Testing Nerandomilast against a placebo for interstitial lung diseases
Official title: FIBRONEER-ACT: A Study to Test Whether Nerandomilast Helps People With Fibrosing Interstitial Lung Disease at Risk for Disease Progression
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)
- Phase 3
- 2 groups
- Sites in Québec, Sherwood Park and 4 more cities
- Recruiting
Interventions
- Medication
Nerandomilast
Nerandomilast
- Medication
Placebo matching nerandomilast
Placebo matching nerandomilast
Canadian Sites (6)
2 of 6 recruiting
- Recruiting
Kelowna Respirology & Allergy Research
Kelowna, British Columbia
- Recruiting
CIC Mauricie (Trois Rivieres)
Trois-Rivières, Quebec
- Not yet recruiting
Synergy Respiratory Care
Sherwood Park, Alberta
- Not yet recruiting
St. Paul's Hospital (Vancouver)
Vancouver, British Columbia
- Not yet recruiting
Toronto General Hospital
Toronto, Ontario
- Not yet recruiting
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
Québec
Eligibility Criteria
See who this study is looking for28 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Male and female individuals ≥18 years of age at the time of first signed informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → at Visit 1a
- +Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - Good Clinical Practice (GCP) and local legislation prior to admission to the trial
- +Diagnosis of fibrosing interstitial lung disease (ILD) other than idiopathic pulmonary fibrosis (IPF) as established by the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →
- +Presence of fibrotic lung disease on high resolution computed tomography (HRCT), defined as reticulation with traction bronchiectasis/ bronchiolectasis and/or honeycombing, and extent of fibrosis ≥10%, as assessed by central review prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
- +Time since ILD diagnosis ≤3 years before randomization
- +FVC ≥45% of predicted normal at Visit 1
- +Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥25% of predicted normal corrected for hemoglobin (Hb) at Visit 1
- +Patients treated with permitted immunosuppressive/immunomodulatory agents for an underlying systemic disease (e.g. methotrexate (MTX), azathioprine (AZA)) need to be on stable treatment for at least 12 weeks prior to Visit 1 and during screening periodScreeningThe checks done before joining, to see whether a study fits.Read more →
- +Further inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → apply.
- +Exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → :
- +Known diagnosis of idiopathic pulmonary fibrosis (IPF) based on multidisciplinary discussion (MDD) and according to the American Thoracic Society (ATS)/European Respiratory Society (ERS) 2022 guidelines
- +Known diagnosis of autoimmune-ILDs other than rheumatoid arthritis-associated ILD (RA-ILD)
- +Known diagnosis of sarcoidosis
- +Patients with predominant features of organizing pneumonia on HRCT, as assessed by central review
- +Patients who developed ILD due to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection/Coronavirus Disease 2019 (COVID-19) (based on investigators judgement)
- +Meeting criteria for progressive pulmonary fibrosis (PPF), as assessed by investigator
- +Meeting criteria for treatment with currently approved therapies for the fibrosing ILD (e.g. PPF), as assessed by investigator
- +Prior or current use of nerandomilast, nintedanib, or pirfenidone
- +Further exclusion criteria apply.
Exclusion
- −Known diagnosis of idiopathic pulmonary fibrosis (IPF) based on multidisciplinary discussion (MDD) and according to the American Thoracic Society (ATS)/European Respiratory Society (ERS) 2022 guidelines
- −Known diagnosis of autoimmune-ILDs other than rheumatoid arthritis-associated ILD (RA-ILD)
- −Known diagnosis of sarcoidosis
- −Patients with predominant features of organizing pneumonia on HRCT, as assessed by central review
- −Patients who developed ILD due to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection/Coronavirus Disease 2019 (COVID-19) (based on investigators judgement)
- −Meeting criteria for progressive pulmonary fibrosis (PPF), as assessed by investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →
- −Meeting criteria for treatment with currently approved therapies for the fibrosing ILD (e.g. PPF), as assessed by investigator
- −Prior or current use of nerandomilast, nintedanib, or pirfenidone
- −Further exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → apply.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Nerandomilast.
Registry label: A: Nerandomilast arm
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo matching nerandomilast.
Registry label: B: Placebo arm
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 466 people.
The study is currently expected to finish around December 2028.
The main measurement is taken over: at baselineBaselineYour starting measurements, taken before treatment begins.Read more →, at week 52.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Absolute change from baselineBaselineYour starting measurements, taken before treatment begins.Read more → in forced vital capacity (FVC) (mL) at Week 52 — measured over at baseline, at week 52.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07540988 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About NerandomilastDrug
Nerandomilast
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Placebo matching nerandomilastDrug
Placebo matching nerandomilast
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: at baselineBaselineYour starting measurements, taken before treatment begins.Read more →, at week 52.
The study as a whole is currently expected to finish around 2028-12-12.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 466 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 10 locations, including: Québec, Canada; Sherwood Park, Alberta, Canada; Kelowna, British Columbia, Canada; Vancouver, British Columbia, Canada; Toronto, Ontario, Canada; Trois-Rivières, Quebec, Canada, and 4 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (5)
University of Michigan
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic, Rochester
Rochester, Minnesota, United States
Weill Cornell Medicine-New York-60569
New York, New York, United States
New York Presbyterian Hospital -Columbia University
New York, New York, United States
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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.