AzTrials
AzTrials

Idiopathic Pulmonary FibrosisPhase 3NCT05321069

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

A Phase 3 study testing BI 1015550 in people with Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 334 sites in 37 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
BI 1015550
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,177 participants
Where
334 sitesin 37 countries
Study dates
6 Oct 2022to 17 Dec 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients ≥40 years old at the time of signed informed consent.
  • Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
  • Diagnosis of Idiopathic Pulmonary Fibrosis (IPF).
  • 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.
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  • Forced Vital Capacity (FVC) ≥45% of predicted normal at Visit 1.
  • Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) ≥25% of predicted normal corrected for hemoglobin (Hb) at Visit 1.
  • Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control. WOCBP taking oral contraceptives (OCs) also have to use one barrier method.

Who cannot join

  • Prebronchodilator Forced Expiratory Volume in 1 second (FEV1)/Forced vital capacity (FVC) <0.7 at Visit 1.
  • In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
  • Acute Idiopathic Pulmonary Fibrosis (IPF) exacerbation within 3 months prior to Visit 1 and/or during the screening period (investigator-determined).
  • Relevant chronic or acute infections including human immunodeficiency virus (HIV) and viral hepatitis.
  • 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).
  • 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.
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  • Any documented active or suspected malignancy or history of malignancy within 5 years prior to Visit 1, except appropriately treated basal cell carcinoma of the skin, in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
  • Aspartate aminotransferase (AST) or Alanine Aminotransferase (ALT) >2.5 x Upper limit of normal (ULN) or total Bilirubin >1.5 x ULN at Visit 1.
  • Further exclusion criteria apply.

Trial locations and contacts

334 sites in 37 countries.

334 sites in 37 countries

United States56 sites

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109-5314

  • Piedmont Healthcare-Atlanta-57055

    Atlanta, Georgia, 30309

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • St. Elizabeth's Medical Center

    Boston, Massachusetts, 02135

  • Lowcountry Lung and Critical Care

    Charleston, South Carolina, 29406

  • The Lung Research Center, LLC

    Chesterfield, Missouri, 63017

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • St. Francis Medical Institute

    Clearwater, Florida, 33765

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • Premier Pulmonary Critical Care and Sleep Medicine

    Denison, Texas, 75020

  • National Jewish Health

    Denver, Colorado, 80206

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Minnesota Lung Center and Sleep Institute

    Edina, Minnesota, 55435

  • Evanston Hospital Pulmonary Clinic

    Evanston, Illinois, 60201

  • Clinical Trials Center of Middle Tennessee, LLC

    Franklin, Tennessee, 37067

  • University of Florida Health Shands Hospital

    Gainesville, Florida, 32610

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Clinical Research Specialists LLC

    Kissimmee, Florida, 34746

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • University of Southern California

    Los Angeles, California, 90033

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • University of California Los Angeles

    Los Angeles, California, 90095

  • Louisville Pulmonary Care

    Louisville, Kentucky, 40207

  • Advanced Pulmonary Research Institute

    Loxahatchee Groves, Florida, 33470

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Northern Westchester Hospital

    Mount Kisco, New York, 10549

  • Vanderbilt University Medical Center - Vanderbilt Lung Institute at 100 Oaks

    Nashville, Tennessee, 37204

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • Tulane University Hospital and Clinic

    New Orleans, Louisiana, 70112

  • Columbia University Medical Center-New York Presbyterian Hospital

    New York, New York, 10032

  • Weill Cornell Medicine-New York-59955

    New York, New York, 10065

  • Christiana Hospital

    Newark, Delaware, 19713

  • Infinity Medical Research

    North Dartmouth, Massachusetts, 02747

  • Creighton University

    Omaha, Nebraska, 68124

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Jefferson Health Honickman Center

    Philadelphia, Pennsylvania, 19107

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • The Oregon Clinic

    Portland, Oregon, 97220

  • Renown Regional Medical Center

    Reno, Nevada, 89502

  • Mayo Clinic, Rochester

    Rochester, Minnesota, 55905

  • Beaumont Health

    Royal Oak, Michigan, 48073

  • University of California Davis

    Sacramento, California, 95817

  • University of Utah Health Sciences Center

    Salt Lake City, Utah, 84108

  • UT Health San Antonio

    San Antonio, Texas, 78229

  • Destin Pulmonary Critical Care

    Santa Rosa Beach, Florida, 32459

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Georgetown University

    Washington D.C., District of Columbia, 20007

  • Southeastern Research Center-Winston-Salem-61365

    Winston-Salem, North Carolina, 27103

Other trials in United States

China33 sites

  • China-Japan Friendship Hospital

    Beijing, 100029

  • Peking Union Medical College Hospital

    Beijing, 100730

  • Chinese PLA General Hospital

    Beijing, 100853

  • The Second Xiangya Hospital Of Central South University

    Changsha, 410011

  • West China Hospital of Sichuan University

    Chengdu, 610041

  • First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120

  • NanFang Hosptial

    Guangzhou, 510515

  • Hangzhou First People's Hospital

    Hangzhou, 310006

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, 310009

  • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

    Hangzhou, 310018

  • Anhui Provincial Hospital

    Hefei, 230001

  • The First hospital of Jiaxing

    Jiaxing, 314000

  • Jinhua Municipal Central Hospital

    Jinhua, 321000

  • Nanjing Drum Tower Hospital

    Nanjing, 210008

  • The First Affiliated Hospital of Ningbo University

    Ningbo, 315010

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, 200025

  • Shanghai Chest Hospital

    Shanghai, 200030

  • Zhongshan Hospital Affiliated to Fudan University

    Shanghai, 200032

  • Huadong Hospital affiliated to Fudan University

    Shanghai, 200040

  • Shanghai Pulmonary Hospital

    Shanghai, 200433

  • China Shenyang Chest Hospital

    Shenyang, 110000

  • Shenzhen People's Hospital

    Shenzhen, 518020

  • The University of Hong Kong-Shenzhen Hospital

    Shenzhen, 518053

  • People's Hospital of Sichuan Province

    Sichuan, 610031

  • The First Affiliated Hospital of Soochow University

    Suzhou, 215006

  • Tianjin Medical University General Hospital

    Tianjin, 30052

  • Wuhan Union Hospital

    Wuhan, 430022

  • Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T

    Wuhan, 430030

  • Renmin Hospital of Wuhan University

    Wuhan, 430060

  • Wuxi People's Hospital

    Wuxi, 214043

  • Second Affiliated Hospital of Xi'an JiaoTong University

    Xi'an, 710004

  • Affiliated Hospital, Xuzhou Medical college

    Xuzhou, 221006

  • Yichang Central People's Hospital

    Yichang, 443000

Other trials in China

Japan33 sites

  • Tosei General Hospital

    Aichi, Seto, 489-8642

  • Fujita Health University Hospital

    Aichi, Toyoake, 470-1192

  • Chiba University Hospital

    Chiba, Chiba, 260-8677

  • IUHW Narita Hospital

    Chiba, Narita, 286-8520

  • University of Fukui Hospital

    Fukui, Yoshida-gun, 910-1193

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, Fukuoka, 810-8563

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582

  • Aso Co.,Ltd Iizuka Hospital

    Fukuoka, Iizuka, 820-8505

  • Kurume University Hospital

    Fukuoka, Kurume, 830-0011

  • Fukushima Medical University Hospital

    Fukushima, Fukushima, 960-1295

  • Tsuboi Hospital

    Fukushima, Koriyama, 963-0197

  • Hiroshima Prefectural Hospital

    Hiroshima, Hiroshima, 734-8530

  • Sapporo Medical University Hospital

    Hokkaido, Sapporo, 060-8543

  • National Hospital Organization Himeji Medical Center

    Hyogo, Himeji, 670-8520

  • Kobe City Medical Center General Hospital

    Hyogo, Kobe, 650-0047

  • Kobe City Hospital Organization Kobe City Medical Center West Hospital

    Hyogo, Kobe, 653-0013

  • Kanagawa Cardiovascular and Respiratory Center

    Kanagawa, Yokohama, 236-0051

  • Saiseikai Kumamoto Hospital

    Kumamoto, Kumamoto, 861-4193

  • Nagasaki University Hospital

    Nagasaki, Nagasaki, 852-8501

  • Kindai University Hospital

    Osaka, Osakasayama, 589-8511

  • National Hospital Organization Kinki-Chuo Chest Medical Center

    Osaka, Sakai, 591-8555

  • Saitama Red Cross Hospital

    Saitama, Saitama, 330-8553

  • Shimane University Hospital

    Shimane, Izumo, 693-8501

  • Hamamatsu University Hospital

    Shizuoka, Hamamatsu, 431-3192

  • Jichi Medical University Hospital

    Tochigi, Shimotsuke, 329-0498

  • Tokushima University Hospital

    Tokushima, Tokushima, 770-8503

  • Juntendo University Hospital

    Tokyo, Bunkyo-ku, 113-8431

  • Toranomon Hospital

    Tokyo, Minato-ku, 105-8470

  • Kyorin University Hospital

    Tokyo, Mitaka, 181-8611

  • Toho University Omori Medical Center

    Tokyo, Ota-ku, 143-8541

  • Tokyo Medical University Hospital

    Tokyo, Shinjuku-ku, 160-0023

  • National Center for Global Health and Medicine

    Tokyo, Shinjuku-ku, 162-8655

  • Wakayama Medical University Hospital

    Wakayama, Wakayama, 641-8510

Other trials in Japan

Spain25 sites

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Universitari Vall D Hebron

    Barcelona, 08035

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital de Basurto

    Bilbao, 48013

  • Hospital Universitario Virgen de la Arrixaca

    El Palmar, 30120

  • Hospital de Galdakao

    Galdakao, 48960

  • Hospital Universitari de Girona Doctor Josep Trueta

    Girona, 17007

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014

  • Hospital de Bellvitge

    L'Hospitalet de Llobregat, 08907

  • Hospital Universitario Lucus Augusti

    Lugo, 27004

  • Hospital La Princesa

    Madrid, 28006

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Universitario Infanta Leonor

    Madrid, 28031

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Virgen de la Victoria

    Málaga, 29010

  • Hospital Central de Asturias

    Oviedo, 33011

  • Hospital Son Espases

    Palma de Mallorca, 07120

  • Hospital Quirónsalud Madrid

    Pozuelo de Alarcón, 28223

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

  • Hospital Clínico de Santiago

    Santiago de Compostela, 15706

  • Hospital Virgen del Rocío

    Seville, 41013

  • Hospital Nuestra Señora de Valme

    Seville, 41014

  • Hospital General Universitario de Valencia

    Valencia, 46014

Other trials in Spain

France23 sites

  • HOP d'Angers

    Angers, 49 933

  • HOP Avicenne

    Bobigny, 93000

  • HOP de la Cavale Blanche

    Brest, 29200

  • HOP Louis Pradel

    Bron, 69677

  • HOP CHU Caen

    Caen, 14033

  • HOP François Mitterrand

    Dijon, 21000

  • HOP Michallon

    La Tronche, 38700

  • HOP Bicêtre

    Le Kremlin-Bicêtre, 94275

  • INS Coeur Poumon

    Lille, 59037

  • HOP Nord

    Marseille, 13915

  • HOP Nord Laennec

    Nantes, 44093

  • HOP Pasteur

    Nice, 06001

  • HOP Paris Saint-Joseph

    Paris, 75014

  • HOP Tenon

    Paris, 75020

  • HOP Bichat

    Paris, 75877

  • HOP Haut-Lévêque

    Pessac, 33604

  • HOP Robert Debré

    Reims, 51100

  • HOP Pontchaillou

    Rennes, 35033

  • HOP Charles Nicolle

    Rouen, 76031

  • HOP Civil

    Strasbourg, 67091

  • HOP Foch

    Suresnes, 92151

  • HOP Larrey

    Toulouse, 31059

  • HOP Bretonneau

    Tours, 37000

Other trials in France

Germany21 sites

  • Velocity Clinical Research Germany GmbH, Ahrensburg

    Ahrensburg, 22926

  • CIMS Studienzentrum Bamberg GmbH

    Bamberg, 96049

  • Vivantes Netzwerk für Gesundheit GmbH

    Berlin, 12351

  • Universitätsklinikum Bonn AöR

    Bonn, 53105

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09116

  • Fachkrankenhaus Coswig GmbH

    Coswig, 01640

  • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

    Essen, 45239

  • Universitätsklinikum Hamburg, Eppendorf

    Hamburg, 20246

  • Klinikum Region Hannover GmbH

    Hanover, 30459

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

    Heidelberg, 69126

  • Lungenklinik Hemer

    Hemer, 58675

  • Lungenfachklinik Immenhausen

    Immenhausen, 34376

  • Klinikum Konstanz

    Konstanz, 78464

  • Klinikum der Universität München - Campus Großhadern

    München, 81377

  • Klinikum Nürnberg

    Nuremberg, 90419

  • Krankenhaus Bethanien gGmbH

    Solingen, 42699

  • Helios Hanseklinikum Stralsund

    Stralsund, 18435

  • Robert-Bosch-Krankenhaus GmbH

    Stuttgart, 70376

  • Universitätsklinikum Tübingen

    Tübingen, 72076

  • Petrus-Krankenhaus

    Wuppertal, 42283

Other trials in Germany

Australia12 sites

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Canberra Hospital

    Canberra, Australian Capital Territory, 2605

  • Lung Research Queensland

    Chermside, Queensland, 4032

  • The Prince Charles Hospital

    Chermside, Queensland, 4032

  • Lung Research Victoria

    Footscray, Victoria, 3011

  • Austin Hospital

    Heidelberg, Victoria, 3084

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Mater Hospital Brisbane

    South Brisbane, Queensland, 4101

  • Trialswest

    Spearwood, Western Australia, 6163

  • Westmead Hospital

    Westmead, New South Wales, 2145

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Canada12 sites

  • University of Alberta Hospital (University of Alberta)

    Edmonton, Alberta, T6G 2G3

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 3A7

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

  • Kelowna Respirology & Allergy Research

    Kelowna, British Columbia, V1Y 3H5

  • Dr. Georges-L.-Dumont University Hospital Centre

    Moncton, New Brunswick, E1C 2Z3

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec, H2X 0A9

  • McGill University Health Centre (MUHC)

    Montreal, Quebec, H4A 3J1

  • IUCPQ (Laval University)

    Québec, G1V 4G5

  • CIC Mauricie Inc.

    Trois-Rivières, Quebec, G8T 7A1

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

  • St. Paul's Hospital (Vancouver)

    Vancouver, British Columbia, V6Z 1Y6

  • Dr. Syed Anees Medicine Professional Corporation

    Windsor, Ontario, N8X 1T3

Other trials in Canada

Italy11 sites

  • A.O.U. Policlinico Vittorio Emanuele

    Catania, 95124

  • A. O. Universitaria Careggi

    Florence, 50137

  • Ospedale Colonnello D Avanzo

    Foggia, 71100

  • Ospedale G.B. Morgagni

    Forlì, 47121

  • Ospedale Classificato San Giuseppe

    Milan, 20123

  • Azienda Ospedaliera Policlinico di Modena

    Modena, 41100

  • Azienda Ospedaliera Universitaria di Padova

    Padova, 35128

  • Pol. Universitario Tor Vergata

    Roma, 00133

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Roma, 00168

  • A.O.U. Senese

    Siena, 53100

  • Ospedali Riuniti di Ancona

    Torrette Di Ancona (Ancona), 60126

Other trials in Italy

United Kingdom9 sites

  • Queen Elizabeth Hospital Birmingham

    Birmingham, B15 2GW

  • Southmead Hospital

    Bristol, BS10 5NB

  • Royal Infirmary of Edinburgh

    Edinburgh, EH16 4SA

  • Royal Devon and Exeter Hospital, Wonford

    Exeter, EX2 5DW

  • Royal Lancaster Infirmary

    Lancaster, LA1 4RP

  • St James's University Hospital

    Leeds, LS9 7TF

  • Royal Brompton Hospital

    London, SW3 6NP

  • Wythenshawe Hospital

    Manchester, M23 9LT

  • Churchill Hospital

    Oxford, OX3 7LJ

Other trials in United Kingdom

Brazil8 sites

  • Serviços Medicos Respirar Sul Fluminense

    Barra Mansa, 27323240

  • Hospital das Clinicas da Universidade Federal de Minas Gerais (HCUFMG)

    Belo Horizonte,Minas Gerais, 31270901

  • Edumed - Educacao e Saude SA

    Curitiba, 80440-210

  • CLARE - Clinica de Pneumologia

    Goiânia, 74110-030

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, 90035-074

  • Instituto D´Or de Pesquisa e Ensino - Bahia

    Salvador, 41920-900

  • CEMEC - Centro Multidisciplinar de Estudos Clínicos

    São Bernardo do Campo, 09780-000

  • Hospital Alemao Oswaldo Cruz

    São Paulo, 01323-020

Other trials in Brazil

South Korea8 sites

  • The Catholic University of Korea, Bucheon St.Mary's Hospital

    Bucheon-si, 14647

  • Seoul National University Bundang Hospital

    Seongnam, 13620

  • Kyung Hee University Hospital

    Seoul, 02447

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital

    Seoul, 03722

  • Soonchunhyang University Hospital Seoul

    Seoul, 04401

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Argentina7 sites

  • Centro de Investigaciones Metabolicas (CINME)-C.A.B.A-61553

    C.a.b.a, 1056

  • CEDIC - Centro de Investigacion Clinica

    CABA, C1060ABN

  • Hospital Italiano de Buenos Aires

    CABA, C1199ABB

  • Consultorios Médicos del Buen Ayre

    Capital Federal, C1425FVH

  • Instituto Ave Pulmo

    Mar del Plata, 7600

  • INSARES

    Mendoza, M5500CCG

  • Centro Respiratorio de Quilmes

    Quilmes, B1878FNR

Other trials in Argentina

Austria7 sites

  • LKH Klagenfurt am Woerthersee

    Klagenfurt, 9020

  • Krems University Hospital

    Krems, 3500

  • Hospital Elisabethinen Linz

    Linz

  • LKH Salzburg University Hospital

    Salzburg, 5020

  • AKH - Medical University of Vienna

    Vienna, 1090

  • Clinic Floridsdorf

    Vienna, 1210

  • Klinikum Wels - Grieskirchen GmbH

    Wels, 4600

Other trials in Austria

Belgium7 sites

  • Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim

    Antwerp, 2020

  • ULB Hopital Erasme

    Brussels, 1070

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • UNIV UZ Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

  • Centre Hospitalier Universitaire de Liège

    Liège, 4000

  • Yvoir - UNIV UCL de Mont-Godinne

    Yvoir, 5530

Other trials in Belgium

Taiwan6 sites

  • Chang-Hua Christian Hospital

    Changhua, 500

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301

  • Taichung Veterans General Hospital

    Taichung, 407

  • NCKUH

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Thailand6 sites

  • Siriraj Hospital

    Bangkok Noi, 10700

  • Songklanagarind Hospital

    Hat Yai, 90110

  • Srinagarind Hospital

    Khon Kaen, 40002

  • Central Chest Institute of Thailand

    Muang, 11000

  • Maharat Nakhonchiangmai Hospital

    Muang, 50200

  • Ramathibodi Hospital

    Ratchatewi, 10400

Other trials in Thailand

Mexico5 sites

  • Centro de Investigacion Integral MEDIVEST S.C

    Chihuahua City, 31203

  • Soltmed Smo

    Mexico City, 03650

  • Centro Respiratorio de Mexico

    Mexico City, 14050

  • Centro de Prevención y Rehabilitación de Enfermedades Pulmon

    Monterrey, 64460

  • Oaxaca Site Management Organization, S.C.

    Oaxaca City, 68000

Other trials in Mexico

Malaysia4 sites

  • Hospital Sultan Idris Shah Serdang

    Kajang, 43000

  • Institut Perubatan Respiratori

    Kuala Lumpur, 53000

  • Sarawak General Hospital

    Kuching, 93586

  • Hospital Pulau Pinang-Pulau Pinang-21953

    Pulau Pinang, 10990

Other trials in Malaysia

New Zealand4 sites

  • Waikato Hospital

    Hamilton, 3204

  • Greenlane Clinical Centre

    One Tree Hill, Auckland, 1051

  • Middlemore Clinical Trials

    Papatoetoe, 2025

  • Tauranga Hospital

    Tauranga South, 3112

Other trials in New Zealand

Denmark3 sites

  • Aarhus University Hospital

    Aarhus N, 8200

  • Herlev and Gentofte Hospital

    Hellerup, 2900

  • Odense University Hospital

    Odense, 5000

Other trials in Denmark

Greece3 sites

  • Hospital of Heraklion (PAGNI)

    Crete, 71500

  • Univ. Gen. Hosp. of Ioannina

    Ioannina, 45 500

  • Univ. Gen. Hosp. of Patras

    Pátrai, 26504

Other trials in Greece

Netherlands3 sites

  • Zuyderland Medisch Centrum

    Heerlen, 6419 PC

  • St. Antonius ziekenhuis, locatie Nieuwegein

    Nieuwegein, 3435 CM

  • Erasmus Medisch Centrum-ROTTERDAM-50697

    Rotterdam, 3015 CE

Other trials in Netherlands

Norway3 sites

  • Haukeland Universitetssykehus

    Bergen, N-5021

  • Akershus Universitetssykehus HF

    Lørenskog, 1478

  • Oslo Universitetssykehus HF, Rikshospitalet

    Oslo, N-0372

Other trials in Norway

Poland3 sites

  • University Clinical Center, Gdansk

    Gdansk, 80-214

  • Alergopneuma Medical Center

    Świdnik, 21040

  • Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa

    Warsaw, 01-138

Other trials in Poland

Singapore3 sites

  • National University Hospital-Singapore-42005

    Singapore, 119074

  • Singapore General Hospital

    Singapore, 169608

  • Tan Tock Seng Hospital

    Singapore, 308433

Other trials in Singapore

South Africa3 sites

  • Busamed Paardevlei Private Hospital

    Cape Town, 7130

  • Melomed Gatesville Hospital

    Cape Town, 7764

  • KwaPhila Health Solutions

    Durban, 4032

Other trials in South Africa

Sweden3 sites

  • Universitetssjukhuset, Linköping

    Linköping, 581 85

  • Sahlgrenska Universitetsjukhuset

    Stockholm, 141 52

  • Akademiska sjukhuset

    Uppsala, 75185

Other trials in Sweden

Chile2 sites

  • Instituto Nacional del Tórax

    Providencia, Santiago de Chile, 7500691

  • Centro de Investigación del Maule

    Talca, 3465586

Other trials in Chile

Finland2 sites

  • HYKS Keuhkosairauksien tutkimusyksikkö

    Helsinki, 000290

  • Oulun yliopistollinen keskussairaala

    Oulu, 90220

Other trials in Finland

Hungary2 sites

  • Koranyi National Institute For Pulmonolgy

    Budapest, 1121

  • University of Debrecen Clinical Centre

    Debrecen, 4032

Other trials in Hungary

Portugal2 sites

  • ULS de Coimbra, E.P.E.

    Coimbra, 3004-561

  • USLM, EPE - Hospital Pedro Hispano

    Matosinhos Municipality, 4454-509

Other trials in Portugal

Croatia1 site

  • University Hospital Dubrava

    Zagreb, 10000

Other trials in Croatia

Estonia1 site

  • North Estonia Medical Centre Foundation, Tallinn

    Tallinn, 13419

Other trials in Estonia

Ireland1 site

  • Connolly Hospital Blanchardstown

    Dublin, D15 X40D

Other trials in Ireland

Puerto Rico1 site

  • Allianze Pulmonary Research LLC

    Guaynabo, 00968

Other trials in Puerto Rico

Switzerland1 site

  • Universitätsspital Basel

    Basel, 4031

Other trials in Switzerland

About this study

Official title: 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.

Being tested
BI 1015550, Placebo
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BI 1015550Drug

    Also called Nerandomilast, JASCAYD®

    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.

  • PlaceboDrug

    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.

Study groups in NCT05321069
Study groupRoleWhat they receive
Nerandomilast 9 mg BIDExperimentalParticipants 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.
Receives: Drug: BI 1015550
Nerandomilast 18 mg BIDExperimentalParticipants 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.
Receives: Drug: BI 1015550
PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absolute Change From Baseline in Forced Vital Capacity (FVC) [mL] 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.

    Measured: 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 outcomes (11)

  1. 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 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.

    Measured: From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months.

  2. Time to First Acute IPF Exacerbation or Death Over the Duration of the Trial

    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.

    Measured: From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months.

  3. Time to Hospitalization for Respiratory Cause or Death Over the Duration of the Trial

    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.

    Measured: From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months.

  4. Time to Absolute Decline in Forced Vital Capacity (FVC) % Predicted of >10% From Baseline or Death Over the Duration of the Trial

    The time to absolute decline of more than 10% from baseline in forced vital capacity (FVC) percent predicted, or death, over the duration of the trial is reported as the number of participants who experienced either event.

    If 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.

    Measured: From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months.

  5. 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

    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.

    Measured: From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months.

  6. Time to Death Over the Duration of the Trial

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

    Time to death 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.

    Measured: From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months.

  7. Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Dyspnea Domain Score 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.

    Measured: 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.

  8. Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Cough Domain Score at Week 52

    The absolute change from baseline in the L-PF Cough domain score at Week 52 is reported. 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.

    Measured: 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.

  9. Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Fatigue Domain Score at Week 52

    The absolute change from baseline in the 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.

    Measured: 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.

  10. Absolute Change From Baseline in Forced Vital Capacity Percent Predicted 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.

    Measured: 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.

  11. Absolute Change From Baseline in Diffusing Capacity of the Lungs for Carbon Monoxide Percent Predicted 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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2022
  2. Study start6 Oct 2022
  3. Primary completion16 Aug 2024
  4. Study completion17 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,177 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05321069
Sponsor's protocol ID
1305-0014
Other IDs
2022-001091-34
Status last verified
Oct 2025
First submitted
4 Apr 2022
Last updated
20 Oct 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Wuyts WA, Richeldi L, Assassi S, Azuma A, Cottin V, Hoffmann-Vold AM, Kreuter M, Oldham JM, Martinez FJ, Valenzuela C, Wijsenbeek MS, Kanakapura M, James A, Weimann G, Drzewuski C, Coeck C, Maher TM. Design of an open-label extension trial of nerandomilast (BI 1015550) in patients with idiopathic pulmonary fibrosis and progressive pulmonary fibrosis (FIBRONEER-ON). BMC Pulm Med. 2025 Dec 4;26(1):10. doi: 10.1186/s12890-025-03973-7.

    PubMed 41345848

  • Richeldi L, Azuma A, Cottin V, Kreuter M, Maher TM, Martinez FJ, Oldham JM, Valenzuela C, Clerisme-Beaty E, Gordat M, Wachtlin D, Liu Y, Schlecker C, Stowasser S, Zoz DF, Wijsenbeek MS; FIBRONEER-IPF Trial Investigators. Nerandomilast in Patients with Idiopathic Pulmonary Fibrosis. N Engl J Med. 2025 Jun 12;392(22):2193-2202. doi: 10.1056/NEJMoa2414108. Epub 2025 May 18.

    PubMed 40387033

  • Richeldi L, Azuma A, Cottin V, Kreuter M, Maher TM, Martinez FJ, Oldham JM, Valenzuela C, Gordat M, Liu Y, Stowasser S, Zoz DF, Wijsenbeek MS. Design of a phase III, double-blind, randomised, placebo-controlled trial of BI 1015550 in patients with idiopathic pulmonary fibrosis (FIBRONEER-IPF). BMJ Open Respir Res. 2023 Aug;10(1):e001563. doi: 10.1136/bmjresp-2022-001563.

    PubMed 37597969

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BI 1015550 in people with Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 334 sites in 37 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 334 sites in United States, China, Japan, Spain, France and 32 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05321069, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.

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