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NCT07201922 · ClinicalTrials.gov registry record · Phase 3
A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis
A Phase 3 study of Interstitial Lung Diseases and Familial Pulmonary Fibrosis, sponsored by Boehringer Ingelheim.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 80
- Enrollment target
- 20
- Study locations
NCT07201922: Recruiting Phase 3 study of Interstitial Lung Diseases and Familial Pulmonary Fibrosis, sponsored by Boehringer Ingelheim.
NCT07201922 is a Phase 3 study of Interstitial Lung Diseases and Familial Pulmonary Fibrosis that is actively recruiting participants, run by Boehringer Ingelheim. The registered enrollment target is 80 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07201922, a Phase 3 study of Interstitial Lung Diseases and Familial Pulmonary Fibrosis, is actively recruiting participants, sponsored by Boehringer Ingelheim.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 80 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Defined as relative decline in forced vital capacity (FVC) % predicted of \>10% from baseline; or absolute decline in diffusing capacity of the lungs for carbon monoxide (DLCO) % predicted \>10% from baseline; or absolute increase in weighted reticulovascular score (wRVS) \>2% and total disease extent (TDE) \>2.5% on chest high resolution CT scan (HRCT), as measured by e-Lung Quantitative HRCT scoring, from baseline
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Nerandomilast
Study Locations (20)
Other
- Centro de Investigaciones Metabolicas (CINME)-C.A.B.A-61553 - C.a.b.a
- Hospital Italiano de Buenos Aires - CABA
- Centro de Investigación Clinica Belgrano - CABA
- CEDIC - Centro de Investigacion Clinica - CABA
- Consultorios Médicos del Buen Ayre - Capital Federal
California
- University of California Los Angeles - Los Angeles
Colorado
- University of Colorado Denver - Aurora
Florida
- Clinical Research Specialists LLC - Kissimmee - Kissimmee
Kansas
- University of Kansas Medical Center - Kansas City
Massachusetts
- Brigham and Women's Hospital - Boston
Michigan
- University of Michigan - Ann Arbor
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2026-02-10 |
| Est. Completion | 2029-05-23 |
| Phase | Phase 3 |
What NCT07201922 shows while recruiting
NCT07201922 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 3 conditions, with Interstitial Lung Diseases appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07201922 names 20 study sites across 16 states, led by Other, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT07201922 about?
NCT07201922 is a clinical study titled "A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis". 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 ab...
What is the current status of trial NCT07201922?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 80 participants. The study started on 2026-02-10. Estimated completion is 2029-05-23.
What conditions does trial NCT07201922 study?
This clinical trial studies the following conditions: Interstitial Lung Diseases, Familial Pulmonary Fibrosis, Interstitial Lung Abnormalities.
What interventions are being tested in trial NCT07201922?
The interventions under investigation include: Placebo (DRUG), Nerandomilast (DRUG).
Who is sponsoring clinical trial NCT07201922?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07201922 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Kansas, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07201922's enrollment target sits among peer trials
80 1756th of 2000 higher than 233 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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