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.

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

All 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.