A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast (FIBRONEER™-ON)

August 19, 2026 updated by: Boehringer Ingelheim

An Open-label Extension Trial of the Long-term Safety and Efficacy of BI 1015550 Taken Orally in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF) (FIBRONEER™-ON)

This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called nerandomilast or BI 1015550.

The goal of this study is to find out how well people with pulmonary fibrosis tolerate long- term treatment with nerandomilast. The study also tests whether nerandomilast improves lung function and prolongs the time until symptoms get worse, participants need to go to the hospital, or die.

Every participant takes nerandomilast as tablets for up to 1 year and 10 months. The participants may also continue their regular treatment for pulmonary fibrosis during the study.

Participants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. Participants also regularly do lung function tests.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1700

Phase

  • 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 Locations

  • Argentina
      • C.a.b.a, Argentina, 1056
        • Active, not recruiting
        • Centro de Investigaciones Metabólicas (CINME)
      • CABA, Argentina, C1060ABN
        • Active, not recruiting
        • CEDIC - Centro de Investigacion Clinica
      • CABA, Argentina, C1199ABD
        • Active, not recruiting
        • Hospital Italiano de Buenos Aires
      • Capital Federal, Argentina, 1425
        • Active, not recruiting
        • Consultorios Médicos del Buen Ayre
      • Florida, Argentina, B1602DQD
        • Active, not recruiting
        • CEMER-Centro Medico De Enfermedades Respiratorias
      • Mar del Plata, Argentina, 7600
        • Active, not recruiting
        • Instituto Ave Pulmo - Fundacion Enfisema
      • Mendoza, Argentina, M5500CCG
        • Active, not recruiting
        • INSARES
      • Quilmes, Argentina, B1878FNR
        • Active, not recruiting
        • Centro Respiratorio de Quilmes
      • Rosario, Argentina, S2000DEJ
        • Completed
        • Instituto Medico de La Fundacion Estudios Clinicos
  • Australia
      • Macquarie Park, Australia, 2109
        • Completed
        • Macquarie University
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • Active, not recruiting
        • Canberra Hospital
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Active, not recruiting
        • Royal Prince Alfred Hospital
      • Westmead, New South Wales, Australia, 2145
        • Active, not recruiting
        • Westmead Hospital
    • Queensland
      • Chermside, Queensland, Australia, 4032
        • Active, not recruiting
        • The Prince Charles Hospital
      • Chermside, Queensland, Australia, 4032
        • Active, not recruiting
        • Lung Research Queensland
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Active, not recruiting
        • Royal Adelaide Hospital
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Active, not recruiting
        • Austin Hospital
      • Melbourne, Victoria, Australia, 3004
        • Active, not recruiting
        • The Alfred Hospital
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Active, not recruiting
        • Fiona Stanley Hospital
      • Spearwood, Western Australia, Australia, 6163
        • Completed
        • Trialswest
  • Austria
      • Krems, Austria, 3500
        • Active, not recruiting
        • Krems University Hospital
      • Salzburg, Austria, 5020
        • Active, not recruiting
        • LKH Salzburg University Hospital
      • Vienna, Austria, 1090
        • Active, not recruiting
        • Medical University of Vienna
      • Vienna, Austria, 1210
        • Active, not recruiting
        • Clinic Floridsdorf
      • Vienna, Austria, 1140
        • Active, not recruiting
        • Standort Penzing der Klinik Ottakring
      • Wels, Austria, 4600
        • Active, not recruiting
        • Klinikum Wels - Grieskirchen GmbH
  • Belgium
      • Antwerp, Belgium, 2020
        • Active, not recruiting
        • Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim
      • Brussels, Belgium, 1200
        • Active, not recruiting
        • Cliniques Universitaires Saint-Luc
      • Brussels, Belgium, 1070
        • Active, not recruiting
        • Hopital Erasme
      • Ghent, Belgium, 9000
        • Active, not recruiting
        • Universitair Ziekenhuis Gent
      • Leuven, Belgium, 3000
        • Active, not recruiting
        • UZ Leuven
      • Liège, Belgium, 4000
        • Completed
        • Centre Hospitalier Universitaire de Liège
      • Yvoir, Belgium, 5530
        • Active, not recruiting
        • Yvoir - UNIV UCL de Mont-Godinne
  • Brazil
      • Barra Mansa, Brazil, 27323240
        • Active, not recruiting
        • Serviços Medicos Respirar Sul Fluminense
      • Belo Horizonte,Minas Gerais, Brazil, 31270901
        • Active, not recruiting
        • Hospital das Clinicas da Universidade Federal de Minas Gerais (HC-UFMG)
      • Curitiba, Brazil, 80810-000
        • Active, not recruiting
        • SAPIENS - Instituto de Estudos e Pesquisa Clínica
      • Goiânia, Brazil, 74110-030
        • Active, not recruiting
        • CLARE - Clinica de Pneumologia
      • Porto Alegre, Brazil, 90020-090
        • Active, not recruiting
        • Irmandade Santa Casa de Misericordia de Porto Alegre
      • Porto Alegre - RS, Brazil, 91350-250
        • Active, not recruiting
        • Hospital Nossa Senhora da Conceicao
      • São Bernardo do Campo, Brazil, 09715-090
        • Active, not recruiting
        • CEMEC - Centro Multidisciplinar de Estudos Clínicos
      • São Paulo, Brazil, 05403-000
        • Active, not recruiting
        • Hospital Das Clinicas Da Faculdade De Medicina Da USP
      • São Paulo, Brazil, 01327-001
        • Active, not recruiting
        • Hospital Alemao Oswaldo Cruz
  • Canada
      • Québec, Canada, G1V 4G5
        • Recruiting
        • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
        • Contact:
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z1
        • Recruiting
        • University of Alberta Hospital (University of Alberta)
        • Contact:
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 3H5
        • Recruiting
        • Kelowna Respirology & Allergy Research
        • Contact:
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Recruiting
        • Vancouver General Hospital
        • Contact:
      • Vancouver, British Columbia, Canada, V1Y 1S1
        • Recruiting
        • St. Paul's Hospital (Vancouver)
        • Contact:
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 2Z3
        • Recruiting
        • Dr. Georges-L.-Dumont University Hospital Centre
        • Contact:
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Recruiting
        • QEII Health Sciences Centre
        • Contact:
    • Ontario
      • Hamilton, Ontario, Canada, L8N 1Y2
        • Recruiting
        • St. Joseph's Healthcare Hamilton
        • Contact:
      • Windsor, Ontario, Canada, N8X 1T3
        • Recruiting
        • Dr. Syed Anees Medicine Professional Corporation
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre (MUHC)
        • Contact:
      • Montreal, Quebec, Canada, H2X 0C1
        • Recruiting
        • Centre Hospitalier de l'Université de Montréal (CHUM)
        • Contact:
      • Trois-Rivières, Quebec, Canada, G8T 7A1
        • Recruiting
        • CIC Mauricie (Trois Rivieres)
        • Contact:
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Recruiting
        • Royal University Hospital (Saskatoon)
        • Contact:
  • Chile
      • Providencia, Santiago de Chile, Chile, 7500000
        • Completed
        • Instituto Nacional del Tórax
      • Talca, Chile, 3465586
        • Active, not recruiting
        • Centro de Investigacion del Maule
  • China
      • Beijing, China, 100730
        • Active, not recruiting
        • Peking Union Medical College Hospital
      • Beijing, China, 100029
        • Active, not recruiting
        • China-Japan Friendship Hospital
      • Beijing, China, 100020
        • Completed
        • Beijing Chao-Yang Hospital
      • Changsha, China, 410011
        • Active, not recruiting
        • The second Xiangya Hospital of Central South University
      • Chengdu, China, 610041
        • Active, not recruiting
        • West China Hospital, Sichuan University
      • Chengdu, China, 610072
        • Active, not recruiting
        • People's Hospital of Sichuan Province
      • Guangzhou, China, 510515
        • Active, not recruiting
        • NanFang Hosptial
      • Guangzhou, China, 510120
        • Active, not recruiting
        • First Affiliated Hospital of Guangzhou Medical University
      • Hangzhou, China, 310009
        • Active, not recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medicine
      • Hangzhou, China, 310013
        • Active, not recruiting
        • Zhejiang Hospital
      • Hangzhou, China, 310006
        • Active, not recruiting
        • Hangzhou First People's Hospital
      • Hangzhou, China, 310016
        • Active, not recruiting
        • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
      • Hefei, China, 230001
        • Active, not recruiting
        • Anhui Provincial Hospital
      • Hohhot, China, 010000
        • Active, not recruiting
        • The Affiliated Hospital of Inner Mongolia Medical University
      • Jiaxing, China, 314000
        • Active, not recruiting
        • The First Hospital of Jiaxing
      • Jinhua, China, 321000
        • Completed
        • Jinhua municipal central hospital
      • Nanjing, China, 210008
        • Active, not recruiting
        • Nanjing Drum Tower Hospital
      • Ningbo, China, 315000
        • Active, not recruiting
        • Ningbo medical center lihuili hospital
      • Ningbo, China, 315010
        • Completed
        • The First Affiliated Hospital of Ningbo University
      • Shanghai, China, 200030
        • Active, not recruiting
        • Shanghai Chest Hospital
      • Shanghai, China, 200040
        • Active, not recruiting
        • Huadong Hospital Affiliated to Fudan University
      • Shanghai, China, 200032
        • Active, not recruiting
        • Zhongshan Hospital Affiliated to Fudan University
      • Shanghai, China, 200025
        • Completed
        • Ruijin Hospital Shanghai Jiao Tong University School of Medicine
      • Shenyang, China, 110000
        • Active, not recruiting
        • China Shenyang Chest Hospital
      • Shenzhen, China, 518020
        • Active, not recruiting
        • Shenzhen People's Hospital
      • Shenzhen, China, 518053
        • Completed
        • The University of Hong Kong-Shenzhen Hospital
      • Suzhou, China, 215006
        • Active, not recruiting
        • The First Affiliated Hospital of Soochow University
      • Tianjin, China, 30052
        • Active, not recruiting
        • Tianjin Medical University General Hospital
      • Wenzhou, China, 325000
        • Active, not recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
      • Wuhan, China, 430060
        • Active, not recruiting
        • Renmin Hospital of Wuhan University
      • Wuhan, China, 430030
        • Active, not recruiting
        • Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
      • Wuhan, China, 430022
        • Active, not recruiting
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
      • Wuxi, China, 214043
        • Active, not recruiting
        • Wuxi People's Hospital
      • Xi'an, China, 710004
        • Active, not recruiting
        • Second Affiliated Hospital of medical college of Xi'an JiaoTong University
      • Xuzhou, China, 221009
        • Active, not recruiting
        • The Affiliated Hospital of Xuzhou Medical College
      • Yichang, China, 443000
        • Active, not recruiting
        • Yichang Central People's Hospital
      • Yinchuan, China, 750004
        • Active, not recruiting
        • General Hospital of Ningxia Medical University
  • Croatia
      • Zagreb, Croatia, 10000
        • Active, not recruiting
        • University Hospital Center Zagreb
      • Zagreb, Croatia, 10000
        • Active, not recruiting
        • University Hospital Dubrava
      • Zagreb, Croatia, 1000
        • Completed
        • Solmed Polyclinic
  • Czechia
      • Prague, Czechia, 140 59
        • Recruiting
        • University Thomayer´s Hospital
        • Contact:
  • Denmark
      • Hellerup, Denmark, 2900
      • Odense C, Denmark, 5000
  • Estonia
      • Tallinn, Estonia, 13419
        • Active, not recruiting
        • North Estonia Medical Centre Foundation, Tallinn
  • Finland
      • Helsinki, Finland, 00029
        • Active, not recruiting
        • HYKS Keuhkosairauksien tutkimusyksikkö
      • Oulu, Finland, 90220
        • Active, not recruiting
        • Oulun yliopistollinen keskussairaala
      • Tampere, Finland, 33520
        • Completed
        • Tampere University Hospital
      • Turku, Finland, 20520
        • Active, not recruiting
        • TYKS
  • France
      • Angers, France, 49933
        • Active, not recruiting
        • HOP d'Angers
      • Bobigny, France, 93000
        • Active, not recruiting
        • HOP Avicenne
      • Brest, France, 29200
        • Completed
        • HOP de la Cavale Blanche
      • Bron, France, 69677
        • Active, not recruiting
        • Hopital Louis Pradel
      • Caen, France, 14033
        • Active, not recruiting
        • HOP CHU Caen
      • Dijon, France, 21000
        • Active, not recruiting
        • HOP François Mitterrand
      • La Tronche, France, 38700
        • Active, not recruiting
        • HOP Michallon
      • Le Kremlin-Bicêtre, France, 94275
        • Completed
        • HOP Bicêtre
      • Lille, France, 59037
        • Active, not recruiting
        • INS Coeur Poumon
      • Marseille, France, 13915
        • Active, not recruiting
        • HOP Nord
      • Nantes, France, 44093
        • Active, not recruiting
        • HOP Nord Laennec
      • Nice, France, 06001
        • Active, not recruiting
        • Hopital PASTEUR
      • Paris, France, 75014
        • Active, not recruiting
        • HOP Paris Saint-Joseph
      • Paris, France, 75015
        • Active, not recruiting
        • HOP Européen G. Pompidou
      • Paris, France, 75877
        • Active, not recruiting
        • HOP Bichat
      • Pessac, France, 33604
        • Active, not recruiting
        • HOP Haut-Lévêque
      • Reims, France, 51100
        • Active, not recruiting
        • HOP Robert Debré
      • Rennes, France, 35033
        • Active, not recruiting
        • HOP Pontchaillou
      • Rouen, France, 76031
        • Active, not recruiting
        • Hôpital Charles Nicolle
      • Suresnes, France, 92151
        • Active, not recruiting
        • HOP Foch
      • Toulouse, France, 31059
        • Active, not recruiting
        • Hôpital Larrey - CHU de Toulouse
  • Georgia
      • Tbilisi, Georgia, 0101
        • Recruiting
        • National Center for Tuberculosis and Lung Diseases, Tbilisi
        • Contact:
      • Tbilisi, Georgia, 0180
      • Tbilisi, Georgia, 0159
  • Germany
      • Ahrensburg, Germany, 22926
        • Active, not recruiting
        • Velocity Clinical Research Germany GmbH, Ahrensburg
      • Bamberg, Germany, 96049
        • Active, not recruiting
        • CIMS Studienzentrum Bamberg GmbH
      • Berlin, Germany, 12351
        • Active, not recruiting
        • Vivantes Netzwerk für Gesundheit GmbH
      • Bonn, Germany, 53127
        • Active, not recruiting
        • Universitätsklinikum Bonn AöR
      • Coswig, Germany, 01640
        • Active, not recruiting
        • Fachkrankenhaus Coswig GmbH
      • Essen, Germany, 45239
        • Active, not recruiting
        • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
      • Hamburg, Germany, 20246
        • Active, not recruiting
        • Universitätsklinikum Hamburg, Eppendorf
      • Hanover, Germany, 30625
        • Active, not recruiting
        • Medizinische Hochschule Hannover
      • Hanover, Germany, 30459
        • Active, not recruiting
        • Klinikum Region Hannover GmbH
      • Heidelberg, Germany, 69126
        • Active, not recruiting
        • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
      • Hemer, Germany, 58675
        • Active, not recruiting
        • Lungenklinik Hemer
      • Immenhausen, Germany, 34376
        • Active, not recruiting
        • Lungenfachklinik Immenhausen
      • Konstanz, Germany, 78464
        • Active, not recruiting
        • Klinikum Konstanz
      • München, Germany, 81377
        • Active, not recruiting
        • Klinikum der Universität München AÖR
      • Nuremberg, Germany, 90419
        • Active, not recruiting
        • Klinikum Nürnberg
      • Solingen, Germany, 42699
        • Active, not recruiting
        • Krankenhaus Bethanien gGmbH
      • Stralsund, Germany, 18435
        • Active, not recruiting
        • Helios Hanseklinikum Stralsund
      • Stuttgart, Germany, 70376
        • Active, not recruiting
        • Robert Bosch Gesellschaft für medizinische Forschung mbH
      • Tübingen, Germany, 72076
        • Active, not recruiting
        • Universitatsklinikum Tubingen
  • Greece
      • Heraklion, Greece, 71110
        • Active, not recruiting
        • Hospital of Heraklion (PAGNI)
      • Ioannina, Greece, 45 500
        • Active, not recruiting
        • Univ. Gen. Hosp. of Ioannina
      • Pátrai, Greece, 26504
        • Active, not recruiting
        • Univ. Gen. Hosp. of Patras
      • Thessaloniki, Greece, 546 42
        • Active, not recruiting
        • General Hospital of Thessaloniki "Hippokrateio"
  • Hungary
      • Budapest, Hungary, 1121
      • Debrecen, Hungary, 4032
  • India
      • Mumbai, India, 400007
      • Mumbai, India, 400067
        • Recruiting
        • P.D. Hinduja National Hospital
        • Contact:
  • Ireland
      • Dublin, Ireland, D15 X40D
        • Active, not recruiting
        • Connolly Hospital Blanchardstown
  • Israel
      • Beer Yaakov, Israel, 7033001
        • Recruiting
        • Shamir Medical Center (Assaf Harofeh)
        • Contact:
      • Haifa, Israel, 3436212
        • Recruiting
        • Lady Davis Carmel Medical Center
        • Contact:
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Shaare Zedek Medical Center
        • Contact:
      • Tel Aviv, Israel, 6093246
  • Italy
      • Brescia, Italy, 25123
        • Recruiting
        • ASST degli Spedali Civili di Brescia
        • Contact:
      • Catania, Italy, 95124
        • Recruiting
        • A.O.U. Policlinico Vittorio Emanuele
        • Contact:
      • Florence, Italy, 50137
        • Recruiting
        • A. O. Universitaria Careggi
        • Contact:
      • Foggia, Italy, 71100
        • Recruiting
        • Ospedale Colonnello D Avanzo
        • Contact:
      • Forlì, Italy, 47121
      • Milan, Italy, 20123
        • Recruiting
        • Ospedale Classificato San Giuseppe
        • Contact:
      • Milan, Italy, 20100
        • Recruiting
        • Ospedale San Paolo-MILANO-18793
        • Contact:
      • Modena, Italy, 41100
        • Recruiting
        • Azienda Ospedaliero-Universitaria di Modena
        • Contact:
      • Monza, Italy, 20052
        • Recruiting
        • A.O. San Gerardo di Monza
        • Contact:
      • Padova, Italy, 35128
        • Recruiting
        • Azienda Ospedaliera Universitaria di Padova
        • Contact:
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
        • Contact:
      • Siena, Italy, 53100
      • Torrette Di Ancona (Ancona), Italy, 60126
        • Recruiting
        • Ospedali Riuniti Di Ancona
        • Contact:
  • Japan
      • Aichi, Seto, Japan, 489-8642
      • Chiba, Chiba, Japan, 260-8677
        • Recruiting
        • Chiba University Hospital
        • Contact:
      • Fukui, Yoshida-gun, Japan, 910-1193
        • Active, not recruiting
        • University of Fukui Hospital
      • Fukuoka, Fukuoka, Japan, 810-8563
        • Recruiting
        • National Hospital Organization Kyushu Medical Center
        • Contact:
      • Fukuoka, Fukuoka, Japan, 812-8582
        • Active, not recruiting
        • Kyushu University Hospital
      • Fukuoka, Iizuka, Japan, 820-8505
        • Recruiting
        • Aso Co.,Ltd Iizuka Hospital
        • Contact:
      • Fukuoka, Kitakyushu, Japan, 807-8556
        • Active, not recruiting
        • Hospital of the University of Occupational and Environmental Health
      • Fukuoka, Kurume, Japan, 830-0011
        • Recruiting
        • Kurume University Hospital
        • Contact:
      • Fukushima, Fukushima, Japan, 960-1295
        • Active, not recruiting
        • Fukushima Medical University Hospital
      • Fukushima, Koriyama, Japan, 963-0197
        • Completed
        • Tsuboi Hospital
      • Hiroshima, Hiroshima, Japan, 734-8530
        • Recruiting
        • Hiroshima Prefectural Hospital
        • Contact:
      • Hokkaido, Sapporo, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital
        • Contact:
      • Hokkaido, Sapporo, Japan, 060-8543
        • Active, not recruiting
        • Sapporo Medical University Hospital
      • Hyogo, Himeji, Japan, 670-8520
        • Recruiting
        • National Hospital Organization Himeji Medical Center
        • Contact:
      • Hyogo, Kobe, Japan, 653-0013
        • Recruiting
        • Kobe City Hospital Organization Kobe City Medical Center West Hospital
        • Contact:
      • Hyogo, Kobe, Japan, 650-0047
        • Active, not recruiting
        • Kobe City Medical Center General Hospital
      • Kagawa, Kita-gun, Japan, 761-0793
        • Active, not recruiting
        • Kagawa University Hospital
      • Kanagawa, Yokohama, Japan, 236-0051
        • Recruiting
        • Kanagawa Cardiovascular and Respiratory Center
        • Contact:
      • Kumamoto, Kumamoto, Japan, 861-4193
        • Recruiting
        • Saiseikai Kumamoto Hospital
        • Contact:
      • Miyagi, Sendai, Japan, 980-8574
        • Recruiting
        • Tohoku University Hospital
        • Contact:
      • Nagasaki, Nagasaki, Japan, 852-8501
        • Active, not recruiting
        • Nagasaki University Hospital
      • Osaka, Sakai, Japan, 591-8555
        • Active, not recruiting
        • National Hospital Organization Kinki-chuo Chest Medical Center
      • Osaka, Sakai, Japan, 590-0197
        • Active, not recruiting
        • Kindai University Hospital
      • Osaka, Takatsuki, Japan, 569-8686
        • Active, not recruiting
        • Osaka Medical and Pharmaceutical University Hospital
      • Saitama, Saitama, Japan, 330-8553
        • Active, not recruiting
        • Saitama Red Cross Hospital
      • Shimane, Izumo, Japan, 693-8501
        • Recruiting
        • Shimane University Hospital
        • Contact:
      • Shizuoka, Hamamatsu, Japan, 431-3192
        • Recruiting
        • Hamamatsu University Hospital
        • Contact:
      • Tochigi, Shimotsuke, Japan, 329-0498
        • Recruiting
        • Jichi Medical University Hospital
        • Contact:
      • Tokushima, Tokushima, Japan, 770-8503
        • Active, not recruiting
        • Tokushima University Hospital
      • Tokyo, Bunkyo-ku, Japan, 113-8431
        • Recruiting
        • Juntendo University Hospital
        • Contact:
      • Tokyo, Bunkyo-ku, Japan, 113-8603
        • Recruiting
        • Nippon Medical School Hospital
        • Contact:
      • Tokyo, Minato-ku, Japan, 105-8470
      • Tokyo, Mitaka, Japan, 181-8611
        • Active, not recruiting
        • Kyorin University Hospital
      • Tokyo, Ota-ku, Japan, 143-8541
        • Recruiting
        • Toho University Omori Medical Center
        • Contact:
      • Tokyo, Shinjuku-ku, Japan, 160-8582
        • Recruiting
        • Keio University Hospital
        • Contact:
      • Tokyo, Shinjuku-ku, Japan, 160-0023
        • Active, not recruiting
        • Tokyo Medical University Hospital
      • Tokyo, Shinjuku-ku, Japan, 162-8655
        • Recruiting
        • National Center for Global Health and Medicine
        • Contact:
      • Wakayama, Wakayama, Japan, 641-8510
        • Recruiting
        • Wakayama Medical University Hospital
        • Contact:
  • Malaysia
      • George Town, Malaysia, 10990
        • Completed
        • Hospital Pulau Pinang-Pulau Pinang-21953
      • Kajang, Malaysia, 43000
        • Active, not recruiting
        • Hospital Sultan Idris Shah Serdang
      • Kuala Lumpur, Malaysia, 53000
        • Active, not recruiting
        • Institut Perubatan Respiratori
      • Kuching, Malaysia, 93586
        • Active, not recruiting
        • Sarawak General Hospital
  • Mexico
      • Chihuahua City, Mexico, 31203
        • Active, not recruiting
        • Centro de Investigacion Integral MEDIVEST S.C
      • Coyoacán, Mexico, 04380
        • Active, not recruiting
        • CREPID Aire y Salud Integral
      • León, Mexico, 37160
        • Active, not recruiting
        • Centro de Investigacion Farmacologica del Bajío, S.C.
      • Mexico City, Mexico, 03650
        • Active, not recruiting
        • Soltmed Smo
      • Mexico City, Mexico, 14050
        • Active, not recruiting
        • Centro Respiratorio de Mexico
      • Monterrey, Mexico, 64460
        • Active, not recruiting
        • Centro de Prevención y Rehabilitación de Enfermedades Pulmon
      • Oaxaca City, Mexico, 68000
        • Active, not recruiting
        • Oaxaca Site Management Organization, S.C.
  • Netherlands
      • HEERLENHeerlen, Netherlands, 6419
        • Active, not recruiting
        • Zuyderland Medisch Centrum
      • Leiden, Netherlands, 2333
        • Active, not recruiting
        • Leids Universitair Medisch Centrum (LUMC)
      • Nieuwegein, Netherlands, 3435 CM
        • Active, not recruiting
        • St. Antonius Ziekenhuis
      • Rotterdam, Netherlands, 3015
        • Active, not recruiting
        • Erasmus Medisch Centrum-ROTTERDAM-50697
  • New Zealand
      • Hamilton, New Zealand, 3204
        • Active, not recruiting
        • Waikato Hospital
      • One Tree Hill, Auckland, New Zealand, 1051
        • Active, not recruiting
        • Greenlane Clinical Centre
      • Tauranga South, New Zealand, 3112
        • Completed
        • Tauranga Hospital
    • Auckland
      • Papatoetoe, Auckland, New Zealand, 2025
        • Active, not recruiting
        • Aotearoa Clinical Trials
  • Norway
      • Bergen, Norway, N-5021
        • Active, not recruiting
        • Haukeland Universitetssykehus
      • Nordbyhagen, Norway, 1478
        • Active, not recruiting
        • Akershus Universitetssykehus HF
      • Oslo, Norway, 0372
        • Active, not recruiting
        • Oslo universitetssykehus HF, Rikshospitalet
  • Poland
      • Gdansk, Poland, 80-214
        • Completed
        • Uniwersyteckie Centrum Kliniczne
      • Katowice, Poland, 40-635
        • Active, not recruiting
        • Leszek Giec Upper-Silesian Med.Cent.Silesian Med.Univ.
      • Warsaw, Poland, 01-138
        • Active, not recruiting
        • Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa
      • Warsaw, Poland, 02097
        • Active, not recruiting
        • University Clinical Center of the Medical University of Warsaw
      • Świdnik, Poland, 21 040
        • Active, not recruiting
        • Przychodnia Alergologiczno-Pulmonologiczna Alergopneuma Sp. z o.o.
  • Portugal
      • Braga, Portugal, 4710-243
        • Active, not recruiting
        • ULS Braga
      • Coimbra, Portugal, 3004-561
        • Active, not recruiting
        • CHUC - Centro Hospitalar e Universitario de Coimbra, EPE
      • Lisbon, Portugal, 1169-024
        • Active, not recruiting
        • ULS de São José, E.P.E.
      • Matosinhos Municipality, Portugal, 4454-509
        • Active, not recruiting
        • USLM, EPE - Hospital Pedro Hispano
      • Vila Nova de Gaia, Portugal, 4434-502
        • Active, not recruiting
        • Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11481
        • Recruiting
        • King Abdullah International Medical Research Center
        • Contact:
  • Serbia
      • Belgrade, Serbia, 11000
        • Active, not recruiting
        • University Clinical Center of Serbia
      • Kamenitz, Serbia, 21204
        • Active, not recruiting
        • Institute for Pulmonary Diseases of Vojvodina
      • Niš, Serbia, 18000
        • Active, not recruiting
        • University Clinical Center Nis
  • Singapore
      • Singapore, Singapore, 169608
        • Active, not recruiting
        • Singapore General Hospital
      • Singapore, Singapore, 308433
        • Completed
        • Tan Tock Seng Hospital
  • Slovenia
      • Golnik, Slovenia, 4204
        • Completed
        • Hospital Golnik - Univ. Clinic of Pulmonary and Allergic Diseases
  • South Africa
      • Mount Edgecombe, South Africa, 4301
        • Active, not recruiting
        • Enhancing Care Foundation NPC
  • South Korea
      • Bucheon-si, South Korea, 14647
        • Active, not recruiting
        • The catholic university of Korea, Bucheon St.Mary's Hospital
      • Seongnam, South Korea, 13620
        • Active, not recruiting
        • Seoul National University Bundang Hospital
      • Seoul, South Korea, 03080
        • Active, not recruiting
        • Seoul National University Hospital
      • Seoul, South Korea, 05505
        • Active, not recruiting
        • Asan Medical Center
      • Seoul, South Korea, 135-710
        • Active, not recruiting
        • Samsung Medical Center
      • Seoul, South Korea, 03722
        • Active, not recruiting
        • Severance Hospital
      • Seoul, South Korea, 02447
        • Active, not recruiting
        • Kyung Hee University Hospital
      • Seoul, South Korea, 04401
        • Active, not recruiting
        • Soonchunhyang University Hospital Seoul
  • Spain
      • Alicante, Spain, 03010
        • Recruiting
        • Hospital General Universitario de Alicante
        • Contact:
      • Barcelona, Spain, 08003
      • Barcelona, Spain, 08036
        • Active, not recruiting
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08035
        • Active, not recruiting
        • Hospital Universitari Vall d'Hebron
      • Bilbao, Spain, 48013
        • Active, not recruiting
        • Hospital de Basurto
      • El Palmar, Spain, 30120
        • Active, not recruiting
        • Hospital Universitario Virgen de La Arrixaca
      • Galdakao, Spain, 48960
        • Active, not recruiting
        • Hospital de Galdakao
      • Granada, Spain, 18014
        • Recruiting
        • Hospital Universitario Virgen de las Nieves
        • Contact:
      • L'Hospitalet de Llobregat, Spain, 08907
        • Recruiting
        • Hospital Universitari de Bellvitge
        • Contact:
      • Madrid, Spain, 28031
        • Recruiting
        • Hospital Universitario Infanta Leonor
        • Contact:
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon Y Cajal
        • Contact:
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
      • Madrid, Spain, 28006
        • Recruiting
        • Hospital Universitario de la Princesa
        • Contact:
      • Madrid, Spain, 28007
        • Active, not recruiting
        • Hospital General Universitario Gregorio Marañon
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
        • Contact:
      • Oviedo, Spain, 33011
        • Active, not recruiting
        • Hospital Central de Asturias
      • Palma de Mallorca, Spain, 07120
      • Pozuelo de Alarcón, Spain, 28223
        • Recruiting
        • Hospital Quironsalud Madrid
        • Contact:
      • Santander, Spain, 39008
        • Recruiting
        • Hospital Universitario Marques De Valdecilla
        • Contact:
      • Santiago de Compostela, Spain, 15706
        • Recruiting
        • Hospital Clínico de Santiago
        • Contact:
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Virgen del Rocio
        • Contact:
      • Seville, Spain, 41014
        • Completed
        • Hospital Nuestra Señora de Valme
      • Valencia, Spain, 46014
        • Recruiting
        • Hospital General Universitario de Valencia
        • Contact:
  • Sweden
      • Linköping, Sweden, 581 85
        • Completed
        • Universitetssjukhuset Linköping
      • Uppsala, Sweden, 75185
        • Active, not recruiting
        • Akademiska Sjukhuset
  • Switzerland
      • Basel, Switzerland, 4031
        • Active, not recruiting
        • Universitatsspital Basel
  • Taiwan
      • Changhua, Taiwan, 500
        • Recruiting
        • Changhua Christian Hospital
        • Contact:
      • Kaohsiung City, Taiwan, 83301
        • Recruiting
        • Kaohsiung Chang Gung Memorial Hospital
        • Contact:
      • Taichung, Taiwan, 407
        • Recruiting
        • Taichung Veterans General Hospital
        • Contact:
      • Tainan, Taiwan, 704
      • Taipei, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
      • Taipei, Taiwan, 100
        • Completed
        • National Taiwan University Hospital
  • Thailand
      • Bangkok Noi, Thailand, 10700
        • Active, not recruiting
        • Siriraj Hospital
      • Khon Kaen, Thailand, 40002
        • Active, not recruiting
        • Srinagarind Hospital
      • Muang, Thailand, 50200
        • Active, not recruiting
        • Maharat Nakhonchiangmai Hospital
      • Ratchatewi, Thailand, 10400
        • Active, not recruiting
        • Ramathibodi Hospital
      • Songkhla, Thailand, 90110
        • Active, not recruiting
        • Songklanagarind Hospital
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06010
        • Recruiting
        • Gulhane Training and Research Hospital
        • Contact:
      • Ankara, Turkey (Türkiye), 06620
        • Recruiting
        • Ankara Universitesi Tip Fakultesi
        • Contact:
      • Antalya, Turkey (Türkiye), 07070
        • Recruiting
        • Akdeniz Universitesi Tip Fakultesi -ANTALYA-33606
        • Contact:
      • Yenimahalle/ANKARA, Turkey (Türkiye), 06560
        • Recruiting
        • Gazi Universitesi Tip Fakultesi
        • Contact:
      • Çapa, Turkey (Türkiye), 34390
        • Recruiting
        • Istanbul Universitesi Istanbul Tip Fakultesi
        • Contact:
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • Active, not recruiting
        • Aberdeen Royal Infirmary
      • Birmingham, United Kingdom, B15 2GW
        • Active, not recruiting
        • Queen Elizabeth Hospital Birmingham
      • Bristol, United Kingdom, BS10 5NB
        • Active, not recruiting
        • Southmead Hospital
      • Edinburgh, United Kingdom, EH16 4SA
        • Active, not recruiting
        • Royal Infirmary of Edinburgh
      • Exeter, United Kingdom, EX2 5DW
        • Active, not recruiting
        • Royal Devon and Exeter Hospital, Wonford
      • Lancaster, United Kingdom, LA1 4RP
        • Active, not recruiting
        • Royal Lancaster Infirmary
      • Leeds, United Kingdom, LS9 7TF
        • Active, not recruiting
        • St James's University Hospital
      • London, United Kingdom, SW3 6NP
        • Active, not recruiting
        • Royal Brompton Hospital
      • London, United Kingdom, SE1 9RT
        • Completed
        • Guy's Hospital
      • Londonderry, United Kingdom, BT47 6SB
        • Active, not recruiting
        • Altnagelvin Area Hospital
      • Manchester, United Kingdom, M23 9QZ
        • Completed
        • Wythenshawe Hospital
      • Oxford, United Kingdom, OX3 7LE
        • Active, not recruiting
        • Churchill Hospital
      • Southampton, United Kingdom, SO16 6YD
        • Active, not recruiting
        • Southampton General Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Active, not recruiting
        • University of Alabama at Birmingham
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Active, not recruiting
        • University of Arizona
    • California
      • Los Angeles, California, United States, 90095
        • Active, not recruiting
        • University of California Los Angeles
      • Los Angeles, California, United States, 90048
        • Active, not recruiting
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90033
        • Active, not recruiting
        • University of Southern California
      • Sacramento, California, United States, 95817
    • Colorado
      • Denver, Colorado, United States, 80206
        • Active, not recruiting
        • National Jewish Health
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Active, not recruiting
        • Yale University School Of Medicine
    • Delaware
      • Newark, Delaware, United States, 19713
        • Completed
        • Christiana Hospital
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Active, not recruiting
        • Georgetown University
    • Florida
      • Clearwater, Florida, United States, 33765
        • Completed
        • St. Francis Medical Institute
      • Gainesville, Florida, United States, 32610
        • Active, not recruiting
        • University of Florida
      • Kissimmee, Florida, United States, 34746
        • Active, not recruiting
        • Clinical Research Specialists LLC - Kissimmee
      • Loxahatchee Groves, Florida, United States, 33470
        • Active, not recruiting
        • Advanced Pulmonary Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Active, not recruiting
        • The Emory Clinic
      • Atlanta, Georgia, United States, 30309
        • Active, not recruiting
        • Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Active, not recruiting
        • NorthShore University Health System
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Active, not recruiting
        • University of Kansas Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Active, not recruiting
        • Tulane Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Active, not recruiting
        • Johns Hopkins Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Active, not recruiting
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Active, not recruiting
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02215
        • Active, not recruiting
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02135
        • Active, not recruiting
        • St. Elizabeth's Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Active, not recruiting
        • University of Michigan
      • Royal Oak, Michigan, United States, 48073
        • Active, not recruiting
        • Corewell Health William Beaumont University Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Active, not recruiting
        • University of Minnesota
      • Rochester, Minnesota, United States, 55905
        • Active, not recruiting
        • Mayo Clinic, Rochester
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Active, not recruiting
        • The Lung Research Center, LLC
    • Nebraska
      • Omaha, Nebraska, United States, 68198
      • Omaha, Nebraska, United States, 68124
    • Nevada
      • Reno, Nevada, United States, 89502
        • Active, not recruiting
        • Renown Regional Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Completed
        • Dartmouth-Hitchcock Medical Center
    • New York
      • Mount Kisco, New York, United States, 10549
      • New York, New York, United States, 10065
        • Active, not recruiting
        • NewYork-Presbyterian/Weill Cornell Medical Center
      • New York, New York, United States, 10032
        • Active, not recruiting
        • Columbia University Medical Center-New York Presbyterian Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Active, not recruiting
        • Duke University Medical Center
      • Winston-Salem, North Carolina, United States, 27103
        • Active, not recruiting
        • Southeastern Research Center-Winston Salem-69289
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Active, not recruiting
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44195
        • Active, not recruiting
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43210
        • Active, not recruiting
        • The Ohio State University Wexner Medical Center
    • Oregon
      • Portland, Oregon, United States, 97220
        • Completed
        • The Oregon Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Active, not recruiting
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Active, not recruiting
        • Temple University
      • Pittsburgh, Pennsylvania, United States, 15212
        • Active, not recruiting
        • Allegheny General Hospital
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Completed
        • Infinity Medical Research, Inc.
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Active, not recruiting
        • Lowcountry Lung and Critical Care
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Recruiting
        • Clinical Trials Center of Middle Tennessee, LLC
        • Contact:
      • Nashville, Tennessee, United States, 37204
        • Active, not recruiting
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75246
        • Active, not recruiting
        • Baylor University Medical Center
      • San Antonio, Texas, United States, 78229
      • The Woodlands, Texas, United States, 77380
    • Utah
      • Murray, Utah, United States, 84107
        • Active, not recruiting
        • Intermountain Medical Center-Murray-69497
      • Salt Lake City, Utah, United States, 84108
        • Active, not recruiting
        • University of Utah Health Sciences Center
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Active, not recruiting
        • University of Vermont
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Active, not recruiting
        • Inova Fairfax Hospital
    • Washington
      • Seattle, Washington, United States, 98101
        • Active, not recruiting
        • Virginia Mason Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Active, not recruiting
        • 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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients who completed treatment in the parent trials (1305-0014, 1305-0023, or 1305-0035) without prematurely discontinuing treatment permanently according to protocol (i.e. completed treatment with or without temporary treatment interruption)
  2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
  3. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. WOCBP taking oral contraceptives (OCs) also have to ensure the use of one barrier method during sexual intercourse with their partner, e.g., condom to account for the risk of potentially reduced efficacy of the OCs in the event of severe vomiting and diarrhoea. For France, fertile males must be ready and able to use acceptable methods of birth control

Exclusion Criteria:

  1. Any disease that may put the patient at risk when participating in this trial at investigator's discretion.

  2. Patient exhibits suicidality, in the clinical judgment of the investigator or according to the following criteria at Visit 1:

    • any suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour)
    • any suicidal ideation of type 4 or 5 in the Columbia-Suicide Severity Rating Scale (C-SSRS) (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)
  3. Patients with clinically relevant severe depression at investigator's discretion or a Hospital Anxiety and Depression Scale (HADS) subscore >14 at Visit 1.
  4. An occurrence of malignant neoplasm other than appropriately treated basal cell carcinoma or in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix at Visit 1.
  5. Patient will undergo lung transplantation, with an assigned date of surgery.
  6. Patients with a Body Mass index (BMI) <18.5 kg/m² that experienced an additional, unexplained and clinically significant (>10%) weight loss during the parent trial
  7. At Visit 1, patients with ongoing Adverse Event of Special Interest (AESI), except for latent tuberculosis (suspected vasculitis, Drug Induced Liver Injury (DILI), severe infections) that led to temporary treatment interruption in the parent trial
  8. Patients who must or wish to take restricted medications or any drug considered likely to interfere with the safe conduct of the trial.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BI 1015550 treatment group
Drug: Nerandomilast
Nerandomilast
Other Names:
  • BI 1015550, JASCAYD®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of any adverse event over the course of the extension trial (yes/no) i.e. up until the follow-up/end of study visit planned at the latest at week 99
Time Frame: Up to 99 weeks and 3 days
Up to 99 weeks and 3 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Absolute change from baseline in Forced vital capacity (FVC) (mL) over time
Time Frame: Up to 98 weeks
Up to 98 weeks
Absolute change from baseline in % predicted in Forced vital capacity (FVC) over time
Time Frame: Up to 98 weeks
Up to 98 weeks
Time to absolute decline in FVC % predicted of >10% from baseline over the duration of the trial
Time Frame: Up to 98 weeks
Up to 98 weeks
Time to first acute Idiopathic Pulmonary Fibrosis/Progressive Pulmonary Fibrosis (IPF/PPF) exacerbation, first hospitalisation for respiratory cause, or death (whichever occurs first) over the duration of the trial
Time Frame: Up to 98 weeks
Up to 98 weeks
Time to first acute Idiopathic Pulmonary Fibrosis/Progressive Pulmonary Fibrosis (IPF/PPF) exacerbation or death over the duration of the trial
Time Frame: Up to 98 weeks
Up to 98 weeks
Time to hospitalisation for respiratory cause or death over the duration of the trial
Time Frame: Up to 98 weeks
Up to 98 weeks
Time to absolute decline in Forced vital capacity (FVC) % predicted of >10% from baseline or death over the duration of the trial
Time Frame: Up to 98 weeks
Up to 98 weeks
Time to relative decline in Forced vital capacity (FVC) % predicted of >10% from baseline or death over the duration of the trial
Time Frame: Up to 98 weeks
Up to 98 weeks

Collaborators and Investigators

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

Sponsor

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)

May 6, 2024

Primary Completion (Estimated)

April 28, 2027

Study Completion (Estimated)

May 5, 2027

Study Registration Dates

First Submitted

January 25, 2024

First Submitted That Met QC Criteria

January 25, 2024

First Posted (Actual)

February 2, 2024

Study Record Updates

Last Update Posted (Actual)

August 20, 2026

Last Update Submitted That Met QC Criteria

August 19, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1305-0031
  • 2023-507353-15-00 (Other Identifier: CTIS)

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.clinicalstudies.boehringer-ingelheim.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

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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