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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: Placebo; Drug: BI 1015550

• Study Type: Interventional
• Enrollment (Actual): 1177
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Boehringer Ingelheim; Phone Number: 1-800-243-0127; Email: clintriage.rdg@boehringer-ingelheim.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1425FVH
    • Consultorios Médicos del Buen Ayre
  • C.a.b.a, Argentina, C1027AAP
    • Centro de Investigaciones Metabólicas (CINME)
  • Caba, Argentina, C1199ABB
    • Hospital Italiano de Buenos Aires
  • Caba, Argentina, C1060ABN
    • CEDIC - Centro de Investigacion Clinica
  • Mar del Plata, Argentina, 7600
    • Instituto Ave Pulmo
  • Mendoza, Argentina, M5500CCG
    • INSARES
  • Quilmes, Argentina, B1878FNR
    • Centro Respiratorio de Quilmes
• Australia
  • Australian Capital Territory
    • Canberra, Australian Capital Territory, Australia, 2605
      • Canberra Hospital
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Royal Prince Alfred Hospital
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
  • Queensland
    • Chermside, Queensland, Australia, 4032
      • The Prince Charles Hospital
    • Chermside, Queensland, Australia, 4032
      • Lung Research Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Mater Hospital Brisbane
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital
  • Victoria
    • Footscray, Victoria, Australia, 3011
      • Lung Research Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Austin Hospital
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital
    • Spearwood, Western Australia, Australia, 6153
      • Trialswest
• Austria
  • Klagenfurt Am Woerthersee, Austria, 9020
    • LKH Klagenfurt am Woerthersee
  • Krems, Austria, 3500
    • Krems University Hospital
  • Linz, Austria, 4020
    • Ordensklinikum Linz GmbH Elisabethinen
  • Salzburg, Austria, 5020
    • LKH Salzburg University Hospital
  • Vienna, Austria, 1210
    • Clinic Floridsdorf
  • Wels, Austria, 4600
    • Klinikum Wels - Grieskirchen GmbH
• Belgium
  • Antwerpen, Belgium, 2020
    • Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim
  • Bruxelles, Belgium, 1200
    • Brussels - UNIV Saint-Luc
  • Bruxelles, Belgium, 1070
    • ULB Hopital Erasme
  • Gent, Belgium, 9000
    • UNIV UZ Gent
  • Leuven, Belgium, 3000
    • UZ Leuven
  • Liège, Belgium, 4000
    • Centre Hospitalier Universitaire de Liège
  • Yvoir, Belgium, 5530
    • Yvoir - UNIV UCL de Mont-Godinne
• Brazil
  • Barra Mansa, Brazil, 27323240
    • Serviços Medicos Respirar Sul Fluminense
  • Belo Horizonte,Minas Gerais, Brazil, 31270901
    • Hospital das Clinicas da Universidade Federal HC-UFMG
  • Curitiba, Brazil, 80440-210
    • Edumed - Educacao e Saude SA
  • Goiania, Brazil, 74110-030
    • CLARE - Clinica de Pneumologia
  • Porto Alegre, Brazil, 90035-074
    • Irmandade da Santa Casa de Misericordia de Porto Alegre
  • Sao Paulo, Brazil, 01323-020
    • Hospital Alemão Oswaldo Cruz
  • São Bernardo do Campo, Brazil, 09780-000
    • CEMEC - Centro Multidisciplinar de Estudos Clínicos
• Canada
  • Quebec, Canada, G1V 4G5
    • IUCPQ (Laval University)
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2G3
      • University of Alberta Hospital (University of Alberta)
  • British Columbia
    • Kelowna, British Columbia, Canada, V1W 1V3
      • Kelowna Respirology & Allergy Research
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • St. Paul's Hospital
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 2Z3
      • Dr. Georges-L.-Dumont University Hospital Centre
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • QEII Health Sciences Centre
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • St. Joseph's Healthcare Hamilton
    • Windsor, Ontario, Canada, N8X 1T3
      • Dr. Syed Anees Medicine Professional Corporation
  • Quebec
    • Montreal, Quebec, Canada, H2X 0A9
      • Centre Hospitalier de l'Université de Montréal (CHUM)
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre (MUHC)
    • Trois-Rivieres, Quebec, Canada, G8T 7A1
      • CIC Mauricie Inc.
• Chile
  • Providencia, Santiago De Chile, Chile, 7500691
    • Instituto Nacional del tórax
  • Talca, Chile, 3465586
    • Centro de Investigación del Maule
• China
  • Beijing, China, 100853
    • Chinese PLA General hospital
  • Beijing, China, 100730
    • Peking Union Medical College Hospital
  • Beijing, China, 100029
    • China-Japan Friendship Hospital
  • Changsha, China, 410011
    • The Second Xiangya Hospital of Central South University
  • Chengdu, China, 610041
    • West China Hospital
  • Guangzhou, China, 510515
    • NanFang Hosptial
  • Guangzhou, China, 510120
    • First Affiliated Hospital of Guangzhou Medical University
  • Hangzhou, China, 310009
    • The Second Affiliated Hospital Zhejiang University School of Medicine
  • Hangzhou, China, 310006
    • Hangzhou First People's Hospital
  • Hangzhou, China, 310018
    • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
  • Hefei, China, 230001
    • Anhui Provincial Hospital
  • Jiaxing, China, 314000
    • The First hospital of Jiaxing
  • Jinhua, China, 321000
    • Jinhua Municipal Central Hospital
  • Nanjing, China, 210008
    • Nanjing Drum Tower Hospital
  • Ningbo, China, 315010
    • The first affiliated hospital of Ningbo University
  • Shanghai, China, 200030
    • Shanghai Chest Hospital
  • Shanghai, China, 200433
    • Shanghai pulmonary hospital
  • Shanghai, China, 200032
    • Zhongshan Hospital Fudan University
  • Shanghai, China, 200025
    • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
  • Shanghai, China, 200040
    • Shanghai Huadong Hospital
  • Shenyang, China, 110000
    • China Shenyang Chest Hospital
  • Shenzhen, China, 518020
    • ShenZhen People's Hospital
  • Shenzhen, China, 518053
    • The University of Hong Kong-Shenzhen Hospital
  • Sichuan, China, 610031
    • People's Hospital of Sichuan Province
  • Suzhou, China, 215006
    • The First Affiliated Hospital of Soochow University
  • Tianjin, China, 30052
    • Tianjin Medical University General Hospital
  • Wuhan, China, 430060
    • Renmin Hospital of Wuhan University
  • Wuhan, China, 430022
    • Wuhan Union Hospital
  • Wuhan, China, 430030
    • Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
  • Wuxi, China, 214043
    • Wuxi People's Hospital
  • Xi'an, China, 710004
    • Second Affiliated Hospital of Xi'an JiaoTong University
  • Xuzhou, China, 221009
    • Affiliated Hospital, Xuzhou Medical college
  • Yichang, China, 443000
    • Yichang NO.1 People's Hospital
• Croatia
  • Zagreb, Croatia, 10000
    • University Hospital Dubrava
• Denmark
  • Aarhus N, Denmark, 8200
    • Aarhus University Hospital
  • Hellerup, Denmark, 2900
    • Herlev and Gentofte Hospital
  • Odense, Denmark, 5000
    • Odense University Hospital
• Estonia
  • Tallinn, Estonia, 11619
    • North Estonia Medical Centre Foundation, Tallinn
• Finland
  • Helsinki, Finland, 000290
    • HYKS Keuhkosairauksien tutkimusyksikkö
  • Oulu, Finland, 90220
    • Oulun yliopistollinen keskussairaala
• France
  • Angers, France, 49 933
    • HOP d'Angers
  • Bobigny, France, 93000
    • HOP Avicenne
  • Brest, France, 29609
    • HOP de la Cavale Blanche
  • Bron, France, 69677
    • HOP Louis Pradel
  • Caen, France, 14033
    • HOP Côte de Nacre
  • Dijon, France, 21000
    • HOP François Mitterrand
  • La Tronche, France, 38700
    • HOP Michallon
  • Le Kremlin-Bicêtre, France, 94275
    • HOP Bicêtre
  • Lille, France, 59037
    • INS Coeur Poumon
  • Marseille, France, 13915
    • HOP Nord
  • Nantes Cedex 01, France, 44093
    • HOP Nord Laennec
  • Nice, France, 06001
    • HOP Pasteur
  • Paris, France, 75014
    • HOP Paris Saint-Joseph
  • Paris, France, 75877
    • HOP Bichat
  • Paris, France, 75020
    • HOP Tenon
  • Pessac, France, 33604
    • HOP Haut-Lévêque
  • Reims, France, 51092
    • HOP Maison Blanche
  • Rennes, France, 35033
    • HOP Pontchaillou
  • Rouen, France, 76031
    • HOP Charles Nicolle
  • Strasbourg, France, 67091
    • HOP Civil
  • Suresnes, France, 92151
    • HOP Foch
  • Toulouse, France, 31059
    • HOP Larrey
  • Tours, France, 37000
    • HOP Bretonneau
• Germany
  • Bamberg, Germany, 96049
    • CIMS Studienzentrum Bamberg GmbH
  • Berlin, Germany, 12351
    • Vivantes Netzwerk für Gesundheit GmbH
  • Bonn, Germany, 53105
    • Universitätsklinikum Bonn AöR
  • Chemnitz, Germany, 09116
    • Klinikum Chemnitz gGmbH
  • Coswig, Germany, 01640
    • Fachkrankenhaus Coswig GmbH
  • Essen, Germany, 45239
    • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
  • Großhansdorf, Germany, 22927
    • Velocity Clinical Research Germany GmbH
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg-Eppendorf
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Hannover, Germany, 30459
    • Klinikum Region Hannover GmbH
  • Heidelberg, Germany, 69126
    • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
  • Hemer, Germany, 58675
    • Lungenklinik Hemer
  • Immenhausen, Germany, 34376
    • Lungenfachklinik Immenhausen
  • Konstanz, Germany, 78464
    • Klinikum Konstanz
  • München, Germany, 81377
    • Klinikum der Universität München - Campus Großhadern
  • Nürnberg, Germany, 90419
    • Klinikum Nürnberg
  • Solingen, Germany, 42699
    • Krankenhaus Bethanien gGmbH
  • Stralsund, Germany, 18435
    • Helios Hanseklinikum Stralsund
  • Stuttgart, Germany, 70376
    • Robert-Bosch-Krankenhaus GmbH
  • Tübingen, Germany, 72076
    • Universitätsklinikum Tübingen
  • Wuppertal, Germany, 42283
    • Petrus-Krankenhaus
• Greece
  • Ioannina, Greece, 45 500
    • Univ. Gen. Hosp. of Ioannina
  • Patras, Greece, 26504
    • Univ. Gen. Hosp. of Patras
  • Voutes, Greece, 71003
    • Hospital of Heraklion (PAGNI)
• Hungary
  • Budapest, Hungary, 1122
    • Koranyi National Institute For Pulmonolgy
  • Debrecen, Hungary, 4032
    • University of Debrecen Clinical Centre
• Ireland
  • Dublin 15, Ireland, D15 X40D
    • Connolly Hospital Blanchardstown
• Italy
  • Catania, Italy, 95124
    • A.O.U. Policlinico Vittorio Emanuele
  • Firenze, Italy, 50100
    • A. O. Universitaria Careggi
  • Foggia, Italy, 71100
    • Ospedale Colonnello D Avanzo
  • Forli', Italy, 47121
    • Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli
  • Milano, Italy, 20123
    • Osp. S. Giuseppe Fatebenefratelli
  • Modena, Italy, 41100
    • Azienda Ospedaliera Policlinico di Modena
  • Padova, Italy, 35128
    • Azienda Ospedaliera Universitaria di Padova
  • Roma, Italy, 00168
    • Poli Univ A. Gemelli
  • Roma, Italy, 00133
    • Pol. Universitario Tor Vergata
  • Siena, Italy, 53100
    • A.O.U. Senese Policlinico Santa Maria alle Scotte
  • Torrette Di Ancona (Ancona), Italy, 60126
    • Ospedali Riuniti di Ancona
• Japan
  • Aichi, Seto, Japan, 489-8642
    • Tosei General Hospital
  • Aichi, Toyoake, Japan, 470-1192
    • Fujita Health University Hospital
  • Chiba, Chiba, Japan, 260-8677
    • Chiba University Hospital
  • Chiba, Narita, Japan, 286-8520
    • IUHW Narita Hospital
  • Fukui, Yoshida-gun, Japan, 910-1193
    • University of Fukui Hospital
  • Fukuoka, Fukuoka, Japan, 810-8563
    • National Hospital Organization Kyushu Medical Center
  • Fukuoka, Fukuoka, Japan, 812-8582
    • Kyushu University Hospital
  • Fukuoka, Iizuka, Japan, 820-8505
    • Aso Co.,Ltd Iizuka Hospital
  • Fukuoka, Kurume, Japan, 830-0011
    • Kurume University Hospital
  • Fukushima, Fukushima, Japan, 960-1295
    • Fukushima Medical University Hospital
  • Fukushima, Koriyama, Japan, 963-0197
    • Tsuboi Hospital
  • Hiroshima, Hiroshima, Japan, 734-8530
    • Hiroshima Prefectural Hospital
  • Hokkaido, Sapporo, Japan, 060-8543
    • Sapporo Medical University Hospital
  • Hyogo, Himeji, Japan, 670-8520
    • National Hospital Organization Himeji Medical Center
  • Hyogo, Kobe, Japan, 650-0047
    • Kobe City Medical Center General Hospital
  • Hyogo, Kobe, Japan, 653-0013
    • Kobe City Hospital Organization Kobe City Medical Center West Hospital
  • Kanagawa, Yokohama, Japan, 236-0051
    • Kanagawa Cardiovascular and Respiratory Center
  • Kumamoto, Kumamoto, Japan, 861-4193
    • Saiseikai Kumamoto Hospital
  • Nagasaki, Nagasaki, Japan, 852-8501
    • Nagasaki University Hospital
  • Osaka, Osakasayama, Japan, 589-8511
    • Kindai University Hospital
  • Osaka, Sakai, Japan, 591-8555
    • National Hospital Organization Kinki-chuo Chest Medical Center
  • Saitama, Saitama, Japan, 330-8553
    • Saitama Red Cross Hospital
  • Shimane, Izumo, Japan, 693-8501
    • Shimane University Hospital
  • Shizuoka, Hamamatsu, Japan, 431-3192
    • Hamamatsu University Hospital
  • Tochigi, Shimotsuke, Japan, 329-0498
    • Jichi Medical University Hospital
  • Tokushima, Tokushima, Japan, 770-8503
    • Tokushima University Hospital
  • Tokyo, Bunkyo-ku, Japan, 113-8431
    • Juntendo University Hospital
  • Tokyo, Minato-ku, Japan, 105-8470
    • Toranomon Hospital
  • Tokyo, Mitaka, Japan, 181-8611
    • Kyorin University Hospital
  • Tokyo, Ota-ku, Japan, 143-8541
    • Toho University Omori Medical Center
  • Tokyo, Shinjuku-ku, Japan, 160-0023
    • Tokyo Medical University Hospital
  • Tokyo, Shinjuku-ku, Japan, 162-8655
    • Center Hospital of the National Center for Global Health and Medicine
  • Wakayama, Wakayama, Japan, 641-8510
    • Wakayama Medical University Hospital
• Korea, Republic of
  • Bucheon, Korea, Republic of, 14647
    • The Catholic University of Korea, Bucheon St.Mary's Hospital
  • Seongnam, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 02447
    • Kyung Hee University Hospital
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 04401
    • Soonchunhyang University Hospital Seoul
• Malaysia
  • Kajang, Malaysia, 43000
    • Hospital Sultan Idris Shah Serdang
  • Kuala Lumpur, Malaysia, 53000
    • Institut Perubatan Respiratori
  • Kuching, Malaysia, 93586
    • Sarawak General Hospital
  • Pulau Pinang, Malaysia, 10990
    • Hospital Pulau Pinang
• Mexico
  • Chihuahua, Mexico, 31203
    • Centro de Investigacion Integral MEDIVEST S.C
  • Ciudad de Mexico, Mexico, 03650
    • Soltmed Smo S.C.
  • Ciudad de Mexico, Mexico, 14050
    • Centro Respiratorio de Mexico
  • Monterrey, Mexico, 64460
    • Centro de Prevención y Rehabilitación de Enfermedades Pulmon
  • Oaxaca, Mexico, 68000
    • Oaxaca Site Management Organization, S.C.
• Netherlands
  • Heerlen, Netherlands, 6419 PC
    • Zuyderland Medisch Centrum
  • Nieuwegein, Netherlands, 3435 CM
    • St. Antonius ziekenhuis, locatie Nieuwegein
  • Rotterdam, Netherlands, 3015 CE
    • Erasmus Medisch Centrum
• New Zealand
  • Hamilton, New Zealand, 3204
    • Waikato Hospital
  • One Tree Hill, Auckland, New Zealand, 1051
    • Greenlane Clinical Centre
  • Papatoetoe, New Zealand, 2025
    • Middlemore Clinical Trials
  • Tauranga South, New Zealand, 3112
    • Tauranga Hospital
• Norway
  • Bergen, Norway, N-5021
    • Haukeland Universitetssykehus
  • Lørenskog, Norway, 1478
    • Akershus Universitetssykehus HF
  • Oslo, Norway, N-0372
    • Oslo Universitetssykehus HF, Rikshospitalet
• Poland
  • Gdansk, Poland, 80-214
    • University Clinical Center, Gdansk
  • Swidnik, Poland, 21040
    • Alergopneuma Medical Center
  • Warsaw, Poland, 01-138
    • Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa
• Portugal
  • Coimbra, Portugal, 3004-561
    • ULS de Coimbra, E.P.E.
  • Matosinhos, Portugal, 4454-509
    • USLM, EPE - Hospital Pedro Hispano
• Puerto Rico
  • Guaynabo, Puerto Rico, 00968
    • Allianze Pulmonary Research LLC
• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital
  • Singapore, Singapore, 119074
    • National University Hospital
  • Singapore, Singapore, 308433
    • Tan Tock Seng Hospital
• South Africa
  • Cape Town, South Africa, 7130
    • Busamed Paardevlei Private Hospital
  • Cape Town, South Africa, 7764
    • Melomed Gatesville Hospital
  • Durban, South Africa, 4032
    • KwaPhila Health Solutions
• Spain
  • Alicante, Spain, 03010
    • Hospital General Universitario de Alicante
  • Barcelona, Spain, 08003
    • Hospital Del Mar
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 08035
    • Hospital Vall d'Hebron
  • Bilbao, Spain, 48013
    • Hospital de Basurto
  • El Palmar, Spain, 30120
    • Hospital Universitario Virgen de la Arrixaca
  • Galdakao, Spain, 48960
    • Hospital de Galdakao
  • Girona, Spain, 17007
    • Hospital Universitari de Girona Doctor Josep Trueta
  • Granada, Spain, 18014
    • Hospital Universitario Virgen de Las Nieves
  • L'Hospitalet de Llobregat, Spain, 08907
    • Hospital de Bellvitge
  • Lugo, Spain, 27004
    • Hospital Universitario Lucus Augusti
  • Madrid, Spain, 28041
    • Hospital Universitario 12 De Octubre
  • Madrid, Spain, 28034
    • Hospital Ramón y Cajal
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon
  • Madrid, Spain, 28006
    • Hospital La Princesa
  • Madrid, Spain, 28031
    • Hospital Universitario Infanta Leonor
  • Malaga, Spain, 29010
    • Hospital Virgen de la Victoria
  • Oviedo, Spain, 33011
    • Hospital Central de Asturias
  • Palma de Mallorca, Spain, 07120
    • Hospital Son Espases
  • Pozuelo de Alarcón, Spain, 28223
    • Hospital Quirónsalud Madrid
  • Santander, Spain, 39008
    • Hospital Universitario Marqués de Valdecilla
  • Santiago de Compostela, Spain, 15706
    • Hospital Clínico de Santiago
  • Sevilla, Spain, 41013
    • Hospital Virgen del Rocio
  • Sevilla, Spain, 41014
    • Hospital Nuestra Señora de Valme
  • Valencia, Spain, 46014
    • Hospital General Universitario de Valencia
• Sweden
  • Linköping, Sweden, 581 85
    • Universitetssjukhuset, Linköping
  • Uppsala, Sweden, 75185
    • Akademiska sjukhuset
• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel
• Taiwan
  • Changhua, Taiwan, 500
    • Chang-Hua Christian Hospital
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kaohsiung, Taiwan, 83301
    • Kaohsiung Chang Gung Memorial Hospital
  • New Taipei City, Taiwan, 220
    • Far Eastern Memorial Hospital
  • Taichung, Taiwan, 407
    • Taichung Veterans General Hospital
  • Tainan, Taiwan, 704
    • NCKUH
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
• Thailand
  • Bangkok Noi, Thailand, 10700
    • Siriraj Hospital
  • Hat Yai, Thailand, 90110
    • Songklanagarind hospital
  • Khon Kaen, Thailand, 40002
    • Srinagarind Hospital
  • Muang, Thailand, 11000
    • Central Chest Institute of Thailand
  • Muang, Thailand, 50200
    • Maharat Nakhonchiangmai Hospital
  • Ratchatewi, Thailand, 10400
    • Ramathibodi Hospital
• United Kingdom
  • Bristol, United Kingdom, BS10 5NB
    • Southmead Hospital
  • Edinburgh, United Kingdom, EH16 4SA
    • Royal Infirmary of Edinburgh
  • Exeter, United Kingdom, EX2 5DW
    • Royal Devon and Exeter Hospital
  • Lancaster, United Kingdom, LA1 4RP
    • Royal Lancaster Infirmary
  • Leeds, United Kingdom, LS9 7TF
    • St James's University Hospital
  • London, United Kingdom, SW3 6NP
    • Royal Brompton Hospital
  • Manchester, United Kingdom, M23 9LT
    • Wythenshawe Hospital
  • Oxford, United Kingdom, OX3 7LJ
    • Churchill Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Sacramento, California, United States, 95817
      • University of California Davis
  • Colorado
    • Denver, Colorado, United States, 80206
      • National Jewish Health
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University School of Medicine
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University
  • Florida
    • Clearwater, Florida, United States, 33765
      • St. Francis Medical Institute
    • Gainesville, Florida, United States, 32610
      • University of Florida Health Shands Hospital
    • Kissimmee, Florida, United States, 34746
      • Clinical Research Specialists LLC
    • Loxahatchee Groves, Florida, United States, 33470
      • Advanced Pulmonary Research Institute
    • Santa Rosa Beach, Florida, United States, 32459
      • Destin Pulmonary Critical Care
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Healthcare
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Evanston Hospital Pulmonary Clinic
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Louisville Pulmonary Care
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University Hospital and Clinic
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02135
      • St. Elizabeth's Medical Center
    • Boston, Massachusetts, United States, 02114-2114
      • Massachusetts General Hospital
    • North Dartmouth, Massachusetts, United States, 02747
      • Infinity Medical Research
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-5314
      • University of Michigan Health System
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Health
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Minnesota Lung Center and Sleep Institute
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic, Rochester
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • The Lung Research Center, LLC
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
    • Omaha, Nebraska, United States, 68124
      • Creighton University
  • Nevada
    • Reno, Nevada, United States, 89502
      • Renown Regional Medical Center
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • New York
    • Mount Kisco, New York, United States, 10549
      • Northern Westchester Hospital
    • New York, New York, United States, 10065
      • Weill Cornell Medicine
    • New York, New York, United States, 10032
      • Columbia University Medical Center-New York Presbyterian Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Winston-Salem, North Carolina, United States, 27103
      • Southeastern Research Center
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center
  • Oregon
    • Portland, Oregon, United States, 97220
      • The Oregon Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Lowcountry Lung and Critical Care
  • Tennessee
    • Franklin, Tennessee, United States, 37067
      • Clinical Trials Center of Middle Tennessee, LLC
    • Nashville, Tennessee, United States, 37204
      • Vanderbilt University Medical Center - Vanderbilt Lung Institute at 100 Oaks
  • Texas
    • Denison, Texas, United States, 75020
      • Premier Pulmonary Critical Care and Sleep Medicine
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
    • San Antonio, Texas, United States, 78229
      • UT Health San Antonio
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah Health Sciences Center
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

1. Patients ≥40 years old at the time of signed informed consent.
2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
3. Diagnosis of Idiopathic Pulmonary Fibrosis (IPF)

4. 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.
5. Forced Vital Capacity (FVC) ≥45% of predicted normal at Visit 1.
6. Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) ≥25% of predicted normal corrected for hemoglobin (Hb) at Visit 1
7. 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

Exclusion criteria

1. Prebronchodilator Forced Expiratory Volume in 1 second (FEV1)/Forced vital capacity (FVC) <0.7 at Visit 1
2. In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
3. Acute Idiopathic Pulmonary Fibrosis (IPF) exacerbation within 3 months prior to Visit 1 and/or during the screening period (investigator-determined).
4. Relevant chronic or acute infections including human immunodeficiency virus (HIV) and viral hepatitis.
5. 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).
6. 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.
7. 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.
8. 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.

Further exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo
Experimental: BI 1015550 low dose	Drug: BI 1015550; BI 1015550; Other Names: Nerandomilast
Experimental: BI 1015550 high dose	Drug: BI 1015550; BI 1015550; Other Names: Nerandomilast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Absolute change from baseline in Forced Vital Capacity (FVC) (mL) at Week 52	at baseline, at week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Dyspnea domain score at Week 52	The L-PF is a 49-item questionnaire with two modules: Symptoms (28 items) and Impact (21 items). The Symptom score has three domain scores: dyspnea, cough, and fatigue, as well as a total symptom score. Items have response options on a five-option numeric rating score with an anchor of 0 "Not at all" to 4 "Extremely", with higher numbers indicating a greater impairment.	at baseline, at week 52
Absolute change from baseline in FVC % predicted at Week 52		at baseline, at week 52
Absolute change from baseline in DLCO % predicted at Week 52		at baseline, at week 52
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	Key secondary endpoint	up to 30 months
Time to first acute Idiopathic Pulmonary Fibrosis (IPF) exacerbation or death over the duration of trial		up to 30 months
Time to hospitalization for respiratory cause or death over the duration of trial		up to 30 months
Time to absolute decline in FVC % predicted of >10% from baseline or death over the duration of the trial		up to 30 months
Time to absolute decline in Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) % predicted of >15% from baseline or death over the duration of the trial		up to 30 months
Time to death over the duration of trial		up to 30 months
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Cough domain score at Week 52	The L-PF is a 49-item questionnaire with two modules: Symptoms (28 items) and Impact (21 items). The Symptom score has three domain scores: dyspnea, cough, and fatigue, as well as a total symptom score. Items have response options on a five-option numeric rating score with an anchor of 0 "Not at all" to 4 "Extremely", with higher numbers indicating a greater impairment.	at baseline, at week 52
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Fatigue domain score at Week 52	The L-PF is a 49-item questionnaire with two modules: Symptoms (28 items) and Impact (21 items). The Symptom score has three domain scores: dyspnea, cough, and fatigue, as well as a total symptom score. Items have response options on a five-option numeric rating score with an anchor of 0 "Not at all" to 4 "Extremely", with higher numbers indicating a greater impairment.	at baseline, at week 52

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2022
• Primary Completion (Estimated): August 5, 2024
• Study Completion (Estimated): November 15, 2024

Study Registration Dates

• First Submitted: April 4, 2022
• First Submitted That Met QC Criteria: April 4, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: 1305-0014; 2022-001091-34 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No