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news.Janssen Biologics (Ireland) has begun dosing in the Phase 3 program evaluating sirukumab (CNTO 136) as part of a collaboration with GlaxoSmithKline (GSK).
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Sirukumab is a human anti-interleukin (IL)-6 monoclonal antibody in Phase 3 development for the treatment of adults with moderately to severely active rheumatoid arthritis (RA).
Janssen Research & Development immunology development head, vice president Jerome Boscia said the company is focused on advancing treatment options for chronic, debilitating autoimmune diseases such as rheumatoid arthritis.
"We are pleased to be collaborating with GlaxoSmithKline on the clinical development of sirukumab, a protein therapeutic that we believe may represent an important treatment option for immunological diseases in the future," Boscia added.
The Phase 3 program is comprised of two studies SIRROUND-T study, in which sirukumab is administered subcutaneously in subjects with active RA despite anti-tumor necrosis factor (TNF)-alpha therapy, and SIRROUND-D study, in which sirukumab is administered subcutaneously in subjects with active RA despite disease modifying anti-rheumatic drug (DMARD) therapy.
The primary objective of the SIRROUND-T study is to evaluate the efficacy of sirukumab as measured by the reduction of the signs and symptoms of RA in subjects with active RA who are refractory or intolerant to anti-TNF-alpha agents.
The primary objective of the SIRROUND-D double-blind, placebo-controlled, parallel group study is to evaluate the efficacy of sirukumab as measured by the reduction of the signs and symptoms of RA and inhibition of radiographic progression in subjects with active RA who are refractory to DMARDs.
GSK Immuno-inflammation senior vice president Paul-Peter Tak said the start of the Phase III program in rheumatoid arthritis is an important milestone in the collaboration with Janssen Biologics.
"It shows progress in the challenging area of autoimmune diseases and our focus of bringing a promising new therapeutic option to patients living with this debilitating disease," Tak added.
Janssen Biologics (Ireland) and GSK entered into a co-development and co-commercialization license agreement for sirukumab, in December 2011.