Nerandomilast for fibrosing interstitial lung disease at risk of progression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial randomizes adults with fibrosing interstitial lung disease (excluding IPF) to receive nerandomilast or a matching placebo for up to about 2 years and 4 months. Participants must have been diagnosed within the last 3 years, show fibrotic changes on HRCT, and meet specified lung function criteria. The study aims to see if nerandomilast slows lung function decline and disease progression compared with placebo, with regular follow-up visits and lung tests. Lead sponsor is Boehringer Ingelheim, with sites at UAB, USC, and Newport Native MD, Inc.

Why it matters

Who can join: the full rules

Inclusion criteria :

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.

Exclusion criteria :

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
9. Further exclusion criteria apply.

Where it's running

• Lung Research Queensland
  Chermside, Queensland, Australia Recruiting
• Kelowna Respirology & Allergy Research
  Kelowna, British Columbia, Canada Recruiting
• CIC Mauricie (Trois Rivieres)
  Trois-Rivières, Quebec, Canada Recruiting
• Soon Chun Hyang University Hospital Bucheon
  Bucheon-si, Gyeonggi-do, South Korea Recruiting
• National Taiwan University Hospital
  Taipei, Taiwan Recruiting
• Heartlands Hospital
  Birmingham, United Kingdom Recruiting

+112 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Boehringer Ingelheim
• Email: clintriage.rdg@boehringer-ingelheim.com
• Phone: 1-800-243-0127

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.