Amgen has reported positive topline outcomes from the Phase III MITIGATE clinical trial assessing UPLIZNA (inebilizumab-cdon) to treat Immunoglobulin G4-related disease (IgG4-RD).
The double-blind, randomised, multicentre, placebo-controlled study enrolled 135 adults across 80 sites in 22 countries.
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It assessed the safety and efficacy of UPLIZNA compared to placebo in reducing the risk of flares in adults with IgG4-RD.
The time to the first treated and adjudicated IgG4-RD flare over a 42-week placebo-controlled period was the primary endpoint.
The trial’s three key secondary endpoints were annualised flare rate, flare-free, treatment-free complete remission, and flare-free, corticosteroid-free complete remission.
According to the findings, the trial met its primary endpoint, demonstrating an 87% decline in flare risk versus placebo.
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By GlobalDataAll key secondary endpoints were also achieved without any new safety signals.
Furthermore, the overall safety data aligned with UPLIZNA’s known safety profile.
Currently, UPLIZNA received approval to treat neuromyelitis optica spectrum disorder (NMOSD) from several regulatory bodies, including the European Medicines Agency, the US Food and Drug Administration, the Brazilian Health Regulatory Agency (ANVISA) and Health Canada, among others.
Following these promising results from the MITIGATE trial, Amgen plans to pursue regulatory approval for UPLIZNA in the treatment of IgG4-RD in the US and various other markets.
Amgen Research and Development executive vice-president and chief scientific officer Jay Bradner said: “MITIGATE is a landmark study with results that demonstrate an important advance in the treatment of patients with IgG4-RD, a devastating and rare disease that currently has no approved therapy.
“We are grateful for the partnership with patients, clinicians and patient advocacy groups critical to a successful study, and we look forward to bringing this therapy to those living with IgG4-RD.”
In November last year, the company reported findings from the Phase II trial of dazodalibep to treat patients with Sjögren’s syndrome, an autoimmune disease.
