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)
3 other identifiers
interventional
466
19 countries
164
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2026
164 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2026
CompletedFirst Posted
Study publicly available on registry
April 21, 2026
CompletedStudy Start
First participant enrolled
September 17, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 5, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 12, 2028
October 1, 2026
September 1, 2026
2.2 years
April 15, 2026
September 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Absolute change from baseline in forced vital capacity (FVC) (mL) at Week 52
at baseline, at week 52
Secondary Outcomes (8)
Absolute change from baseline in total disease extent (TDE [%]), as measured by e-Lung quantitative high resolution computed tomography (HRCT) scoring 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
at baseline, at week 52
Absolute change from baseline in FVC (% predicted) 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
up to 28 months
Time to absolute decline from baseline in FVC (% predicted) of >5% or death over the duration of the trial
up to 28 months
- +3 more secondary outcomes
Study Arms (2)
Nerandomilast arm
EXPERIMENTALPlacebo arm
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Male and female individuals ≥18 years of age at the time of first signed informed consent 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 investigator
- 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
- 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 period
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (167)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of Southern California
Los Angeles, California, 90033, United States
Newport Native MD, Inc
Newport Beach, California, 92663, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
Clinical Research Specialists LLC - Kissimmee
Kissimmee, Florida, 34746, United States
Lakeland Regional Medical Center - Lakeland
Lakeland, Florida, 33805, United States
Advanced Pulmonary Research Institute
Loxahatchee Groves, Florida, 33470, United States
Essence MD Research
Naples, Florida, 34102, United States
Avanza Medical Research Center
Pensacola, Florida, 32503, United States
Coastal Pulmonary & Critical Care
St. Petersburg, Florida, 33704, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Indiana University Health Enterprise Clinical Research Operation
Indianapolis, Indiana, 46202, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic, Rochester
Rochester, Minnesota, 55905, United States
Henderson Clinical Trials
Henderson, Nevada, 89052, United States
Weill Cornell Medicine-New York-60569
New York, New York, 10021, United States
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, 10032, United States
Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine
New Bern, North Carolina, 28562, United States
Southeastern Research Center-Winston-Salem-61365
Winston-Salem, North Carolina, 27103, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Lowcountry Lung and Critical Care
Charleston, South Carolina, 29406, United States
Clinical Trials Center of Middle Tennessee, LLC
Franklin, Tennessee, 37067, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Metroplex Pulmonary & Sleep Center
McKinney, Texas, 75069, United States
UT Health San Antonio
San Antonio, Texas, 78229, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, 84108, United States
Instituto de Medicina Respiratoria (IMeR)
Alberdi Sur, X5003DCE, Argentina
Hospital Aleman
CABA, 1118, Argentina
Fundacion NIBA Neurologia Infantil Buenos Aires
CABA, 1182, Argentina
Consultorios Medicos del Buen Ayre
Capital Federal, 1425, Argentina
Instituto Ave Pulmo - Fundacion Enfisema
Mar del Plata, 7600, Argentina
INSARES
Mendoza, M5500CCG, Argentina
Fundacion Innovaciencia
Rosario, 2000, Argentina
Royal Prince Alfred Hospital
Camperdown, Sydney, New South Wales, 2050, Australia
Lung Research Queensland
Chermside, Queensland, 4032, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Medical University of Graz
Graz, 8036, Austria
Hospital Elisabethinen Linz
Linz, 4020, Austria
Johannes Kepler University Linz
Linz, 4020, Austria
Wiener Gesundheitsverbund
Vienna, 1140, Austria
Wiener Gesundheitsverbund
Vienna, 1210, Austria
UZ Leuven
Leuven, 3000, Belgium
Centre Hospitalier Universitaire de Liège
Liège, 4000, Belgium
AZ Delta
Roeselare, 8800, Belgium
CLARE - Clinica de Pneumologia
Goiânia, 74110-030, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, 90050-170, Brazil
IMIP Pernambuco
Recife, 50070902, Brazil
Fundaçao Faculdade Regional de Medicina de Sao Jose do Rio Preto
São José do Rio Preto, 15090-000, Brazil
INCOR e Hospital das Clínicas da Universidade de São Paulo
São Paulo, 05403-000, Brazil
Synergy Respiratory Care
Sherwood Park, Alberta, T8H 0N2, Canada
Kelowna Respirology & Allergy Research
Kelowna, British Columbia, V1Y 3H5, Canada
St. Paul's Hospital (Vancouver)
Vancouver, British Columbia, V6Z 1Y6, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
CIC Mauricie (Trois Rivieres)
Trois-Rivières, Quebec, G8T 7A1, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
Québec, G1V 4G5, Canada
Beijing Chao-Yang Hospital
Beijing, 100020, China
The Second Xiangya Hospital Of Central South University
Changsha, 410011, China
West China Hospital, Sichuan University
Chengdu, 610041, China
Sichuan Provincial People's Hospital
Chengdu, 610072, China
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510000, China
Zhejiang Hospital
Hangzhou, 310013, China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, 310016, China
Nanjing Drum Tower Hospital
Nanjing, 210008, China
Shanghai Chest Hospital
Shanghai, 200030, China
Shanghai Pulmonary Hospital
Shanghai, 200433, China
The First Affiliated Hospital of Soochow University
Suzhou, 215006, China
Tianjin Medical University General Hospital
Tianjin, 300052, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430022, China
Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
Wuhan, 430030, China
Wuxi People's Hospital
Wuxi, 214043, China
Second Affiliated Hospital of medical college of Xi'an JiaoTong University
Xi'an, 710004, China
General Hospital of Ningxia Medical University
Yinchuan, 750004, China
Henan Provincial People's Hospital
Zhengzhou, 450003, China
HYKS Keuhkosairauksien tutkimusyksikkö
Helsinki, 000290, Finland
Oulun yliopistollinen keskussairaala
Oulu, 90220, Finland
Turku University Hospital / TYKS
Turku, 20520, Finland
HOP d'Angers
Angers, 49933, France
HOP Avicenne
Bobigny, 93000, France
Hopital Louis Pradel
Bron, 69677, France
HOP CHU Caen
Caen, 14033, France
HOP CHU de Grenoble
La Tronche, 38700, France
INS Coeur Poumon
Lille, 59037, France
HOP Nord
Marseille, 13015, France
Hopital Pasteur
Nice, 06000, France
HOP Bichat
Paris, 75018, France
HOP Pontchaillou
Rennes, 35033, France
Charité - Universitätsmedizin Berlin
Berlin, 10117, Germany
Vivantes Netzwerk für Gesundheit GmbH
Berlin, 12351, Germany
Universitätsklinikum Bonn AöR
Bonn, 53127, Germany
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, 45239, Germany
Klinikum Region Hannover GmbH
Hanover, 30459, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg, 69126, Germany
Lungenfachklinik Immenhausen
Immenhausen, 34376, Germany
Klinikum der Universität München AÖR
München, 81377, Germany
Robert Bosch Gesellschaft für medizinische Forschung mbH
Stuttgart, 70376, Germany
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Catania, 95124, Italy
Ospedale Colonnello D Avanzo
Foggia, 71100, Italy
Ospedale G.B. Morgagni
Forlì, 47121, Italy
Ospedale Classificato San Giuseppe
Milan, 20123, Italy
A.O. San Gerardo di Monza
Monza, 20900, Italy
Azienda Ospedaliera Universitaria di Padova
Padova, 35128, Italy
Pol. Universitario Tor Vergata
Roma, 00133, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168, Italy
Tosei General Hospital
Aichi, Seto, 489-8642, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, Fukuoka, 810-8563, Japan
Hospital of the University of Occupational and Environmental Health
Fukuoka, Kitakyushu, 807-8556, Japan
Hiroshima Prefectural Hospital
Hiroshima, Hiroshima, 734-8530, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551, Japan
Sapporo Medical University Hospital
Hokkaido, Sapporo, 060-8543, Japan
Kagawa University Hospital
Kagawa, Kita-gun, 761-0793, Japan
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, Yokohama, 236-0051, Japan
Kindai University Hospital
Osaka, Sakai, 590-0197, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Osaka, Sakai, 591-8555, Japan
Hamamatsu University Hospital
Shizuoka, Hamamatsu, 431-3192, Japan
Tokushima University Hospital
Tokushima, Tokushima, 770-8503, Japan
Juntendo University Hospital
Tokyo, Bunkyo-ku, 113-8431, Japan
Keio University Hospital
Tokyo, Shinjuku-ku, 160-8582, Japan
National Center for Global Health and Medicine
Tokyo, Shinjuku-ku, 162-8655, Japan
Centro de Investigacion Integral MEDIVEST S.C
Chihuahua City, 31203, Mexico
Centro de Investigacion Farmacologica del Bajío, S.C.
León, 37160, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, 64460, Mexico
St. Antonius Ziekenhuis
Nieuwegein, 3435 CM, Netherlands
Erasmus Medisch Centrum
Rotterdam, 3015 GD, Netherlands
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214, Poland
Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu
Poznan, 60-569, Poland
Przychodnia Alergologiczno-Pulmonologiczna Alergopneuma Sp. z o.o.
Świdnik, 21-040, Poland
National Institute Of Tuberculosis And Lung Diseases
Warsaw, 01-138, Poland
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
Warsaw, 02-637, Poland
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, Gyeonggi-do, 14584, South Korea
Inje University Busan Paik Hospital
Busan, 47392, South Korea
Inje University Haeundae Paik Hospital
Busan, 48108, South Korea
Seoul National University Bundang Hospital
Seongnam, 13620, South Korea
Kyung Hee University Hospital
Seoul, 02447, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Hospital Germans Trias i Pujol
Badalona, 08916, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitario Reina Sofía
Córdoba, 14004, Spain
Hospital de Galdakao
Galdakao, 48960, Spain
Hospital General de Granollers
Granollers, 08402, Spain
Hospital Universitari de Bellvitge
Hospitalet Llobregat, 08907, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, 08907, Spain
Hospital Universitario Ramon Y Cajal
Madrid, 28034, Spain
Hospital Clínico San Carlos
Madrid, 28040, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301, Taiwan
China Medical University Hospital
Taichung, 404, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
Royal Devon and Exeter Hospital, Wonford
Exeter, EX2 5DW, United Kingdom
Royal Lancaster Infirmary
Lancaster, LA1 4RP, United Kingdom
St James's University Hospital
Leeds, LS9 7TF, United Kingdom
Glenfield Hospital
Leicester, LE3 9QP, United Kingdom
St George's Hospital
London, SW17 0RE, United Kingdom
Royal Brompton Hospital
London, SW3 6HP, United Kingdom
Wythenshawe Hospital
Manchester, M23 9LT, United Kingdom
Churchill Hospital
Oxford, OX3 7LE, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2026
First Posted
April 21, 2026
Study Start
September 17, 2026
Primary Completion (Estimated)
December 5, 2028
Study Completion (Estimated)
December 12, 2028
Last Updated
October 1, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- 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.
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