J&J and GlaxoSmithKline’s Sirukumab Phase III Trials Begin
GlaxoSmithKline and Johnson & Johnson (J&J) announced yesterday that they have started Phase III clinical trials of their investigational rheumatoid arthritis (RA) treatment, sirukumab.
Johnson & Johnson’s Janssen Biologics unit in Ireland and GlaxoSmithKline have begun a Phase III development programme for sirukumab (otherwise known as CNTO 136), a human anti-interleukin (IL)-6 monoclonal antibody. The drug is being trialled for the treatment of adults with moderate to severe active rheumatoid arthritis.
The programme consists of two clinical studies, the first of which, SIRROUND-T, includes patients with active RA despite anti-tumour necrosis factor (TNF)-alpha therapy. The second, SIRROUND-D, contains patients with active RA despite taking disease modifying anti-rheumatic drugs (DMARDs).
The studies are multi-centre, randomized trials that compare the medication, which is administered under the skin, with a placebo. Both are double-blinded, meaning neither the patients nor the researchers will know who is getting the real drug and who is getting the dummy pill.
Jerome Boscia, head of immunology development at Janssen R&D, commented that “we are focused on advancing treatment options for chronic, debilitating autoimmune diseases,” adding that sirukumab is “a protein therapeutic that we believe may represent an important treatment option.”
GlaxoSmithKline entered into a co-development and commercialisation license pact for sirukumab for rheumatoid arthritis with Johnson & Johnson in December 2011.