A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis
Boehringer Ingelheim · NCT07201922
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 40+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 80
- US sites recruiting
- 11
- Study start
- February 10, 2026
- Record last updated
- September 30, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Nerandomilast; Placebo
Conditions: Familial Pulmonary Fibrosis; Interstitial Lung Abnormalities; Interstitial Lung Diseases
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Individuals ≥40 years of age at the time of first signed informed consent at Visit 1a
- 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, mucin 5B (MUC5B) mutation, surfactant protein mutations])
- High resolution computed tomography (HRCT) scan with evidence of interstitial lung abnormalities involving at least 5% of a single lung zone or interstitial lung disease (ILD), based on central evaluation
- Forced vital capacity (FVC) ≥80% of predicted normal at Visit 1b
- Diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin ≥70% of predicted normal at Visit 1b Further inclusion criteria apply.
Exclusion Criteria
- Prior known pulmonary 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 pulmonary fibrosis (e.g. known connective tissue disease)
- Prior or current use of nerandomilast, nintedanib, or pirfenidone Further exclusion criteria apply.
Recruiting US locations
University of Colorado Denver
Aurora, CO 80045
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Clinical Research Specialists LLC - Kissimmee
Kissimmee, FL 34746
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
University of Kansas Medical Center
Kansas City, KS 66160
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Brigham and Women's Hospital
Boston, MA 02115
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
University of Michigan
Ann Arbor, MI 48109
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
University of Minnesota
Minneapolis, MN 55455
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Weill Cornell Medicine-New York-60569
New York, NY 10065
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
University of Pennsylvania
Philadelphia, PA 19104
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Medical University of South Carolina
Charleston, SC 29425
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Baylor College of Medicine
Houston, TX 77030
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Virginia Commonwealth University
Richmond, VA 23219
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Study contacts (from the official record)
- Boehringer Ingelheim · 1-800-243-0127 · clintriage.rdg@boehringer-ingelheim.com