Phase 3 Interstitial Lung Disease Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- Children and teenagers between 2 and 17 years old (at the second study visit).
- Participants who have signs of scarring lung disease (fibrosing ILD) shown on a special type of lung scan (CT scan) taken within the past 12 months, confirmed by study reviewers.
- For children aged 6 and older: participants whose lungs are working at 25% or more of the expected level for their age and size (confirm with trial site).
- Participants whose scarring lung disease is considered significant by the doctor, based on disease severity scoring, a meaningful decline in lung function, worsening symptoms, increased scarring on scans, or other signs of the lung disease getting worse (such as needing more oxygen).
Who may not be able to join:
- Anyone who has previously been treated with a drug called nerandomilast (the drug being studied in this trial).
- Participants who have taken certain medications that affect a specific enzyme in the body (oral/systemic PDE4 or non-selective PDE inhibitors) within the 30 days before the first study visit.
- Participants who have taken a lung disease medication called pirfenidone within the 8 weeks before the first study visit.
- Participants who have unstable high blood pressure in the lungs (pulmonary arterial hypertension).
- Participants who have active, unstable, or uncontrolled blood vessel inflammation (vasculitis) within 8 weeks before the first study visit or during the screening period.
- Anyone who has ever made a suicide attempt or taken preparatory steps toward suicide at any point in their life.
- Participants who have had serious thoughts of suicide (with a specific method and/or intent) within the past 3 months, as measured by a standard assessment tool.
- Participants who show significant signs of depression, based on a short questionnaire score of 8 or higher.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Phone: 1-800-243-0127
Australian sites
1800271035
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Area under the concentration curve (AUC) T,SS based on sampling at steady state using rich sampling in participants from 6 years to less than 18 years and sparse sampling in participants younger than 6 years; Occurrence of a treatment-emergent adverse event
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.