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A double-blind, randomized, placebo-controlled trial investigating the efficacy and safety of nerandomilast over at least 52 weeks in patients with fibrosing interstitial lung disease at risk for disease progression (FIBRONEER-ACT)

FIBRONEER-ACT: A study to test whether nerandomilast helps people with fibrosing interstitial lung disease at risk for disease progression (FIBRONEER-ACT)

Saito Isao

Boehringer Ingelheim

ThinkPark Tower 2-1-1, Osaki, Shinagawa-ku,Tokyo

medchiken.jp@boehringer-ingelheim.com

Yamada Nobuko

Boehringer Ingelheim

ThinkPark Tower 2-1-1 Osaki Shinagawa-ku,Tokyo

+81-120-189-779

medchiken.jp@boehringer-ingelheim.com

Pending

Sept. 15, 2026

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1. Male and female individuals aged 18 years or older at the time of first signed informed consent at Visit 1a
2. 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
3. Diagnosis of fibrosing interstitial lung disease (ILD) other than idiopathic pulmonary fibrosis (IPF) as established by the investigator
4. Presence of fibrotic lung disease on high resolution computed tomography (HRCT), defined as reticulation with traction bronchiectasis/ bronchiolectasis and/or honeycombing with fibrosis involving at least 10% of the lung. as assessed by central review prior to randomization
5. Time since ILD diagnosis within 3 years before randomization
6. FVC with 45% or more of predicted normal at Visit 1
7. Diffusing capacity of the lungs for carbon monoxide (DLCO) with 25% and more of predicted normal corrected for hemoglobin (Hb) at Visit 1
8. 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

1. 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
2. Known diagnosis of autoimmune-ILDs other than rheumatoid arthritis-associated ILD (RA-ILD)
3. Known diagnosis of sarcoidosis
4. Patients with predominant features of organizing pneumonia on HRCT, as assessed by central review
5. 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)
6. Meeting criteria for progressive pulmonary fibrosis (PPF), as assessed by investigator
7. Meeting criteria for treatment with currently approved therapies for the fibrosing ILD (e.g. PPF), as assessed by investigator
8. Prior or current use of nerandomilast, nintedanib, or pirfenidone

Both

Fibrosing Interstitial Lung Diseases other than idiopathic pulmonary fibrosis

Participants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets, and the other group takes placebo tablets. P.Participant duratiion is up to 2 years and 4 months.

fibrosing interstitial lung disease ,ILD

D011658

Absolute change from baseline in forced vital capacity (FVC) (mL) at Week 52

Absolute change from baseline in total disease extent (TDE [%]), as measured by e-Lung quantitative high resolution computed tomography (HRCT) scoring at Week 52
Absolute change from baseline in reticulovascular score (RVS [%]), as measured by e-Lung quantitative high resolution computed tomography (HRCT) scoring at Week 52
Absolute change from baseline in FVC (% predicted) at Week 52
Time to development of incident progressive pulmonary fibrosis (PPF) (as assessed and documented by investigator) or death over the duration of the trial
Time to absolute decline from baseline in FVC (% predicted) of >5% or death over the duration of the trial
Time to relative decline from baseline in FVC (% predicted) of >10% or death over the duration of the trial
Absolute change from baseline in diffusing capacity of the lungs for carbon monoxide (DLCO [% predicted]) at Week 52
Time to absolute decline from baseline in diffusing capacity of the lungs for carbon monoxide (DLCO [% predicted]) of >10% or death over the duration of the trial

Yes

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharin.

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