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
FIBRONEER™-ON
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)
3 other identifiers
interventional
1,666
41 countries
337
Brief 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. 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2024
Typical duration for phase_3
337 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2024
CompletedFirst Posted
Study publicly available on registry
February 2, 2024
CompletedStudy Start
First participant enrolled
May 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 7, 2027
September 30, 2026
September 1, 2026
3 years
January 25, 2024
September 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Up to 99 weeks and 3 days
Secondary Outcomes (8)
Absolute change from baseline in Forced vital capacity (FVC) (mL) over time
Up to 98 weeks
Absolute change from baseline in % predicted in Forced vital capacity (FVC) over time
Up to 98 weeks
Time to absolute decline in FVC % predicted of >10% from baseline over the duration of the trial
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
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
Up to 98 weeks
- +3 more secondary outcomes
Study Arms (1)
BI 1015550 treatment group
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (373)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
University of Arizona
Tucson, Arizona, 85724, United States
University of Southern California
Los Angeles, California, 90033, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
University of California Los Angeles
Los Angeles, California, 90095, United States
University of California Davis
Sacramento, California, 95817, United States
National Jewish Health
Denver, Colorado, 80206, United States
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
Christiana Hospital
Newark, Delaware, 19713, United States
Georgetown University
Washington D.C., District of Columbia, 20007, United States
St. Francis Medical Institute
Clearwater, Florida, 33765, United States
University of Florida
Gainesville, Florida, 32610, United States
Clinical Research Specialists LLC - Kissimmee
Kissimmee, Florida, 34746, United States
Advanced Pulmonary Research Institute
Loxahatchee Groves, Florida, 33470, United States
Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead
Atlanta, Georgia, 30309, United States
The Emory Clinic
Atlanta, Georgia, 30322, United States
Northshore University Health System
Evanston, Illinois, 60201, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Tulane Medical Center
New Orleans, Louisiana, 70112, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21224, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
St. Elizabeth's Medical Center
Boston, Massachusetts, 02135, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic, Rochester
Rochester, Minnesota, 55905, United States
The Lung Research Center, LLC
Chesterfield, Missouri, 63017, United States
Creighton University
Omaha, Nebraska, 68124, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Northern Westchester Hospital
Mount Kisco, New York, 10549, United States
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, 10032, United States
NewYork-Presbyterian/Weill Cornell Medical Center
New York, New York, 10065, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Southeastern Research Center-Winston Salem-69289
Winston-Salem, North Carolina, 27103, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
The Oregon Clinic
Portland, Oregon, 97220, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Infinity Medical Research, Inc.
East Providence, Rhode Island, 02914, United States
Lowcountry Lung and Critical Care
Charleston, South Carolina, 29406, United States
Clinical Trials Center of Middle Tennessee, LLC
Franklin, Tennessee, 37067, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37204, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
UT Health San Antonio
San Antonio, Texas, 78229, United States
Renovatio Clinical-The Woodlands-69551
The Woodlands, Texas, 77380, United States
Intermountain Medical Center-Murray-69497
Murray, Utah, 84107, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, 84108, United States
University of Vermont
Burlington, Vermont, 05401, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Centro de Investigaciones Metabolicas (CINME)
C.a.b.a, 1056, Argentina
Fundacion NIBA Neurologia Infantil Buenos Aires
CABA, 1182, Argentina
Hospital Italiano de Buenos Aires
CABA, C1199ABD, Argentina
Consultorios Medicos del Buen Ayre
Capital Federal, 1425, Argentina
CEMER-Centro Medico De Enfermedades Respiratorias
Florida, B1602DQD, Argentina
Instituto Ave Pulmo - Fundacion Enfisema
Mar del Plata, 7600, Argentina
INSARES
Mendoza, M5500CCG, Argentina
Centro Respiratorio de Quilmes
Quilmes, B1878FNR, Argentina
Instituto Medico de la Fundacion Estudios Clinicos
Rosario, S2000DEJ, Argentina
Canberra Hospital
Garran, Australian Capital Territory, 2605, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Lung Research Queensland
Chermside, Queensland, 4032, Australia
The Prince Charles Hospital
Chermside, Queensland, 4032, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Austin Hospital
Heidelberg, Victoria, 3084, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Trialswest
Spearwood, Western Australia, 6163, Australia
Macquarie University
Macquarie Park, 2109, Australia
Krems University Hospital
Krems, 3500, Austria
LKH Salzburg University Hospital
Salzburg, 5020, Austria
Medical University of Vienna
Vienna, 1090, Austria
Standort Penzing der Klinik Ottakring
Vienna, 1140, Austria
Clinic Floridsdorf
Vienna, 1210, Austria
Klinikum Wels - Grieskirchen GmbH
Wels, 4600, Austria
Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim
Antwerp, 2020, Belgium
Hopital Erasme
Brussels, 1070, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
UZ Leuven
Leuven, 3000, Belgium
Centre Hospitalier Universitaire de Liège
Liège, 4000, Belgium
Yvoir - UNIV UCL de Mont-Godinne
Yvoir, 5530, Belgium
Serviços Medicos Respirar Sul Fluminense
Barra Mansa, 27323240, Brazil
Hospital das Clinicas da Universidade Federal de Minas Gerais (HC-UFMG)
Belo Horizonte,Minas Gerais, 31270901, Brazil
SAPIENS - Instituto de Estudos e Pesquisa Clinica
Curitiba, 80810-000, Brazil
CLARE - Clinica de Pneumologia
Goiânia, 74110-030, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90020-090, Brazil
Hospital Nossa Senhora da Conceição
Porto Alegre - RS, 91350-250, Brazil
CEMEC - Centro Multidisciplinar de Estudos Clínicos
São Bernardo do Campo, 09715-090, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, 01327-001, Brazil
Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, 05403-000, Brazil
University of Alberta Hospital (University of Alberta)
Edmonton, Alberta, T6G 1Z1, Canada
Kelowna Respirology & Allergy Research
Kelowna, British Columbia, V1Y 3H5, Canada
St. Paul's Hospital (Vancouver)
Vancouver, British Columbia, V1Y 1S1, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
Dr. Georges-L.-Dumont University Hospital Centre
Moncton, New Brunswick, E1C 2Z3, Canada
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 1Y2, Canada
Dr. Syed Anees Medicine Professional Corporation
Windsor, Ontario, N8X 1T3, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, H2X 0C1, Canada
McGill University Health Centre (MUHC)
Montreal, Quebec, H4A 3J1, Canada
CIC Mauricie (Trois Rivieres)
Trois-Rivières, Quebec, G8T 7A1, Canada
Royal University Hospital (Saskatoon)
Saskatoon, Saskatchewan, S7N 0W8, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
Québec, G1V 4G5, Canada
Instituto Nacional del Torax
Providencia, Santiago de Chile, 7500000, Chile
Centro de Investigacion del Maule
Talca, 3465586, Chile
Beijing Chao-Yang Hospital
Beijing, 100020, China
China-Japan Friendship Hospital
Beijing, 100029, China
Peking Union Medical College Hospital
Beijing, 100730, China
The Second Xiangya Hospital Of Central South University
Changsha, 410011, China
West China Hospital, Sichuan University
Chengdu, 610041, China
Sichuan Provincial People's Hospital
Chengdu, 610072, China
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510120, China
NanFang Hosptial
Guangzhou, 510515, China
Hangzhou First People's Hospital
Hangzhou, 310006, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, 310009, China
Zhejiang Hospital
Hangzhou, 310013, China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, 310016, China
Anhui Provincial Hospital
Hefei, 230001, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, 010000, China
The First Hospital of Jiaxing
Jiaxing, 314000, China
Jinhua Municipal Central Hospital
Jinhua, 321000, China
Nanjing Drum Tower Hospital
Nanjing, 210008, China
Ningbo Medical Center Lihuili Hospital
Ningbo, 315000, China
The First Affiliated Hospital of Ningbo University
Ningbo, 315010, China
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, 200025, China
Shanghai Chest Hospital
Shanghai, 200030, China
Zhongshan Hospital Affiliated to Fudan University
Shanghai, 200032, China
Huadong Hospital affiliated to Fudan University
Shanghai, 200040, China
China Shenyang Chest Hospital
Shenyang, 110000, China
Shenzhen People's Hospital
Shenzhen, 518020, China
The University of Hong Kong-Shenzhen Hospital
Shenzhen, 518053, China
The First Affiliated Hospital of Soochow University
Suzhou, 215006, China
Tianjin Medical University General Hospital
Tianjin, 30052, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430022, China
Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
Wuhan, 430030, China
Renmin Hospital of Wuhan University
Wuhan, 430060, China
Wuxi People's Hospital
Wuxi, 214043, China
Second Affiliated Hospital of medical college of Xi'an JiaoTong University
Xi'an, 710004, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, 221009, China
Yichang Central People's Hospital
Yichang, 443000, China
General Hospital of Ningxia Medical University
Yinchuan, 750004, China
University hospital center Zagreb
Zagreb, 10000, Croatia
University Hospital Dubrava
Zagreb, 10000, Croatia
Solmed Polyclinic
Zagreb, 1000, Croatia
University Thomayer´s Hospital
Prague, 140 59, Czechia
Gentofte Hospital
Hellerup, 2900, Denmark
Odense University Hospital
Odense C, 5000, Denmark
North Estonia Medical Centre Foundation, Tallinn
Tallinn, 13419, Estonia
HYKS Keuhkosairauksien tutkimusyksikkö
Helsinki, 00029, Finland
Oulun yliopistollinen keskussairaala
Oulu, 90220, Finland
Tampere University Hospital
Tampere, 33520, Finland
TYKS
Turku, 20520, Finland
HOP d'Angers
Angers, 49933, France
HOP Avicenne
Bobigny, 93000, France
HOP de la Cavale Blanche
Brest, 29200, France
Hopital Louis Pradel
Bron, 69677, France
HOP CHU Caen
Caen, 14033, France
HOP François Mitterrand
Dijon, 21000, France
HOP Michallon
La Tronche, 38700, France
HOP Bicêtre
Le Kremlin-Bicêtre, 94275, France
INS Coeur Poumon
Lille, 59037, France
HOP Nord
Marseille, 13915, France
HOP Nord Laennec
Nantes, 44093, France
Hopital Pasteur
Nice, 06001, France
HOP Paris Saint-Joseph
Paris, 75014, France
HOP Européen G. Pompidou
Paris, 75015, France
HOP Bichat
Paris, 75877, France
HOP Haut-Lévêque
Pessac, 33604, France
HOP Robert Debré
Reims, 51100, France
HOP Pontchaillou
Rennes, 35033, France
Hôpital Charles Nicolle
Rouen, 76031, France
HOP Foch
Suresnes, 92151, France
Hôpital Larrey - CHU de Toulouse
Toulouse, 31059, France
National Center for Tuberculosis and Lung Diseases, Tbilisi
Tbilisi, 0101, Georgia
LLC Diacor
Tbilisi, 0159, Georgia
LTD The First Medical Center
Tbilisi, 0180, Georgia
Velocity Clinical Research Germany GmbH, Ahrensburg
Ahrensburg, 22926, Germany
CIMS Studienzentrum Bamberg GmbH
Bamberg, 96049, Germany
Vivantes Netzwerk für Gesundheit GmbH
Berlin, 12351, Germany
Universitätsklinikum Bonn AöR
Bonn, 53127, Germany
Fachkrankenhaus Coswig GmbH
Coswig, 01640, Germany
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, 45239, Germany
Universitätsklinikum Hamburg, Eppendorf
Hamburg, 20246, Germany
Klinikum Region Hannover GmbH
Hanover, 30459, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg, 69126, Germany
Lungenklinik Hemer
Hemer, 58675, Germany
Lungenfachklinik Immenhausen
Immenhausen, 34376, Germany
Klinikum Konstanz
Konstanz, 78464, Germany
Klinikum der Universität München AÖR
München, 81377, Germany
Klinikum Nürnberg
Nuremberg, 90419, Germany
Krankenhaus Bethanien gGmbH
Solingen, 42699, Germany
Helios Hanseklinikum Stralsund
Stralsund, 18435, Germany
Robert Bosch Gesellschaft für medizinische Forschung mbH
Stuttgart, 70376, Germany
Universitätsklinikum Tübingen
Tübingen, 72076, Germany
Hospital of Heraklion (PAGNI)
Heraklion, 71110, Greece
Univ. Gen. Hosp. of Ioannina
Ioannina, 45 500, Greece
Univ. Gen. Hosp. of Patras
Pátrai, 26504, Greece
General Hospital of Thessaloniki "Hippokrateio"
Thessaloniki, 546 42, Greece
Koranyi National Institute For Pulmonolgy
Budapest, 1121, Hungary
University of Debrecen Clinical Centre
Debrecen, 4032, Hungary
Bhatia Hospital
Mumbai, 400007, India
P.D. Hinduja National Hospital
Mumbai, 400067, India
Connolly Hospital Blanchardstown
Dublin, D15 X40D, Ireland
Shamir Medical Center (Assaf Harofeh)
Beer Yaakov, 7033001, Israel
Lady Davis Carmel Medical Center
Haifa, 3436212, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Sourasky Medical Center
Tel Aviv, 6093246, Israel
ASST degli Spedali Civili di Brescia
Brescia, 25123, Italy
A.O.U. Policlinico Vittorio Emanuele
Catania, 95124, Italy
A. O. Universitaria Careggi
Florence, 50137, Italy
Ospedale Colonnello D Avanzo
Foggia, 71100, Italy
Ospedale G.B. Morgagni
Forlì, 47121, Italy
Ospedale San Paolo-MILANO-18793
Milan, 20100, Italy
Ospedale Classificato San Giuseppe
Milan, 20123, Italy
Azienda Ospedaliero-Universitaria di Modena
Modena, 41100, Italy
A.O. San Gerardo di Monza
Monza, 20052, Italy
Azienda Ospedaliera Universitaria di Padova
Padova, 35128, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168, Italy
A.O.U. Senese
Siena, 53100, Italy
Ospedali Riuniti di Ancona
Torrette Di Ancona (Ancona), 60126, Italy
Tosei General Hospital
Aichi, Seto, 489-8642, Japan
Chiba University Hospital
Chiba, Chiba, 260-8677, Japan
University of Fukui Hospital
Fukui, Yoshida-gun, 910-1193, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, Fukuoka, 810-8563, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582, Japan
Aso Co.,Ltd Iizuka Hospital
Fukuoka, Iizuka, 820-8505, Japan
Hospital of the University of Occupational and Environmental Health
Fukuoka, Kitakyushu, 807-8556, Japan
Kurume University Hospital
Fukuoka, Kurume, 830-0011, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, 960-1295, Japan
Tsuboi Hospital
Fukushima, Koriyama, 963-0197, Japan
Hiroshima Prefectural Hospital
Hiroshima, Hiroshima, 734-8530, Japan
Sapporo Medical University Hospital
Hokkaido, Sapporo, 060-8543, Japan
Hokkaido University Hospital
Hokkaido, Sapporo, 060-8648, Japan
National Hospital Organization Himeji Medical Center
Hyogo, Himeji, 670-8520, Japan
Kobe City Medical Center General Hospital
Hyogo, Kobe, 650-0047, Japan
Kobe City Hospital Organization Kobe City Medical Center West Hospital
Hyogo, Kobe, 653-0013, Japan
Kagawa University Hospital
Kagawa, Kita-gun, 761-0793, Japan
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, Yokohama, 236-0051, Japan
Saiseikai Kumamoto Hospital
Kumamoto, Kumamoto, 861-4193, Japan
Tohoku University Hospital
Miyagi, Sendai, 980-8574, Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, 852-8501, Japan
Kindai University Hospital
Osaka, Sakai, 590-0197, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Osaka, Sakai, 591-8555, Japan
Osaka Medical and Pharmaceutical University Hospital
Osaka, Takatsuki, 569-8686, Japan
Saitama Red Cross Hospital
Saitama, Saitama, 330-8553, Japan
Shimane University Hospital
Shimane, Izumo, 693-8501, Japan
Hamamatsu University Hospital
Shizuoka, Hamamatsu, 431-3192, Japan
Jichi Medical University Hospital
Tochigi, Shimotsuke, 329-0498, Japan
Tokushima University Hospital
Tokushima, Tokushima, 770-8503, Japan
Juntendo University Hospital
Tokyo, Bunkyo-ku, 113-8431, Japan
Nippon Medical School Hospital
Tokyo, Bunkyo-ku, 113-8603, Japan
Toranomon Hospital
Tokyo, Minato-ku, 105-8470, Japan
Kyorin University Hospital
Tokyo, Mitaka, 181-8611, Japan
Toho University Omori Medical Center
Tokyo, Ota-ku, 143-8541, Japan
Tokyo Medical University Hospital
Tokyo, Shinjuku-ku, 160-0023, Japan
Keio University Hospital
Tokyo, Shinjuku-ku, 160-8582, Japan
National Center for Global Health and Medicine
Tokyo, Shinjuku-ku, 162-8655, Japan
Wakayama Medical University Hospital
Wakayama, Wakayama, 641-8510, Japan
Hospital Pulau Pinang-Pulau Pinang-21953
George Town, 10990, Malaysia
Hospital Sultan Idris Shah Serdang
Kajang, 43000, Malaysia
Institut Perubatan Respiratori
Kuala Lumpur, 53000, Malaysia
Sarawak General Hospital
Kuching, 93586, Malaysia
Centro de Investigacion Integral MEDIVEST S.C
Chihuahua City, 31203, Mexico
CREPID Aire y Salud Integral
Coyoacán, 04380, Mexico
Centro de Investigacion Farmacologica del Bajío, S.C.
León, 37160, Mexico
Soltmed Smo
Mexico City, 03650, Mexico
Centro Respiratorio de Mexico
Mexico City, 14050, Mexico
Centro de Prevención y Rehabilitación de Enfermedades Pulmon
Monterrey, 64460, Mexico
Oaxaca Site Management Organization, S.C.
Oaxaca City, 68000, Mexico
Zuyderland Medisch Centrum
HEERLENHeerlen, 6419, Netherlands
Leids Universitair Medisch Centrum (LUMC)
Leiden, 2333, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, 3435 CM, Netherlands
Erasmus Medisch Centrum-ROTTERDAM-50697
Rotterdam, 3015, Netherlands
Aotearoa Clinical Trials
Papatoetoe, Auckland, 2025, New Zealand
Waikato Hospital
Hamilton, 3204, New Zealand
Greenlane Clinical Centre
One Tree Hill, Auckland, 1051, New Zealand
Tauranga Hospital
Tauranga South, 3112, New Zealand
Haukeland Universitetssykehus
Bergen, N-5021, Norway
Akershus Universitetssykehus HF
Nordbyhagen, 1478, Norway
Oslo Universitetssykehus HF, Rikshospitalet
Oslo, 0372, Norway
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214, Poland
Leszek Giec Upper-Silesian Med.Cent.Silesian Med.Univ.
Katowice, 40-635, Poland
Przychodnia Alergologiczno-Pulmonologiczna Alergopneuma Sp. z o.o.
Świdnik, 21 040, Poland
Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa
Warsaw, 01-138, Poland
University Clinical Center of the Medical University of Warsaw
Warsaw, 02097, Poland
ULS de Braga, E.P.E
Braga, 4710-243, Portugal
CHUC - Centro Hospitalar e Universitario de Coimbra, EPE
Coimbra, 3004-561, Portugal
ULS de São José, E.P.E.
Lisbon, 1169-024, Portugal
USLM, EPE - Hospital Pedro Hispano
Matosinhos Municipality, 4454-509, Portugal
Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
Vila Nova de Gaia, 4434-502, Portugal
King Abdullah International Medical Research Center
Riyadh, 11481, Saudi Arabia
University Clinical Center of Serbia
Belgrade, 11000, Serbia
Institute for Pulmonary Diseases of Vojvodina
Kamenitz, 21204, Serbia
University Clinical Center Nis
Niš, 18000, Serbia
Singapore General Hospital
Singapore, 169608, Singapore
Tan Tock Seng Hospital
Singapore, 308433, Singapore
Hospital Golnik - Univ. Clinic of Pulmonary and Allergic Diseases
Golnik, 4204, Slovenia
Enhancing Care Foundation NPC
Mount Edgecombe, 4301, South Africa
The Catholic University of Korea, Bucheon St.Mary's Hospital
Bucheon-si, 14647, South Korea
Seoul National University Bundang Hospital
Seongnam, 13620, South Korea
Kyung Hee University Hospital
Seoul, 02447, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital
Seoul, 03722, South Korea
Soonchunhyang University Hospital Seoul
Seoul, 04401, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
Hospital General Universitario de Alicante
Alicante, 03010, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clínic de Barcelona
Barcelona, 08036, Spain
Hospital de Basurto
Bilbao, 48013, Spain
Hospital Universitario Virgen de la Arrixaca
El Palmar, 30120, Spain
Hospital de Galdakao
Galdakao, 48960, Spain
Hospital Universitario Virgen de las Nieves
Granada, 18014, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, 08907, Spain
Hospital Universitario De La Princesa
Madrid, 28006, Spain
Hospital General Universitario Gregorio Marañón
Madrid, 28007, Spain
Hospital Universitario Infanta Leonor
Madrid, 28031, Spain
Hospital Universitario Ramon Y Cajal
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario Virgen de la Victoria
Málaga, 29010, Spain
Hospital Central de Asturias
Oviedo, 33011, Spain
Hospital Son Espases
Palma de Mallorca, 07120, Spain
Hospital Quirónsalud Madrid
Pozuelo de Alarcón, 28223, Spain
Hospital Universitario Marqués de Valdecilla
Santander, 39008, Spain
Hospital Clínico de Santiago
Santiago de Compostela, 15706, Spain
Hospital Virgen del Rocio
Seville, 41013, Spain
Hospital Nuestra Señora de Valme
Seville, 41014, Spain
Hospital General Universitario de Valencia
Valencia, 46014, Spain
Universitetssjukhuset Linköping
Linköping, 581 85, Sweden
Akademiska sjukhuset
Uppsala, 75185, Sweden
Universitätsspital Basel
Basel, 4031, Switzerland
Changhua Christian Hospital
Changhua, 500, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301, Taiwan
Taichung Veterans General Hospital
Taichung, 407, Taiwan
NCKUH
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Siriraj Hospital
Bangkok Noi, 10700, Thailand
Srinagarind Hospital
Khon Kaen, 40002, Thailand
Maharat Nakhonchiangmai Hospital
Muang, 50200, Thailand
Ramathibodi Hospital
Ratchatewi, 10400, Thailand
Songklanagarind Hospital
Songkhla, 90110, Thailand
Gulhane Training and Research Hospital
Ankara, 06010, Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi
Ankara, 06620, Turkey (Türkiye)
Akdeniz Universitesi Tip Fakultesi -ANTALYA-33606
Antalya, 07070, Turkey (Türkiye)
Istanbul Universitesi Istanbul Tip Fakultesi
Çapa, 34390, Turkey (Türkiye)
Gazi Universitesi Tip Fakultesi
Yenimahalle/ANKARA, 06560, Turkey (Türkiye)
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN, United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham, B15 2GW, United Kingdom
Southmead Hospital
Bristol, BS10 5NB, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA, United Kingdom
Royal Devon and Exeter Hospital, Wonford
Exeter, EX2 5DW, United Kingdom
Royal Lancaster Infirmary
Lancaster, LA1 4RP, United Kingdom
St James's University Hospital
Leeds, LS9 7TF, United Kingdom
Guy's Hospital
London, SE1 9RT, United Kingdom
Royal Brompton Hospital
London, SW3 6NP, United Kingdom
Altnagelvin Area Hospital
Londonderry, BT47 6SB, United Kingdom
Wythenshawe Hospital
Manchester, M23 9QZ, United Kingdom
Churchill Hospital
Oxford, OX3 7LE, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
Related Publications (1)
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.
PMID: 41345848DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2024
First Posted
February 2, 2024
Study Start
May 6, 2024
Primary Completion (Estimated)
April 28, 2027
Study Completion (Estimated)
May 7, 2027
Last Updated
September 30, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
- Access Criteria
- For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
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.