Idiopathic Pulmonary FibrosisPhase 3FIBRONEER™-ONNCT06238622
A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast
A Phase 3 study testing Nerandomilast in people with Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis, run by Boehringer Ingelheim at 374 sites in 44 countries.
Trial summary
This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called nerandomilast or BI 1015550. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
- What is being tested?
- Nerandomilast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,666 participants
- Where
- 374 sitesin 44 countries
- Study dates
- 26 Sep 2024to 7 May 2027
- 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
- Patients who completed treatment in the parent trials (1305-0014, 1305-0023, or 1305-0035) without prematurely discontinuing treatment permanently according to protocol (i.e. completed treatment with or without temporary treatment interruption)
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. WOCBP taking oral contraceptives (OCs) also have to ensure the use of one barrier method during sexual intercourse with their partner, e.g., condom to account for the risk of potentially reduced efficacy of the OCs in the event of severe vomiting and diarrhoea. For France, fertile males must be ready and able to use acceptable methods of birth control
Who cannot join
- Any disease that may put the patient at risk when participating in this trial at investigator's discretion.
- Patient exhibits suicidality, in the clinical judgment of the investigator or according to the following criteria at Visit 1:
- any suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour)
- any suicidal ideation of type 4 or 5 in the Columbia-Suicide Severity Rating Scale (C-SSRS) (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)
- Patients with clinically relevant severe depression at investigator's discretion or a Hospital Anxiety and Depression Scale (HADS) subscore >14 at Visit 1.
- An occurrence of malignant neoplasm other than appropriately treated basal cell carcinoma or in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix at Visit 1.
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- Patient will undergo lung transplantation, with an assigned date of surgery.
- Patients with a Body Mass index (BMI) <18.5 kg/m² that experienced an additional, unexplained and clinically significant (>10%) weight loss during the parent trial
- At Visit 1, patients with ongoing Adverse Event of Special Interest (AESI), except for latent tuberculosis (suspected vasculitis, Drug Induced Liver Injury (DILI), severe infections) that led to temporary treatment interruption in the parent trial
- Patients who must or wish to take restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
- Further exclusion criteria apply.
Trial locations and contacts
374 sites in 44 countries.
374 sites in 44 countries
United States58 sites
University of Michigan
Ann Arbor, Michigan, 48109
Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead
Atlanta, Georgia, 30309
The Emory Clinic
Atlanta, Georgia, 30322
Johns Hopkins Hospital
Baltimore, Maryland, 21224
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
St. Elizabeth's Medical Center
Boston, Massachusetts, 02135
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of Vermont
Burlington, Vermont, 05401
Lowcountry Lung and Critical Care
Charleston, South Carolina, 29406
The Lung Research Center, LLC
Chesterfield, Missouri, 63017
University of Cincinnati
Cincinnati, Ohio, 45267
St. Francis Medical Institute
Clearwater, Florida, 33765
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Baylor University Medical Center
Dallas, Texas, 75246
National Jewish Health
Denver, Colorado, 80206
Duke University Medical Center
Durham, North Carolina, 27710
Infinity Medical Research, Inc.
East Providence, Rhode Island, 02914
Northshore University Health System
Evanston, Illinois, 60201
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Clinical Trials Center of Middle Tennessee, LLC
Franklin, Tennessee, 37067
University of Florida
Gainesville, Florida, 32610
University of Kansas Medical Center
Kansas City, Kansas, 66160
Clinical Research Specialists LLC - Kissimmee
Kissimmee, Florida, 34746
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Southern California
Los Angeles, California, 90033
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of California Los Angeles
Los Angeles, California, 90095
Advanced Pulmonary Research Institute
Loxahatchee Groves, Florida, 33470
University of Wisconsin
Madison, Wisconsin, 53792
University of Minnesota
Minneapolis, Minnesota, 55455
Northern Westchester Hospital
Mount Kisco, New York, 10549
Intermountain Medical Center-Murray-69497
Murray, Utah, 84107
Vanderbilt University Medical Center
Nashville, Tennessee, 37204
Yale University School of Medicine
New Haven, Connecticut, 06510
Tulane Medical Center
New Orleans, Louisiana, 70112
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, 10032
NewYork-Presbyterian/Weill Cornell Medical Center
New York, New York, 10065
Christiana Hospital
Newark, Delaware, 19713
Creighton University
Omaha, Nebraska, 68124
University of Nebraska Medical Center
Omaha, Nebraska, 68198
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Temple University
Philadelphia, Pennsylvania, 19140
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
The Oregon Clinic
Portland, Oregon, 97220
Renown Regional Medical Center
Reno, Nevada, 89502
Mayo Clinic, Rochester
Rochester, Minnesota, 55905
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073
University of California Davis
Sacramento, California, 95817
University of Utah Health Sciences Center
Salt Lake City, Utah, 84108
UT Health San Antonio
San Antonio, Texas, 78229
Virginia Mason Medical Center
Seattle, Washington, 98101
Renovatio Clinical-The Woodlands-69551
The Woodlands, Texas, 77380
University of Arizona
Tucson, Arizona, 85724
Georgetown University
Washington D.C., District of Columbia, 20007
Southeastern Research Center-Winston Salem-69289
Winston-Salem, North Carolina, 27103
Japan38 sites
Tosei General Hospital
Aichi, Seto, 489-8642
Chiba University Hospital
Chiba, Chiba, 260-8677
University of Fukui Hospital
Fukui, Yoshida-gun, 910-1193
National Hospital Organization Kyushu Medical Center
Fukuoka, Fukuoka, 810-8563
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582
Aso Co.,Ltd Iizuka Hospital
Fukuoka, Iizuka, 820-8505
Hospital of the University of Occupational and Environmental Health
Fukuoka, Kitakyushu, 807-8556
Kurume University Hospital
Fukuoka, Kurume, 830-0011
Fukushima Medical University Hospital
Fukushima, Fukushima, 960-1295
Tsuboi Hospital
Fukushima, Koriyama, 963-0197
Hiroshima Prefectural Hospital
Hiroshima, Hiroshima, 734-8530
Sapporo Medical University Hospital
Hokkaido, Sapporo, 060-8543
Hokkaido University Hospital
Hokkaido, Sapporo, 060-8648
National Hospital Organization Himeji Medical Center
Hyogo, Himeji, 670-8520
Kobe City Medical Center General Hospital
Hyogo, Kobe, 650-0047
Kobe City Hospital Organization Kobe City Medical Center West Hospital
Hyogo, Kobe, 653-0013
Kagawa University Hospital
Kagawa, Kita-gun, 761-0793
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, Yokohama, 236-0051
Saiseikai Kumamoto Hospital
Kumamoto, Kumamoto, 861-4193
Tohoku University Hospital
Miyagi, Sendai, 980-8574
Nagasaki University Hospital
Nagasaki, Nagasaki, 852-8501
Kindai University Hospital
Osaka, Sakai, 590-0197
National Hospital Organization Kinki-Chuo Chest Medical Center
Osaka, Sakai, 591-8555
Osaka Medical and Pharmaceutical University Hospital
Osaka, Takatsuki, 569-8686
Saitama Red Cross Hospital
Saitama, Saitama, 330-8553
Shimane University Hospital
Shimane, Izumo, 693-8501
Hamamatsu University Hospital
Shizuoka, Hamamatsu, 431-3192
Jichi Medical University Hospital
Tochigi, Shimotsuke, 329-0498
Tokushima University Hospital
Tokushima, Tokushima, 770-8503
Juntendo University Hospital
Tokyo, Bunkyo-ku, 113-8431
Nippon Medical School Hospital
Tokyo, Bunkyo-ku, 113-8603
Toranomon Hospital
Tokyo, Minato-ku, 105-8470
Kyorin University Hospital
Tokyo, Mitaka, 181-8611
Toho University Omori Medical Center
Tokyo, Ota-ku, 143-8541
Tokyo Medical University Hospital
Tokyo, Shinjuku-ku, 160-0023
Keio University Hospital
Tokyo, Shinjuku-ku, 160-8582
National Center for Global Health and Medicine
Tokyo, Shinjuku-ku, 162-8655
Wakayama Medical University Hospital
Wakayama, Wakayama, 641-8510
China37 sites
Beijing Chao-Yang Hospital
Beijing, 100020
China-Japan Friendship Hospital
Beijing, 100029
Peking Union Medical College Hospital
Beijing, 100730
The Second Xiangya Hospital Of Central South University
Changsha, 410011
West China Hospital, Sichuan University
Chengdu, 610041
Sichuan Provincial People's Hospital
Chengdu, 610072
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510120
NanFang Hosptial
Guangzhou, 510515
Hangzhou First People's Hospital
Hangzhou, 310006
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, 310009
Zhejiang Hospital
Hangzhou, 310013
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, 310016
Anhui Provincial Hospital
Hefei, 230001
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, 010000
The First Hospital of Jiaxing
Jiaxing, 314000
Jinhua Municipal Central Hospital
Jinhua, 321000
Nanjing Drum Tower Hospital
Nanjing, 210008
Ningbo Medical Center Lihuili Hospital
Ningbo, 315000
The First Affiliated Hospital of Ningbo University
Ningbo, 315010
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, 200025
Shanghai Chest Hospital
Shanghai, 200030
Zhongshan Hospital Affiliated to Fudan University
Shanghai, 200032
Huadong Hospital affiliated to Fudan University
Shanghai, 200040
China Shenyang Chest Hospital
Shenyang, 110000
Shenzhen People's Hospital
Shenzhen, 518020
The University of Hong Kong-Shenzhen Hospital
Shenzhen, 518053
The First Affiliated Hospital of Soochow University
Suzhou, 215006
Tianjin Medical University General Hospital
Tianjin, 30052
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430022
Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
Wuhan, 430030
Renmin Hospital of Wuhan University
Wuhan, 430060
Wuxi People's Hospital
Wuxi, 214043
Second Affiliated Hospital of medical college of Xi'an JiaoTong University
Xi'an, 710004
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, 221009
Yichang Central People's Hospital
Yichang, 443000
General Hospital of Ningxia Medical University
Yinchuan, 750004
Spain23 sites
Hospital General Universitario de Alicante
Alicante, 03010
Hospital del Mar
Barcelona, 08003
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Clínic de Barcelona
Barcelona, 08036
Hospital de Basurto
Bilbao, 48013
Hospital Universitario Virgen de la Arrixaca
El Palmar, 30120
Hospital de Galdakao
Galdakao, 48960
Hospital Universitario Virgen de las Nieves
Granada, 18014
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, 08907
Hospital Universitario De La Princesa
Madrid, 28006
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Hospital Universitario Infanta Leonor
Madrid, 28031
Hospital Universitario Ramon Y Cajal
Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Hospital Central de Asturias
Oviedo, 33011
Hospital Son Espases
Palma de Mallorca, 07120
Hospital Quirónsalud Madrid
Pozuelo de Alarcón, 28223
Hospital Universitario Marqués de Valdecilla
Santander, 39008
Hospital Clínico de Santiago
Santiago de Compostela, 15706
Hospital Virgen del Rocio
Seville, 41013
Hospital Nuestra Señora de Valme
Seville, 41014
Hospital General Universitario de Valencia
Valencia, 46014
France21 sites
HOP d'Angers
Angers, 49933
HOP Avicenne
Bobigny, 93000
HOP de la Cavale Blanche
Brest, 29200
Hopital Louis Pradel
Bron, 69677
HOP CHU Caen
Caen, 14033
HOP François Mitterrand
Dijon, 21000
HOP Michallon
La Tronche, 38700
HOP Bicêtre
Le Kremlin-Bicêtre, 94275
INS Coeur Poumon
Lille, 59037
HOP Nord
Marseille, 13915
HOP Nord Laennec
Nantes, 44093
Hopital Pasteur
Nice, 06001
HOP Paris Saint-Joseph
Paris, 75014
HOP Européen G. Pompidou
Paris, 75015
HOP Bichat
Paris, 75877
HOP Haut-Lévêque
Pessac, 33604
HOP Robert Debré
Reims, 51100
HOP Pontchaillou
Rennes, 35033
Hôpital Charles Nicolle
Rouen, 76031
HOP Foch
Suresnes, 92151
Hôpital Larrey - CHU de Toulouse
Toulouse, 31059
Germany19 sites
Velocity Clinical Research Germany GmbH, Ahrensburg
Ahrensburg, 22926
CIMS Studienzentrum Bamberg GmbH
Bamberg, 96049
Vivantes Netzwerk für Gesundheit GmbH
Berlin, 12351
Universitätsklinikum Bonn AöR
Bonn, 53127
Fachkrankenhaus Coswig GmbH
Coswig, 01640
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, 45239
Universitätsklinikum Hamburg, Eppendorf
Hamburg, 20246
Klinikum Region Hannover GmbH
Hanover, 30459
Medizinische Hochschule Hannover
Hanover, 30625
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg, 69126
Lungenklinik Hemer
Hemer, 58675
Lungenfachklinik Immenhausen
Immenhausen, 34376
Klinikum Konstanz
Konstanz, 78464
Klinikum der Universität München AÖR
München, 81377
Klinikum Nürnberg
Nuremberg, 90419
Krankenhaus Bethanien gGmbH
Solingen, 42699
Helios Hanseklinikum Stralsund
Stralsund, 18435
Robert Bosch Gesellschaft für medizinische Forschung mbH
Stuttgart, 70376
Universitätsklinikum Tübingen
Tübingen, 72076
Canada13 sites
University of Alberta Hospital (University of Alberta)
Edmonton, Alberta, T6G 1Z1
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 1Y2
Kelowna Respirology & Allergy Research
Kelowna, British Columbia, V1Y 3H5
Dr. Georges-L.-Dumont University Hospital Centre
Moncton, New Brunswick, E1C 2Z3
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, H2X 0C1
McGill University Health Centre (MUHC)
Montreal, Quebec, H4A 3J1
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
Québec, G1V 4G5
Royal University Hospital (Saskatoon)
Saskatoon, Saskatchewan, S7N 0W8
CIC Mauricie (Trois Rivieres)
Trois-Rivières, Quebec, G8T 7A1
St. Paul's Hospital (Vancouver)
Vancouver, British Columbia, V1Y 1S1
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Dr. Syed Anees Medicine Professional Corporation
Windsor, Ontario, N8X 1T3
Italy13 sites
ASST degli Spedali Civili di Brescia
Brescia, 25123
A.O.U. Policlinico Vittorio Emanuele
Catania, 95124
A. O. Universitaria Careggi
Florence, 50137
Ospedale Colonnello D Avanzo
Foggia, 71100
Ospedale G.B. Morgagni
Forlì, 47121
Ospedale San Paolo-MILANO-18793
Milan, 20100
Ospedale Classificato San Giuseppe
Milan, 20123
Azienda Ospedaliero-Universitaria di Modena
Modena, 41100
A.O. San Gerardo di Monza
Monza, 20052
Azienda Ospedaliera Universitaria di Padova
Padova, 35128
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
A.O.U. Senese
Siena, 53100
Ospedali Riuniti di Ancona
Torrette Di Ancona (Ancona), 60126
United Kingdom13 sites
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN
Queen Elizabeth Hospital Birmingham
Birmingham, B15 2GW
Southmead Hospital
Bristol, BS10 5NB
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA
Royal Devon and Exeter Hospital, Wonford
Exeter, EX2 5DW
Royal Lancaster Infirmary
Lancaster, LA1 4RP
St James's University Hospital
Leeds, LS9 7TF
Guy's Hospital
London, SE1 9RT
Royal Brompton Hospital
London, SW3 6NP
Altnagelvin Area Hospital
Londonderry, BT47 6SB
Wythenshawe Hospital
Manchester, M23 9QZ
Churchill Hospital
Oxford, OX3 7LE
Southampton General Hospital
Southampton, SO16 6YD
Australia11 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Lung Research Queensland
Chermside, Queensland, 4032
The Prince Charles Hospital
Chermside, Queensland, 4032
Canberra Hospital
Garran, Australian Capital Territory, 2605
Austin Hospital
Heidelberg, Victoria, 3084
Macquarie University
Macquarie Park, 2109
The Alfred Hospital
Melbourne, Victoria, 3004
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Trialswest
Spearwood, Western Australia, 6163
Westmead Hospital
Westmead, New South Wales, 2145
Argentina9 sites
Centro de Investigaciones Metabolicas (CINME)
C.a.b.a, 1056
Fundacion NIBA Neurologia Infantil Buenos Aires
CABA, 1182
Hospital Italiano de Buenos Aires
CABA, C1199ABD
Consultorios Medicos del Buen Ayre
Capital Federal, 1425
CEMER-Centro Medico De Enfermedades Respiratorias
Florida, B1602DQD
Instituto Ave Pulmo - Fundacion Enfisema
Mar del Plata, 7600
INSARES
Mendoza, M5500CCG
Centro Respiratorio de Quilmes
Quilmes, B1878FNR
Instituto Medico de la Fundacion Estudios Clinicos
Rosario, S2000DEJ
Brazil9 sites
Serviços Medicos Respirar Sul Fluminense
Barra Mansa, 27323240
Hospital das Clinicas da Universidade Federal de Minas Gerais (HC-UFMG)
Belo Horizonte,Minas Gerais, 31270901
SAPIENS - Instituto de Estudos e Pesquisa Clinica
Curitiba, 80810-000
CLARE - Clinica de Pneumologia
Goiânia, 74110-030
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90020-090
Hospital Nossa Senhora da Conceição
Porto Alegre - RS, 91350-250
CEMEC - Centro Multidisciplinar de Estudos Clínicos
São Bernardo do Campo, 09715-090
Hospital Alemao Oswaldo Cruz
São Paulo, 01327-001
Hospital das Clinicas da Faculdade de Medicina da USP
São Paulo, 05403-000
South Korea8 sites
The Catholic University of Korea, Bucheon St.Mary's Hospital
Bucheon-si, 14647
Seoul National University Bundang Hospital
Seongnam, 13620
Kyung Hee University Hospital
Seoul, 02447
Seoul National University Hospital
Seoul, 03080
Severance Hospital
Seoul, 03722
Soonchunhyang University Hospital Seoul
Seoul, 04401
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 135-710
Belgium7 sites
Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim
Antwerp, 2020
Hopital Erasme
Brussels, 1070
Cliniques Universitaires Saint-Luc
Brussels, 1200
Universitair Ziekenhuis Gent
Ghent, 9000
UZ Leuven
Leuven, 3000
Centre Hospitalier Universitaire de Liège
Liège, 4000
Yvoir - UNIV UCL de Mont-Godinne
Yvoir, 5530
Mexico7 sites
Centro de Investigacion Integral MEDIVEST S.C
Chihuahua City, 31203
CREPID Aire y Salud Integral
Coyoacán, 04380
Centro de Investigacion Farmacologica del Bajío, S.C.
León, 37160
Soltmed Smo
Mexico City, 03650
Centro Respiratorio de Mexico
Mexico City, 14050
Centro de Prevención y Rehabilitación de Enfermedades Pulmon
Monterrey, 64460
Oaxaca Site Management Organization, S.C.
Oaxaca City, 68000
Taiwan7 sites
Changhua Christian Hospital
Changhua, 500
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
Taichung Veterans General Hospital
Taichung, 407
NCKUH
Tainan, 704
National Taiwan University Hospital
Taipei, 100
Taipei Veterans General Hospital
Taipei, 11217
Austria6 sites
Krems University Hospital
Krems, 3500
LKH Salzburg University Hospital
Salzburg, 5020
Medical University of Vienna
Vienna, 1090
Standort Penzing der Klinik Ottakring
Vienna, 1140
Clinic Floridsdorf
Vienna, 1210
Klinikum Wels - Grieskirchen GmbH
Wels, 4600
Poland5 sites
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214
Leszek Giec Upper-Silesian Med.Cent.Silesian Med.Univ.
Katowice, 40-635
Przychodnia Alergologiczno-Pulmonologiczna Alergopneuma Sp. z o.o.
Świdnik, 21 040
Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa
Warsaw, 01-138
University Clinical Center of the Medical University of Warsaw
Warsaw, 02097
Portugal5 sites
ULS de Braga, E.P.E
Braga, 4710-243
CHUC - Centro Hospitalar e Universitario de Coimbra, EPE
Coimbra, 3004-561
ULS de São José, E.P.E.
Lisbon, 1169-024
USLM, EPE - Hospital Pedro Hispano
Matosinhos Municipality, 4454-509
Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
Vila Nova de Gaia, 4434-502
Thailand5 sites
Siriraj Hospital
Bangkok Noi, 10700
Srinagarind Hospital
Khon Kaen, 40002
Maharat Nakhonchiangmai Hospital
Muang, 50200
Ramathibodi Hospital
Ratchatewi, 10400
Songklanagarind Hospital
Songkhla, 90110
Turkey (Türkiye)5 sites
Gulhane Training and Research Hospital
Ankara, 06010
Ankara Universitesi Tip Fakultesi
Ankara, 06620
Akdeniz Universitesi Tip Fakultesi -ANTALYA-33606
Antalya, 07070
Istanbul Universitesi Istanbul Tip Fakultesi
Çapa, 34390
Gazi Universitesi Tip Fakultesi
Yenimahalle/ANKARA, 06560
Finland4 sites
HYKS Keuhkosairauksien tutkimusyksikkö
Helsinki, 00029
Oulun yliopistollinen keskussairaala
Oulu, 90220
Tampere University Hospital
Tampere, 33520
TYKS
Turku, 20520
Greece4 sites
Hospital of Heraklion (PAGNI)
Heraklion, 71110
Univ. Gen. Hosp. of Ioannina
Ioannina, 45 500
Univ. Gen. Hosp. of Patras
Pátrai, 26504
General Hospital of Thessaloniki "Hippokrateio"
Thessaloniki, 546 42
Israel4 sites
Shamir Medical Center (Assaf Harofeh)
Beer Yaakov, 7033001
Lady Davis Carmel Medical Center
Haifa, 3436212
Shaare Zedek Medical Center
Jerusalem, 9103102
Sourasky Medical Center
Tel Aviv, 6093246
Malaysia4 sites
Hospital Pulau Pinang-Pulau Pinang-21953
George Town, 10990
Hospital Sultan Idris Shah Serdang
Kajang, 43000
Institut Perubatan Respiratori
Kuala Lumpur, 53000
Sarawak General Hospital
Kuching, 93586
Netherlands4 sites
Zuyderland Medisch Centrum
HEERLENHeerlen, 6419
Leids Universitair Medisch Centrum (LUMC)
Leiden, 2333
St. Antonius Ziekenhuis
Nieuwegein, 3435 CM
Erasmus Medisch Centrum-ROTTERDAM-50697
Rotterdam, 3015
New Zealand4 sites
Waikato Hospital
Hamilton, 3204
Greenlane Clinical Centre
One Tree Hill, Auckland, 1051
Aotearoa Clinical Trials
Papatoetoe, Auckland, 2025
Tauranga Hospital
Tauranga South, 3112
Croatia3 sites
University hospital center Zagreb
Zagreb, 10000
University Hospital Dubrava
Zagreb, 10000
Solmed Polyclinic
Zagreb, 1000
Georgia3 sites
National Center for Tuberculosis and Lung Diseases, Tbilisi
Tbilisi, 0101
LLC Diacor
Tbilisi, 0159
LTD The First Medical Center
Tbilisi, 0180
Norway3 sites
Haukeland Universitetssykehus
Bergen, N-5021
Akershus Universitetssykehus HF
Nordbyhagen, 1478
Oslo Universitetssykehus HF, Rikshospitalet
Oslo, 0372
Serbia3 sites
University Clinical Center of Serbia
Belgrade, 11000
Institute for Pulmonary Diseases of Vojvodina
Kamenitz, 21204
University Clinical Center Nis
Niš, 18000
Chile2 sites
Instituto Nacional del Torax
Providencia, Santiago de Chile, 7500000
Centro de Investigacion del Maule
Talca, 3465586
Denmark2 sites
Gentofte Hospital
Hellerup, 2900
Odense University Hospital
Odense C, 5000
Hungary2 sites
Koranyi National Institute For Pulmonolgy
Budapest, 1121
University of Debrecen Clinical Centre
Debrecen, 4032
India2 sites
Bhatia Hospital
Mumbai, 400007
P.D. Hinduja National Hospital
Mumbai, 400067
Singapore2 sites
Singapore General Hospital
Singapore, 169608
Tan Tock Seng Hospital
Singapore, 308433
Sweden2 sites
Universitetssjukhuset Linköping
Linköping, 581 85
Akademiska sjukhuset
Uppsala, 75185
Saudi Arabia1 site
King Abdullah International Medical Research Center
Riyadh, 11481
Slovenia1 site
Hospital Golnik - Univ. Clinic of Pulmonary and Allergic Diseases
Golnik, 4204
About this study
Official title: An Open-label Extension Trial of the Long-term Safety and Efficacy of BI 1015550 Taken Orally in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF) (FIBRONEER™-ON)
This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called nerandomilast or BI 1015550.
The goal of this study is to find out how well people with pulmonary fibrosis tolerate long- term treatment with nerandomilast. The study also tests whether nerandomilast improves lung function and prolongs the time until symptoms get worse, participants need to go to the hospital, or die.
Read more
Every participant takes nerandomilast as tablets for up to 1 year and 10 months. The participants may also continue their regular treatment for pulmonary fibrosis during the study.
Participants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. Participants also regularly do lung function tests.
- Being tested
- Nerandomilast
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NerandomilastDrug
Also called BI 1015550, JASCAYD®
Nerandomilast
| Study group | Role | What they receive |
|---|---|---|
| BI 1015550 treatment group | Experimental | Not described Receives: Drug: Nerandomilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of any adverse event over the course of the extension trial (yes/no) i.e. up until the follow-up/end of study visit planned at the latest at week 99
Measured: Up to 99 weeks and 3 days
Secondary outcomes (8)
Absolute change from baseline in Forced vital capacity (FVC) (mL) over time
Measured: Up to 98 weeks
Absolute change from baseline in % predicted in Forced vital capacity (FVC) over time
Measured: Up to 98 weeks
Time to absolute decline in FVC % predicted of >10% from baseline over the duration of the trial
Measured: Up to 98 weeks
Time to first acute Idiopathic Pulmonary Fibrosis/Progressive Pulmonary Fibrosis (IPF/PPF) exacerbation, first hospitalisation for respiratory cause, or death (whichever occurs first) over the duration of the trial
Measured: Up to 98 weeks
Time to first acute Idiopathic Pulmonary Fibrosis/Progressive Pulmonary Fibrosis (IPF/PPF) exacerbation or death over the duration of the trial
Measured: Up to 98 weeks
Time to hospitalisation for respiratory cause or death over the duration of the trial
Measured: Up to 98 weeks
Time to absolute decline in Forced vital capacity (FVC) % predicted of >10% from baseline or death over the duration of the trial
Measured: Up to 98 weeks
Time to relative decline in Forced vital capacity (FVC) % predicted of >10% from baseline or death over the duration of the trial
Measured: Up to 98 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start26 Sep 2024
- Primary completion28 Apr 2027 (estimated)
- Study completion7 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,666 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238622
- Sponsor's protocol ID
- 1305-0031
- Other IDs
- 2023-507353-15-00, 2023
- Acronym
- FIBRONEER™-ON
- Status last verified
- Oct 2026
- First submitted
- 25 Jan 2024
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Publications
Wuyts WA, Richeldi L, Assassi S, Azuma A, Cottin V, Hoffmann-Vold AM, Kreuter M, Oldham JM, Martinez FJ, Valenzuela C, Wijsenbeek MS, Kanakapura M, James A, Weimann G, Drzewuski C, Coeck C, Maher TM. Design of an open-label extension trial of nerandomilast (BI 1015550) in patients with idiopathic pulmonary fibrosis and progressive pulmonary fibrosis (FIBRONEER-ON). BMC Pulm Med. 2025 Dec 4;26(1):10. doi: 10.1186/s12890-025-03973-7.
PubMed 41345848