- FIBRONEER-ACT: A Study to Test Whether Nerandomilast Helps People With Fibrosing Interstitial Lung Disease at Risk for Disease Progression — Recruiting • Phase III • Respiratory / COPD / Asthma • NCT07540988.
- Sponsor: Boehringer Ingelheim.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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…
- : 1. Male and female individuals ≥18 years of age 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, and extent of fibrosis ≥10%, as assessed by central review prior to randomization 5. Time since ILD diagnosis ≤3 years before randomization 6. FVC ≥45% of predicted normal at Visit 1 7. Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥25% 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 9. Further inclusion criteria apply.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.