Clinical Research Directory
Browse clinical research sites, groups, and studies.
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
2026-09-17
Completion Date
2028-12-12
Last Updated
2026-10-28
Healthy Volunteers
No
Conditions
Interventions
Nerandomilast
Nerandomilast
Placebo matching nerandomilast
Placebo matching nerandomilast
Locations (162)
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
New York Presbyterian Hospital -Columbia University
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
Fundacion NIBA Neurologia Infantil Buenos Aires
CABA, Argentina
Consultorios Medicos del Buen Ayre
Capital Federal, Argentina
Hospital Aleman
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