The EFFISAYIL 2 trial demonstrated that spesolimab can prevent flares in adolescents and adults with GPP for up to 48 weeks. Credit: Eszter Miller from Pixabay.

Boehringer Ingelheim has reported positive data from the Phase IIb EFFISAYIL 2 clinical trial of spesolimab for generalised pustular psoriasis (GPP) flares.

The randomised, multicentre, double-blind, placebo-controlled trial has been designed to evaluate the safety and efficacy of maintenance treatment with subcutaneous (SC) spesolimab to prevent GPP flares and sustained symptom control in adolescents and adults.

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.

The EFFISAYIL 2 trial of spesolimab met its primary and key secondary endpoints.

It demonstrated that the anti-interleukin-36 receptor antibody can prevent flares in adolescents and adults with GPP for up to 48 weeks.

Safety data in the study was found to be in line with clinical trials that were conducted earlier with spesolimab.

Boehringer Ingelheim Human Pharma Board of Managing Directors member Carinne Brouillon said: “Painful GPP flares can occur suddenly, escalate quickly, and may require urgent hospital care, leaving people anxious and uncertain about what the future might hold.

“The EFFISAYIL 2 results reinforce the potential of spesolimab to prevent GPP flares, giving patients the power to plan their lives, regardless of their disease. We look forward to presenting the data later this year and sharing the findings with regulatory authorities.”

Marketed as SPEVIGO, the new, humanised, selective antibody spesolimab is currently indicated to treat GPP flares in adults. 

Regulatory authorities in several countries including Japan, the US, Mainland China, and the European Union granted approval for spesolimab to treat GPP flares in adults.

The antibody is also being investigated for the treatment of other IL-36 mediated skin diseases.

EFFISAYIL 2 is part of the EFFISAYIL clinical trial programme, which also includes EFFISAYIL 1 and EFFISAYIL ON studies.

Last October, Boehringer Ingelheim enrolled the first subject in the Phase III FIBRONEER-IPF trial of BI 1015550 to treat idiopathic pulmonary fibrosis patients.