A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis

Conditions

• Familial Pulmonary Fibrosis
• Interstitial Lung Abnormalities
• Interstitial Lung Diseases

Eligibility Criteria

Sex

ALL

Age

40 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nerandomilast — DRUG
  Nerandomilast
• Placebo — DRUG
  Placebo

Study Details

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.

Key Dates

Start date

Feb 10, 2026

Status verified

Jun 2026

Primary completion

May 14, 2029

Completion

May 23, 2029

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Nerandomilast
• Placebo Comparator: Placebo

Primary Outcome Measure

Time to physiologic or radiologic worsening of ILA/ILD over the whole trial [ Time Frame: up to 164 weeks ]

Central Contacts

• Boehringer Ingelheim
  1-800-243-0127
  [email protected]

Locations (13)

Find similar trials in Los Angeles, CA

Related Studies

• Mechanisms of Familial Pulmonary Fibrosis
  Recruiting · Vanderbilt University Medical Center · Nashville, Tennessee
• A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases
  PHASE3 · Recruiting · Boehringer Ingelheim · Birmingham, Alabama
• FIBRONEER-ACT: A Study to Test Whether Nerandomilast Helps People With Fibrosing Interstitial Lung Disease at Risk for Disease Progression
  PHASE3 · Not Yet Recruiting · Boehringer Ingelheim · Birmingham, Alabama
• A Study of the Natural Progression of Interstitial Lung Disease (ILD)
  Recruiting · University of Chicago · Chicago, Illinois