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Recruiting Phase 3 Interventional

FIBRONEER-ACT: A Study to Test Whether Nerandomilast Helps People With Fibrosing Interstitial Lung Disease at Risk for Disease Progression

ClinicalTrials.gov ID: NCT07540988

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.

ClinicalTrials.gov public records Last synced Oct 25, 2026, 10:12 AM EDT

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
Lead sponsor
Boehringer Ingelheim
Industry
Enrollment
466 participants

Conditions and interventions

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.

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