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FIBRONEER-ACT: A Study to Test Whether Nerandomilast Helps People With Fibrosing Interstitial Lung Disease at Risk for Disease Progression

StatusRecruiting
PhasePhase 3
Started2026-09-17
View on ClinicalTrials.gov ↗

Amendment history

2026-09-02
notable
Study Status, Contacts/Locations v10
Trial started: 2026-09-17 (last estimated 2026-09-14)
Recruitment opened
Trial sites expanded: 163 → 166 locations
Start date2026-08-28→2026-09-14
2026-08-19
minor
Study Status, Contacts/Locations v9
Trial sites expanded: 151 → 162 locations
2026-08-05
minor
Study Status, Contacts/Locations v8
Study sites150→151
2026-07-22
minor
Study Status, Contacts/Locations v7
Trial sites expanded: 144 → 150 locations
2026-07-08
minor
Study Status, Contacts/Locations v6
Study sites142→144
2026-06-23
minor
Study Status, Contacts/Locations v5
Trial sites expanded: 126 → 142 locations
2026-06-08
minor
Study Status, Contacts/Locations v4
Trial sites expanded: 100 → 126 locations
2026-05-31
minor
Study Status, Contacts/Locations v3
Trial sites expanded: 52 → 100 locations
2026-05-11
minor
Study Status, Contacts/Locations v2
Trial sites expanded: 35 → 52 locations
2026-04-27
minor
Study Status, Contacts/Locations v1
Trial sites expanded: 2 → 35 locations
2026-04-15
minor
Original filing
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 participants' health and take note of any unwanted effects.
Trial Details
NCT Number NCT07540988
Lead Sponsor Boehringer Ingelheim
Conditions Interstitial Lung Diseases
Enrollment 466 participants
Start Date 2026-09-17
Primary Completion 2028-12-05 (estimated)
Study Completion 2028-12-12 (estimated)
Updated on ClinicalTrials.gov 2026-10-01