Amgen announces positive results for phase 3 registrational trial evaluating Inebilizumab for treatment of immunoglobulin G4-related diseases (IgG4-RD)
June 11, 2024 – Biotechnology, Drug Discovery –
Data shows a statistically significant 87% reduction in IgG4-RD flares, with primary and all key secondary endpoints met
First randomised, placebo-controlled trial to demonstrate benefit in IgG4-RD
5 June 2024 – Thousand Oaks, CA, US – Amgen (NASDAQ:AMGN) today announced positive topline results from its randomised, double-blind, multicenter, placebo-controlled phase 3 clinical trial (NCT04540497) evaluating the efficacy and safety of inebilizumab for the treatment of Immunoglobulin G4-related disease (IgG4-RD).
The trial met its primary endpoint, showing a statistically significant 87% reduction in the risk of IgG4-RD flare compared to placebo (Hazard Ratio 0.13, p<0.0001) during the 52-week placebo-controlled period. All key secondary endpoints were also met, which were annualised flare rate; flare-free, treatment-free complete remission; and flare-free, corticosteroid-free complete remission. No new safety signals were identified. The overall safety results during the placebo-controlled period of the trial were consistent with the known safety profile of inebilizumab. Full data from the trial will be presented at a future medical meeting.
MITIGATE was conducted at 80 sites in 22 countries. It is the first placebo-controlled trial providing class 1 evidence for treating IgG4-RD, a chronic, systemic, immune-mediated, fibroinflammatory disease that can affect almost any organ in the body, often involving multiple organs at a time, and can result in irreversible organ damage. The novel, steroid-sparing study design paves the way for a reduced toxicity treatment approach.
“IgG4-RD is a devastating, chronic, immune-mediated disease that has just begun to be fully understood over the last few decades,” said John Stone, MD, MPH, principal investigator, and a professor of medicine at Harvard Medical School and the Edward A. Fox Chair in Medicine at the Massachusetts General Hospital. “These data mark a major milestone for the IgG4-RD community and provide substantial insight into not only how inebilizumab can help manage IgG4-RD, but also key insights into the nature of this condition.”
UPLIZNA® (inebilizumab) is currently approved for Neuromyelitis Optica Spectrum Disorder (NMOSD) by several regulatory bodies, including the U.S. Food and Drug Administration, the European Medicines Agency, Health Canada and the Brazilian Health Regulatory Agency (ANVISA), among others.
Based on the MITIGATE primary analysis results, Amgen is planning to file for approval in the U.S. followed by other key markets.
The trial was conducted with the support of Mitsubishi Tanabe Pharma and Hansoh Pharma. Mitsubishi Tanabe Pharma holds marketing authorization for UPLIZNA in Japan, Thailand, South Korea, Indonesia, Vietnam, Malaysia, Philippines, Singapore, and Taiwan. Hansoh Pharma is the exclusive licensee, local regulatory and commercial agent for China’s mainland, Hong Kong, and Macau.
