A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)
A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of BI 1015550 Over at Least 52 Weeks in Patients With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)
2 other identifiers
interventional
1,178
42 countries
389
Brief Summary
This study is open to adults with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs). People who have a form of PF-ILD other than Idiopathic Pulmonary Fibrosis (IPF) can join the study. If they already take nintedanib, 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 PF-ILD. 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 Nov 2022
389 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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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
November 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 14, 2025
CompletedResults Posted
Study results publicly available
January 9, 2026
CompletedJanuary 9, 2026
December 1, 2025
2.1 years
April 4, 2022
December 17, 2025
December 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Absolute Change From Baseline in Forced Vital Capacity (FVC) in Milliliters [mL] at Week 52
The absolute change from baseline in forced vital capacity (FVC) in milliliters \[mL\] at Week 52 is reported. The absolute change from baseline in FVC was analyzed by a restricted maximum likelihood (REML)-based mixed model with repeated measurements (MMRM) comparing the change from baseline in FVC at Week 52 between treatment groups. The analysis included the fixed, categorical effects of treatment, baseline intake of antifibrotic (AF) treatment, and baseline High-resolution Computed Tomography (HRCT) pattern at each visit, as well as the fixed continuous effects of baseline FVC value at each visit. Visits were treated as a repeated measure with an unstructured covariance structure used to model within-patient measurements.
The MMRM model is a longitudinal analysis, and it incorporated FVC measurements change from baseline at Week 1, Week 2, Week 6, Week 12, Week 18, Week 26, Week 36, Week 44 and Week 52. Data presented is the FVC adjusted change from baseline at Week 52.
Secondary Outcomes (11)
Key Secondary Endpoint: Time to First Occurrence of Any of the Components of the Composite Endpoint: Time to First Acute ILD Exacerbation, First Hospitalisation for Respiratory Cause, or Death (Whichever Occurred First) Over the Duration of the Trial
From first administration of trial drug (Nerandomilast or Placebo) till end of study, up to 26.2 months.
Time to First Acute ILD Exacerbation or Death Over the Duration of the Trial
From first administration of trial drug (Nerandomilast or Placebo) till end of study, up to 26.2 months.
Time to Hospitalisation for Respiratory Cause or Death Over the Duration of the Trial
From first administration of trial drug (Nerandomilast or Placebo) till end of study, up to 26.2 months.
Time to Death Over the Duration of the Trial
From first administration of trial drug (Nerandomilast or Placebo) till end of study, up to 26.2 months.
Absolute Change From Baseline in Forced Vital Capacity (FVC) Percent (%) Predicted at Week 52
The MMRM model is a longitudinal analysis, and it incorporated FVC % predicted change from baseline at Week 1, Week 2, Week 6, Week 12, Week 18, Week 26, Week 36, Week 44 and Week 52. Data presented is change from baseline in FVC % predicted at Week 52.
- +6 more secondary outcomes
Study Arms (3)
Nerandomilast 9 mg
EXPERIMENTALPatients with progressive fibrosing interstitial lung disease (PF-ILD) or progressive pulmonary fibrosis (PPF), other than idiopathic pulmonary fibrosis (IPF), were administered 9 milligrams (mg) nerandomilast, taken orally as film-coated tablets twice daily (18 mg total), in the morning and in the evening for an initial 52 weeks, followed by a variable duration till end of trial.
Nerandomilast 18 mg
EXPERIMENTALPatients with progressive fibrosing interstitial lung disease (PF-ILD) or progressive pulmonary fibrosis (PPF), other than idiopathic pulmonary fibrosis (IPF), were administered 18 mg nerandomilast, taken orally as film-coated tablets twice daily (36 mg total), in the morning and in the evening for an initial 52 weeks, followed by a variable duration till end of trial.
Placebo
PLACEBO COMPARATORPatients with progressive fibrosing interstitial lung disease (PF-ILD) or progressive pulmonary fibrosis (PPF), other than idiopathic pulmonary fibrosis (IPF), were administered placebo matching nerandomilast, taken orally as film-coated tablets twice daily, in the morning and in the evening for an initial 52 weeks, followed by a variable duration till end of trial.
Interventions
Participants received film-coated nerandomilast tablets orally, twice daily, at doses of either 9 mg or 18 mg, in the morning and in the evening.
Participants received placebo matching 9 mg or 18 mg nerandomilast film-coated tablets orally, twice daily, in the morning and in the evening.
Eligibility Criteria
You may qualify if:
- Patients ≥18 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 progressive fibrosing ILD other than IPF (physician confirmed).
- Patients may be either:
- on a stable therapy\* with nintedanib for at least 12 weeks prior to Visit 1 and during screening and are planning to stay on this background treatment after randomization. (\*stable therapy is defined as a tolerated regimen of nintedanib (with no dose changes) for at least 12 weeks)
- not on treatment with nintedanib 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.
- 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
- Patients treated with permitted immunosuppressive agents (other than corticosteroids) for an underlying systemic disease (e.g. Methotrexate (MTX), Azathioprine (AZA)) need to be on a stable treatment for at least 12 weeks prior to Visit 1 and during the screening period.
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 Interstitial Lung Disease (ILD) 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.
- Patients having developed ILD due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection/coronavirus disease 2019 (COVID-19) within 12 months of screening (based on investigators judgement).
- 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 (400)
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, 19718, 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 Physicians Pulmonary & Sleep Medicine of Buckhead
Atlanta, Georgia, 30309, United States
The Emory Clinic
Atlanta, Georgia, 30322, United States
Evanston Hospital Pulmonary Clinic
Evanston, Illinois, 60201, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Tulane University Hospital and Clinic
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
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
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic, Rochester
Rochester, Minnesota, 55905, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Stony Brook University Medical Center
Commack, New York, 11725, United States
Lenox Hill Hospital
New York, New York, 10021, 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-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
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 - Vanderbilt Lung Institute at 100 Oaks
Nashville, Tennessee, 37204, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Premier Pulmonary Critical Care and Sleep Medicine
Denison, Texas, 75020, United States
UT Health San Antonio
San Antonio, Texas, 78229, 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-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, 1425, Argentina
APRILLUS-Asistencia e Investigacion
Ciudad Autonoma Buenos Aires, C1046AAQ, Argentina
CEMER-Centro Medico De Enfermedades Respiratorias
Florida, B1602DQD, Argentina
Instituto Ave Pulmo
Mar del Plata, 7600, Argentina
INSARES
Mendoza, M5500CCG, Argentina
Centro Respiratorio de Quilmes
Quilmes, B1878FNR, Argentina
Instituto Médico de la Fundación Estudios Clínicos
Rosario, S2000DEJ, Argentina
Canberra Hospital
Garran, Australian Capital Territory, 2605, Australia
Royal Prince Alfred Hospital
Camperdown, Sydney, New South Wales, 2050, Australia
Macquarie University
Macquarie Park, New South Wales, 2109, 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
Royal Adelaide Hospital
Adelaide, South Australia, 5000, 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
Medical University of Graz State Hospital - University Hospital Graz
Graz, 8036, Austria
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
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
ULB 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 (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
Hospital Nossa Senhora da Conceição
Porto Alegre - RS, CEP 91350-, Brazil
Instituto D´Or de Pesquisa e Ensino - Bahia
Salvador, 41920-900, Brazil
Faculdade de Medicina do ABC
Santo André, 09060-870, Brazil
CEMEC - Centro Multidisciplinar de Estudos Clínicos
São Bernardo do Campo, 09780-000, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, 01323-020, Brazil
Hospital das Clinicas da FMUSP
São Paulo, 05403-000, Brazil
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
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 0A9, Canada
McGill University Health Centre (MUHC)
Montreal, Quebec, H4A 3J1, Canada
IUCPQ (Laval University)
Québec, Quebec, G1V 4G5, Canada
CIC Mauricie Inc.
Trois-Rivières, Quebec, G8T 7A1, Canada
Royal University Hospital (Saskatoon)
Saskatoon, Saskatchewan, S7N 0W8, Canada
Instituto Nacional del Tórax
Providencia, Santiago de Chile, 7500000, Chile
Centro de Investigación 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, 100032, 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
Guangdong Provincial People's Hospital
Guangzhou, 510080, 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
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
The First Affiliated Hospital of Wenzhou Medical University
Wenxzhou, 325000, 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
General Hospital of Ningxia Medical University
Yinchuan, 750004, China
Yuncheng Central Hospital
Yuncheng, 044000, 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
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
Tampere University Hospital
Tampere, 33521, Finland
TYKS
Turku, 20520, 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
INS Coeur Poumon
Lille, 59037, France
HOP Nord
Marseille, 13915, France
HOP Arnaud de Villeneuve
Montpellier, 34295, France
HOP Nord Laennec
Nantes, 44093, France
HOP Pasteur
Nice, 06001, 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
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
National Center for Tuberculosis and Lung Diseases, Tbilisi
Tbilisi, 0101, Georgia
LLC Diacor
Tbilisi, 0159, 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
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 AÖR
München, 81377, Germany
Westfälische Wilhelms-Universität Münster
Münster, 48149, 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
General Hospital of Athens "Laiko"
Athens, 115 27, Greece
Hospital of Heraklion (PAGNI)
Crete, 71500, 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
Semmelweis University
Budapest, 1083, Hungary
Koranyi National Institute For Pulmonolgy
Budapest, 1121, Hungary
University of Debrecen Clinical Centre
Debrecen, 4032, Hungary
Hindustan Hospital
Coimbatore, 641028, India
Bhatia Hospital
Mumbai, 400007, India
P.D. Hinduja National Hospital
Mumbai, 400016, India
Jehangir Clinical Development Centre Pvt. Ltd.
Pune, 411 001, India
Mater Misericordiae University Hospital
Dublin, D07 R2WY, Ireland
Shamir Medical Center (Assaf Harofeh)
Beer Yaakov, 7033001, Israel
Soroka Univ. Medical Center
Beersheba, 84101, Israel
Lady Davis Carmel Medical Center
Haifa, 3436212, Israel
Shaare Zedek Medical Center, Jerusalem 91031
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, 20900, Italy
Osp. dei Colli Monaldi
Naples, 80131, 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
Ospedale di Cattinara
Trieste, 34100, Italy
Tosei General Hospital
Aichi, Seto, 489-8642, Japan
Fujita Health University Hospital
Aichi, Toyoake, 470-1192, 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
Kyoto University Hospital
Kyoto, Kyoto, 606-8507, 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
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
Institute of Science Tokyo Hospital
Tokyo, Bunkyo-ku, 113-8519, 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 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
CREPID Aire y Salud
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
Heerlen, 6419 PC, Netherlands
Leids Universitair Medisch Centrum (LUMC)
Leiden, 2333 ZA, 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
Leszek Giec Upper-Silesian Med.Cent.Silesian Med.Univ.
Katowice, 40-635, Poland
Alergopneuma Medical Center
Świdnik, 21040, 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 Braga
Braga, 4710-243, Portugal
ULS de São José, E.P.E.
Lisbon, 1169-024, Portugal
USLM, EPE - Hospital Pedro Hispano
Matosinhos Municipality, 4454-509, Portugal
ULS de Gaia/Espinho, EPE
Vila Nova de Gaia, 4434-502, Portugal
Allianze Pulmonary Research LLC
Guaynabo, 00968, Puerto Rico
King Fahad Specialist Hospital - Research Center
Dammam, 31444, Saudi Arabia
King Faisal Specialist Hospital and Research Center
Riyadh, 11211, Saudi Arabia
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 of Kragujevac
Kragujevac, 34000, Serbia
University Clinical Center Nis
Niš, 18000, Serbia
National University Hospital-Singapore-42005
Singapore, 119074, Singapore
Singapore General Hospital
Singapore, 169608, Singapore
Hospital Golnik - Univ. Clinic of Pulmonary and Allergic Diseases
Golnik, 4204, Slovenia
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 Universitari de Bellvitge
L'Hospitalet de Llobregat, 08907, 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 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
Akademiska sjukhuset
Uppsala, 75185, Sweden
Universitätsspital Basel
Basel, 4031, Switzerland
University Hospital Bern
Bern, 3010, 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
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
Gulhane Training and Research Hospital
Ankara, 06010, Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi
Ankara, 06620, Turkey (Türkiye)
Akdeniz Universitesi Tip Fakultesi -ANTALYA-33606
Antalya, 07059, Turkey (Türkiye)
Uludag Universitesi Tip Fakultesi
Bursa, 16120, Turkey (Türkiye)
Istanbul Universitesi Istanbul Tip Fakultesi
Istanbul, 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 9LT, United Kingdom
Churchill Hospital
Oxford, OX3 7LJ, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, 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: 41345848DERIVEDMaher TM, Assassi S, Azuma A, Cottin V, Hoffmann-Vold AM, Kreuter M, Oldham JM, Richeldi L, Valenzuela C, Wijsenbeek MS, Clerisme-Beaty E, Coeck C, Gu H, Ritter I, Schlosser A, Stowasser S, Voss F, Weimann G, Zoz DF, Martinez FJ; FIBRONEER-ILD Trial Investigators. Nerandomilast in Patients with Progressive Pulmonary Fibrosis. N Engl J Med. 2025 Jun 12;392(22):2203-2214. doi: 10.1056/NEJMoa2503643. Epub 2025 May 19.
PMID: 40388329DERIVEDMaher TM, Assassi S, Azuma A, Cottin V, Hoffmann-Vold AM, Kreuter M, Oldham JM, Richeldi L, Valenzuela C, Wijsenbeek MS, Coeck C, Schlecker C, Voss F, Wachtlin D, Martinez FJ. Design of a phase III, double-blind, randomised, placebo-controlled trial of BI 1015550 in patients with progressive pulmonary fibrosis (FIBRONEER-ILD). BMJ Open Respir Res. 2023 Sep;10(1):e001580. doi: 10.1136/bmjresp-2022-001580.
PMID: 37709661DERIVED
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
November 16, 2022
Primary Completion
December 18, 2024
Study Completion
April 14, 2025
Last Updated
January 9, 2026
Results First Posted
January 9, 2026
Record last verified: 2025-12
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.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.