At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Nerandomilast (drug), Placebo (drug)
- How long the study runs
- Study runs about 39 months (dates as stated)
- About the drug or intervention
- Nerandomilast — drug: Nerandomilast · Placebo — drug: Placebo
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 40 Years and over
- Who
- All
- Number of participants
- 80
- Started
- 2026-02-10
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for familial pulmonary fibrosis
- • Phase3 - 80 participants
- • This study is open to people aged 40 years or older who have at least 1 family member with pulmonary fibrosis
Who can take part?
- • Ages 40 Years and over
- • Diagnosed with familial pulmonary fibrosis
Where?
- • Exeter - Royal Devon and Exeter Hospital, Wonford
- • London - Royal Brompton Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study is open to people aged 40 years or older who have at least 1 family member with pulmonary fibrosis. Pulmonary fibrosis is a condition where lung tissue becomes scarred, making it harder to breathe. People can join if a lung scan shows early changes in the lung, called interstitial lung abnormalities, which may lead to lung scarring. People with family members who have pulmonary fibrosis are more likely to develop it themselves. That is why it is important to check early for lung changes and find ways to prevent the condition from getting worse. The purpose of this study is to find out whether a medicine called nerandomilast can help slow down changes in the lung in people with a family history of pulmonary fibrosis. Participants are put into one of 2 groups randomly, which means the group is chosen by chance. One group takes nerandomilast tablets, and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take a tablet twice a day for about 2 to 3 years. There is a 3 out of 5 chance that participants will receive nerandomilast instead of the placebo. Participants are in the study for about 2 to 3 years. Participants visit the study site multiple times: more frequently during the first 2 years (about every 3 months), and then every 6 months thereafter. In the 3rd year, participants also have phone calls with the site staff every 3 months. Doctors regularly test lung function and take chest scans to see if the treatment works. The results are compared between the 2 groups to see if nerandomilast helps. The doctors also check participants' health and take note of any unwanted effects.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 40 Years and over
- Who can join: All genders
What the study is looking for
- ✓Individuals ≥40 years of age at the time of first signed agreement to take part at Visit 1a
- ✓Forced vital capacity (FVC) ≥80% of predicted normal at Visit 1b
- ✓Diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for red blood cell level ≥70% of predicted normal at...
Who cannot take part
- ✗Prior known lung fibrosis that, in the opinion of the Investigator, requires treatment with approved therapies
- ✗Prebronchodilator forced expiratory volume in 1 second (FEV1)/FVC \<0.7 at Visit 1b
- ✗HRCT findings consistent with probable or definite usual interstitial pneumonia (UIP) pattern
- ✗Any medical condition that is known to predispose to the development of lung fibrosis (e.g. known connective...
- ✗Prior or current use of nerandomilast, nintedanib, or pirfenidone Further exclusion criteria apply.
See the full criteria
Where Is This Study? (2 UK sites)
Royal Devon and Exeter Hospital, Wonford
Exeter EX2 5DW, United Kingdom
Royal Brompton Hospital
London SW3 6HP, United Kingdom
How to Get in Touch
Boehringer Ingelheim
Sponsor contactCONTACT