RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Boehringer Ingelheim • ClinicalTrials.gov ID: NCT07540988

Registry updated: 2026-10-14

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Description

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.

Interventions

Nerandomilast (Drug)
Nerandomilast
Placebo matching nerandomilast (Drug)
Placebo matching nerandomilast

Eligibility criteria

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.

Conditions

Interstitial Lung Diseases

Locations

University of Alabama at Birmingham — Birmingham, Alabama, United States
University of Southern California — Los Angeles, California, United States
Newport Native MD, Inc — Newport Beach, California, United States
Yale University School of Medicine — New Haven, Connecticut, United States
Clinical Research Specialists LLC - Kissimmee — Kissimmee, Florida, United States
Lakeland Regional Medical Center - Lakeland — Lakeland, Florida, United States
Advanced Pulmonary Research Institute — Loxahatchee Groves, Florida, United States
Essence MD Research — Naples, Florida, United States
Avanza Medical Research Center — Pensacola, Florida, United States
Coastal Pulmonary & Critical Care — St. Petersburg, Florida, United States
Cleveland Clinic Florida — Weston, Florida, United States
Indiana University Health Enterprise Clinical Research Operation — Indianapolis, Indiana, United States
University of Kansas Medical Center — Kansas City, Kansas, United States
University of Michigan — Ann Arbor, Michigan, United States
University of Minnesota — Minneapolis, Minnesota, United States
Mayo Clinic, Rochester — Rochester, Minnesota, United States
Henderson Clinical Trials — Henderson, Nevada, United States
Weill Cornell Medicine-New York-60569 — New York, New York, United States
Columbia University Medical Center-New York Presbyterian Hospital — New York, New York, United States
Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine — New Bern, North Carolina, United States
Southeastern Research Center-Winston-Salem-61365 — Winston-Salem, North Carolina, United States
University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
University of Pennsylvania — Philadelphia, Pennsylvania, United States
Temple University — Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
Lowcountry Lung and Critical Care — Charleston, South Carolina, United States
Baylor University Medical Center — Dallas, Texas, United States
Metroplex Pulmonary & Sleep Center — McKinney, Texas, United States
UT Health San Antonio — San Antonio, Texas, United States
University of Utah Health Sciences Center — Salt Lake City, Utah, United States
Instituto de Medicina Respiratoria (IMeR) — Alberdi Sur, Argentina
Hospital Aleman — CABA, Argentina
Fundacion NIBA Neurologia Infantil Buenos Aires — CABA, Argentina
Consultorios Medicos del Buen Ayre — Capital Federal, Argentina
Instituto Ave Pulmo - Fundacion Enfisema — Mar del Plata, Argentina
INSARES — Mendoza, Argentina
Fundacion Innovaciencia — Rosario, Argentina
Royal Prince Alfred Hospital — Camperdown, Sydney, New South Wales, Australia
Lung Research Queensland — Chermside, Queensland, Australia
Fiona Stanley Hospital — Murdoch, Western Australia, Australia
Medical University of Graz — Graz, Austria
Hospital Elisabethinen Linz — Linz, Austria
Johannes Kepler University Linz — Linz, Austria
Wiener Gesundheitsverbund — Vienna, Austria
Wiener Gesundheitsverbund — Vienna, Austria
UZ Leuven — Leuven, Belgium
Centre Hospitalier Universitaire de Liège — Liège, Belgium
AZ Delta — Roeselare, Belgium
CLARE - Clinica de Pneumologia — Goiânia, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre — Porto Alegre, Brazil
IMIP Pernambuco — Recife, Brazil
Fundaçao Faculdade Regional de Medicina de Sao Jose do Rio Preto — São José do Rio Preto, Brazil
INCOR e Hospital das Clínicas da Universidade de São Paulo — São Paulo, Brazil
Synergy Respiratory Care — Sherwood Park, Alberta, Canada
Kelowna Respirology & Allergy Research — Kelowna, British Columbia, Canada
St. Paul's Hospital (Vancouver) — Vancouver, British Columbia, Canada
Toronto General Hospital — Toronto, Ontario, Canada
CIC Mauricie (Trois Rivieres) — Trois-Rivières, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ) — Québec, Canada
Beijing Chao-Yang Hospital — Beijing, China
The Second Xiangya Hospital Of Central South University — Changsha, China
West China Hospital, Sichuan University — Chengdu, China
Sichuan Provincial People's Hospital — Chengdu, China
First Affiliated Hospital of Guangzhou Medical University — Guangzhou, China
Zhejiang Hospital — Hangzhou, China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine — Hangzhou, China
Nanjing Drum Tower Hospital — Nanjing, China
Shanghai Chest Hospital — Shanghai, China
Shanghai Pulmonary Hospital — Shanghai, China
The First Affiliated Hospital of Soochow University — Suzhou, China
Tianjin Medical University General Hospital — Tianjin, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, China
Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T — Wuhan, China
Wuxi People's Hospital — Wuxi, China
Second Affiliated Hospital of medical college of Xi'an JiaoTong University — Xi'an, China
General Hospital of Ningxia Medical University — Yinchuan, China
Henan Provincial People's Hospital — Zhengzhou, China
HYKS Keuhkosairauksien tutkimusyksikkö — Helsinki, Finland
Oulun yliopistollinen keskussairaala — Oulu, Finland
Turku University Hospital / TYKS — Turku, Finland
HOP d'Angers — Angers, France
HOP Avicenne — Bobigny, France
Hopital Louis Pradel — Bron, France
HOP CHU Caen — Caen, France
HOP CHU de Grenoble — La Tronche, France
INS Coeur Poumon — Lille, France
HOP Nord — Marseille, France
Hopital Pasteur — Nice, France
HOP Bichat — Paris, France
HOP Pontchaillou — Rennes, France
Charité - Universitätsmedizin Berlin — Berlin, Germany
Vivantes Netzwerk für Gesundheit GmbH — Berlin, Germany
Universitätsklinikum Bonn AöR — Bonn, Germany
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH — Essen, Germany
Klinikum Region Hannover GmbH — Hanover, Germany
Medizinische Hochschule Hannover — Hanover, Germany
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg — Heidelberg, Germany
Klinikum der Universität München AÖR — München, Germany
Robert Bosch Gesellschaft für medizinische Forschung mbH — Stuttgart, Germany
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania — Catania, Italy
Ospedale Colonnello D Avanzo — Foggia, Italy
Ospedale G.B. Morgagni — Forlì, Italy
A.O. San Gerardo di Monza — Monza, Italy
Azienda Ospedaliera Universitaria di Padova — Padova, Italy
Pol. Universitario Tor Vergata — Roma, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Italy
Tosei General Hospital — Aichi, Seto, Japan
National Hospital Organization Kyushu Medical Center — Fukuoka, Fukuoka, Japan
Hospital of the University of Occupational and Environmental Health — Fukuoka, Kitakyushu, Japan
Hiroshima Prefectural Hospital — Hiroshima, Hiroshima, Japan
Hiroshima University Hospital — Hiroshima, Hiroshima, Japan
Sapporo Medical University Hospital — Hokkaido, Sapporo, Japan
Kagawa University Hospital — Kagawa, Kita-gun, Japan
Kanagawa Cardiovascular and Respiratory Center — Kanagawa, Yokohama, Japan
Kindai University Hospital — Osaka, Sakai, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center — Osaka, Sakai, Japan
Hamamatsu University Hospital — Shizuoka, Hamamatsu, Japan
Tokushima University Hospital — Tokushima, Tokushima, Japan
Juntendo University Hospital — Tokyo, Bunkyo-ku, Japan
Keio University Hospital — Tokyo, Shinjuku-ku, Japan
National Center for Global Health and Medicine — Tokyo, Shinjuku-ku, Japan
Centro de Investigacion Integral MEDIVEST S.C — Chihuahua City, Mexico
Centro de Investigacion Farmacologica del Bajío, S.C. — León, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez — Monterrey, Mexico
St. Antonius Ziekenhuis — Nieuwegein, Netherlands
Erasmus Medisch Centrum — Rotterdam, Netherlands
Uniwersyteckie Centrum Kliniczne — Gdansk, Poland
Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu — Poznan, Poland
Przychodnia Alergologiczno-Pulmonologiczna Alergopneuma Sp. z o.o. — Świdnik, Poland
National Institute Of Tuberculosis And Lung Diseases — Warsaw, Poland
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji — Warsaw, Poland
Soon Chun Hyang University Hospital Bucheon — Bucheon-si, Gyeonggi-do, South Korea
Inje University Busan Paik Hospital — Busan, South Korea
Inje University Haeundae Paik Hospital — Busan, South Korea
Seoul National University Bundang Hospital — Seongnam, South Korea
Kyung Hee University Hospital — Seoul, South Korea
Seoul National University Hospital — Seoul, South Korea
Asan Medical Center — Seoul, South Korea
Samsung Medical Center — Seoul, South Korea
Hospital Germans Trias i Pujol — Badalona, Spain
Hospital Universitari Vall d'Hebron — Barcelona, Spain
Hospital Universitario Reina Sofía — Córdoba, Spain
Hospital de Galdakao — Galdakao, Spain
Hospital General de Granollers — Granollers, Spain
Hospital Universitari de Bellvitge — Hospitalet Llobregat, Spain
Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat, Spain
Hospital Universitario Ramon Y Cajal — Madrid, Spain
Hospital Clínico San Carlos — Madrid, Spain
Hospital Clinico Universitario de Valencia — Valencia, Spain
Kaohsiung Veterans General Hospital — Kaohsiung City, Taiwan
Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City, Taiwan
China Medical University Hospital — Taichung, Taiwan
Taichung Veterans General Hospital — Taichung, Taiwan
National Taiwan University Hospital — Taipei, Taiwan
Taipei Veterans General Hospital — Taipei, Taiwan
Heartlands Hospital — Birmingham, United Kingdom
Royal Devon and Exeter Hospital, Wonford — Exeter, United Kingdom
Royal Lancaster Infirmary — Lancaster, United Kingdom
St James's University Hospital — Leeds, United Kingdom
Glenfield Hospital — Leicester, United Kingdom
St George's Hospital — London, United Kingdom
Royal Brompton Hospital — London, United Kingdom
Wythenshawe Hospital — Manchester, United Kingdom
Churchill Hospital — Oxford, United Kingdom

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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