Not yet recruitingPHASE3INTERVENTIONAL

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

This study, called FIBRONEER-ACT, is for adults with a condition where their lungs become scarred, known as fibrosing interstitial lung disease (ILD). This is not for a specific type called idiopathic pulmonary fibrosis (IPF). We're looking for people diagnosed within the last three years who are at risk of their lung condition getting worse. The main goal is to find out if a new medicine, nerandomilast, can help slow down this scarring process. Participants are put into two groups by chance: one group gets the real medicine, and the other gets a placebo (a pill with no medicine). Over about two years, doctors regularly check lung function and look at lung scans to see if the medicine works and if there are any side effects.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

Boehringer Ingelheim

Enrolment target

466

Start

28 Aug 2026

Estimated completion

12 Dec 2028

Interstitial Lung Diseases

What is this study about?

This study, called FIBRONEER-ACT, is looking into a new medicine for certain types of lung scarring, known as fibrosing interstitial lung disease (ILD). This is a condition where the lungs become stiff and scarred over time, making it harder to breathe. This particular study is for people who have ILD other than a specific type called idiopathic pulmonary fibrosis (IPF). We are particularly interested in those who have been diagnosed recently (within the last three years) and are at risk of their lung condition getting worse.

The main aim of this study is to see if a medicine called nerandomilast can help. This medicine might work by helping to reduce the decline in lung function and slow down how quickly the disease progresses. To find out if it works, some people in the study will take nerandomilast, and others will take a 'placebo' – this is a dummy pill that looks exactly like the real medicine but contains no active ingredients. This way, we can compare the two groups fairly to see if the medicine has a real effect.

Throughout the study, which lasts about two years and four months, doctors will closely monitor participants' lung health. This involves regular lung function tests, like blowing into a machine, and special scans of the lungs to see how the condition is changing. The results from the nerandomilast group will be compared to the placebo group. Doctors will also carefully watch for any side effects from the medicine, making sure everyone's safety and well-being are a top priority.

Key takeaways

This study is for certain types of lung scarring (fibrosing ILD), but not IPF.
It tests if a new medicine, nerandomilast, can stop the disease from worsening.
You'll take either the study medicine or a dummy pill (placebo).
Participation lasts about 2 years and 4 months, with regular clinic visits.
Doctors will closely monitor your lung health and any side effects.
Taking part helps research and could benefit future patients.

Who may be eligible?

This study is looking for adults who are 18 years or older and have a type of fibrosing interstitial lung disease (ILD) that is not idiopathic pulmonary fibrosis (IPF). You would need to have been diagnosed with your lung condition within the last three years.

To join, your lung scans (like HRCT) must show signs of scarring, affecting at least 10% of your lungs. Your lung function tests (like how much air you can breathe out and how well your lungs absorb oxygen) also need to be above a certain level.

You cannot join if you have IPF, certain other autoimmune-related ILDs (besides rheumatoid arthritis-related ILD), sarcoidosis, or ILD caused by COVID-19. If you're taking specific medicines for an underlying condition, they need to have been stable for at least 12 weeks before starting the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a type of fibrosing interstitial lung disease that is NOT IPF?
Were you diagnosed within the last three years?
Do your lung scans show certain levels of scarring?
Are your lung function tests above a minimum level?
Are you NOT diagnosed with specific other lung conditions like sarcoidosis or COVID-19 related ILD?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be in the study for about two years and four months. During this time, you will visit the study clinic regularly. At these visits, doctors will perform various tests to check your lung health. This includes breathing tests, like blowing into a machine (called spirometry) to measure how much air you can breathe out, and tests to see how well oxygen moves from your lungs into your blood.

You will also have special scans of your lungs (called HRCT scans) to see how your condition is changing over time. You will be asked to take either the study medicine (nerandomilast) or a placebo tablet (a dummy pill with no medicine) every day. Doctors will also carefully monitor your general health and record any new health problems or unwanted effects you might experience. You will be told which group you are in only after the study ends, not during your participation.

Potential risks and benefits

Participating in this study might offer potential benefits, such as contributing valuable information to help others with similar conditions in the future, and receiving close medical attention and monitoring throughout the study. However, there are potential risks, as with any medication, including experiencing side effects from the study drug, or from receiving the placebo and not the active treatment. You will be fully informed of all known side effects before making a decision. Remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (126)

University of Alabama at Birmingham
Verified postcode
Birmingham, United States
University of Southern California
Verified postcode
Los Angeles, United States
Newport Native MD, Inc
Verified postcode
Newport Beach, United States
Clinical Research Specialists LLC - Kissimmee
Verified postcode
Kissimmee, United States
Lakeland Regional Medical Center - Lakeland
Verified postcode
Lakeland, United States
Advanced Pulmonary Research Institute
Verified postcode
Loxahatchee Groves, United States
Avanza Medical Research Center
Verified postcode
Pensacola, United States
University of Kansas Medical Center
Verified postcode
Kansas City, United States
University of Michigan
Verified postcode
Ann Arbor, United States
University of Minnesota
Verified postcode
Minneapolis, United States
Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine
Verified postcode
New Bern, United States
Southeastern Research Center-Winston-Salem-61365
Verified postcode
Winston-Salem, United States

Common questions

What is 'fibrosing interstitial lung disease'?

It's a group of lung conditions where the lung tissue becomes scarred and stiff, making it harder to breathe.

What does 'placebo' mean?

A placebo is a 'dummy' pill that looks just like the real medicine but doesn't contain any active drug. It helps compare the effects fairly.

How long will I be in the study?

You'll be in the study for roughly two years and four months, with regular visits to the clinic during that time.

Will I know if I'm getting the real medicine or the placebo?

No, you won't know during the study itself. This helps ensure the results are accurate and unbiased. You'll find out after the study finishes.

What kind of tests will I have?

You'll have regular lung function tests involving breathing into a machine, and special scans of your lungs to check for changes.

How to find out more

Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com 1-800-243-0127 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.