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)

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.

Study Overview

• Status: Completed
• Conditions: Lung Diseases, Interstitial
• Intervention / Treatment: Drug: BI 1015550; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1178
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • C.a.b.a, Argentina, 1056
    • Centro de Investigaciones Metabolicas (CINME)-C.A.B.A-61553
  • CABA, Argentina, C1060ABN
    • CEDIC - Centro de Investigacion Clinica
  • CABA, Argentina, C1199ABB
    • Hospital Italiano de Buenos Aires
  • Capital Federal, Argentina, 1425
    • Consultorios Médicos del Buen Ayre
  • Ciudad Autonoma Buenos Aires, Argentina, C1046AAQ
    • APRILLUS-Asistencia e Investigacion
  • Florida, Argentina, B1602DQD
    • CEMER-Centro Medico De Enfermedades Respiratorias
  • Mar del Plata, Argentina, 7600
    • Instituto Ave Pulmo
  • Mendoza, Argentina, M5500CCG
    • INSARES
  • Quilmes, Argentina, B1878FNR
    • Centro Respiratorio de Quilmes
  • Rosario, Argentina, S2000DEJ
    • Instituto Médico de la Fundación Estudios Clínicos
• Australia
  • Australian Capital Territory
    • Garran, Australian Capital Territory, Australia, 2605
      • Canberra Hospital
  • New South Wales
    • Camperdown, Sydney, New South Wales, Australia, 2050
      • Royal Prince Alfred Hospital
    • Macquarie Park, New South Wales, Australia, 2109
      • Macquarie University
    • 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
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide 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, 6163
      • Trialswest
• Austria
  • Graz, Austria, 8036
    • Medical University of Graz State Hospital - University Hospital Graz
  • Klagenfurt, Austria, 9020
    • LKH Klagenfurt am Woerthersee
  • Krems, Austria, 3500
    • Krems University Hospital
  • Linz, Austria
    • Hospital Elisabethinen Linz
  • Salzburg, Austria, 5020
    • LKH Salzburg University Hospital
  • Vienna, Austria, 1090
    • AKH - Medical University of Vienna
  • Vienna, Austria, 1210
    • Clinic Floridsdorf
  • Vienna, Austria, 1140
    • Standort Penzing der Klinik Ottakring
  • Wels, Austria, 4600
    • Klinikum Wels - Grieskirchen GmbH
• Belgium
  • Antwerp, Belgium, 2020
    • Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-Luc
  • Brussels, Belgium, 1070
    • ULB Hopital Erasme
  • Ghent, Belgium, 9000
    • Universitair Ziekenhuis Gent
  • Leuven, Belgium, 3000
    • UZ Leuven
  • Liège, Belgium, 4000
    • Centre Hospitalier Universitaire de Liege
  • 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 de Minas Gerais (HCUFMG)
  • Curitiba, Brazil, 80440-210
    • Edumed - Educacao e Saude SA
  • Goiânia, Brazil, 74110-030
    • CLARE - Clinica de Pneumologia
  • Porto Alegre, Brazil, 90035-074
    • Irmandade da Santa Casa de Misericórdia de Porto Alegre
  • Porto Alegre - RS, Brazil, CEP 91350-
    • Hospital Nossa Senhora da Conceicao
  • Salvador, Brazil, 41920-900
    • Instituto D´Or de Pesquisa e Ensino - Bahia
  • Santo André, Brazil, 09060-870
    • Faculdade de Medicina do ABC
  • São Bernardo do Campo, Brazil, 09780-000
    • CEMEC - Centro Multidisciplinar de Estudos Clínicos
  • São Paulo, Brazil, 01323-020
    • Hospital Alemao Oswaldo Cruz
  • São Paulo, Brazil, 05403-000
    • Hospital das Clínicas da FMUSP
• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 3H5
      • Kelowna Respirology & Allergy Research
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • St. Paul's Hospital (Vancouver)
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 2Z3
      • Dr. Georges-L.-Dumont University Hospital Centre
  • Ontario
    • Hamilton, Ontario, Canada, L8N 1Y2
      • 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)
    • Québec, Quebec, Canada, G1V 4G5
      • IUCPQ (Laval University)
    • Trois-Rivières, Quebec, Canada, G8T 7A1
      • CIC Mauricie inc.
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Royal University Hospital (Saskatoon)
• Chile
  • Providencia, Santiago de Chile, Chile, 7500000
    • Instituto Nacional del Tórax
  • Talca, Chile, 3465586
    • Centro de Investigación del Maule
• China
  • Beijing, China, 100853
    • Chinese PLA General Hospital
  • Beijing, China, 100020
    • Beijing Chao-Yang Hospital
  • Beijing, China, 100029
    • China-Japan Friendship Hospital
  • Beijing, China, 100032
    • Peking Union Medical College Hospital
  • Changsha, China, 410011
    • The Second Xiangya Hospital of Central South University
  • Chengdu, China, 610041
    • West China Hospital of Sichuan University
  • Guangzhou, China, 510080
    • Guangdong Provincial People's Hospital
  • Guangzhou, China, 510515
    • NanFang Hosptial
  • Guangzhou, China, 510120
    • First Affiliated Hospital of Guangzhou Medical University
  • Hangzhou, China, 310013
    • Zhejiang Hospital
  • Hangzhou, China, 310009
    • The Second Affiliated Hospital Zhejiang University School of Medicine
  • Hangzhou, China, 310006
    • Hangzhou First People's Hospital
  • Hangzhou, China, 310016
    • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
  • Hefei, China, 230001
    • Anhui Provincial Hospital
  • Hohhot, China, 010000
    • The Affiliated Hospital of Inner Mongolia Medical University
  • Jiaxing, China, 314000
    • The First hospital of Jiaxing
  • Jinhua, China, 321000
    • Jinhua Municipal Central Hospital
  • Nanjing, China, 210008
    • Nanjing Drum Tower Hospital
  • Ningbo, China, 315000
    • Ningbo Medical Center Lihuili 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 Affiliated to Fudan University
  • Shanghai, China, 200025
    • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
  • Shanghai, China, 200040
    • Huadong Hospital Affiliated to Fudan University
  • 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
  • Wenxzhou, China, 325000
    • The First Affiliated Hospital of Wenzhou Medical University
  • 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, 221006
    • Affiliated Hospital, Xuzhou Medical college
  • Yichang, China, 443000
    • Yichang Central People's Hospital
  • Yinchuan, China, 750004
    • General Hospital of Ningxia Medical University
  • Yuncheng, China, 044000
    • Yuncheng Central Hospital
• Croatia
  • Zagreb, Croatia, 10000
    • University hospital center Zagreb
  • Zagreb, Croatia, 10000
    • University Hospital Dubrava
  • Zagreb, Croatia, 1000
    • Solmed Polyclinic
• Czechia
  • Prague, Czechia, 140 59
    • University Thomayer´s Hospital
• Denmark
  • Hellerup, Denmark, 2900
    • Herlev and Gentofte Hospital
  • Odense, Denmark, 5000
    • Odense University Hospital
• Estonia
  • Tallinn, Estonia, 13419
    • North Estonia Medical Centre Foundation, Tallinn
• Finland
  • Helsinki, Finland, 000290
    • HYKS Keuhkosairauksien tutkimusyksikkö
  • Oulu, Finland, 90220
    • Oulun yliopistollinen keskussairaala
  • Tampere, Finland, 33521
    • Tampere University Hospital
  • Turku, Finland, 20520
    • TYKS
• France
  • Angers, France, 49 933
    • HOP d'Angers
  • Bobigny, France, 93000
    • HOP Avicenne
  • Brest, France, 29200
    • HOP de la Cavale Blanche
  • Bron, France, 69677
    • HOP Louis Pradel
  • Caen, France, 14033
    • HOP CHU Caen
  • Dijon, France, 21000
    • HOP François Mitterrand
  • La Tronche, France, 38700
    • HOP Michallon
  • Lille, France, 59037
    • INS Coeur Poumon
  • Marseille, France, 13915
    • HOP Nord
  • Montpellier, France, 34295
    • HOP Arnaud de Villeneuve
  • Nantes, France, 44093
    • HOP Nord Laennec
  • Nice, France, 06001
    • HOP Pasteur
  • Paris, France, 75877
    • HOP Bichat
  • Paris, France, 75015
    • HOP Européen G. Pompidou
  • Pessac, France, 33604
    • HOP Haut-Lévêque
  • Reims, France, 51100
    • HOP Robert Debré
  • 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
• Georgia
  • Tbilisi, Georgia, 0101
    • National Center for Tuberculosis and Lung Diseases, Tbilisi
  • Tbilisi, Georgia, 0159
    • LLC Diacor
• Germany
  • Ahrensburg, Germany, 22926
    • Velocity Clinical Research Germany GmbH, Ahrensburg
  • Bamberg, Germany, 96049
    • CIMS Studienzentrum Bamberg GmbH
  • Berlin, Germany, 12351
    • Vivantes Netzwerk für Gesundheit GmbH
  • Bonn, Germany, 53127
    • 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
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg, Eppendorf
  • Hanover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Hanover, 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 AÖR
  • Münster, Germany, 48149
    • Westfälische Wilhelms-Universität Münster
  • Nuremberg, Germany, 90419
    • Klinikum Nürnberg
  • Solingen, Germany, 42699
    • Krankenhaus Bethanien gGmbH
  • Stralsund, Germany, 18435
    • Helios Hanseklinikum Stralsund
  • Stuttgart, Germany, 70376
    • Robert Bosch Gesellschaft für medizinische Forschung mbH
  • Tübingen, Germany, 72076
    • Universitätsklinikum Tübingen
• Greece
  • Athens, Greece, 115 27
    • General Hospital of Athens "Laiko"
  • Crete, Greece, 71500
    • Hospital of Heraklion (PAGNI)
  • Ioannina, Greece, 45 500
    • Univ. Gen. Hosp. of Ioannina
  • Pátrai, Greece, 26504
    • Univ. Gen. Hosp. of Patras
  • Thessaloniki, Greece, 546 42
    • General Hospital of Thessaloniki "Hippokrateio"
• Hungary
  • Budapest, Hungary, 1083
    • Semmelweis University
  • Budapest, Hungary, 1121
    • Koranyi National Institute For Pulmonolgy
  • Debrecen, Hungary, 4032
    • University of Debrecen Clinical Centre
• India
  • Coimbatore, India, 641028
    • Hindustan Hospital
  • Mumbai, India, 400007
    • Bhatia Hospital
  • Mumbai, India, 400016
    • P.D. Hinduja National Hospital
  • Pune, India, 411 001
    • Jehangir Clinical Development Centre Pvt. Ltd.
• Ireland
  • Dublin, Ireland, D07 R2WY
    • Mater Misericordiae University Hospital
• Israel
  • Beer Yaakov, Israel, 7033001
    • Shamir Medical Center (Assaf Harofeh)
  • Beersheba, Israel, 84101
    • Soroka Univ. Medical Center
  • Haifa, Israel, 3436212
    • Lady Davis Carmel Medical Center
  • Jerusalem, Israel, 9103102
    • Shaare Zedek Medical Center, Jerusalem 91031
  • Tel Aviv, Israel, 6093246
    • Sourasky Medical Center
• Italy
  • Brescia, Italy, 25123
    • ASST degli Spedali Civili di Brescia
  • Catania, Italy, 95124
    • A.O.U. Policlinico Vittorio Emanuele
  • Florence, Italy, 50137
    • A. O. Universitaria Careggi
  • Foggia, Italy, 71100
    • Ospedale Colonnello D Avanzo
  • Forlì, Italy, 47121
    • Ospedale G.B. Morgagni
  • Milan, Italy, 20123
    • Ospedale Classificato San Giuseppe
  • Milan, Italy, 20100
    • Ospedale San Paolo-MILANO-18793
  • Modena, Italy, 41100
    • Azienda Ospedaliero-Universitaria di Modena
  • Monza, Italy, 20900
    • A.O. San Gerardo di Monza
  • Napoli, Italy, 80131
    • Osp. dei Colli Monaldi
  • Padua, Italy, 35128
    • Azienda Ospedaliera Universitaria di Padova
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario A. Gemelli IRCCS
  • Roma, Italy, 00133
    • Pol. Universitario Tor Vergata
  • Siena, Italy, 53100
    • A.O.U. Senese
  • Torrette Di Ancona (Ancona), Italy, 60126
    • Ospedali Riuniti di Ancona
  • Trieste, Italy, 34100
    • Ospedale di Cattinara
• Japan
  • Aichi, Seto, Japan, 489-8642
    • Tosei General Hospital
  • Aichi, Toyoake, Japan, 470-1192
    • Fujita Health University 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, Kitakyushu, Japan, 807-8556
    • Hospital of the University of Occupational and Environmental Health
  • 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
  • Hokkaido, Sapporo, Japan, 060-8648
    • Hokkaido 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
  • Kagawa, Kita-gun, Japan, 761-0793
    • Kagawa University Hospital
  • Kanagawa, Yokohama, Japan, 236-0051
    • Kanagawa Cardiovascular and Respiratory Center
  • Kumamoto, Kumamoto, Japan, 861-4193
    • Saiseikai Kumamoto Hospital
  • Kyoto, Kyoto, Japan, 606-8507
    • Kyoto University Hospital
  • Miyagi, Sendai, Japan, 980-8574
    • Tohoku University Hospital
  • Nagasaki, Nagasaki, Japan, 852-8501
    • Nagasaki University Hospital
  • Osaka, Sakai, Japan, 591-8555
    • National Hospital Organization Kinki-Chuo Chest Medical Center
  • Osaka, Sakai, Japan, 590-0197
    • Kindai University Hospital
  • Osaka, Takatsuki, Japan, 569-8686
    • Osaka Medical and Pharmaceutical University Hospital
  • Saitama, Saitama, Japan, 330-8553
    • Saitama Red Cross 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, Bunkyo-ku, Japan, 113-8603
    • Nippon Medical School Hospital
  • Tokyo, Bunkyo-ku, Japan, 113-8519
    • Institute of Science Tokyo 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, 160-8582
    • Keio University Hospital
  • Tokyo, Shinjuku-ku, Japan, 162-8655
    • National Center for Global Health and Medicine
  • Wakayama, Wakayama, Japan, 641-8510
    • Wakayama Medical University Hospital
• 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-Pulau Pinang-21953
• Mexico
  • Chihuahua City, Mexico, 31203
    • Centro de Investigacion Integral MEDIVEST S.C
  • Coyoacán, Mexico, 04380
    • CREPID Aire y Salud
  • León, Mexico, 37160
    • Centro de Investigacion Farmacologica del Bajío, S.C.
  • Mexico City, Mexico, 03650
    • Soltmed Smo
  • Mexico City, Mexico, 14050
    • Centro Respiratorio de Mexico
  • Monterrey, Mexico, 64460
    • Centro de Prevención y Rehabilitación de Enfermedades Pulmon
  • Oaxaca City, Mexico, 68000
    • Oaxaca Site Management Organization, S.C.
• Netherlands
  • Heerlen, Netherlands, 6419 PC
    • Zuyderland Medisch Centrum
  • Leiden, Netherlands, 2333 ZA
    • Leids Universitair Medisch Centrum (LUMC)
  • Nieuwegein, Netherlands, 3435 CM
    • St. Antonius Ziekenhuis, locatie Nieuwegein
  • Rotterdam, Netherlands, 3015 CE
    • Erasmus Medisch Centrum-ROTTERDAM-50697
• 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
  • Katowice, Poland, 40-635
    • Leszek Giec Upper-Silesian Med.Cent.Silesian Med.Univ.
  • Warsaw, Poland, 01-138
    • Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa
  • Warsaw, Poland, 02097
    • University Clinical Center of the Medical University of Warsaw
  • Świdnik, Poland, 21040
    • Alergopneuma Medical Center
• Portugal
  • Braga, Portugal, 4710-243
    • ULS Braga
  • Lisbon, Portugal, 1169-024
    • ULS de São José, E.P.E.
  • Matosinhos Municipality, Portugal, 4454-509
    • USLM, EPE - Hospital Pedro Hispano
  • Vila Nova de Gaia, Portugal, 4434-502
    • ULS de Gaia/Espinho, EPE
• Puerto Rico
  • Guaynabo, Puerto Rico, 00968
    • Allianze Pulmonary Research LLC
• Saudi Arabia
  • Dammam, Saudi Arabia, 31444
    • King Fahad Specialist Hospital - Research Center
  • Riyadh, Saudi Arabia, 11211
    • King Faisal Specialist Hospital and Research Center
  • Riyadh, Saudi Arabia, 11481
    • King Abdullah International Medical Research Center
• Serbia
  • Belgrade, Serbia, 11000
    • University Clinical Center of Serbia
  • Kamenitz, Serbia, 21204
    • Institute for Pulmonary Diseases of Vojvodina
  • Kragujevac, Serbia, 34000
    • University Clinical Center of Kragujevac
  • Niš, Serbia, 18000
    • University Clinical Center Nis
• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital
  • Singapore, Singapore, 119074
    • National University Hospital-Singapore-42005
• Slovenia
  • Golnik, Slovenia, 4204
    • Hospital Golnik - Univ. Clinic of Pulmonary and Allergic Diseases
• 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
• South Korea
  • Bucheon-si, South Korea, 14647
    • The Catholic University of Korea, Bucheon St.Mary's Hospital
  • Seongnam, South Korea, 13620
    • Seoul National University Bundang Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 04401
    • Soonchunhyang University Hospital Seoul
  • Seoul, South Korea, 03722
    • Severance Hospital
  • Seoul, South Korea, 02447
    • Kyung Hee University Hospital
• 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 Universitari 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 Universitari de Bellvitge
  • Madrid, Spain, 28034
    • Hospital Universitario Ramón y Cajal
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañón
  • Madrid, Spain, 28006
    • Hospital La Princesa
  • Madrid, Spain, 28031
    • Hospital Universitario Infanta Leonor
  • Málaga, Spain, 29010
    • Hospital Virgen de la Victoria
  • Oviedo, Spain, 33011
    • Hospital Central de Asturias
  • Pozuelo de Alarcón, Spain, 28223
    • Hospital Quirónsalud Madrid
  • Santander, Spain, 39008
    • Hospital Universitario Marques de Valdecilla
  • Santiago de Compostela, Spain, 15706
    • Hospital Clínico de Santiago
  • Seville, Spain, 41013
    • Hospital Virgen Del Rocio
  • Seville, Spain, 41014
    • Hospital Nuestra Señora de Valme
• Sweden
  • Uppsala, Sweden, 75185
    • Akademiska sjukhuset
• Switzerland
  • Basel, Switzerland, 4031
    • Universitätsspital Basel
  • Bern, Switzerland, 3010
    • University Hospital Bern
• Taiwan
  • Changhua, Taiwan, 500
    • Chang-Hua Christian Hospital
  • Kaohsiung City, Taiwan, 83301
    • Kaohsiung Chang Gung Memorial Hospital
  • Taichung, Taiwan, 407
    • Taichung Veterans General Hospital
  • Tainan, Taiwan, 704
    • NCKUH
  • 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
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06620
    • Ankara Universitesi Tip Fakultesi
  • Ankara, Turkey (Türkiye), 06010
    • Gulhane Training and Research Hospital
  • Antalya, Turkey (Türkiye), 07059
    • Akdeniz Universitesi Tip Fakultesi -ANTALYA-33606
  • Bursa, Turkey (Türkiye), 16120
    • Uludag Universitesi Tip Fakultesi
  • Istanbul, Turkey (Türkiye), 34390
    • Istanbul Universitesi Istanbul Tip Fakultesi
  • Yenimahalle/ANKARA, Turkey (Türkiye), 06560
    • Gazi Universitesi Tip Fakultesi
• United Kingdom
  • Aberdeen, United Kingdom, AB25 2ZN
    • Aberdeen Royal Infirmary
  • Birmingham, United Kingdom, B15 2GW
    • Queen Elizabeth Hospital Birmingham
  • 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, Wonford
  • Lancaster, United Kingdom, LA1 4RP
    • Royal Lancaster Infirmary
  • Leeds, United Kingdom, LS9 7TF
    • St James's University Hospital
  • London, United Kingdom, SE1 9RT
    • Guy's Hospital
  • London, United Kingdom, SW3 6NP
    • Royal Brompton Hospital
  • Londonderry, United Kingdom, BT47 6SB
    • Altnagelvin Area Hospital
  • Manchester, United Kingdom, M23 9LT
    • Wythenshawe Hospital
  • Oxford, United Kingdom, OX3 7LJ
    • Churchill Hospital
  • Southampton, United Kingdom, SO16 6YD
    • Southampton General Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona
  • 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
  • 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, 30322
      • The Emory Clinic
    • Atlanta, Georgia, United States, 30309
      • Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Evanston Hospital Pulmonary Clinic
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University Hospital and Clinic
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02135
      • St. Elizabeth's Medical Center
    • 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
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic, Rochester
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • Nevada
    • Reno, Nevada, United States, 89502
      • Renown Regional Medical Center
  • New York
    • Commack, New York, United States, 11725
      • Stony Brook University Medical Center
    • New York, New York, United States, 10032
      • Columbia University Medical Center-New York Presbyterian Hospital
    • New York, New York, United States, 10021
      • Lenox Hill Hospital
    • New York, New York, United States, 10065
      • NewYork-Presbyterian/Weill Cornell Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Winston-Salem, North Carolina, United States, 27103
      • Southeastern Research Center-Winston-Salem-61365
  • 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, 19140
      • Temple University Hospital
    • Philadelphia, Pennsylvania, United States, 19107
      • Jefferson Health Honickman Center
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • Infinity Medical Research, Inc.
  • 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
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center
    • Denison, Texas, United States, 75020
      • Premier Pulmonary Critical Care and Sleep Medicine
    • San Antonio, Texas, United States, 78229
      • UT Health San Antonio
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center-Murray-69497
    • Salt Lake City, Utah, United States, 84108
      • University of Utah Health Sciences Center
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital
  • 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: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

1. Patients ≥18 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 progressive fibrosing ILD other than IPF (physician confirmed).

4. 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.
5. Forced Vital Capacity (FVC) ≥45% of predicted normal at Visit 1.
6. 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
8. 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.

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 Interstitial Lung Disease (ILD) 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. 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).
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
Experimental: Nerandomilast 9 mg; Patients 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.	Drug: BI 1015550; 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.; Other Names: Nerandomilast, JASCAYD®
Experimental: Nerandomilast 18 mg; Patients 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.	Drug: BI 1015550; 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.; Other Names: Nerandomilast, JASCAYD®
Placebo Comparator: Placebo; Patients 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.	Drug: Placebo; Participants received placebo matching 9 mg or 18 mg nerandomilast film-coated tablets orally, twice daily, in the morning and in the evening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Time to first occurrence of any of the components of the composite endpoint - acute interstitial lung disease (ILD) exacerbation, first hospitalisation for respiratory cause, or death (whichever occurred first) - is reported as the number of participants who experienced any of these events during the trial. Acute exacerbation of ILD describes an acute, clinically significant, respiratory deterioration characterized by evidence of new widespread alveolar abnormality with all of the following: Acute worsening or development of dyspnea typically with less than 1 month duration, computed tomography with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with fibrosing ILD, and deterioration not fully explained by cardiac failure or fluid overload. If more than one component occurred on the same day, the patient was counted under the first event according to the following hierarchy: acute ILD exacerbation, hospitalization, death.	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	Time to first acute ILD exacerbation or death over the duration of the trial is reported as the number of patients who experienced either event. Acute exacerbation of ILD describes an acute, clinically significant, respiratory deterioration characterized by evidence of new widespread alveolar abnormality with all of the following: Acute worsening or development of dyspnea typically with less than 1 month duration, computed tomography with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with fibrosing ILD, and deterioration not fully explained by cardiac failure or fluid overload. If more than one component occurred on the same day, the patient was counted under the first event according to the following hierarchy: acute IPF exacerbation followed by death.	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	Time to hospitalisation for respiratory cause or death over the duration of the trial is reported as the number of participants who experienced either event. Hospitalizations due to respiratory causes were recorded on a specific non-elective hospitalization CRF page. This page captured the hospitalization date, confirmation of a respiratory cause, and the primary admission diagnosis. Time to death was based either on the date of death on the adverse event (AE) report for patients with AEs leading to death or was based on the information from the vital status assessment.	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	Time to death over the duration of the trial is reported as the number of participants who died. Time to death was based either on the date of death on the AE report for patients with AEs leading to death or based on the information from the vital status assessment.	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	Absolute change from baseline in forced vital capacity (FVC) percent (%) predicted at Week 52 is reported. Analysis was based on a Mixed Model for Repeated Measures (MMRM), with fixed, categorical effects of treatment at each visit, baseline antifibrotic therapy at each visit, baseline HRCT pattern at each visit, the fixed continuous effects of baseline FVC [% pred] at each visit and unstructured covariance for repeated measures. Baseline antifibrotic therapy and HRCT pattern as entered in the CRF pages were used as covariates.	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.
Time to Absolute Decline in Forced Vital Capacity (FVC) % Predicted of >10% From Baseline or Death Over the Duration of the Trial	The time to absolute decline of more than 10% from baseline in forced vital capacity (FVC) percent predicted, or death, over the duration of the trial is reported as the number of participants who experienced either event. If multiple components occurred on the day of first event, then the patient was only counted in the first component based on the following hierarchy: absolute decline in FVC % predicted of > 10% followed by death.	From first administration of trial drug (Nerandomilast or Placebo) till end of study, up to 26.2 months.
Absolute Change From Baseline in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) % Predicted (Corrected for Hb) at Week 52	The absolute change from baseline in Diffusing Capacity of the Lungs for Carbon Monoxide percent predicted (corrected for hemoglobin, Hb) at Week 52 is reported.. Analysis was based on a Mixed Model for Repeated Measures (MMRM), with fixed, categorical effects of treatment at each visit, baseline antifibrotic therapy at each visit, baseline HRCT pattern at each visit, the fixed continuous effects of baseline DLCO [% pred] at each visit and unstructured covariance for repeated measures. Baseline antifibrotic therapy and HRCT pattern as entered in the CRF pages were used as covariates.	The MMRM model is a longitudinal analysis and it incorporated DLCO measurements from baseline (Week -8 to Week -1) and Week 12, Week 26, and Week 52. The data represent the adjusted Least Square Means for change from baseline at Week 52.
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	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 is reported as the number of participants who experienced either event. The Predicted DLCO value was corrected for hemoglobin (Hb). If more than one component occurred on the same day, the patient was counted under the first event according to the hierarchy: Absolute decline in DLCO % predicted of > 15%, followed by Death.	From first administration of trial drug (Nerandomilast or Placebo) till end of study, up to 26.2 months.
Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Dyspnea Domain Score at Week 52	The absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Dyspnea domain score at Week 52 is reported. The Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44-item tool consisting of two modules: Symptoms (23 items) and Impacts (21 items). The Symptoms module yields three domain scores: Dyspnoea, Cough, and Fatigue, as well as a Total Symptoms score. Scoring is based on the mean of item ratings within each domain, multiplied by 100. Scores range from 0 to 100, with higher scores indicating greater impairment. This endpoint was analyzed using a Mixed Model for Repeated Measures (MMRM). The model included fixed effects for treatment, baseline antifibrotic therapy, baseline HRCT pattern, and fixed continuous effect of baseline L-PF dyspnea score at each visit, with an unstructured covariance for repeated measures. Baseline antifibrotic therapy and HRCT pattern as entered in the CRF pages were covariates.	The MMRM model is a longitudinal analysis and it incorporated L-PF measurements from baseline (Week -8 to Week -1) and Week 12, Week 26, Week 36, Week 44 and Week 52. The data represent the adjusted Least Square Means for change from baseline at Week 52.
Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Cough Domain Score at Week 52	The absolute change from baseline in the L-PF Cough domain score at Week 52 is reported. The Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44-item tool consisting of two modules: Symptoms (23 items) and Impacts (21 items). The Symptoms module yields three domain scores: Dyspnea, Cough, and Fatigue, as well as a Total Symptoms score. Scoring is based on the mean of item ratings within each domain, multiplied by 100. Scores range from 0 to 100, with higher scores indicating greater impairment. This endpoint was analyzed using a Mixed Model for Repeated Measures (MMRM). The model included fixed effects for treatment, baseline antifibrotic therapy, baseline HRCT pattern, and fixed continuous effect of baseline L-PF dyspnea score at each visit, with an unstructured covariance for repeated measures. Baseline antifibrotic therapy and HRCT pattern as entered in the CRF pages were covariates.	The MMRM model is a longitudinal analysis and it incorporated L-PF measurements from baseline (Week -8 to Week -1) and Week 12, Week 26, Week 36, Week 44 and Week 52. The data represent the adjusted Least Square Means for change from baseline at Week 52.
Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Fatigue Domain Score at Week 52	The absolute change from baseline in the L-PF Fatigue domain score at Week 52 is reported. The Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44-item tool consisting of two modules: Symptoms (23 items) and Impacts (21 items). The Symptoms module yields three domain scores: Dyspnea, Cough, and Fatigue, as well as a Total Symptoms score. Scoring is based on the mean of item ratings within each domain, multiplied by 100. Scores range from 0 to 100, with higher scores indicating greater impairment. This endpoint was analyzed using a Mixed Model for Repeated Measures (MMRM). The model included fixed effects for treatment, baseline antifibrotic therapy, and baseline HRCT pattern at each visit, and fixed continuous effect of baseline L-PF Fatigue score at each visit, with an unstructured covariance for repeated measures. Baseline antifibrotic therapy and HRCT pattern as entered in the CRF pages were covariates.	The MMRM model is a longitudinal analysis and it incorporated L-PF measurements from baseline (Week -8 to Week -1) and Week 12, Week 26, Week 36, Week 44 and Week 52. The data represent the adjusted Least Square Means for change from baseline at Week 52.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

General Publications

• Maher 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.
• Maher 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.
• 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. doi: 10.1186/s12890-025-03973-7. Online ahead of print.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2022
• Primary Completion (Actual): December 18, 2024
• Study Completion (Actual): April 14, 2025

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): January 9, 2026
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Substandard Drugs; Pharmaceutical Preparations; BI 1015550
• Other Study ID Numbers: 1305-0023; 2022-001134-11 (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: 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.
• 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