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NCT07540988 · ClinicalTrials.gov registry record · Phase 3
FIBRONEER-ACT: A Study to Test Whether Nerandomilast Helps People With Fibrosing Interstitial Lung Disease at Risk for Disease Progression
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Not yet
- Registry status
- Phase 3
- Development phase
- 466
- Enrollment target
NCT07540988 is a Phase 3 study that has not yet begun recruiting, run by Boehringer Ingelheim. The registered enrollment target is 466 participants.
The verdict
NCT07540988, a Phase 3 study, has not yet begun recruiting, sponsored by Boehringer Ingelheim.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 466 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Nerandomilast
- DRUG Placebo matching nerandomilast
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 466 participants |
| Start Date | 2026-08-28 |
| Est. Completion | 2028-12-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07540988
The ClinicalTrials.gov registry entry for NCT07540988 describes a study currently listed as not yet recruiting, categorized as Phase 3. The registered enrollment target is 466 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Nerandomilast is the first listed.
NCT07540988 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07540988 about?
NCT07540988 is a clinical study titled "FIBRONEER-ACT: A Study to Test Whether Nerandomilast Helps People With Fibrosing Interstitial Lung Disease at Risk for Disease Progression". 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 purpos...
What is the current status of trial NCT07540988?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 466 participants. The study started on 2026-08-28. Estimated completion is 2028-12-12.
What interventions are being tested in trial NCT07540988?
The interventions under investigation include: Nerandomilast (DRUG), Placebo matching nerandomilast (DRUG).
Who is sponsoring clinical trial NCT07540988?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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