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FIBRONEER-ACT: A Study to Test Whether Nerandomilast Helps People With Fibrosing Interstitial Lung Disease at Risk for Disease Progression
Sponsor: Boehringer Ingelheim
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
466
Start Date
2026-08-28
Completion Date
2028-12-12
Last Updated
2026-06-02
Healthy Volunteers
No
Conditions
Interventions
Nerandomilast
Nerandomilast
Placebo matching nerandomilast
Placebo matching nerandomilast
Locations (100)
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Southern California
Los Angeles, California, 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
Avanza Medical Research Center
Pensacola, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Minnesota
Minneapolis, Minnesota, 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
Temple University Hospital
Philadelphia, Pennsylvania, United States
Lowcountry Lung and Critical Care
Charleston, South Carolina, United States
Clinical Trials Center of Middle Tennessee, LLC
Franklin, Tennessee, United States
Baylor University Medical Center
Dallas, 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 Médicos del Buen Ayre
Capital Federal, Argentina
Instituto Ave Pulmo - Fundacion Enfisema
Mar del Plata, Argentina
INSARES
Mendoza, Argentina
Fundacion Innovaciencia
Rosario, Argentina
UZ Leuven
Leuven, Belgium
Centre Hospitalier Universitaire de Liège
Liège, Belgium
Roeselare - HOSP AZ Delta
Roeselare, Belgium
CLARE - Clinica de Pneumologia
Goiânia, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Brazil
INCOR e Hospital das Clínicas da Universidade de São Paulo
São Paulo, Brazil
Kelowna Respirology & Allergy Research
Kelowna, British Columbia, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Beijing Chao-Yang Hospital
Beijing, China
The Second Xiangya Hospital Of Central South University
Changsha, China
West China Hospital, Sichuan University
Chengdu, China
People's Hospital of Sichuan Province
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
Wuhan Union Hospital
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 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
Turku University Hospital / TYKS
Turku, Finland
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
Lungenfachklinik Immenhausen
Immenhausen, Germany
Klinikum der Universität München AÖR
München, Germany
Robert-Bosch-Krankenhaus GmbH
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
Ospedale Classificato San Giuseppe
Milan, 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
Hiroshima Prefectural Hospital
Hiroshima, Hiroshima, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, Japan
Sapporo Medical University Hospital
Hokkaido, Sapporo, Japan
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, Yokohama, Japan
Kindai University Hospital
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
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, Mexico
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Erasmus Medisch Centrum
Rotterdam, Netherlands
Inje University Busan Paik Hospital
Busan, South Korea
Inje University Haeundae Paik Hospital
Busan, South Korea
Seoul National University Bundang Hospital
Seongnam, South Korea
Seoul National University Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital de Galdakao
Galdakao, Spain
Hospital General de Granollers
Granollers, Spain
Hospital Universitari de Bellvitge
Hospitalet Llobregat, 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