GlaxoSmithKline (GSK) has announced the initiation of patient dosing in the Phase III study of sirukumab (CNTO 136), as part of its collaboration with Janssen Biologics.
The Phase III programme will evaluate sirukumab, an investigational human monoclonal IgG1 kappa antibody, in the treatment of patients with moderately to severely active rheumatoid arthritis (RA).
The programme is comprised of two multicentre, randomised, double-blind, placebo-controlled, parallel group studies, SIRROUND-T and SIRROUND-D.
GSK Immuno-inflammation senior vice president Paul-Peter Tak said the start of the programme is an important milestone in the company’s 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 said.
The primary objective of the SIRROUND-T study is 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-tumour necrosis factor-a agents.
In contrast, the primary objective of the SIRROUND-D study is 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 disease modifying anti-rheumatic drugs.
Janssen Research and Development vice president and head of immunology Dr Jerome Boscia said; "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 companies entered into a co-development and co-commercialisation license agreement for sirukumab in December 2011, before which Janssen Research & Development had been developing sirukumab for RA.
Image: GSK, Janssen Phase III programme will asess sirukumab in rheumatoid arthritis patients. Photo: Courtesy of Maxwell Hamilton.