Recruiting
Phase 3

Nerandomilast

Sponsor:

Boehringer Ingelheim

Code:

NCT07201922

Conditions

Familial Pulmonary Fibrosis

Interstitial Lung Abnormalities

Interstitial Lung Diseases

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Nerandomilast

Placebo

Study Details

Brief summary:

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.

Conditions

Familial Pulmonary Fibrosis

Interstitial Lung Abnormalities

Interstitial Lung Diseases

Study ID

NCT07201922

Start date

Feb 10, 2026

Status verified date

Aug, 2026

Completion date

May 23, 2029

Anticipated

Primary completion date

May 14, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Nerandomilast

placebo comparator: Placebo

Interventions

Nerandomilast

Nerandomilast

Placebo

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 and Locations

Central contacts

Locations

University of Colorado Denver

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Clinical Research Specialists LLC - Kissimmee

Recruiting

Kissimmee, Florida, United States, 34746

Contacts

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Weill Cornell Medicine-New York-60569

Recruiting

New York, New York, United States, 10065

Contacts

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

More Information

Sponsor

Boehringer Ingelheim

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Boehringer Ingelheim on 2026-08-18.