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.
Trial 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). Read more about this study
- 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
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
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- 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
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- 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.
164 sites in 20 countries
United States30 sites, 30 recruiting
- Not yet 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
China18 sites, 18 recruiting
- Not yet 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
Japan15 sites, 15 recruiting
- Not yet 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
France10 sites, 10 recruiting
- Not yet 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
Spain10 sites, 10 recruiting
- Not yet 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
Germany9 sites, 9 recruiting
- Not yet 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
United Kingdom9 sites, 9 recruiting
- Not yet 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
South Korea8 sites, 8 recruiting
- Not yet 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
Argentina7 sites, 7 recruiting
- Not yet 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
Italy7 sites, 7 recruiting
- Not yet 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
Canada6 sites, 6 recruiting
- Recruiting
Kelowna Respirology & Allergy Research
Kelowna, British Columbia, V1Y 3H5
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
- Not yet 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
- Recruiting
CIC Mauricie (Trois Rivieres)
Trois-Rivières, Quebec, G8T 7A1
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
- Not yet recruiting
St. Paul's Hospital (Vancouver)
Vancouver, British Columbia, V6Z 1Y6
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
Taiwan6 sites, 6 recruiting
- Not yet 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
Austria5 sites, 5 recruiting
- Not yet 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
Brazil5 sites, 5 recruiting
- Not yet 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
Poland5 sites, 5 recruiting
- Not yet 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
Australia3 sites, 3 recruiting
- Not yet recruiting
Royal Prince Alfred Hospital
Camperdown, Sydney, New South Wales, 2050
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Recruiting
Lung Research Queensland
Chermside, Queensland, 4032
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Not yet recruiting
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
Belgium3 sites, 3 recruiting
- Not yet 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
Finland3 sites, 3 recruiting
- Not yet 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
Mexico3 sites, 3 recruiting
- Not yet 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
Netherlands2 sites, 2 recruiting
- Not yet 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
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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