GSK announces start of Phase III programme of sirukumab in rheumatoid arthritis

GlaxoSmithKline plc (GSK) today announced that – as part of its collaboration with Janssen Biologics (Ireland) – the Phase III programme evaluating sirukumab (CNTO 136), a human anti-interleukin (IL)-6 monoclonal antibody in the treatment of patients with moderately to severely active rheumatoid arthritis (RA), has commenced dosing. The two studies comprising the Phase III programme are:

• IRROUND-T: A multicentre, randomised, double-blind, placebo-controlled, parallel group study of sirukumab administered subcutaneously in subjects with active RA despite anti-tumour necrosis factor (TNF)-α therapy. The primary objective is to assess 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-α agents.
• SIRROUND-D: A multicentre, randomised, double-blind, placebo-controlled, parallel group study of sirukumab administered subcutaneously in subjects with active RA despite disease modifying anti-rheumatic drug (DMARD) therapy. The primary objective is to assess 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.

“The start of the Phase III programme in rheumatoid arthritis is an important milestone in our collaboration with Janssen Biologics.” commented Paul-Peter Tak, Senior Vice President, GSK Immuno-inflammation. “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.”

About sirukumab (CNTO 136)

Sirukumab is an investigational human monoclonal IgG1 kappa antibody in Phase III development for the treatment of moderately to severely active rheumatoid arthritis (RA). It is not approved as a treatment for RA or any other indication anywhere in the world. Sirukumab targets the cytokine interleukin (IL)-6, a naturally occurring protein that is believed to play a role in autoimmune conditions like RA.

In December 2011, GSK and Janssen Biologics (Ireland) entered into a co-development and co-commercialisation license agreement with respect to sirukumab for RA. Prior to the agreement, Janssen Research & Development, LLC had been developing sirukumab for RA.

About rheumatoid arthritis

Rheumatoid arthritis is a chronic, systemic inflammatory condition that is often characterised by symptoms that include pain, stiffness and inflammation, and in some cases, joint destruction and disability. It is estimated that 1.5 million Americans and more than 23.5 million people worldwide are affected by the condition, for which there is no cure.