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Janssen Announces Initiation Of Phase 3 Development Program For Sirukumab In Rheumatoid Arthritis
Date:8/23/2012

CORK, Ireland and SPRING HOUSE, Pa., Aug. 23, 2012 /PRNewswire/ -- Janssen Biologics (Ireland) announced today it has initiated the Phase 3 development program for sirukumab (CNTO 136) as part of a collaboration with GlaxoSmithKline plc (GSK).  Sirukumab is a human anti-interleukin (IL)-6 monoclonal antibody being studied for the treatment of adults with moderately to severely active rheumatoid arthritis (RA). 

"We are focused on advancing treatment options for chronic, debilitating autoimmune diseases such as rheumatoid arthritis," said Jerome A. Boscia, M.D., Vice President, Head of Immunology Development, Janssen Research & Development, LLC.  "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."

The two studies comprising the Phase 3 program are:

  • SIRROUND-T: A multicentre, randomised, double-blind, placebo-controlled, parallel group study of sirukumab administered subcutaneously in subjects with active RA despite anti-tumor necrosis factor (TNF)-alpha 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-alpha 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.

About Sirukumab (CNTO 136)
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SOURCE Janssen Research & Development, LLC
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