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

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Interstitial Lung Diseases

In brief

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.

Key facts

Study ID: NCT07540988
Run by: Boehringer Ingelheim
People needed: 466
Starts: 2026-08-28
Expected to finish: 2028-12-12
Last updated by the study team: 2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male and female individuals ≥18 years of age at the time of first signed informed consent at Visit 1a
Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - Good Clinical Practice (GCP) and local legislation prior to admission to the trial
Diagnosis of fibrosing interstitial lung disease (ILD) other than idiopathic pulmonary fibrosis (IPF) as established by the investigator
Presence of fibrotic lung disease on high resolution computed tomography (HRCT), defined as reticulation with traction bronchiectasis/ bronchiolectasis and/or honeycombing, and extent of fibrosis ≥10%, as assessed by central review prior to randomization
Time since ILD diagnosis ≤3 years before randomization
FVC ≥45% of predicted normal at Visit 1
Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥25% of predicted normal corrected for hemoglobin (Hb) at Visit 1
Patients treated with permitted immunosuppressive/immunomodulatory agents for an underlying systemic disease (e.g. methotrexate (MTX), azathioprine (AZA)) need to be on stable treatment for at least 12 weeks prior to Visit 1 and during screening period
Further inclusion criteria apply.

You may not qualify if…

Known diagnosis of idiopathic pulmonary fibrosis (IPF) based on multidisciplinary discussion (MDD) and according to the American Thoracic Society (ATS)/European Respiratory Society (ERS) 2022 guidelines
Known diagnosis of autoimmune-ILDs other than rheumatoid arthritis-associated ILD (RA-ILD)
Known diagnosis of sarcoidosis
Patients with predominant features of organizing pneumonia on HRCT, as assessed by central review
Patients who developed ILD due to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection/Coronavirus Disease 2019 (COVID-19) (based on investigators judgement)
Meeting criteria for progressive pulmonary fibrosis (PPF), as assessed by investigator
Meeting criteria for treatment with currently approved therapies for the fibrosing ILD (e.g. PPF), as assessed by investigator
Prior or current use of nerandomilast, nintedanib, or pirfenidone
Further exclusion criteria apply.

Where it is running

University of Southern California — Los Angeles, California, United States
Newport Native MD, Inc — Newport Beach, California, United States
Clinical Research Specialists LLC - Kissimmee — Kissimmee, Florida, United States
Lakeland Regional Medical Center - Lakeland — Lakeland, Florida, United States
Advanced Pulmonary Research Institute — Loxahatchee Groves, Florida, United States
Avanza Medical Research Center — Pensacola, Florida, United States
Coastal Pulmonary & Critical Care — St. Petersburg, Florida, United States
Indiana University Health Enterprise Clinical Research Operation — Indianapolis, Indiana, United States
University of Kansas Medical Center — Kansas City, Kansas, United States
University of Michigan — Ann Arbor, Michigan, United States
University of Minnesota — Minneapolis, Minnesota, United States
Mayo Clinic, Rochester — Rochester, Minnesota, United States
Henderson Clinical Trials — Henderson, Nevada, United States
Weill Cornell Medicine-New York-60569 — New York, New York, United States
Columbia University Medical Center-New York Presbyterian Hospital — New York, New York, United States
Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine — New Bern, North Carolina, United States
Southeastern Research Center-Winston-Salem-61365 — Winston-Salem, North Carolina, United States
University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
University of Pennsylvania — Philadelphia, Pennsylvania, United States
Temple University — Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
Lowcountry Lung and Critical Care — Charleston, South Carolina, United States
Clinical Trials Center of Middle Tennessee, LLC — Franklin, Tennessee, United States
Baylor University Medical Center — Dallas, Texas, United States
University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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