AzTrials
AzTrials

Lung Diseases, InterstitialPhase 3NCT05321082

A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)

A Phase 3 study testing BI 1015550 in people with Lung Diseases, Interstitial, run by Boehringer Ingelheim at 400 sites in 45 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 Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs). People who have a form of PF-ILD other than Idiopathic Pulmonary Fibrosis (IPF) can join the study. If they already take nintedanib, they can continue treatment throughout the study. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Diseases, Interstitial
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
1,178 participants
Where
400 sitesin 45 countries
Study dates
16 Nov 2022to 14 Apr 2025
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients ≥18 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 progressive fibrosing ILD other than IPF (physician confirmed).
  • Patients may be either:
  • on a stable therapy* with nintedanib for at least 12 weeks prior to Visit 1 and during screening and are planning to stay on this background treatment after randomization. (*stable therapy is defined as a tolerated regimen of nintedanib (with no dose changes) for at least 12 weeks)
  • not on treatment with nintedanib for at least 8 weeks prior to Visit 1 and during the screening period (e.g. either Antifibrotic (AF)-treatment naïve or previously discontinued) and do not plan to start or re-start antifibrotic treatment.
Show all 10Show fewer
  • Forced Vital Capacity (FVC) ≥45% of predicted normal at Visit 1.
  • 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
  • Patients treated with permitted immunosuppressive agents (other than corticosteroids) for an underlying systemic disease (e.g. Methotrexate (MTX), Azathioprine (AZA)) need to be on a stable treatment for at least 12 weeks prior to Visit 1 and during the screening period.

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 Interstitial Lung Disease (ILD) 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.
  • Patients having developed ILD due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection/coronavirus disease 2019 (COVID-19) within 12 months of screening (based on investigators judgement).
  • 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.
Show all 9Show fewer
  • 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

400 sites in 45 countries.

400 sites in 45 countries

United States59 sites

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109-5314

  • Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead

    Atlanta, Georgia, 30309

  • The Emory Clinic

    Atlanta, Georgia, 30322

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21224

  • 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

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • University of Vermont

    Burlington, Vermont, 05401

  • Lowcountry Lung and Critical Care

    Charleston, South Carolina, 29406

  • 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

  • Stony Brook University Medical Center

    Commack, New York, 11725

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • Premier Pulmonary Critical Care and Sleep Medicine

    Denison, Texas, 75020

  • National Jewish Health

    Denver, Colorado, 80206

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Infinity Medical Research, Inc.

    East Providence, Rhode Island, 02914

  • Evanston Hospital Pulmonary Clinic

    Evanston, Illinois, 60201

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • Clinical Trials Center of Middle Tennessee, LLC

    Franklin, Tennessee, 37067

  • University of Florida Health Shands Hospital

    Gainesville, Florida, 32610

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Clinical Research Specialists LLC

    Kissimmee, Florida, 34746

  • 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

  • Advanced Pulmonary Research Institute

    Loxahatchee Groves, Florida, 33470

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Intermountain Medical Center-Murray-69497

    Murray, Utah, 84107

  • 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

  • Lenox Hill Hospital

    New York, New York, 10021

  • Columbia University Medical Center-New York Presbyterian Hospital

    New York, New York, 10032

  • NewYork-Presbyterian/Weill Cornell Medical Center

    New York, New York, 10065

  • Christiana Hospital

    Newark, Delaware, 19718

  • Infinity Medical Research

    North Dartmouth, Massachusetts, 02747

  • 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

  • University of Arizona

    Tucson, Arizona, 85724

  • Southeastern Research Center-Winston-Salem-61365

    Winston-Salem, North Carolina, 27103

Other trials in United States

China41 sites

  • Beijing Chao-Yang Hospital

    Beijing, 100020

  • China-Japan Friendship Hospital

    Beijing, 100029

  • Peking Union Medical College Hospital

    Beijing, 100032

  • Chinese PLA General Hospital

    Beijing, 100853

  • The Second Xiangya Hospital Of Central South University

    Changsha, 410011

  • West China Hospital of Sichuan University

    Chengdu, 610041

  • Guangdong Provincial People's Hospital

    Guangzhou, 510080

  • 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

  • Zhejiang Hospital

    Hangzhou, 310013

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

    Hangzhou, 310016

  • Anhui Provincial Hospital

    Hefei, 230001

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, 010000

  • The First hospital of Jiaxing

    Jiaxing, 314000

  • Jinhua Municipal Central Hospital

    Jinhua, 321000

  • Nanjing Drum Tower Hospital

    Nanjing, 210008

  • Ningbo Medical Center Lihuili Hospital

    Ningbo, 315000

  • 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

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenxzhou, 325000

  • 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

  • General Hospital of Ningxia Medical University

    Yinchuan, 750004

  • Yuncheng Central Hospital

    Yuncheng, 044000

Other trials in China

Japan39 sites

  • Tosei General Hospital

    Aichi, Seto, 489-8642

  • Fujita Health University Hospital

    Aichi, Toyoake, 470-1192

  • 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

  • Hospital of the University of Occupational and Environmental Health

    Fukuoka, Kitakyushu, 807-8556

  • 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

  • Hokkaido University Hospital

    Hokkaido, Sapporo, 060-8648

  • 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

  • Kagawa University Hospital

    Kagawa, Kita-gun, 761-0793

  • Kanagawa Cardiovascular and Respiratory Center

    Kanagawa, Yokohama, 236-0051

  • Saiseikai Kumamoto Hospital

    Kumamoto, Kumamoto, 861-4193

  • Kyoto University Hospital

    Kyoto, Kyoto, 606-8507

  • Tohoku University Hospital

    Miyagi, Sendai, 980-8574

  • Nagasaki University Hospital

    Nagasaki, Nagasaki, 852-8501

  • Kindai University Hospital

    Osaka, Sakai, 590-0197

  • National Hospital Organization Kinki-Chuo Chest Medical Center

    Osaka, Sakai, 591-8555

  • Osaka Medical and Pharmaceutical University Hospital

    Osaka, Takatsuki, 569-8686

  • Saitama Red Cross Hospital

    Saitama, Saitama, 330-8553

  • 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

  • Institute of Science Tokyo Hospital

    Tokyo, Bunkyo-ku, 113-8519

  • Nippon Medical School Hospital

    Tokyo, Bunkyo-ku, 113-8603

  • 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

  • Keio University Hospital

    Tokyo, Shinjuku-ku, 160-8582

  • National Center for Global Health and Medicine

    Tokyo, Shinjuku-ku, 162-8655

  • Wakayama Medical University Hospital

    Wakayama, Wakayama, 641-8510

Other trials in Japan

France22 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

  • INS Coeur Poumon

    Lille, 59037

  • HOP Nord

    Marseille, 13915

  • HOP Arnaud de Villeneuve

    Montpellier, 34295

  • HOP Nord Laennec

    Nantes, 44093

  • HOP Pasteur

    Nice, 06001

  • HOP Européen G. Pompidou

    Paris, 75015

  • 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

Spain22 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 Universitari de Bellvitge

    L'Hospitalet de Llobregat, 08907

  • 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 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

Other trials in Spain

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, 53127

  • 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 AÖR

    München, 81377

  • Westfälische Wilhelms-Universität Münster

    Münster, 48149

  • Klinikum Nürnberg

    Nuremberg, 90419

  • Krankenhaus Bethanien gGmbH

    Solingen, 42699

  • Helios Hanseklinikum Stralsund

    Stralsund, 18435

  • Robert Bosch Gesellschaft für medizinische Forschung mbH

    Stuttgart, 70376

  • Universitätsklinikum Tübingen

    Tübingen, 72076

Other trials in Germany

Italy16 sites

  • ASST degli Spedali Civili di Brescia

    Brescia, 25123

  • 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 San Paolo-MILANO-18793

    Milan, 20100

  • Ospedale Classificato San Giuseppe

    Milan, 20123

  • Azienda Ospedaliero-Universitaria di Modena

    Modena, 41100

  • A.O. San Gerardo di Monza

    Monza, 20900

  • Osp. dei Colli Monaldi

    Naples, 80131

  • 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

  • Ospedale di Cattinara

    Trieste, 34100

Other trials in Italy

Australia13 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Royal Prince Alfred Hospital

    Camperdown, Sydney, New South Wales, 2050

  • Lung Research Queensland

    Chermside, Queensland, 4032

  • The Prince Charles Hospital

    Chermside, Queensland, 4032

  • Lung Research Victoria

    Footscray, Victoria, 3011

  • Canberra Hospital

    Garran, Australian Capital Territory, 2605

  • Austin Hospital

    Heidelberg, Victoria, 3084

  • Macquarie University

    Macquarie Park, New South Wales, 2109

  • 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

Other trials in Australia

United Kingdom13 sites

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN

  • 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

  • Guy's Hospital

    London, SE1 9RT

  • Royal Brompton Hospital

    London, SW3 6NP

  • Altnagelvin Area Hospital

    Londonderry, BT47 6SB

  • Wythenshawe Hospital

    Manchester, M23 9LT

  • Churchill Hospital

    Oxford, OX3 7LJ

  • Southampton General Hospital

    Southampton, SO16 6YD

Other trials in United Kingdom

Brazil11 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

  • Hospital Nossa Senhora da Conceição

    Porto Alegre - RS, CEP 91350-

  • Instituto D´Or de Pesquisa e Ensino - Bahia

    Salvador, 41920-900

  • Faculdade de Medicina do ABC

    Santo André, 09060-870

  • CEMEC - Centro Multidisciplinar de Estudos Clínicos

    São Bernardo do Campo, 09780-000

  • Hospital Alemao Oswaldo Cruz

    São Paulo, 01323-020

  • Hospital das Clinicas da FMUSP

    São Paulo, 05403-000

Other trials in Brazil

Canada11 sites

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 1Y2

  • 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, Quebec, G1V 4G5

  • Royal University Hospital (Saskatoon)

    Saskatoon, Saskatchewan, S7N 0W8

  • 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

Argentina10 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, 1425

  • APRILLUS-Asistencia e Investigacion

    Ciudad Autonoma Buenos Aires, C1046AAQ

  • CEMER-Centro Medico De Enfermedades Respiratorias

    Florida, B1602DQD

  • Instituto Ave Pulmo

    Mar del Plata, 7600

  • INSARES

    Mendoza, M5500CCG

  • Centro Respiratorio de Quilmes

    Quilmes, B1878FNR

  • Instituto Médico de la Fundación Estudios Clínicos

    Rosario, S2000DEJ

Other trials in Argentina

Austria9 sites

  • Medical University of Graz State Hospital - University Hospital Graz

    Graz, 8036

  • 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

  • Standort Penzing der Klinik Ottakring

    Vienna, 1140

  • Clinic Floridsdorf

    Vienna, 1210

  • Klinikum Wels - Grieskirchen GmbH

    Wels, 4600

Other trials in Austria

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

Belgium7 sites

  • Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim

    Antwerp, 2020

  • ULB Hopital Erasme

    Brussels, 1070

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Universitair Ziekenhuis 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

Mexico7 sites

  • Centro de Investigacion Integral MEDIVEST S.C

    Chihuahua City, 31203

  • CREPID Aire y Salud

    Coyoacán, 04380

  • Centro de Investigacion Farmacologica del Bajío, S.C.

    León, 37160

  • 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

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

Turkey (Türkiye)6 sites

  • Gulhane Training and Research Hospital

    Ankara, 06010

  • Ankara Universitesi Tip Fakultesi

    Ankara, 06620

  • Akdeniz Universitesi Tip Fakultesi -ANTALYA-33606

    Antalya, 07059

  • Uludag Universitesi Tip Fakultesi

    Bursa, 16120

  • Istanbul Universitesi Istanbul Tip Fakultesi

    Istanbul, 34390

  • Gazi Universitesi Tip Fakultesi

    Yenimahalle/ANKARA, 06560

Other trials in Turkey (Türkiye)

Greece5 sites

  • General Hospital of Athens "Laiko"

    Athens, 115 27

  • Hospital of Heraklion (PAGNI)

    Crete, 71500

  • Univ. Gen. Hosp. of Ioannina

    Ioannina, 45 500

  • Univ. Gen. Hosp. of Patras

    Pátrai, 26504

  • General Hospital of Thessaloniki "Hippokrateio"

    Thessaloniki, 546 42

Other trials in Greece

Israel5 sites

  • Shamir Medical Center (Assaf Harofeh)

    Beer Yaakov, 7033001

  • Soroka Univ. Medical Center

    Beersheba, 84101

  • Lady Davis Carmel Medical Center

    Haifa, 3436212

  • Shaare Zedek Medical Center, Jerusalem 91031

    Jerusalem, 9103102

  • Sourasky Medical Center

    Tel Aviv, 6093246

Other trials in Israel

Poland5 sites

  • University Clinical Center, Gdansk

    Gdansk, 80-214

  • Leszek Giec Upper-Silesian Med.Cent.Silesian Med.Univ.

    Katowice, 40-635

  • Alergopneuma Medical Center

    Świdnik, 21040

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

    Warsaw, 01-138

  • University Clinical Center of the Medical University of Warsaw

    Warsaw, 02097

Other trials in Poland

Taiwan5 sites

  • Chang-Hua Christian Hospital

    Changhua, 500

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301

  • Taichung Veterans General Hospital

    Taichung, 407

  • NCKUH

    Tainan, 704

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Finland4 sites

  • HYKS Keuhkosairauksien tutkimusyksikkö

    Helsinki, 000290

  • Oulun yliopistollinen keskussairaala

    Oulu, 90220

  • Tampere University Hospital

    Tampere, 33521

  • TYKS

    Turku, 20520

Other trials in Finland

India4 sites

  • Hindustan Hospital

    Coimbatore, 641028

  • Bhatia Hospital

    Mumbai, 400007

  • P.D. Hinduja National Hospital

    Mumbai, 400016

  • Jehangir Clinical Development Centre Pvt. Ltd.

    Pune, 411 001

Other trials in India

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

Netherlands4 sites

  • Zuyderland Medisch Centrum

    Heerlen, 6419 PC

  • Leids Universitair Medisch Centrum (LUMC)

    Leiden, 2333 ZA

  • St. Antonius ziekenhuis, locatie Nieuwegein

    Nieuwegein, 3435 CM

  • Erasmus Medisch Centrum-ROTTERDAM-50697

    Rotterdam, 3015 CE

Other trials in Netherlands

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

Portugal4 sites

  • ULS Braga

    Braga, 4710-243

  • ULS de São José, E.P.E.

    Lisbon, 1169-024

  • USLM, EPE - Hospital Pedro Hispano

    Matosinhos Municipality, 4454-509

  • ULS de Gaia/Espinho, EPE

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Serbia4 sites

  • University Clinical Center of Serbia

    Belgrade, 11000

  • Institute for Pulmonary Diseases of Vojvodina

    Kamenitz, 21204

  • University Clinical Center of Kragujevac

    Kragujevac, 34000

  • University Clinical Center Nis

    Niš, 18000

Other trials in Serbia

Croatia3 sites

  • University hospital center Zagreb

    Zagreb, 10000

  • University Hospital Dubrava

    Zagreb, 10000

  • Solmed Polyclinic

    Zagreb, 1000

Other trials in Croatia

Hungary3 sites

  • Semmelweis University

    Budapest, 1083

  • Koranyi National Institute For Pulmonolgy

    Budapest, 1121

  • University of Debrecen Clinical Centre

    Debrecen, 4032

Other trials in Hungary

Norway3 sites

  • Haukeland Universitetssykehus

    Bergen, N-5021

  • Akershus Universitetssykehus HF

    Lørenskog, 1478

  • Oslo Universitetssykehus HF, Rikshospitalet

    Oslo, N-0372

Other trials in Norway

Saudi Arabia3 sites

  • King Fahad Specialist Hospital - Research Center

    Dammam, 31444

  • King Faisal Specialist Hospital and Research Center

    Riyadh, 11211

  • King Abdullah International Medical Research Center

    Riyadh, 11481

Other trials in Saudi Arabia

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

Chile2 sites

  • Instituto Nacional del Tórax

    Providencia, Santiago de Chile, 7500000

  • Centro de Investigación del Maule

    Talca, 3465586

Other trials in Chile

Denmark2 sites

  • Herlev and Gentofte Hospital

    Hellerup, 2900

  • Odense University Hospital

    Odense, 5000

Other trials in Denmark

Georgia2 sites

  • National Center for Tuberculosis and Lung Diseases, Tbilisi

    Tbilisi, 0101

  • LLC Diacor

    Tbilisi, 0159

Other trials in Georgia

Singapore2 sites

  • National University Hospital-Singapore-42005

    Singapore, 119074

  • Singapore General Hospital

    Singapore, 169608

Other trials in Singapore

Switzerland2 sites

  • Universitätsspital Basel

    Basel, 4031

  • University Hospital Bern

    Bern, 3010

Other trials in Switzerland

Czechia1 site

  • University Thomayer´s Hospital

    Prague, 140 59

Other trials in Czechia

Estonia1 site

  • North Estonia Medical Centre Foundation, Tallinn

    Tallinn, 13419

Other trials in Estonia

Ireland1 site

  • Mater Misericordiae University Hospital

    Dublin, D07 R2WY

Other trials in Ireland

Puerto Rico1 site

  • Allianze Pulmonary Research LLC

    Guaynabo, 00968

Other trials in Puerto Rico

Slovenia1 site

  • Hospital Golnik - Univ. Clinic of Pulmonary and Allergic Diseases

    Golnik, 4204

Other trials in Slovenia

Sweden1 site

  • Akademiska sjukhuset

    Uppsala, 75185

Other trials in Sweden

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 Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)

This study is open to adults with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs). People who have a form of PF-ILD other than Idiopathic Pulmonary Fibrosis (IPF) can join the study. If they already take nintedanib, they can continue treatment throughout the study.

The purpose of this study is to find out whether a medicine called BI 1015550 helps people with PF-ILD. Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of BI 1015550 as tablets twice a day. Participants in the placebo group take placebo tablets twice a day. Placebo tablets look like BI 1015550 tablets but do not contain any medicine.

Participants are in the study for up to two and a half years. During the first year, they visit the study site 10 times. Afterwards, they visit the study site every 3 months. The doctors regularly test participants' lung function. The results of the lung function tests are compared between the groups. The doctors also regularly check participants' health and take note of any unwanted effects.

Being tested
BI 1015550, Placebo
Medical subject headings
Lung Diseases, Interstitial

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, in the morning and in the evening.

  • PlaceboDrug

    Participants received placebo matching 9 mg or 18 mg nerandomilast film-coated tablets orally, twice daily, in the morning and in the evening.

Study groups in NCT05321082
Study groupRoleWhat they receive
Nerandomilast 9 mgExperimentalPatients with progressive fibrosing interstitial lung disease (PF-ILD) or progressive pulmonary fibrosis (PPF), other than idiopathic pulmonary fibrosis (IPF), were administered 9 milligrams (mg) nerandomilast, taken orally as film-coated tablets twice daily (18 mg total), in the morning and in the evening for an initial 52 weeks, followed by a variable duration till end of trial.
Receives: Drug: BI 1015550
Nerandomilast 18 mgExperimentalPatients with progressive fibrosing interstitial lung disease (PF-ILD) or progressive pulmonary fibrosis (PPF), other than idiopathic pulmonary fibrosis (IPF), were administered 18 mg nerandomilast, taken orally as film-coated tablets twice daily (36 mg total), in the morning and in the evening for an initial 52 weeks, followed by a variable duration till end of trial.
Receives: Drug: BI 1015550
PlaceboPlacebo comparatorPatients with progressive fibrosing interstitial lung disease (PF-ILD) or progressive pulmonary fibrosis (PPF), other than idiopathic pulmonary fibrosis (IPF), were administered placebo matching nerandomilast, taken orally as film-coated tablets twice daily, in the morning and in the evening for an initial 52 weeks, followed by a variable duration till end of trial.
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) in Milliliters [mL] at Week 52

    The absolute change from baseline in forced vital capacity (FVC) in milliliters [mL] at Week 52 is reported. The absolute change from baseline in FVC was analyzed by a restricted maximum likelihood (REML)-based mixed model with repeated measurements (MMRM) comparing the change from baseline in FVC at Week 52 between treatment groups. The analysis included the fixed, categorical effects of treatment, baseline intake of antifibrotic (AF) treatment, and baseline High-resolution Computed Tomography (HRCT) pattern at each visit, as well as the fixed continuous effects of baseline FVC value at each visit. Visits were treated as a repeated measure with an unstructured covariance structure used to model within-patient measurements.

    Measured: The MMRM model is a longitudinal analysis, and it incorporated FVC measurements change from baseline at Week 1, Week 2, Week 6, Week 12, Week 18, Week 26, Week 36, Week 44 and Week 52. Data presented is the FVC adjusted change from baseline at Week 52.

Secondary outcomes (11)

  1. Key Secondary Endpoint: Time to First Occurrence of Any of the Components of the Composite Endpoint: Time to First Acute ILD Exacerbation, First Hospitalisation for Respiratory Cause, or Death (Whichever Occurred First) Over the Duration of the Trial

    Time to first occurrence of any of the components of the composite endpoint - acute interstitial lung disease (ILD) exacerbation, first hospitalisation for respiratory cause, or death (whichever occurred first) - is reported as the number of participants who experienced any of these events during the trial.

    Acute exacerbation of ILD describes an acute, clinically significant, respiratory deterioration characterized by evidence of new widespread alveolar abnormality with all of the following: Acute worsening or development of dyspnea typically with less than 1 month duration, computed tomography with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with fibrosing ILD, and deterioration not fully explained by cardiac failure or fluid overload.

    If more than one component occurred on the same day, the patient was counted under the first event according to the following hierarchy: acute ILD exacerbation, hospitalization, death.

    Measured: From first administration of trial drug (Nerandomilast or Placebo) till end of study, up to 26.2 months.

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

    Time to first acute ILD exacerbation or death over the duration of the trial is reported as the number of patients who experienced either event. Acute exacerbation of ILD describes an acute, clinically significant, respiratory deterioration characterized by evidence of new widespread alveolar abnormality with all of the following: Acute worsening or development of dyspnea typically with less than 1 month duration, computed tomography with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with fibrosing ILD, and deterioration not fully explained by cardiac failure or fluid overload.

    If more than one component occurred on the same day, the patient was counted under the first event according to the following hierarchy: acute IPF exacerbation followed by death.

    Measured: From first administration of trial drug (Nerandomilast or Placebo) till end of study, up to 26.2 months.

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

    Time to hospitalisation for respiratory cause or death over the duration of the trial is reported as the number of participants who experienced either event. Hospitalizations due to respiratory causes were recorded on a specific non-elective hospitalization CRF page. This page captured the hospitalization date, confirmation of a respiratory cause, and the primary admission diagnosis. Time to death was based either on the date of death on the adverse event (AE) report for patients with AEs leading to death or was based on the information from the vital status assessment.

    Measured: From first administration of trial drug (Nerandomilast or Placebo) till end of study, up to 26.2 months.

  4. Time to Death Over the Duration of the Trial

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

    Time to death was based either on the date of death on the AE report for patients with AEs leading to death or based on the information from the vital status assessment.

    Measured: From first administration of trial drug (Nerandomilast or Placebo) till end of study, up to 26.2 months.

  5. Absolute Change From Baseline in Forced Vital Capacity (FVC) Percent (%) Predicted at Week 52

    Absolute change from baseline in forced vital capacity (FVC) percent (%) predicted at Week 52 is reported.

    Analysis was based on a Mixed Model for Repeated Measures (MMRM), with fixed, categorical effects of treatment at each visit, baseline antifibrotic therapy at each visit, baseline HRCT pattern at each visit, the fixed continuous effects of baseline FVC [% pred] at each visit and unstructured covariance for repeated measures. Baseline antifibrotic therapy and HRCT pattern as entered in the CRF pages were used as covariates.

    Measured: The MMRM model is a longitudinal analysis, and it incorporated FVC % predicted change from baseline at Week 1, Week 2, Week 6, Week 12, Week 18, Week 26, Week 36, Week 44 and Week 52. Data presented is change from baseline in FVC % predicted at Week 52.

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

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

    If multiple components occurred on the day of first event, then the patient was only counted in the first component based on the following hierarchy: absolute decline in FVC % predicted of > 10% followed by death.

    Measured: From first administration of trial drug (Nerandomilast or Placebo) till end of study, up to 26.2 months.

  7. Absolute Change From Baseline in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) % Predicted (Corrected for Hb) at Week 52

    The absolute change from baseline in Diffusing Capacity of the Lungs for Carbon Monoxide percent predicted (corrected for hemoglobin, Hb) at Week 52 is reported.. Analysis was based on a Mixed Model for Repeated Measures (MMRM), with fixed, categorical effects of treatment at each visit, baseline antifibrotic therapy at each visit, baseline HRCT pattern at each visit, the fixed continuous effects of baseline DLCO [% pred] at each visit and unstructured covariance for repeated measures. Baseline antifibrotic therapy and HRCT pattern as entered in the CRF pages were used as covariates.

    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 adjusted Least Square Means for change from baseline at Week 52.

  8. Time to Absolute Decline in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) Percentage Predicted by More Than 15% From Baseline or Death, Measured Over the Duration of the Trial

    Time to absolute decline in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) percentage predicted by more than 15% from baseline or death, measured over the duration of the trial is reported as the number of participants who experienced either event. The Predicted DLCO value was corrected for hemoglobin (Hb). If more than one component occurred on the same day, the patient was counted under the first event according to the hierarchy: Absolute decline in DLCO % predicted of > 15%, followed by Death.

    Measured: From first administration of trial drug (Nerandomilast or Placebo) till end of study, up to 26.2 months.

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

    The absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Dyspnea domain score at Week 52 is reported. The Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44-item tool consisting of two modules: Symptoms (23 items) and Impacts (21 items). The Symptoms module yields three domain scores: Dyspnoea, Cough, and Fatigue, as well as a Total Symptoms score. Scoring is based on the mean of item ratings within each domain, multiplied by 100. Scores range from 0 to 100, with higher scores indicating greater impairment.

    This endpoint was analyzed using a Mixed Model for Repeated Measures (MMRM). The model included fixed effects for treatment, baseline antifibrotic therapy, baseline HRCT pattern, and fixed continuous effect of baseline L-PF dyspnea score at each visit, with an unstructured covariance for repeated measures. Baseline antifibrotic therapy and HRCT pattern as entered in the CRF pages were covariates.

    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 adjusted Least Square Means for change from baseline at Week 52.

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

    The absolute change from baseline in the L-PF Cough domain score at Week 52 is reported. The Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44-item tool consisting of two modules: Symptoms (23 items) and Impacts (21 items). The Symptoms module yields three domain scores: Dyspnea, Cough, and Fatigue, as well as a Total Symptoms score. Scoring is based on the mean of item ratings within each domain, multiplied by 100. Scores range from 0 to 100, with higher scores indicating greater impairment.

    This endpoint was analyzed using a Mixed Model for Repeated Measures (MMRM). The model included fixed effects for treatment, baseline antifibrotic therapy, baseline HRCT pattern, and fixed continuous effect of baseline L-PF dyspnea score at each visit, with an unstructured covariance for repeated measures. Baseline antifibrotic therapy and HRCT pattern as entered in the CRF pages were covariates.

    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 adjusted Least Square Means for change from baseline at Week 52.

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

    The absolute change from baseline in the L-PF Fatigue domain score at Week 52 is reported. The Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44-item tool consisting of two modules: Symptoms (23 items) and Impacts (21 items). The Symptoms module yields three domain scores: Dyspnea, Cough, and Fatigue, as well as a Total Symptoms score. Scoring is based on the mean of item ratings within each domain, multiplied by 100. Scores range from 0 to 100, with higher scores indicating greater impairment.

    This endpoint was analyzed using a Mixed Model for Repeated Measures (MMRM). The model included fixed effects for treatment, baseline antifibrotic therapy, and baseline HRCT pattern at each visit, and fixed continuous effect of baseline L-PF Fatigue score at each visit, with an unstructured covariance for repeated measures. Baseline antifibrotic therapy and HRCT pattern as entered in the CRF pages were covariates.

    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 adjusted Least Square Means for change from baseline 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 start16 Nov 2022
  3. Primary completion18 Dec 2024
  4. Study completion14 Apr 2025

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
1,178 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05321082
Sponsor's protocol ID
1305-0023
Other IDs
2022-001134-11
Status last verified
Dec 2025
First submitted
4 Apr 2022
Last updated
9 Jan 2026
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

  • Distler JHW, Frech T, McMahan ZH. Preferential phosphodiesterase inhibition as a novel strategy to modulate key pathways in systemic sclerosis. Front Immunol. 2026 Oct 2;17:1829186. doi: 10.3389/fimmu.2026.1829186. eCollection 2026.

    PubMed 42890786

  • 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

  • Maher TM, Assassi S, Azuma A, Cottin V, Hoffmann-Vold AM, Kreuter M, Oldham JM, Richeldi L, Valenzuela C, Wijsenbeek MS, Clerisme-Beaty E, Coeck C, Gu H, Ritter I, Schlosser A, Stowasser S, Voss F, Weimann G, Zoz DF, Martinez FJ; FIBRONEER-ILD Trial Investigators. Nerandomilast in Patients with Progressive Pulmonary Fibrosis. N Engl J Med. 2025 Jun 12;392(22):2203-2214. doi: 10.1056/NEJMoa2503643. Epub 2025 May 19.

    PubMed 40388329

  • Maher TM, Assassi S, Azuma A, Cottin V, Hoffmann-Vold AM, Kreuter M, Oldham JM, Richeldi L, Valenzuela C, Wijsenbeek MS, Coeck C, Schlecker C, Voss F, Wachtlin D, Martinez FJ. Design of a phase III, double-blind, randomised, placebo-controlled trial of BI 1015550 in patients with progressive pulmonary fibrosis (FIBRONEER-ILD). BMJ Open Respir Res. 2023 Sep;10(1):e001580. doi: 10.1136/bmjresp-2022-001580.

    PubMed 37709661

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BI 1015550 in people with Lung Diseases, Interstitial, run by Boehringer Ingelheim at 400 sites in 45 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 10 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 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 400 sites in United States, China, Japan, France, Spain and 40 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 9 Jan 2026). 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) in Milliliters [mL] at Week 52 (time frame: The MMRM model is a longitudinal analysis, and it incorporated FVC measurements change from baseline at Week 1, Week 2, Week 6, Week 12, Week 18, Week 26, Week 36, Week 44 and Week 52. Data presented is the FVC adjusted change from baseline at Week 52.). 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 NCT05321082, which also lists 4 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 9 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in