A Randomized, Double-blind, Placebo-controlled Phase 2 Study with Open-label Extension to Assess the Efficacy and Safety of Namilumab in Subjects with Chronic Pulmonary Sarcoidosis. Grant uri icon

abstract

  • A randomized, double-blind and placebo-controlled with and optional open-label extension (OLE) study to access the efficacy and safety of Namilumab in subjects with chronic pulmonary sarcoidosis. Sarcoidosis is a multi-organ autoimmune disease characterized by non-necrotizing granulomas believed to be formed an exaggerated immune response to unidentified antigens. Granulomas are tight clusters of monocytes/macrophages and multinucleated giant cells (MGCs) interspersed with CD4+ T cells. Nearly all (~90%) subjects exhibit pulmonary involvement. Granulocyte-macrophage colony-stimulating factor (GM-CSF), a proinflammatory cytokine and myeloid cell growth factor, is thought to play a key role in the granulomatous response by stimulating the fusion of macrophages into MGCs, activating the mobilization of macrophage precursors into tissues, and supporting the crosstalk between CD4+ T cells and myeloid cells. Over the past 30 years, a multitude of human tissue and mouse model studies have shown that GM-CSF plays a key role in the formation of granulomas, including sarcoid granulomas. Namilumab, a monoclonal antibody that neutralizes GM-CSF, has the potential to improve outcomes in CPS by downregulating the granulomatous response that drives the disease. This study will include adult subjects who have been diagnosed with CPS ?6 months who are not well controlled by OCS and/or immunosuppressive therapy (IST). 100 total subjects (50 subjects in each of the 2 treatment arms, randomized 1:1 namilumab:placebo) are planned for this study.

date/time interval

  • April 2022 - December 2025