Interstitial Lung DiseasesPhase 3NCT07540988

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

A Phase 3 study testing Nerandomilast in people with Interstitial Lung Diseases, run by Boehringer Ingelheim at 164 sites in 20 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Interstitial Lung Diseases
What is being tested?: Nerandomilast
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 466 participants
Where: 164 sitesin 20 countries
Study dates: 17 Sep 2026to 12 Dec 2028
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 9Show fewer

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
Further inclusion criteria apply.

Who cannot join

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

Show all 9Show fewer

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
Further exclusion criteria apply.

Trial locations and contacts

164 sites in 20 countries. Contact the study team or a site near you to ask about taking part.

Boehringer Ingelheim contact

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

Country

City, postcode or hospital

Sites recruiting now only

164 sites in 20 countries

United States30 sites, 30 recruiting

University of Michigan
Ann Arbor, Michigan, 48109
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Lowcountry Lung and Critical Care
Charleston, South Carolina, 29406
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Baylor University Medical Center
Dallas, Texas, 75246
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Henderson Clinical Trials
Henderson, Nevada, 89052
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Indiana University Health Enterprise Clinical Research Operation
Indianapolis, Indiana, 46202
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Clinical Research Specialists LLC - Kissimmee
Kissimmee, Florida, 34746
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Lakeland Regional Medical Center - Lakeland
Lakeland, Florida, 33805
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
University of Southern California
Los Angeles, California, 90033
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Advanced Pulmonary Research Institute
Loxahatchee Groves, Florida, 33470
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Metroplex Pulmonary & Sleep Center
McKinney, Texas, 75069
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Essence MD Research
Naples, Florida, 34102
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine
New Bern, North Carolina, 28562
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Yale University School of Medicine
New Haven, Connecticut, 06520
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Weill Cornell Medicine-New York-60569
New York, New York, 10021
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, 10032
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Newport Native MD, Inc
Newport Beach, California, 92663
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Avanza Medical Research Center
Pensacola, Florida, 32503
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Temple University
Philadelphia, Pennsylvania, 19140
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Mayo Clinic, Rochester
Rochester, Minnesota, 55905
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
University of Utah Health Sciences Center
Salt Lake City, Utah, 84108
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
UT Health San Antonio
San Antonio, Texas, 78229
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Coastal Pulmonary & Critical Care
St. Petersburg, Florida, 33704
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Cleveland Clinic Florida
Weston, Florida, 33331
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Southeastern Research Center-Winston-Salem-61365
Winston-Salem, North Carolina, 27103
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting

Other trials in United States

China18 sites, 18 recruiting

Beijing Chao-Yang Hospital
Beijing, 100020
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Not yet recruiting
The Second Xiangya Hospital Of Central South University
Changsha, 410011
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Not yet recruiting
West China Hospital, Sichuan University
Chengdu, 610041
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Not yet recruiting
Sichuan Provincial People's Hospital
Chengdu, 610072
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Not yet recruiting
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Not yet recruiting
Zhejiang Hospital
Hangzhou, 310013
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Not yet recruiting
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, 310016
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Not yet recruiting
Nanjing Drum Tower Hospital
Nanjing, 210008
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Not yet recruiting
Shanghai Chest Hospital
Shanghai, 200030
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Not yet recruiting
Shanghai Pulmonary Hospital
Shanghai, 200433
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Not yet recruiting
The First Affiliated Hospital of Soochow University
Suzhou, 215006
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Not yet recruiting
Tianjin Medical University General Hospital
Tianjin, 300052
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Not yet recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430022
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Not yet recruiting
Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
Wuhan, 430030
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Not yet recruiting
Wuxi People's Hospital
Wuxi, 214043
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Not yet recruiting
Second Affiliated Hospital of medical college of Xi'an JiaoTong University
Xi'an, 710004
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Not yet recruiting
General Hospital of Ningxia Medical University
Yinchuan, 750004
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Not yet recruiting
Henan Provincial People's Hospital
Zhengzhou, 450003
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Not yet recruiting

Other trials in China

Japan15 sites, 15 recruiting

Tosei General Hospital
Aichi, Seto, 489-8642
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Not yet recruiting
National Hospital Organization Kyushu Medical Center
Fukuoka, Fukuoka, 810-8563
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Not yet recruiting
Hospital of the University of Occupational and Environmental Health
Fukuoka, Kitakyushu, 807-8556
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Not yet recruiting
Hiroshima Prefectural Hospital
Hiroshima, Hiroshima, 734-8530
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Not yet recruiting
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Not yet recruiting
Sapporo Medical University Hospital
Hokkaido, Sapporo, 060-8543
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Not yet recruiting
Kagawa University Hospital
Kagawa, Kita-gun, 761-0793
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Not yet recruiting
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, Yokohama, 236-0051
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Not yet recruiting
Kindai University Hospital
Osaka, Sakai, 590-0197
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Not yet recruiting
National Hospital Organization Kinki-Chuo Chest Medical Center
Osaka, Sakai, 591-8555
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Not yet recruiting
Hamamatsu University Hospital
Shizuoka, Hamamatsu, 431-3192
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Not yet recruiting
Tokushima University Hospital
Tokushima, Tokushima, 770-8503
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Not yet recruiting
Juntendo University Hospital
Tokyo, Bunkyo-ku, 113-8431
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Not yet recruiting
Keio University Hospital
Tokyo, Shinjuku-ku, 160-8582
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Not yet recruiting
National Center for Global Health and Medicine
Tokyo, Shinjuku-ku, 162-8655
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Not yet recruiting

Other trials in Japan

France10 sites, 10 recruiting

HOP d'Angers
Angers, 49933
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
Not yet recruiting
HOP Avicenne
Bobigny, 93000
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
Not yet recruiting
Hopital Louis Pradel
Bron, 69677
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
Not yet recruiting
HOP CHU Caen
Caen, 14033
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
Not yet recruiting
HOP CHU de Grenoble
La Tronche, 38700
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
Not yet recruiting
INS Coeur Poumon
Lille, 59037
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
Not yet recruiting
HOP Nord
Marseille, 13015
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
Not yet recruiting
Hopital Pasteur
Nice, 06000
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
Not yet recruiting
HOP Bichat
Paris, 75018
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
Not yet recruiting
HOP Pontchaillou
Rennes, 35033
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
Not yet recruiting

Other trials in France

Spain10 sites, 10 recruiting

Hospital Germans Trias i Pujol
Badalona, 08916
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Not yet recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Not yet recruiting
Hospital Universitario Reina Sofía
Córdoba, 14004
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Not yet recruiting
Hospital de Galdakao
Galdakao, 48960
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Not yet recruiting
Hospital General de Granollers
Granollers, 08402
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Not yet recruiting
Hospital Universitari de Bellvitge
Hospitalet Llobregat, 08907
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Not yet recruiting
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, 08907
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Not yet recruiting
Hospital Universitario Ramon Y Cajal
Madrid, 28034
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Not yet recruiting
Hospital Clínico San Carlos
Madrid, 28040
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Not yet recruiting
Hospital Clinico Universitario de Valencia
Valencia, 46010
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Not yet recruiting

Other trials in Spain

Germany9 sites, 9 recruiting

Charité - Universitätsmedizin Berlin
Berlin, 10117
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Not yet recruiting
Vivantes Netzwerk für Gesundheit GmbH
Berlin, 12351
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Not yet recruiting
Universitätsklinikum Bonn AöR
Bonn, 53127
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Not yet recruiting
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, 45239
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Not yet recruiting
Klinikum Region Hannover GmbH
Hanover, 30459
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Not yet recruiting
Medizinische Hochschule Hannover
Hanover, 30625
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Not yet recruiting
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg, 69126
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Not yet recruiting
Klinikum der Universität München AÖR
München, 81377
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Not yet recruiting
Robert Bosch Gesellschaft für medizinische Forschung mbH
Stuttgart, 70376
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Not yet recruiting

Other trials in Germany

United Kingdom9 sites, 9 recruiting

Heartlands Hospital
Birmingham, B9 5SS
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Not yet recruiting
Royal Devon and Exeter Hospital, Wonford
Exeter, EX2 5DW
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Not yet recruiting
Royal Lancaster Infirmary
Lancaster, LA1 4RP
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Not yet recruiting
St James's University Hospital
Leeds, LS9 7TF
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Not yet recruiting
Glenfield Hospital
Leicester, LE3 9QP
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Not yet recruiting
St George's Hospital
London, SW17 0RE
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Not yet recruiting
Royal Brompton Hospital
London, SW3 6HP
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Not yet recruiting
Wythenshawe Hospital
Manchester, M23 9LT
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Not yet recruiting
Churchill Hospital
Oxford, OX3 7LE
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Not yet recruiting

Other trials in United Kingdom

South Korea8 sites, 8 recruiting

Soon Chun Hyang University Hospital Bucheon
Bucheon-si, Gyeonggi-do, 14584
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
Not yet recruiting
Inje University Busan Paik Hospital
Busan, 47392
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
Not yet recruiting
Inje University Haeundae Paik Hospital
Busan, 48108
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
Not yet recruiting
Seoul National University Bundang Hospital
Seongnam, 13620
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
Not yet recruiting
Kyung Hee University Hospital
Seoul, 02447
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
Not yet recruiting
Seoul National University Hospital
Seoul, 03080
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
Not yet recruiting
Asan Medical Center
Seoul, 05505
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
Not yet recruiting
Samsung Medical Center
Seoul, 06351
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
Not yet recruiting

Other trials in South Korea

Argentina7 sites, 7 recruiting

Instituto de Medicina Respiratoria (IMeR)
Alberdi Sur, X5003DCE
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
Not yet recruiting
Hospital Aleman
CABA, 1118
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
Not yet recruiting
Fundacion NIBA Neurologia Infantil Buenos Aires
CABA, 1182
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
Not yet recruiting
Consultorios Medicos del Buen Ayre
Capital Federal, 1425
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
Not yet recruiting
Instituto Ave Pulmo - Fundacion Enfisema
Mar del Plata, 7600
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
Not yet recruiting
INSARES
Mendoza, M5500CCG
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
Not yet recruiting
Fundacion Innovaciencia
Rosario, 2000
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
Not yet recruiting

Other trials in Argentina

Italy7 sites, 7 recruiting

Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Catania, 95124
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
Not yet recruiting
Ospedale Colonnello D Avanzo
Foggia, 71100
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
Not yet recruiting
Ospedale G.B. Morgagni
Forlì, 47121
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
Not yet recruiting
A.O. San Gerardo di Monza
Monza, 20900
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
Not yet recruiting
Azienda Ospedaliera Universitaria di Padova
Padova, 35128
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
Not yet recruiting
Pol. Universitario Tor Vergata
Roma, 00133
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
Not yet recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
Not yet recruiting

Other trials in Italy

Canada6 sites, 6 recruiting

Kelowna Respirology & Allergy Research
Kelowna, British Columbia, V1Y 3H5
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
Recruiting
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
Québec, G1V 4G5
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
Not yet recruiting
Synergy Respiratory Care
Sherwood Park, Alberta, T8H 0N2
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
Not yet recruiting
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
Not yet recruiting
CIC Mauricie (Trois Rivieres)
Trois-Rivières, Quebec, G8T 7A1
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
Recruiting
St. Paul's Hospital (Vancouver)
Vancouver, British Columbia, V6Z 1Y6
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
Not yet recruiting

Other trials in Canada

Taiwan6 sites, 6 recruiting

Kaohsiung Veterans General Hospital
Kaohsiung City, 81362
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
Not yet recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
Not yet recruiting
China Medical University Hospital
Taichung, 404
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
Not yet recruiting
Taichung Veterans General Hospital
Taichung, 40705
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
Not yet recruiting
National Taiwan University Hospital
Taipei, 10002
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
Not yet recruiting
Taipei Veterans General Hospital
Taipei, 112
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
Not yet recruiting

Other trials in Taiwan

Austria5 sites, 5 recruiting

Medical University of Graz
Graz, 8036
Boehringer Ingelheim, 0800017900, oesterreich@bitrialsupport.com
Not yet recruiting
Hospital Elisabethinen Linz
Linz, 4020
Boehringer Ingelheim, 0800017900, oesterreich@bitrialsupport.com
Not yet recruiting
Johannes Kepler University Linz
Linz, 4020
Boehringer Ingelheim, 0800017900, oesterreich@bitrialsupport.com
Not yet recruiting
Wiener Gesundheitsverbund
Vienna, 1140
Boehringer Ingelheim, 0800017900, oesterreich@bitrialsupport.com
Not yet recruiting
Wiener Gesundheitsverbund
Vienna, 1210
Boehringer Ingelheim, 0800017900, oesterreich@bitrialsupport.com
Not yet recruiting

Other trials in Austria

Brazil5 sites, 5 recruiting

CLARE - Clinica de Pneumologia
Goiânia, 74110-030
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
Not yet recruiting
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, 90050-170
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
Not yet recruiting
IMIP Pernambuco
Recife, 50070902
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
Not yet recruiting
Fundaçao Faculdade Regional de Medicina de Sao Jose do Rio Preto
São José do Rio Preto, 15090-000
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
Not yet recruiting
INCOR e Hospital das Clínicas da Universidade de São Paulo
São Paulo, 05403-000
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
Not yet recruiting

Other trials in Brazil

Poland5 sites, 5 recruiting

Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Not yet recruiting
Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu
Poznan, 60-569
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Not yet recruiting
Przychodnia Alergologiczno-Pulmonologiczna Alergopneuma Sp. z o.o.
Świdnik, 21-040
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Not yet recruiting
National Institute Of Tuberculosis And Lung Diseases
Warsaw, 01-138
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Not yet recruiting
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
Warsaw, 02-637
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Not yet recruiting

Other trials in Poland

Australia3 sites, 3 recruiting

Royal Prince Alfred Hospital
Camperdown, Sydney, New South Wales, 2050
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
Not yet recruiting
Lung Research Queensland
Chermside, Queensland, 4032
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
Recruiting
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
Not yet recruiting

Other trials in Australia

Belgium3 sites, 3 recruiting

UZ Leuven
Leuven, 3000
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
Not yet recruiting
Centre Hospitalier Universitaire de Liège
Liège, 4000
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
Not yet recruiting
AZ Delta
Roeselare, 8800
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
Not yet recruiting

Other trials in Belgium

Finland3 sites, 3 recruiting

HYKS Keuhkosairauksien tutkimusyksikkö
Helsinki, 000290
Boehringer Ingelheim, 0800918118, suomi@bitrialsupport.com
Not yet recruiting
Oulun yliopistollinen keskussairaala
Oulu, 90220
Boehringer Ingelheim, 0800918118, suomi@bitrialsupport.com
Not yet recruiting
Turku University Hospital / TYKS
Turku, 20520
Boehringer Ingelheim, 0800918118, suomi@bitrialsupport.com
Not yet recruiting

Other trials in Finland

Mexico3 sites, 3 recruiting

Centro de Investigacion Integral MEDIVEST S.C
Chihuahua City, 31203
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
Not yet recruiting
Centro de Investigacion Farmacologica del Bajío, S.C.
León, 37160
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
Not yet recruiting
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, 64460
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
Not yet recruiting

Other trials in Mexico

Netherlands2 sites, 2 recruiting

St. Antonius Ziekenhuis
Nieuwegein, 3435 CM
Boehringer Ingelheim, 08000204613, nederland@bitrialsupport.com
Not yet recruiting
Erasmus Medisch Centrum
Rotterdam, 3015 GD
Boehringer Ingelheim, 08000204613, nederland@bitrialsupport.com
Not yet recruiting

Other trials in Netherlands

About this study

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)

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.

Conditions: Interstitial Lung Diseases
Being tested: Nerandomilast, Placebo matching nerandomilast
Medical subject headings: Lung Diseases, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NerandomilastDrug
Nerandomilast
Placebo matching nerandomilastDrug
Placebo matching nerandomilast

Study groups in NCT07540988
Study group	Role	What they receive
Nerandomilast arm	Experimental	Not described Receives: Drug: Nerandomilast
Placebo arm	Placebo comparator	Not described Receives: Drug: Placebo matching nerandomilast

What is being measured

The primary outcome is the main question the study is designed to answer.

Absolute change from baseline in forced vital capacity (FVC) (mL) at Week 52
Measured: 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
Measured: 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
Measured: at baseline, at week 52
Absolute change from baseline in FVC (% predicted) at Week 52
Measured: 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
Measured: up to 28 months
Time to absolute decline from baseline in FVC (% predicted) of >5% or death over the duration of the trial
Measured: up to 28 months
Time to relative decline from baseline in FVC (% predicted) of >10% or death over the duration of the trial
Measured: up to 28 months
Absolute change from baseline in diffusing capacity of the lungs for carbon monoxide (DLCO [% predicted]) at Week 52
Measured: 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
Measured: up to 28 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Sep 202612 Dec 2028

First posted21 Apr 2026
Study start17 Sep 2026
Primary completion5 Dec 2028 (estimated)
Study completion12 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Interstitial Lung DiseasesStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 466 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07540988
Sponsor's protocol ID: 1305-0152
Other IDs: U1111-1337-1080, 2026-526028-38
Status last verified: Oct 2026
First submitted: 15 Apr 2026
Last updated: 14 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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

Interested in taking part?

Boehringer Ingelheim

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 3
Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Pulmonary Hypertension, Interstitial Lung Disease
RecruitingPhase 2
Cobimetinib in Refractory Langerhans Cell Histiocytosis (LCH), and Other Histiocytic Disorders
Langerhan's Cell Histiocytosis, Juvenile Xanthogranuloma
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 3
Fibrotic Disease Activity in Cardiopulmonary Disorders Using 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) PET/CT Imaging
Allogeneic Stem Cell Transplantation, Lung Allograft Transplantation

All Interstitial Lung Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT07540988
Acronym / sponsor ID: 1305-0152
Conditions: Interstitial Lung Diseases
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 466 participants (estimated)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 17 Sep 2026 (actual)
Primary completion: 5 Dec 2028 (estimated)
Study completion: 12 Dec 2028 (estimated)
First posted: 21 Apr 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Nerandomilast arm	Experimental	Drug: Nerandomilast
Placebo arm	Placebo comparator	Drug: Placebo matching nerandomilast

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (9 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NerandomilastNerandomilast	Drug	Nerandomilast arm
Placebo matching nerandomilastPlacebo matching nerandomilast	Drug	Placebo arm

Primary outcome

Absolute change from baseline in forced vital capacity (FVC) (mL) at Week 52
Time frame: at baseline, at week 52

8 secondary outcomes

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
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
Absolute change from baseline in FVC (% predicted) at Week 52
Time frame: 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
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
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
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
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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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

Related trials for Interstitial Lung Diseases

RecruitingPhase 3
Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Pulmonary Hypertension, Interstitial Lung Disease
RecruitingPhase 2
Cobimetinib in Refractory Langerhans Cell Histiocytosis (LCH), and Other Histiocytic Disorders
Langerhan's Cell Histiocytosis, Juvenile Xanthogranuloma
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 3
Fibrotic Disease Activity in Cardiopulmonary Disorders Using 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) PET/CT Imaging
Allogeneic Stem Cell Transplantation, Lung Allograft Transplantation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Boehringer Ingelheim contact

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

164 sites in 20 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nerandomilast in people with Interstitial Lung Diseases, run by Boehringer Ingelheim at 164 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 164 sites in United States, China, Japan, France, Spain and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Boehringer Ingelheim (1-800-243-0127, clintriage.rdg@boehringer-ingelheim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute change from baseline in forced vital capacity (FVC) (mL) at Week 52 (time frame: at baseline, at week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07540988.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.