Date: 2016-04-18
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: GSK (UK)
Product: GSK3196165 /MOR103
Action
mechanism: monoclonal antibody. MOR103 is a fully human monoclonal antibody directed towards human GM-CSF, a cytokine that leads to activation and proliferation of immune cells causing inflammation. Preclinical studies have shown that MOR103 neutralizes the biological function of human GM-CSF and significantly reduces inflammation by blocking its interaction with cell surface receptors of inflammatory cells, thus inhibiting their activation. These studies suggest that GM-CSF is involved in the pathogenesis of autoimmune diseases such as rheumatoid arthritis and multiple sclerosis. In 2013 GSK assumed exclusive worldwide responsibility of GSK3196165 (previously MOR103) from Morphosys for all development and commercialisation activities in all therapeutic fields. GSK3196165 is also in phase II development as a potential treatment for rheumatoid arthritis.
Disease: inflammatory hand osteoarthritis
Therapeutic area: Inflammatory diseases - Rheumatic diseases
Country: Germany, UK
Trial
details: This randomized, Phase IIa, multicentre, double-blind, placebo-controlled parallel group study will assess the efficacy potential of GSK3196165 on pain, in subjects with active inflammatory hand osteoarthritis (HOA). Approximately 40 subjects will be enrolled into the study, following a screening period of up to 4 weeks. The total treatment period will be 12 weeks, with the follow up period completing at Week 22. At least 40 subjects will be randomized across the two treatment arms, to either placebo or GSK3196165 in a 1:1 ratio. (NCT02683785 )
Latest
news: * On April 18, 2016, GSK announced the start of a phase II study to evaluate the efficacy and safety of GSK3196165, an anti GM-CSF antibody, in patients with inflammatory hand osteoarthritis. This European multi-center phase 2 double-blind, placebo-controlled study will investigate the efficacy and safety of subcutaneous injections of GSK3196165 in 40 adult subjects with inflammatory hand osteoarthritis. The primary objective of the randomised, multicentre, double-blind, placebo-controlled parallel group study is to assess the efficacy potential of subcutaneous injections of GSK3196165 on pain. Secondary objectives include the assessment of safety and pharmacokinetics of GSK3196165.
