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
- 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
- Sep 17, 2026 (Actual)
- Primary completion
- Dec 5, 2028 (Estimated)
- Completion
- Dec 12, 2028 (Estimated)
- Last update posted
- Oct 14, 2026
2026 – 2028
United States locations
- U.S. sites
- 30
- U.S. states
- 16
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | Not yet recruiting |
| University of Southern California | Los Angeles | California | 90033 | Not yet recruiting |
| Newport Native MD, Inc | Newport Beach | California | 92663 | Not yet recruiting |
| Yale University School of Medicine | New Haven | Connecticut | 06520 | Not yet recruiting |
| Clinical Research Specialists LLC - Kissimmee | Kissimmee | Florida | 34746 | Not yet recruiting |
| Lakeland Regional Medical Center - Lakeland | Lakeland | Florida | 33805 | Not yet recruiting |
| Advanced Pulmonary Research Institute | Loxahatchee Groves | Florida | 33470 | Not yet recruiting |
| Essence MD Research | Naples | Florida | 34102 | Not yet recruiting |
| Avanza Medical Research Center | Pensacola | Florida | 32503 | Not yet recruiting |
| Coastal Pulmonary & Critical Care | St. Petersburg | Florida | 33704 | Not yet recruiting |
| Cleveland Clinic Florida | Weston | Florida | 33331 | Not yet recruiting |
| Indiana University Health Enterprise Clinical Research Operation | Indianapolis | Indiana | 46202 | Not yet recruiting |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | Not yet recruiting |
| University of Michigan | Ann Arbor | Michigan | 48109 | Not yet recruiting |
| University of Minnesota | Minneapolis | Minnesota | 55455 | Not yet recruiting |
| Mayo Clinic, Rochester | Rochester | Minnesota | 55905 | Not yet recruiting |
| Henderson Clinical Trials | Henderson | Nevada | 89052 | Not yet recruiting |
| Weill Cornell Medicine-New York-60569 | New York | New York | 10021 | Not yet recruiting |
| Columbia University Medical Center-New York Presbyterian Hospital | New York | New York | 10032 | Not yet recruiting |
| Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine | New Bern | North Carolina | 28562 | Not yet recruiting |
| Southeastern Research Center-Winston-Salem-61365 | Winston-Salem | North Carolina | 27103 | Not yet recruiting |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | Not yet recruiting |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | Not yet recruiting |
| Temple University | Philadelphia | Pennsylvania | 19140 | Not yet recruiting |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | Not yet recruiting |
| Lowcountry Lung and Critical Care | Charleston | South Carolina | 29406 | Not yet recruiting |
| Baylor University Medical Center | Dallas | Texas | 75246 | Not yet recruiting |
| Metroplex Pulmonary & Sleep Center | McKinney | Texas | 75069 | Not yet recruiting |
| UT Health San Antonio | San Antonio | Texas | 78229 | Not yet recruiting |
| University of Utah Health Sciences Center | Salt Lake City | Utah | 84108 | Not yet recruiting |
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 134 non-U.S. sites.
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 Oct 14, 2026 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07540988 live on ClinicalTrials.gov.