Amgen said that Uplizna (inebilizumab-cdon) has met the primary and all key secondary endpoints of a Phase 3 clinical trial in Immunoglobulin G4-related disease (IgG4-RD).

The randomised, double-blind, placebo-controlled MITIGATE trial assessed the efficacy and safety of Uplizna against placebo.

It enrolled 135 adults who were randomised 1:1 to get 300mg intravenous (IV) Uplizna or placebo on Days 1, 15, and Week 26 after premedication. The therapy was followed for the 52-week randomised control period.

The primary endpoint of the MITIGATE trial focused on the time taken for the first treated and adjudicated IgG4-RD flare.

Additionally, the trial assessed annualised flare rate, achieving complete remission without the need for treatment, and achieving complete remission without corticosteroids while remaining flare-free as key secondary endpoints.

Furthermore, the trial offers participants the option to enter a three-year open-label treatment phase, followed by a safety follow-up period lasting up to two years after discontinuation of inebilizumab.

The trial demonstrated an 87% reduction in the risk of IgG4-RD flare compared to the placebo group over the 52-week placebo-controlled period.  

The results showed no new safety concerns and the safety profile observed during the trial aligns with the already established profile of Uplizna.

Amgen chief scientific officer and research and development executive vice president 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.”

The drug has obtained approval for the treatment of neuromyelitis optica spectrum disorder (NMOSD) from various regulatory authorities in the US, the European Union (EU), Canada, Brazil, and others.

Based on the primary analysis results from the MITIGATE trial, Amgen intends to seek approval in the US initially, followed by other key markets.