The first patient has been enrolled in Boehringer Ingelheim’s Phase 3 clinical trial investigating the effectiveness and safety of Ofev (nintedanib) in progressive fibrosing interstitial lung diseases (PF-ILD).
ILD encompasses a large group of over 200 lung disorders that affect the tissue and space around the air sacs of the lungs (interstitium). Patients with ILDs can exhibit a progressive fibrosing behavior – a process commonly referred to asc.
PF-ILD follows a similar course to idiopathic pulmonary fibrosis (IPF), with worsening of respiratory symptoms, lung function decline, and difficulty in performing daily activities.
The double-blind, randomized, and placebo-controlled study (NCT02999178) will evaluate the effectiveness and safety of Ofev 150 mg twice daily over 52 weeks in patients with PF-ILD. The trial, which is currently recruiting up to 600 eligible patients, is taking place at sites across the U.S., Canada, Europe, Latin America and in China and Japan.
The primary endpoint of the trial is the annual rate of decline in forced vital capacity (FVC; a measure of lung function). Other measures include the absolute change from baseline in the King’s Brief Interstitial Lung Disease Questionnaire (K-BILD).
“This trial enrolls patients who have lung fibrosis of at least 10% by chest imaging that is getting worse by symptoms, physiology or imaging despite treatment. This trial is an innovative way to study a potential treatment for patients with progressive fibrosing lung diseases and is an important step in exploring the way fibrosis of the lung is treated and whether nintedanib could be an effective therapy,” Kevin Flaherty, coordinating principal investigator of the PF-ILD trial, said in a press release.
Ofev is not yet approved for use in PF-ILD patients, as its safety and effectiveness has not yet been fully established in this patient population. The drug was approved by the U.S. Food and Drug Administration (FDA) to treat IPF in 2014.
Based on promising real-world results in IPF, this new trial is now exploring whether Ofev can be effective at targeting the scarring (fibrosis) in the lungs of PF-ILD patients.
“Boehringer Ingelheim is dedicated to advancing the understanding of fibrosing lung diseases where no or limited treatments exist. Our innovative PF-ILD trial is designed to include patients with fibrosing lung diseases who would not otherwise be eligible to participate in a clinical trial,” said Christopher Corsico, Boehringer Ingelheim’s chief medical officer.
For more information about this clinical trial and how to participate, please visit this link. The study is expected to end in July 2019.