Phase 3 Nerandomilast Trial for Fibrosing ILD Progression
Summary
NIH registered Phase 3 clinical trial NCT07540988 (FIBRONEER-ACT) to evaluate nerandomilast tablets versus placebo in adults with non-IPF fibrosing interstitial lung disease at risk for progressive pulmonary fibrosis. The randomized, double-blind study has an estimated duration of approximately 2 years and 4 months. Primary efficacy endpoints include forced vital capacity (FVC) and diffusing capacity (DLCO), with high-resolution CT imaging for disease monitoring.
What changed
This is a clinical trial registration entry for FIBRONEER-ACT (NCT07540988), a Phase 3 randomized controlled trial. The trial will enroll adults with fibrosing interstitial lung disease (excluding idiopathic pulmonary fibrosis) who are at risk of progressive pulmonary fibrosis, assigning participants to nerandomilast or placebo for approximately 2 years and 4 months.
For sponsors and clinical investigators, this registration confirms an active Phase 3 study in a distinct ILD subpopulation and signals continued regulatory and commercial interest in PDE4B inhibitors for fibrosing lung disease. Sites seeking participation or patients seeking enrollment may reference ClinicalTrials.gov for contact and eligibility criteria.
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Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
FIBRONEER-ACT: A Study to Test Whether Nerandomilast Helps People With Fibrosing Interstitial Lung Disease at Risk for Disease Progression
Phase 3 NCT07540988 Kind: PHASE3 Apr 21, 2026
Abstract
This study is open to adults with fibrosing interstitial lung disease (ILD) other than idiopathic pulmonary fibrosis (IPF). People can join the study if they have been diagnosed with this condition within the last 3 years and are at risk of developing progressive pulmonary fibrosis (PPF). The purpose of this study is to find out whether a medicine called nerandomilast helps people with fibrosing interstitial lung disease who may be at risk for their disease getting worse.
Participants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets, and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Nerandomilast is a type of medicine that may help reduce lung function decline and slow disease progression.
Participants are in the study for up to about 2 years and 4 months. During this time, they visit the study site regularly. Doctors regularly test lung function using methods like spirometry to measure forced vital capacity (FVC, maximum amount of air a participant can blow out after taking a deep breath) and DLCO (diffusing capacity of the lungs for carbon monoxide; it estimates how well oxygen moves from the lungs into the blood). Additionally, high-resolution computed tomography (HRCT) is performed to monitor how the lung condition is changing over time. The results are compared between the groups to see whether the treatment works. The doctors also regularly check pa...
Conditions: Interstitial Lung Diseases
Interventions: Nerandomilast, Placebo matching nerandomilast
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