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FIBRONEER-ACT: A Study to Test Whether Nerandomilast Helps People With Fibrosing Interstitial Lung Disease at Risk for Disease Progression
466 patients around the world
Available in Argentina
Boehringer Ingelheim
6Research sites
466Patients around the world
This study is for people with
Interstitial Lung Disease
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Instituto de Medicina Respiratoria IMER - Córdoba
Hospital Alemán
NIBA - Neurología Infantil de Buenos Aires
Consultorios Médicos del Buen Ayre
Fundación Enfisema - Instituto Ave Pulmo
Instituto INSARES - Mendoza
SponsorBoehringer Ingelheim
Study typeInterventional
Conditions
Interstitial Lung Disease
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07540988
