A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)

October 15, 2025 updated by: Boehringer Ingelheim

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1177

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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, C1425FVH
        • Consultorios Médicos del Buen Ayre
      • 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, 6163
        • TrialsWest
  • Austria
      • 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
      • 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
        • UNIV UZ 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 Misericordia de Porto Alegre
      • Salvador, Brazil, 41920-900
        • Instituto D´Or de Pesquisa e Ensino - Bahia
      • São Bernardo do Campo, Brazil, 09780-000
        • CEMEC - Centro Multidisciplinar de Estudos Clínicos
      • São Paulo, Brazil, 01323-020
        • Hospital Alemao Oswaldo Cruz
  • Canada
      • Québec, 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, 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
    • 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'Universite de Montreal (CHUM)
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre (MUHC)
      • Trois-Rivières, Quebec, Canada, G8T 7A1
        • CIC Mauricie inc.
  • Chile
      • Providencia, Santiago de Chile, Chile, 7500691
        • Instituto Nacional del tórax
      • Talca, Chile, 3465586
        • Centro de Investigacion 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 of Sichuan University
      • 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 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
      • 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
  • 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, 13419
        • 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, 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
      • Le Kremlin-Bicêtre, France, 94275
        • HOP Bicêtre
      • Lille, France, 59037
        • INS Coeur Poumon
      • Marseille, France, 13915
        • HOP Nord
      • Nantes, 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, 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
  • 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, 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
      • 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 - Campus Grosshadern
      • Nuremberg, 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
        • Universitatsklinikum Tubingen
      • Wuppertal, Germany, 42283
        • Petrus-Krankenhaus
  • Greece
      • Crete, Greece, 71500
        • Hospital of Heraklion (PAGNI)
      • Ioannina, Greece, 45 500
        • Univ. Gen. Hosp. of Ioannina
      • Pátrai, Greece, 26504
        • Univ. Gen. Hosp. of Patras
  • Hungary
      • Budapest, Hungary, 1121
        • Koranyi National Institute For Pulmonolgy
      • Debrecen, Hungary, 4032
        • University of Debrecen Clinical Centre
  • Ireland
      • Dublin, Ireland, D15 X40D
        • Connolly Hospital Blanchardstown
  • Italy
      • 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
      • Modena, Italy, 41100
        • Azienda Ospedaliera Policlinico di Modena
      • 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
  • 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
        • 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
      • 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
      • 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
      • Warsaw, Poland, 01-138
        • Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa
      • Świdnik, Poland, 21040
        • Alergopneuma Medical Center
  • Portugal
      • Coimbra, Portugal, 3004-561
        • ULS de Coimbra, E.P.E.
      • Matosinhos Municipality, 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, 308433
        • Tan Tock Seng Hospital
      • Singapore, Singapore, 119074
        • National University Hospital-Singapore-42005
  • 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 Clínic 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 De Bellvitge
      • Lugo, Spain, 27004
        • Hospital Universitario Lucus Augusti
      • Madrid, Spain, 28034
        • Hospital Universitario Ramón y Cajal
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de octubre
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon
      • 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
      • 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
      • Seville, Spain, 41013
        • Hospital Virgen del Rocío
      • Seville, Spain, 41014
        • Hospital Nuestra Senora de Valme
      • Valencia, Spain, 46014
        • Hospital General Universitario de Valencia
  • Sweden
      • Linköping, Sweden, 581 85
        • Universitetssjukhuset, Linköping
      • Stockholm, Sweden, 141 52
        • Sahlgrenska Universitetsjukhuset
      • Uppsala, Sweden, 75185
        • Akademiska Sjukhuset
  • Switzerland
      • Basel, Switzerland, 4031
        • Universitätsspital Basel
  • 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 City, 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
      • 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, 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, 19713
        • Christiana Hospital
    • District of Columbia
      • Washington D.C., 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-Atlanta-57055
    • 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, 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
      • 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
      • St 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, 10032
        • Columbia University Medical Center-New York Presbyterian Hospital
      • New York, New York, United States, 10065
        • Weill Cornell Medicine-New York-59955
    • 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
    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Nerandomilast 9 mg BID
Participants received 9 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.
Drug: BI 1015550
Participants received film-coated nerandomilast tablets orally twice daily at doses of either 9 mg or 18 mg, with each dose administered at least 12 hours apart and taken with 250 mL of water.
Other Names:
  • Nerandomilast, JASCAYD®
Experimental: Nerandomilast 18 mg BID
Participants received 18 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.
Drug: BI 1015550
Participants received film-coated nerandomilast tablets orally twice daily at doses of either 9 mg or 18 mg, with each dose administered at least 12 hours apart and taken with 250 mL of water.
Other Names:
  • Nerandomilast, JASCAYD®
Placebo Comparator: Placebo
Participants received placebo matching 9 mg or 18 mg nerandomilast film-coated tablets orally twice daily, with doses given at least 12 hours apart and each taken with 250 mL of water.
Drug: Placebo
Participants received placebo matching 9 mg or 18 mg nerandomilast film-coated tablets orally twice daily, with doses given at least 12 hours apart and each taken with 250 mL of water.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Absolute Change From Baseline in Forced Vital Capacity (FVC) [mL] at Week 52
Time Frame: The MMRM model is a longitudinal analysis, and it incorporated FVC measurements from baseline (Week -8 to Week -1) and Week 2, Week 6, Week 12, Week 18, Week 26, Week 36, Week 44 and Week 52. The data represent the Least Squares Mean at Week 52

The absolute change from baseline in Forced Vital Capacity (FVC) [mL] at Week 52 is reported.

The absolute change from baseline in forced vital capacity (FVC) at Week 52 was analyzed using a restricted maximum likelihood (REML)-based mixed model with repeated measures (MMRM). The model included fixed categorical effects of treatment and baseline antifibrotic use at each visit, as well as the continuous effect of baseline FVC. Visit was treated as a repeated measure, with an unstructured covariance structure for within-patient variability.
The MMRM model is a longitudinal analysis, and it incorporated FVC measurements from baseline (Week -8 to Week -1) and Week 2, Week 6, Week 12, Week 18, Week 26, Week 36, Week 44 and Week 52. The data represent the Least Squares Mean at Week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Key Secondary Endpoint: Time to the First Occurrence of Any of the Components of the Composite Endpoint: Time to First Acute IPF Exacerbation, First Hospitalization for Respiratory Cause, or Death (Whichever Occurs First) Over the Duration of the Trial
Time Frame: From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months.

Time to the first occurrence of any component of the composite endpoint-acute IPF exacerbation, hospitalization for a respiratory cause, or death (whichever occurred first)-is reported as the number of participants who experienced one or more of these events during the trial.

Acute IPF is defined as 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 of less than 1 month's duration.

Computed tomography showing new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with IPF.

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, hospitalization, death.
From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months.
Time to First Acute IPF Exacerbation or Death Over the Duration of the Trial
Time Frame: From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months.

The time to first acute IPF exacerbation or death during the trial is reported as the number of participants who experienced either event.

Acute IPF is defined as 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 of less than 1 month's duration.

Computed tomography showing new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with IPF.

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 any trial drug (Nerandomilast or Placebo) up to 22.9 months.
Time to Hospitalization for Respiratory Cause or Death Over the Duration of the Trial
Time Frame: From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months.

Time to hospitalization for respiratory cause or death over the duration of the trial 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.

If more than one component occurred on the same day, the patient was counted under the first event according to the hierarchy: hospitalization for respiratory cause, followed by death.
From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months.
Time to Absolute Decline in Forced Vital Capacity (FVC) % Predicted of >10% From Baseline or Death Over the Duration of the Trial
Time Frame: From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months.

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 more than one component occurred on the same day, the patient was counted under the first event according to the hierarchy; Absolute decline in FVC % predicted of > 10% followed by death.
From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months.
Time to Absolute Decline in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) Percentage Predicted by More Than 15% From Baseline or Death, Measured Over the Duration of the Trial
Time Frame: From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months.

The time to absolute decline of more than 15% from baseline in diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted, or death, over the duration of the trial is reported as the number of participants who experienced either event.

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 any trial drug (Nerandomilast or Placebo) up to 22.9 months.
Time to Death Over the Duration of the Trial
Time Frame: From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months.

Time to death over the duration of the trial is reported as the number of participants who died.

Time to death will be based either on the date of death on the AE report for patients with AEs leading to death or will be based on the information from the vital status assessment.
From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months.
Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Dyspnea Domain Score at Week 52
Time Frame: 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 Least Squares Mean at Week 52.

The absolute change from baseline in the Living with Pulmonary Fibrosis (L-PF) Symptoms Dyspnea domain score at Week 52 is reported. This endpoint was analyzed using a Mixed Model for Repeated Measures (MMRM). The model included fixed effects for treatment, baseline use of antifibrotic therapy, and baseline dyspnea score at each visit, with an unstructured covariance structure to model repeated measures.

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.
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 Least Squares Mean at Week 52.
Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Cough Domain Score at Week 52
Time Frame: 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 Least Squares Mean at Week 52.

The absolute change from baseline in the L-PF Cough domain score at Week 52 is reported. This endpoint was analyzed using a Mixed Model for Repeated Measures (MMRM). The model included fixed effects for treatment, baseline antifibrotic therapy, and baseline L-PF Cough score at each visit, with an unstructured covariance matrix for repeated measures.

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.
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 Least Squares Mean at Week 52.
Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Fatigue Domain Score at Week 52
Time Frame: 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 Least Squares Mean at Week 52.

The absolute change from baseline in the Living with Pulmonary Fibrosis (L-PF) Fatigue domain score at Week 52 is reported.

The analysis used a mixed model for repeated measures (MMRM) with fixed categorical effects for treatment, baseline antifibrotic (AF) therapy, and the fixed continuous effect of baseline L-PF score. Covariance was unstructured. Baseline AF therapy was a covariate.

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.
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 Least Squares Mean at Week 52.
Absolute Change From Baseline in Forced Vital Capacity Percent Predicted at Week 52
Time Frame: The MMRM model is a longitudinal analysis, and it incorporated FVC measurements from baseline (Week -8 to Week -1) and Week 1, Week 2, Week 6, Week 12, Week 18, Week 26, Week 36, Week 44 and Week 52. The data represent the Least Squares Mean at Week 52.

The absolute change from baseline in Forced Vital Capacity percent predicted at Week 52 is reported.

Analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment at each visit, baseline use of antifibrotic therapy at each visit, and the fixed continuous effects of baseline forced vital capacity (FVC) percentage predicted at each visit. An unstructured covariance structure was used to model repeated measures within patients.

Baseline use of antifibrotic therapy, as recorded in the concomitant medication case report form (CRF) page, was included as a covariate.
The MMRM model is a longitudinal analysis, and it incorporated FVC measurements from baseline (Week -8 to Week -1) and Week 1, Week 2, Week 6, Week 12, Week 18, Week 26, Week 36, Week 44 and Week 52. The data represent the Least Squares Mean at Week 52.
Absolute Change From Baseline in Diffusing Capacity of the Lungs for Carbon Monoxide Percent Predicted at Week 52
Time Frame: 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 Least Squares Mean at Week 52.

The absolute change from baseline in Diffusing Capacity of the Lungs for Carbon Monoxide percent predicted at Week 52 is reported.

The analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment at each visit, baseline use of antifibrotic therapy at each visit, and the fixed continuous effects of baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted at each visit. An unstructured covariance structure was used to model repeated measures within patients.

Baseline use of antifibrotic therapy, as recorded in the concomitant medication case report form (CRF) page, was included as a covariate.
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 Least Squares Mean at Week 52.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 6, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 16, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 17, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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