A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)
A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of BI 1015550 Over at Least 52 Weeks in Patients With Idiopathic Pulmonary Fibrosis (IPF)
2 other identifiers
interventional
1,177
35 countries
326
Brief Summary
This study is open to adults with a lung disease called Idiopathic Pulmonary Fibrosis (IPF). People can join the study if they are 40 years or older. If they already take nintedanib or pirfenidone for their IPF, they can continue treatment throughout the study. The purpose of this study is to find out whether a medicine called BI 1015550 helps people with IPF. Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of BI 1015550 as tablets twice a day. Participants in the placebo group take placebo tablets twice a day. Placebo tablets look like BI 1015550 tablets but do not contain any medicine. Participants are in the study for up to two and a half years. During the first year, they visit the study site 10 times. Afterwards, they visit the study site every 3 months. The doctors regularly test participants' lung function. The results of the lung function tests are compared between the groups. The doctors also regularly check participants' health and take note of any unwanted effects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2022
326 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
April 4, 2022
CompletedFirst Posted
Study publicly available on registry
April 11, 2022
CompletedStudy Start
First participant enrolled
October 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 16, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 17, 2024
CompletedResults Posted
Study results publicly available
September 12, 2025
CompletedOctober 20, 2025
October 1, 2025
1.9 years
April 4, 2022
August 13, 2025
October 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Absolute Change From Baseline in Forced Vital Capacity (FVC) [mL] at Week 52
The absolute change from baseline in Forced Vital Capacity (FVC) \[mL\] at Week 52 is reported. The absolute change from baseline in forced vital capacity (FVC) at Week 52 was analyzed using a restricted maximum likelihood (REML)-based mixed model with repeated measures (MMRM). The model included fixed categorical effects of treatment and baseline antifibrotic use at each visit, as well as the continuous effect of baseline FVC. Visit was treated as a repeated measure, with an unstructured covariance structure for within-patient variability.
The MMRM model is a longitudinal analysis, and it incorporated FVC measurements from baseline (Week -8 to Week -1) and Week 2, Week 6, Week 12, Week 18, Week 26, Week 36, Week 44 and Week 52. The data represent the Least Squares Mean at Week 52
Secondary Outcomes (11)
Key Secondary Endpoint: Time to the First Occurrence of Any of the Components of the Composite Endpoint: Time to First Acute IPF Exacerbation, First Hospitalization for Respiratory Cause, or Death (Whichever Occurs First) Over the Duration of the Trial
From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months.
Time to First Acute IPF Exacerbation or Death Over the Duration of the Trial
From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months.
Time to Hospitalization for Respiratory Cause or Death Over the Duration of the Trial
From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months.
Time to Absolute Decline in Forced Vital Capacity (FVC) % Predicted of >10% From Baseline or Death Over the Duration of the Trial
From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months.
Time to Absolute Decline in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) Percentage Predicted by More Than 15% From Baseline or Death, Measured Over the Duration of the Trial
From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months.
- +6 more secondary outcomes
Study Arms (3)
Nerandomilast 9 mg BID
EXPERIMENTALParticipants received 9 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.
Nerandomilast 18 mg BID
EXPERIMENTALParticipants received 18 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.
Placebo
PLACEBO COMPARATORParticipants received placebo matching 9 mg or 18 mg nerandomilast film-coated tablets orally twice daily, with doses given at least 12 hours apart and each taken with 250 mL of water.
Interventions
Participants received film-coated nerandomilast tablets orally twice daily at doses of either 9 mg or 18 mg, with each dose administered at least 12 hours apart and taken with 250 mL of water.
Participants received placebo matching 9 mg or 18 mg nerandomilast film-coated tablets orally twice daily, with doses given at least 12 hours apart and each taken with 250 mL of water.
Eligibility Criteria
You may qualify if:
- Patients ≥40 years old at the time of signed informed consent.
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- Diagnosis of Idiopathic Pulmonary Fibrosis (IPF).
- Patients may be either:
- on a stable therapy\* with nintedanib or pirfenidone for at least 12 weeks prior to Visit 1 and during screening and are planning to stay on this background treatment after randomization. Combination of nintedanib plus pirfenidone is not allowed. (\*stable therapy is defined as the individually and general tolerated regimen of either nintedanib or pirfenidone (no dose changes) for at least 12 weeks).
- not on a treatment with nintedanib or pirfenidone for at least 8 weeks prior to Visit 1 and during the screening period (e.g. either Antifibrotic (AF)-treatment naïve or previously discontinued) and do not plan to start or re-start antifibrotic treatment.
- Forced Vital Capacity (FVC) ≥45% of predicted normal at Visit 1.
- Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) ≥25% of predicted normal corrected for hemoglobin (Hb) at Visit 1.
- Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control. WOCBP taking oral contraceptives (OCs) also have to use one barrier method.
You may not qualify if:
- Prebronchodilator Forced Expiratory Volume in 1 second (FEV1)/Forced vital capacity (FVC) \<0.7 at Visit 1.
- In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
- Acute Idiopathic Pulmonary Fibrosis (IPF) exacerbation within 3 months prior to Visit 1 and/or during the screening period (investigator-determined).
- Relevant chronic or acute infections including human immunodeficiency virus (HIV) and viral hepatitis.
- Confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) not fully recovered according to investigator judgement within the 4 weeks prior to randomization (Visit 2).
- Major surgery (major according to the investigator's assessment) performed within 6 weeks prior to Visit 2 or planned during the trial period, e.g. hip replacement. Registration on lung transplantation list would not be considered as planned major surgery.
- Any documented active or suspected malignancy or history of malignancy within 5 years prior to Visit 1, except appropriately treated basal cell carcinoma of the skin, in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
- Aspartate aminotransferase (AST) or Alanine Aminotransferase (ALT) \>2.5 x Upper limit of normal (ULN) or total Bilirubin \>1.5 x ULN at Visit 1.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (334)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, 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 Health Shands Hospital
Gainesville, Florida, 32610, United States
Clinical Research Specialists LLC
Kissimmee, Florida, 34746, United States
Advanced Pulmonary Research Institute
Loxahatchee Groves, Florida, 33470, United States
Destin Pulmonary Critical Care
Santa Rosa Beach, Florida, 32459, United States
Piedmont Healthcare-Atlanta-57055
Atlanta, Georgia, 30309, United States
Evanston Hospital Pulmonary Clinic
Evanston, Illinois, 60201, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Louisville Pulmonary Care
Louisville, Kentucky, 40207, United States
Tulane University Hospital and Clinic
New Orleans, Louisiana, 70112, 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
Infinity Medical Research
North Dartmouth, Massachusetts, 02747, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109-5314, United States
Beaumont Health
Royal Oak, Michigan, 48073, United States
Minnesota Lung Center and Sleep Institute
Edina, Minnesota, 55435, 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
Washington University School of Medicine
St Louis, Missouri, 63110, 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
Weill Cornell Medicine-New York-59955
New York, New York, 10065, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Southeastern Research Center-Winston-Salem-61365
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
Jefferson Health Honickman Center
Philadelphia, Pennsylvania, 19107, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, 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 - Vanderbilt Lung Institute at 100 Oaks
Nashville, Tennessee, 37204, United States
Premier Pulmonary Critical Care and Sleep Medicine
Denison, Texas, 75020, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
UT Health San Antonio
San Antonio, Texas, 78229, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, 84108, 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-61553
C.a.b.a, 1056, Argentina
CEDIC - Centro de Investigacion Clinica
CABA, C1060ABN, Argentina
Hospital Italiano de Buenos Aires
CABA, C1199ABB, Argentina
Consultorios Médicos del Buen Ayre
Capital Federal, C1425FVH, Argentina
Instituto Ave Pulmo
Mar del Plata, 7600, Argentina
INSARES
Mendoza, M5500CCG, Argentina
Centro Respiratorio de Quilmes
Quilmes, B1878FNR, Argentina
Canberra Hospital
Canberra, 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
Mater Hospital Brisbane
South Brisbane, Queensland, 4101, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Lung Research Victoria
Footscray, Victoria, 3011, 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
LKH Klagenfurt am Woerthersee
Klagenfurt, 9020, Austria
Krems University Hospital
Krems, 3500, Austria
Hospital Elisabethinen Linz
Linz, Austria
LKH Salzburg University Hospital
Salzburg, 5020, Austria
AKH - Medical University of Vienna
Vienna, 1090, Austria
Clinic Floridsdorf
Vienna, 1210, Austria
Klinikum Wels - Grieskirchen GmbH
Wels, 4600, Austria
Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim
Antwerp, 2020, Belgium
ULB Hopital Erasme
Brussels, 1070, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
UNIV UZ 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 (HCUFMG)
Belo Horizonte,Minas Gerais, 31270901, Brazil
Edumed - Educacao e Saude SA
Curitiba, 80440-210, Brazil
CLARE - Clinica de Pneumologia
Goiânia, 74110-030, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, 90035-074, Brazil
Instituto D´Or de Pesquisa e Ensino - Bahia
Salvador, 41920-900, Brazil
CEMEC - Centro Multidisciplinar de Estudos Clínicos
São Bernardo do Campo, 09780-000, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, 01323-020, Brazil
University of Alberta Hospital (University of Alberta)
Edmonton, Alberta, T6G 2G3, Canada
Kelowna Respirology & Allergy Research
Kelowna, British Columbia, V1Y 3H5, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
St. Paul's Hospital (Vancouver)
Vancouver, British Columbia, V6Z 1Y6, 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 4A6, Canada
Dr. Syed Anees Medicine Professional Corporation
Windsor, Ontario, N8X 1T3, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, H2X 0A9, Canada
McGill University Health Centre (MUHC)
Montreal, Quebec, H4A 3J1, Canada
CIC Mauricie Inc.
Trois-Rivières, Quebec, G8T 7A1, Canada
IUCPQ (Laval University)
Québec, G1V 4G5, Canada
Instituto Nacional del Tórax
Providencia, Santiago de Chile, 7500691, Chile
Centro de Investigación del Maule
Talca, 3465586, Chile
China-Japan Friendship Hospital
Beijing, 100029, China
Peking Union Medical College Hospital
Beijing, 100730, China
Chinese PLA General Hospital
Beijing, 100853, China
The Second Xiangya Hospital Of Central South University
Changsha, 410011, China
West China Hospital of Sichuan University
Chengdu, 610041, 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
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, 310018, China
Anhui Provincial Hospital
Hefei, 230001, China
The First hospital of Jiaxing
Jiaxing, 314000, China
Jinhua Municipal Central Hospital
Jinhua, 321000, China
Nanjing Drum Tower Hospital
Nanjing, 210008, 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
Shanghai Pulmonary Hospital
Shanghai, 200433, 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
People's Hospital of Sichuan Province
Sichuan, 610031, China
The First Affiliated Hospital of Soochow University
Suzhou, 215006, China
Tianjin Medical University General Hospital
Tianjin, 30052, China
Wuhan Union Hospital
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 Xi'an JiaoTong University
Xi'an, 710004, China
Affiliated Hospital, Xuzhou Medical college
Xuzhou, 221006, China
Yichang Central People's Hospital
Yichang, 443000, China
University Hospital Dubrava
Zagreb, 10000, Croatia
Aarhus University Hospital
Aarhus N, 8200, Denmark
Herlev and Gentofte Hospital
Hellerup, 2900, Denmark
Odense University Hospital
Odense, 5000, Denmark
North Estonia Medical Centre Foundation, Tallinn
Tallinn, 13419, Estonia
HYKS Keuhkosairauksien tutkimusyksikkö
Helsinki, 000290, Finland
Oulun yliopistollinen keskussairaala
Oulu, 90220, Finland
HOP d'Angers
Angers, 49 933, France
HOP Avicenne
Bobigny, 93000, France
HOP de la Cavale Blanche
Brest, 29200, France
HOP 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
HOP Pasteur
Nice, 06001, France
HOP Paris Saint-Joseph
Paris, 75014, France
HOP Tenon
Paris, 75020, France
HOP Bichat
Paris, 75877, France
HOP Haut-Lévêque
Pessac, 33604, France
HOP Robert Debré
Reims, 51100, France
HOP Pontchaillou
Rennes, 35033, France
HOP Charles Nicolle
Rouen, 76031, France
HOP Civil
Strasbourg, 67091, France
HOP Foch
Suresnes, 92151, France
HOP Larrey
Toulouse, 31059, France
HOP Bretonneau
Tours, 37000, France
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, 53105, Germany
Klinikum Chemnitz gGmbH
Chemnitz, 09116, 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 - Campus Großhadern
München, 81377, Germany
Klinikum Nürnberg
Nuremberg, 90419, Germany
Krankenhaus Bethanien gGmbH
Solingen, 42699, Germany
Helios Hanseklinikum Stralsund
Stralsund, 18435, Germany
Robert-Bosch-Krankenhaus GmbH
Stuttgart, 70376, Germany
Universitätsklinikum Tübingen
Tübingen, 72076, Germany
Petrus-Krankenhaus
Wuppertal, 42283, Germany
Hospital of Heraklion (PAGNI)
Crete, 71500, Greece
Univ. Gen. Hosp. of Ioannina
Ioannina, 45 500, Greece
Univ. Gen. Hosp. of Patras
Pátrai, 26504, Greece
Koranyi National Institute For Pulmonolgy
Budapest, 1121, Hungary
University of Debrecen Clinical Centre
Debrecen, 4032, Hungary
Connolly Hospital Blanchardstown
Dublin, D15 X40D, Ireland
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 Classificato San Giuseppe
Milan, 20123, Italy
Azienda Ospedaliera Policlinico di Modena
Modena, 41100, Italy
Azienda Ospedaliera Universitaria di Padova
Padua, 35128, Italy
Pol. Universitario Tor Vergata
Roma, 00133, Italy
Fondazione Policlinico Universitario A. 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
Fujita Health University Hospital
Aichi, Toyoake, 470-1192, Japan
Chiba University Hospital
Chiba, Chiba, 260-8677, Japan
IUHW Narita Hospital
Chiba, Narita, 286-8520, 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
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
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
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, Yokohama, 236-0051, Japan
Saiseikai Kumamoto Hospital
Kumamoto, Kumamoto, 861-4193, Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, 852-8501, Japan
Kindai University Hospital
Osaka, Osakasayama, 589-8511, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Osaka, Sakai, 591-8555, 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
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
National Center for Global Health and Medicine
Tokyo, Shinjuku-ku, 162-8655, Japan
Wakayama Medical University Hospital
Wakayama, Wakayama, 641-8510, Japan
Hospital Sultan Idris Shah Serdang
Kajang, 43000, Malaysia
Institut Perubatan Respiratori
Kuala Lumpur, 53000, Malaysia
Sarawak General Hospital
Kuching, 93586, Malaysia
Hospital Pulau Pinang-Pulau Pinang-21953
Pulau Pinang, 10990, Malaysia
Centro de Investigacion Integral MEDIVEST S.C
Chihuahua City, 31203, 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
Heerlen, 6419 PC, Netherlands
St. Antonius ziekenhuis, locatie Nieuwegein
Nieuwegein, 3435 CM, Netherlands
Erasmus Medisch Centrum-ROTTERDAM-50697
Rotterdam, 3015 CE, Netherlands
Waikato Hospital
Hamilton, 3204, New Zealand
Greenlane Clinical Centre
One Tree Hill, Auckland, 1051, New Zealand
Middlemore Clinical Trials
Papatoetoe, 2025, New Zealand
Tauranga Hospital
Tauranga South, 3112, New Zealand
Haukeland Universitetssykehus
Bergen, N-5021, Norway
Akershus Universitetssykehus HF
Lørenskog, 1478, Norway
Oslo Universitetssykehus HF, Rikshospitalet
Oslo, N-0372, Norway
University Clinical Center, Gdansk
Gdansk, 80-214, Poland
Alergopneuma Medical Center
Świdnik, 21040, Poland
Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa
Warsaw, 01-138, Poland
ULS de Coimbra, E.P.E.
Coimbra, 3004-561, Portugal
USLM, EPE - Hospital Pedro Hispano
Matosinhos Municipality, 4454-509, Portugal
Allianze Pulmonary Research LLC
Guaynabo, 00968, Puerto Rico
National University Hospital-Singapore-42005
Singapore, 119074, Singapore
Singapore General Hospital
Singapore, 169608, Singapore
Tan Tock Seng Hospital
Singapore, 308433, Singapore
Busamed Paardevlei Private Hospital
Cape Town, 7130, South Africa
Melomed Gatesville Hospital
Cape Town, 7764, South Africa
KwaPhila Health Solutions
Durban, 4032, 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, 06351, 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 Universitari de Girona Doctor Josep Trueta
Girona, 17007, Spain
Hospital Universitario Virgen de las Nieves
Granada, 18014, Spain
Hospital de Bellvitge
L'Hospitalet de Llobregat, 08907, Spain
Hospital Universitario Lucus Augusti
Lugo, 27004, Spain
Hospital 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 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 Rocío
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
Sahlgrenska Universitetsjukhuset
Stockholm, 141 52, Sweden
Akademiska sjukhuset
Uppsala, 75185, Sweden
Universitätsspital Basel
Basel, 4031, Switzerland
Chang-Hua 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
Songklanagarind Hospital
Hat Yai, 90110, Thailand
Srinagarind Hospital
Khon Kaen, 40002, Thailand
Central Chest Institute of Thailand
Muang, 11000, Thailand
Maharat Nakhonchiangmai Hospital
Muang, 50200, Thailand
Ramathibodi Hospital
Ratchatewi, 10400, Thailand
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
Royal Brompton Hospital
London, SW3 6NP, United Kingdom
Wythenshawe Hospital
Manchester, M23 9LT, United Kingdom
Churchill Hospital
Oxford, OX3 7LJ, United Kingdom
Related Publications (3)
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: 41345848DERIVEDRicheldi L, Azuma A, Cottin V, Kreuter M, Maher TM, Martinez FJ, Oldham JM, Valenzuela C, Clerisme-Beaty E, Gordat M, Wachtlin D, Liu Y, Schlecker C, Stowasser S, Zoz DF, Wijsenbeek MS; FIBRONEER-IPF Trial Investigators. Nerandomilast in Patients with Idiopathic Pulmonary Fibrosis. N Engl J Med. 2025 Jun 12;392(22):2193-2202. doi: 10.1056/NEJMoa2414108. Epub 2025 May 18.
PMID: 40387033DERIVEDRicheldi L, Azuma A, Cottin V, Kreuter M, Maher TM, Martinez FJ, Oldham JM, Valenzuela C, Gordat M, Liu Y, Stowasser S, Zoz DF, Wijsenbeek MS. Design of a phase III, double-blind, randomised, placebo-controlled trial of BI 1015550 in patients with idiopathic pulmonary fibrosis (FIBRONEER-IPF). BMJ Open Respir Res. 2023 Aug;10(1):e001563. doi: 10.1136/bmjresp-2022-001563.
PMID: 37597969DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2022
First Posted
April 11, 2022
Study Start
October 6, 2022
Primary Completion
August 16, 2024
Study Completion
December 17, 2024
Last Updated
October 20, 2025
Results First Posted
September 12, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
- 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.mystudywindow.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.