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news.GSK has started dosing in a phase III randomized, double-blind, placebo-controlled study evaluating sirukumab, a human anti-interleukin (IL)-6 monoclonal antibody, to treat giant cell arteritis (GCA).
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GCA is characterized by the inflammation of large and medium-sized arteries, mostly in the head and neck, which occurs in people aged 50 or older.
Under the study, dubbed Sirresta, GSK will evaluate the efficacy and safety of two subcutaneous doses of sirukumab with a pre-specified tapering dose of prednisone.
The doses of sirukumab include 100mg every two weeks and 50mg every four weeks.
The trial, which includes two parts, will identify whether sirukumab can reduce the duration of steroid treatment in clinical practice. GSK intends to identify the proportion of patients that achieve sustained remission.
GSK immuno-inflammation R&D senior vice president Paul-Peter Tak said: "The start of our study with sirukumab for GCA, which is currently under investigation for rheumatoid arthritis, marks the progress we are making to apply our knowledge of the underlying cause of a variety of immune-mediated inflammatory diseases and explore the potential of our immuno-inflammation pipeline to treat multiple conditions."
Sirukumab targets the cytokine interleukin (IL)-6, a naturally occurring protein that is believed to play a role in autoimmune conditions.
In December 2011, GSK signed a licensing and co-development collaboration agreement with Janssen Biologics (Ireland) to investigate sirukumab in several indications.
A phase III program was started in August 2012 to evaluate sirukumab for the treatment of moderately to severely active rheumatoid arthritis.