Anti-neutrophil Cytoplasmic Antibodies) positive vasculitis – a condition that involves inflammation of the blood vessels.
Benlysta® was first approved by the FDA in 2011 for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy. It was also approved by the European Commission in 2011 as add-on therapy in adult patients with active, autoantibody-positive SLE with a high degree of disease activity (e.g., positive anti-dsDNA and low complement) despite standard therapy. Its use has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus, HIV, a history of, or current, hepatitis B or C, hypogammaglobulinaemia (IgG <400 mg/dl) or IgA deficiency (IgA <10 mg/dl), a history of major organ transplant or hematopoietic stem /cell /marrow transplant or renal transplant; and it has not been studied in combination with other biologics or intravenous cyclophosphamide.
Is
general: Yes
