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

May 31, 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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

466

Phase

  • 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 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
  • 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 Misericordia de Porto Alegre
        • Contact:
      • São Paulo, Brazil, 05403-000
        • INCOR e Hospital das Clínicas da Universidade de São Paulo
        • Contact:
  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 3H5
        • Kelowna Respirology & Allergy Research
        • Contact:
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
  • 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:
      • Hiroshima, Hiroshima, Japan, 734-8530
      • Hiroshima, Hiroshima, Japan, 734-8551
      • Hokkaido, Sapporo, Japan, 060-8543
        • Sapporo Medical University Hospital
        • Contact:
      • Kanagawa, Yokohama, Japan, 236-0051
        • Kanagawa Cardiovascular and Respiratory 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:
      • Monterrey, Mexico, 64460
        • Hospital Universitario Dr Jose Eleuterio Gonzalez
        • Contact:
  • Netherlands
      • Nieuwegein, Netherlands, 3435 CM
      • Rotterdam, Netherlands, 3015 GD
  • 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
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebrón
        • Contact:
      • Galdakao, Spain, 48960
      • Granollers, Spain, 08402
      • Hospitalet Llobregat, Spain, 08907
  • 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
    • 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
    • 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, 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

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
Intervention / Treatment
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

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

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

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)

August 28, 2026

Primary Completion (Estimated)

December 5, 2028

Study Completion (Estimated)

December 12, 2028

Study Registration Dates

First Submitted

April 15, 2026

First Submitted That Met QC Criteria

April 15, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 31, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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