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

June 8, 2026 updated by: Boehringer Ingelheim

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)

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
466

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Alberdi Sur, Argentina, X5003DCE
      • CABA, Argentina, 1118
      • CABA, Argentina, 1182
        • Fundacion NIBA Neurologia Infantil Buenos Aires
        • Contact:
      • Capital Federal, Argentina, 1425
      • Mar del Plata, Argentina, 7600
      • Mendoza, Argentina, M5500CCG
      • Rosario, Argentina, 2000
  • Austria
  • Belgium
      • Leuven, Belgium, 3000
      • Liège, Belgium, 4000
      • Roeselare, Belgium, 8800
  • Brazil
      • Goiânia, Brazil, 74110-030
      • Porto Alegre, Brazil, 90050-170
        • Irmandade Da Santa Casa De Misericórdia De Porto Alegre
        • Contact:
      • Recife, Brazil, 50070902
      • São José do Rio Preto, Brazil, 15090-000
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto
        • Contact:
      • São Paulo, Brazil, 05403-000
        • INCOR e Hospital das Clínicas da Universidade de São Paulo
        • Contact:
  • Canada
    • Alberta
      • Sherwood Park, Alberta, Canada, T8H 0N2
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 3H5
        • Kelowna Respirology & Allergy Research
        • Contact:
      • Vancouver, British Columbia, Canada, V6Z 1Y6
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
    • Quebec
      • Trois-Rivières, Quebec, Canada, G8T 7A1
  • China
      • Beijing, China, 100020
      • Changsha, China, 410011
        • The second Xiangya Hospital of Central South University
        • Contact:
      • Chengdu, China, 610041
        • West China Hospital, Sichuan University
        • Contact:
      • Chengdu, China, 610072
        • People's Hospital of Sichuan Province
        • Contact:
      • Guangzhou, China, 510000
        • First Affiliated Hospital of Guangzhou Medical University
        • Contact:
      • Hangzhou, China, 310013
      • Hangzhou, China, 310016
        • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
        • Contact:
      • Nanjing, China, 210008
      • Shanghai, China, 200030
      • Shanghai, China, 200433
      • Suzhou, China, 215006
        • The First Affiliated Hospital of Soochow University
        • Contact:
      • Tianjin, China, 300052
        • Tianjin Medical University General Hospital
        • Contact:
      • Wuhan, China, 430022
      • Wuhan, China, 430030
        • Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
        • Contact:
      • Wuxi, China, 214043
      • Xi'an, China, 710004
        • Second Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
      • Yinchuan, China, 750004
        • General Hospital of Ningxia Medical University
        • Contact:
      • Zhengzhou, China, 450003
        • Henan Provincial People's Hospital
        • Contact:
  • Finland
      • Helsinki, Finland, 000290
        • HYKS Keuhkosairauksien tutkimusyksikkö
        • Contact:
      • Turku, Finland, 20521
        • Turku University Hospital / TYKS
        • Contact:
  • Germany
      • Berlin, Germany, 12351
      • Berlin, Germany, 10117
      • Bonn, Germany, 53127
      • Essen, Germany, 45239
        • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
        • Contact:
      • Hanover, Germany, 30625
      • Hanover, Germany, 30459
      • Heidelberg, Germany, 69126
        • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
        • Contact:
      • Immenhausen, Germany, 34376
      • München, Germany, 81377
      • Stuttgart, Germany, 70376
  • Italy
      • Catania, Italy, 95124
        • Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
        • Contact:
      • Foggia, Italy, 71100
      • Forlì, Italy, 47121
      • Milan, Italy, 20123
      • Monza, Italy, 20900
      • Padova, Italy, 35128
        • Azienda Ospedaliera Universitaria di Padova
        • Contact:
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
        • Contact:
      • Roma, Italy, 00133
  • Japan
      • Aichi, Seto, Japan, 489-8642
      • Fukuoka, Fukuoka, Japan, 810-8563
        • National Hospital Organization Kyushu Medical Center
        • Contact:
      • Fukuoka, Kitakyushu, Japan, 807-8556
        • Hospital of the University of Occupational and Environmental Health
        • Contact:
      • Hiroshima, Hiroshima, Japan, 734-8530
      • Hiroshima, Hiroshima, Japan, 734-8551
      • Hokkaido, Sapporo, Japan, 060-8543
        • Sapporo Medical University Hospital
        • Contact:
      • Kagawa, Kita-gun, Japan, 761-0793
      • Kanagawa, Yokohama, Japan, 236-0051
        • Kanagawa Cardiovascular and Respiratory Center
        • Contact:
      • Osaka, Sakai, Japan, 591-8555
        • National Hospital Organization Kinki-chuo Chest Medical Center
        • Contact:
      • Osaka, Sakai, Japan, 590-0197
      • Shizuoka, Hamamatsu, Japan, 431-3192
      • Tokushima, Tokushima, Japan, 770-8503
      • Tokyo, Bunkyo-ku, Japan, 113-8431
      • Tokyo, Shinjuku-ku, Japan, 160-8582
      • Tokyo, Shinjuku-ku, Japan, 162-8655
        • National Center for Global Health and Medicine
        • Contact:
  • Mexico
      • Chihuahua City, Mexico, 31203
        • Centro de Investigacion Integral MEDIVEST S.C
        • Contact:
      • León, Mexico, 37160
        • Centro de Investigacion Farmacologica del Bajío, S.C.
        • Contact:
      • Monterrey, Mexico, 64460
        • Hospital Universitario Dr Jose Eleuterio Gonzalez
        • Contact:
  • Netherlands
      • Nieuwegein, Netherlands, 3435 CM
      • Rotterdam, Netherlands, 3015 GD
  • Poland
      • Poznan, Poland, 60-569
        • Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu
        • Contact:
      • Warsaw, Poland, 01-138
        • National Institute Of Tuberculosis And Lung Diseases
        • Contact:
      • Warsaw, Poland, 02-637
        • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
        • Contact:
      • Świdnik, Poland, 21-040
        • Przychodnia Alergologiczno-Pulmonologiczna Alergopneuma Sp. z o.o.
        • Contact:
  • South Korea
      • Busan, South Korea, 47392
        • Inje University Busan Paik Hospital
        • Contact:
      • Busan, South Korea, 48108
        • Inje University Haeundae Paik Hospital
        • Contact:
      • Seongnam, South Korea, 13620
        • Seoul National University Bundang Hospital
        • Contact:
      • Seoul, South Korea, 03080
      • Seoul, South Korea, 05505
      • Seoul, South Korea, 06351
  • Spain
      • Badalona, Spain, 08916
      • Barcelona, Spain, 08035
      • Córdoba, Spain, 14004
      • Galdakao, Spain, 48960
      • Granollers, Spain, 08402
      • Hospitalet Llobregat, Spain, 08907
      • L'Hospitalet de Llobregat, Spain, 08907
      • Madrid, Spain, 28034
        • Hospital Universitario Ramón y Cajal
        • Contact:
      • Madrid, Spain, 28040
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
        • Contact:
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital
        • Contact:
      • Kaohsiung City, Taiwan, 81362
        • Kaohsiung Veterans General Hospital
        • Contact:
      • Taichung, Taiwan, 404
      • Taichung, Taiwan, 40705
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
        • Contact:
      • Taipei, Taiwan, 112
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
    • California
      • Los Angeles, California, United States, 90033
      • Newport Beach, California, United States, 92663
    • Florida
      • Kissimmee, Florida, United States, 34746
      • Lakeland, Florida, United States, 33805
      • Loxahatchee Groves, Florida, United States, 33470
      • Pensacola, Florida, United States, 32503
    • Kansas
      • Kansas City, Kansas, United States, 66160
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
    • North Carolina
      • New Bern, North Carolina, United States, 28562
        • Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine
        • Contact:
      • Winston-Salem, North Carolina, United States, 27103
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19140
    • South Carolina
      • Charleston, South Carolina, United States, 29406
    • Tennessee
      • Franklin, Tennessee, United States, 37067
    • Texas
      • Dallas, Texas, United States, 75246
    • Utah
      • Salt Lake City, Utah, United States, 84108

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria :

  1. Male and female individuals ≥18 years of age at the time of first signed informed consent at Visit 1a
  2. 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
  3. Diagnosis of fibrosing interstitial lung disease (ILD) other than idiopathic pulmonary fibrosis (IPF) as established by the investigator
  4. 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 randomization
  5. Time since ILD diagnosis ≤3 years before randomization
  6. FVC ≥45% of predicted normal at Visit 1
  7. Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥25% of predicted normal corrected for hemoglobin (Hb) at Visit 1
  8. 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 period
  9. Further inclusion criteria apply.

Exclusion criteria :

  1. 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
  2. Known diagnosis of autoimmune-ILDs other than rheumatoid arthritis-associated ILD (RA-ILD)
  3. Known diagnosis of sarcoidosis
  4. Patients with predominant features of organizing pneumonia on HRCT, as assessed by central review
  5. 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)
  6. Meeting criteria for progressive pulmonary fibrosis (PPF), as assessed by investigator
  7. Meeting criteria for treatment with currently approved therapies for the fibrosing ILD (e.g. PPF), as assessed by investigator
  8. Prior or current use of nerandomilast, nintedanib, or pirfenidone
  9. Further exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo arm
Drug: Placebo matching nerandomilast
Placebo matching nerandomilast
Experimental: Nerandomilast arm
Drug: Nerandomilast
Nerandomilast

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Absolute change from baseline in forced vital capacity (FVC) (mL) at Week 52
Time Frame: at baseline, at week 52
at baseline, at week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Absolute change from baseline in total disease extent (TDE [%]), as measured by e-Lung quantitative high resolution computed tomography (HRCT) scoring at Week 52
Time Frame: at baseline, at week 52
at baseline, at week 52
Absolute change from baseline in reticulovascular score (RVS [%]), as measured by e-Lung quantitative high resolution computed tomography (HRCT) scoring at Week 52
Time Frame: at baseline, at week 52
at baseline, at week 52
Absolute change from baseline in FVC (% predicted) at Week 52
Time Frame: at baseline, at week 52
at baseline, at week 52
Time to development of incident progressive pulmonary fibrosis (PPF) (as assessed and documented by investigator) or death over the duration of the trial
Time Frame: up to 28 months
up to 28 months
Time to absolute decline from baseline in FVC (% predicted) of >5% or death over the duration of the trial
Time Frame: up to 28 months
up to 28 months
Time to relative decline from baseline in FVC (% predicted) of >10% or death over the duration of the trial
Time Frame: up to 28 months
up to 28 months
Absolute change from baseline in diffusing capacity of the lungs for carbon monoxide (DLCO [% predicted]) at Week 52
Time Frame: at baseline, at week 52
at baseline, at week 52
Time to absolute decline from baseline in diffusing capacity of the lungs for carbon monoxide (DLCO [% predicted]) of >10% or death over the duration of the trial
Time Frame: up to 28 months
up to 28 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 28, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 5, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 12, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1305-0152
  • U1111-1337-1080 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))
  • 2026-526028-38 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

IPD Sharing Time Frame

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD Sharing Access Criteria

For study documents -upon signing of a 'Document Sharing Agreement'. For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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