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A study to test whether nerandomilast can help slow down changes in the lung in people with a family history of pulmonary fibrosis
EU CTIS ID: 2025-522383-33-00
What this study is testing
The primary objective is to investigate the effect of nerandomilast in reducing the overall risk of worsening of lung abnormalities/fibrosis in participants with a family history of pulmonary fibrosis.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Individuals ≥40 years of age at the time of first signed informed consent at Visit 1a
- 2. Participants must have at least 1 first-degree relative (biological parent, sibling, or child) with confirmed pulmonary fibrosis (idiopathic pulmonary fibrosis [IPF], idiopathic nonspecific interstitial pneumonia [NSIP], and/or pulmonary fibrosis due to known genetic cause [e.g. short telomere syndrome, MUC5B mutation, surfactant protein mutations])
- 3. HRCT scan with evidence of interstitial lung abnormalities involving at least 5% of a single lung zone, or ILD, based on central evaluation.
- 4. FVC ≥80% of predicted normal at Visit 1b
- 5. Diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin ≥70% of predicted normal at Visit 1b
- Further inclusion criteria apply.
You likely can't join if
- 1. Prior known pulmonary fibrosis that, in the opinion of the Investigator, requires treatment with approved therapies
- 2. Prebronchodilator FEV1/FVC <0.7 at Visit 1b
- 3. HRCT findings consistent with probable or definite usual interstitial pneumonia (UIP) pattern
- 4. Any medical condition that is known to predispose to the development of pulmonary fibrosis (e.g. known connective tissue disease)
- 5. Prior or current use of nerandomilast, nintedanib, or pirfenidone
- Further exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- Canada
- United Kingdom
- Australia
- United States
- Korea, Republic of
- Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; Canada; United Kingdom; Australia; United States; Korea, Republic of and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.