FIBRONEER-ACT: A Study to Test Whether Nerandomilast Helps People With Fibrosing Interstitial Lung Disease at Risk for Disease Progression
Public ClinicalTrials.gov record NCT07540988. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double-blind, Randomized, Placebo-controlled Trial Investigating the Efficacy and Safety of Nerandomilast Over at Least 52 Weeks in Patients With Fibrosing Interstitial Lung Disease at Risk for Disease Progression (FIBRONEER-ACT)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is open to adults with fibrosing interstitial lung disease (ILD) other than idiopathic pulmonary fibrosis (IPF). People can join the study if they have been diagnosed with this condition within the last 3 years and are at risk of developing progressive pulmonary fibrosis (PPF). The purpose of this study is to find out whether a medicine called nerandomilast helps people with fibrosing interstitial lung disease who may be at risk for their disease getting worse. Participants are put into 2 groups randomly, which means 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. Nerandomilast is a type of medicine that may help reduce lung function decline and slow disease progression. Participants are in the study for up to about 2 years and 4 months. During this time, they visit the study site regularly. Doctors regularly test lung function using methods like spirometry to measure forced vital capacity (FVC, maximum amount of air a participant can blow out after taking a deep breath) and DLCO (diffusing capacity of the lungs for carbon monoxide; it estimates how well oxygen moves from the lungs into the blood). Additionally, high-resolution computed tomography (HRCT) is performed to monitor how the lung condition is changing over time. The results are compared between the groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
Study identification
- NCT ID
- NCT07540988
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 466 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 27, 2026
- Primary completion
- Dec 4, 2028
- Completion
- Dec 11, 2028
- Last update posted
- Jul 22, 2026
2026 – 2028
United States locations
- U.S. sites
- 27
- U.S. states
- 16
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| University of Southern California | Los Angeles | California | 90033 | — |
| Newport Native MD, Inc | Newport Beach | California | 92663 | — |
| Clinical Research Specialists LLC - Kissimmee | Kissimmee | Florida | 34746 | — |
| Lakeland Regional Medical Center - Lakeland | Lakeland | Florida | 33805 | — |
| Advanced Pulmonary Research Institute | Loxahatchee Groves | Florida | 33470 | — |
| Avanza Medical Research Center | Pensacola | Florida | 32503 | — |
| Coastal Pulmonary & Critical Care | St. Petersburg | Florida | 33704 | — |
| Indiana University Health Enterprise Clinical Research Operation | Indianapolis | Indiana | 46202 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic, Rochester | Rochester | Minnesota | 55905 | — |
| Henderson Clinical Trials | Henderson | Nevada | 89052 | — |
| Weill Cornell Medicine-New York-60569 | New York | New York | 10021 | — |
| Columbia University Medical Center-New York Presbyterian Hospital | New York | New York | 10032 | — |
| Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine | New Bern | North Carolina | 28562 | — |
| Southeastern Research Center-Winston-Salem-61365 | Winston-Salem | North Carolina | 27103 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| Lowcountry Lung and Critical Care | Charleston | South Carolina | 29406 | — |
| Clinical Trials Center of Middle Tennessee, LLC | Franklin | Tennessee | 37067 | — |
| Baylor University Medical Center | Dallas | Texas | 75246 | — |
| Metroplex Pulmonary & Sleep Center | McKinney | Texas | 75069 | — |
| University of Utah Health Sciences Center | Salt Lake City | Utah | 84108 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 123 non-U.S. sites.
Recently updated Interstitial Lung Diseases trials
Other public records listing Interstitial Lung Diseases. Sorted by last update posted; newest first. Not a recommendation.
- NCT00470327: A Study of the Natural Progression of Interstitial Lung Disease (ILD) Recruiting
- NCT07201922: A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis Recruiting
- NCT06806592: A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases Recruiting
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07540988, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 22, 2026 · Synced Aug 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07540988 live on ClinicalTrials.gov.