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

Lung Diseases, Interstitial Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05321082
• Other study ID #: 1305-0023
• Secondary ID: 2022-001134-11
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 5, 2022
• Est. completion date: March 19, 2025

Study information

• Verified date: June 2024
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1178
• Est. completion date: March 19, 2025
• Est. primary completion date: December 17, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria

1. Patients =18 years old at the time of signed informed consent.

2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.

3. Diagnosis of progressive fibrosing ILD other than IPF (physician confirmed).

4. Patients may be either:

• on a stable therapy* with nintedanib for at least 12 weeks prior to Visit 1 and during screening and are planning to stay on this background treatment after randomization. (*stable therapy is defined as a tolerated regimen of nintedanib (with no dose changes) for at least 12 weeks)

• not on treatment with nintedanib for at least 8 weeks prior to Visit 1 and during the screening period (e.g. either Antifibrotic (AF)-treatment naïve or previously discontinued) and do not plan to start or re-start antifibrotic treatment.

5. Forced Vital Capacity (FVC) =45% of predicted normal at Visit 1.

6. DLCO =25% of predicted normal corrected for hemoglobin (Hb) at Visit 1.

7. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control. WOCBP taking oral contraceptives (OCs) also have to use one barrier method

8. Patients treated with permitted immunosuppressive agents (other than corticosteroids) for an underlying systemic disease (e.g. Methotrexate (MTX), Azathioprine (AZA)) need to be on a stable treatment for at least 12 weeks prior to Visit 1 and during the screening period.

Exclusion criteria

1. Prebronchodilator Forced Expiratory Volume in 1 second (FEV1)/Forced vital capacity (FVC) <0.7 at Visit 1

2. In the opinion of the Investigator, other clinically significant pulmonary abnormalities.

3. Acute Interstitial Lung Disease (ILD) exacerbation within 3 months prior to Visit 1 and/or during the screening period (investigator-determined).

4. Relevant chronic or acute infections including human immunodeficiency virus (HIV) and viral hepatitis.

5. Patients having developed ILD due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection/coronavirus disease 2019 (COVID-19) within 12 months of screening (based on investigators judgement).

6. Major surgery (major according to the investigator's assessment) performed within 6 weeks prior to Visit 2 or planned during the trial period, e.g. hip replacement. Registration on lung transplantation list would not be considered as planned major surgery.

7. Any documented active or suspected malignancy or history of malignancy within 5 years prior to Visit 1, except appropriately treated basal cell carcinoma of the skin, in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.

8. Aspartate aminotransferase (AST) or Alanine Aminotransferase (ALT) >2.5 x upper limit of normal (ULN) or total Bilirubin >1.5 x ULN at Visit 1.

Further exclusion criteria apply.

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Drug:
• BI 1015550
BI 1015550
• Placebo
Placebo

Locations

Country	Name	City	State
Argentina	Centro de Investigaciones Metabólicas (CINME)	C.a.b.a
Argentina	CEDIC - Centro de Investigacion Clinica	Caba
Argentina	Hospital Italiano de Buenos Aires	Caba
Argentina	Consultorios Médicos del Buen Ayre	Capital Federal
Argentina	APRILLUS-Asistencia e Investigación	Ciudad Autonoma Buenos Aires
Argentina	CEMER-Centro Medico De Enfermedades Respiratorias	Florida
Argentina	Instituto Ave Pulmo	Mar del Plata
Argentina	INSARES	Mendoza
Argentina	Centro Respiratorio de Quilmes	Quilmes
Argentina	Instituto Médico de la Fundación Estudios Clínicos	Rosario
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Royal Prince Alfred Hospital	Camperdown, Sydney	New South Wales
Australia	Lung Research Queensland	Chermside	Queensland
Australia	The Prince Charles Hospital	Chermside	Queensland
Australia	Lung Research Victoria	Footscray	Victoria
Australia	Canberra Hospital	Garran	Australian Capital Territory
Australia	Austin Hospital	Heidelberg	Victoria
Australia	Macquarie University	Macquarie Park	New South Wales
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	Mater Hospital Brisbane	South Brisbane	Queensland
Australia	Trialswest	Spearwood	Western Australia
Australia	Westmead Hospital	Westmead	New South Wales
Austria	Medical University of Graz State Hospital - University Hospital Graz	Graz
Austria	LKH Klagenfurt am Woerthersee	Klagenfurt Am Woerthersee
Austria	Krems University Hospital	Krems
Austria	Ordensklinikum Linz GmbH Elisabethinen	Linz
Austria	LKH Salzburg University Hospital	Salzburg
Austria	AKH - Medical University of Vienna	Vienna
Austria	Clinic Floridsdorf	Vienna
Austria	Klinik Penzing SMZ Baumgartner Hoehe	Vienna
Austria	Klinikum Wels - Grieskirchen GmbH	Wels
Belgium	Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim	Antwerpen
Belgium	Brussels - UNIV Saint-Luc	Bruxelles
Belgium	ULB Hopital Erasme	Bruxelles
Belgium	UNIV UZ Gent	Gent
Belgium	UZ Leuven	Leuven
Belgium	Centre Hospitalier Universitaire de Liège	Liège
Belgium	Yvoir - UNIV UCL de Mont-Godinne	Yvoir
Brazil	Serviços Medicos Respirar Sul Fluminense	Barra Mansa
Brazil	Hospital das Clinicas da Universidade Federal HC-UFMG	Belo Horizonte,Minas Gerais
Brazil	Edumed - Educacao e Saude SA	Curitiba
Brazil	CLARE - Clinica de Pneumologia	Goiania
Brazil	Irmandade da Santa Casa de Misericórdia de Porto Alegre	Porto Alegre
Brazil	Hospital Nossa Senhora da Conceição	Porto Alegre - RS
Brazil	Instituto D´Or de Pesquisa e Ensino - Bahia	Salvador
Brazil	Faculdade de Medicina do ABC	Santo André
Brazil	CEMEC - Centro Multidisciplinar de Estudos Clínicos	São Bernardo do Campo
Brazil	Hospital Alemao Oswaldo Cruz	Sao Paulo
Brazil	Hospital das Clinicas da FMUSP	São Paulo
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario
Canada	Kelowna Respirology & Allergy Research	Kelowna	British Columbia
Canada	Dr. Georges-L.-Dumont University Hospital Centre	Moncton	New Brunswick
Canada	Centre Hospitalier de l'Universite de Montreal (CHUM)	Montreal	Quebec
Canada	McGill University Health Centre (MUHC)	Montreal	Quebec
Canada	IUCPQ (Laval University)	Quebec
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Canada	CIC Mauricie Inc.	Trois-Rivieres	Quebec
Canada	St. Paul's Hospital	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	Dr. Syed Anees Medicine Professional Corporation	Windsor	Ontario
Chile	Instituto Nacional del Tórax	Providencia, Santiago De Chile
Chile	Centro de Investigación del Maule	Talca
China	Beijing Chao-Yang Hospital	Beijing
China	China-Japan Friendship Hospital	Beijing
China	Chinese PLA General Hospital	Beijing
China	Peking Union Medical College Hospital	Beijing
China	The Second Xiangya Hospital Of Central South University	Changsha
China	West China Hospital	Chengdu
China	First Affiliated Hospital of Guangzhou Medical University	Guangzhou
China	Guangdong Provincial People's Hospital	Guangzhou
China	NanFang Hosptial	Guangzhou
China	Hangzhou First People's Hospital	Hangzhou
China	Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine	Hangzhou
China	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou
China	Zhejiang Hospital	Hangzhou
China	Anhui Provincial Hospital	Hefei
China	The Affiliated Hospital of Inner Mongolia Medical University	Hohhot
China	The First hospital of Jiaxing	Jiaxing
China	Jinhua Municipal Central Hospital	Jinhua
China	Nanjing Drum Tower Hospital	Nanjing
China	Ningbo Medical Center Lihuili Hospital	Ningbo
China	The First Affiliated Hospital of Ningbo University	Ningbo
China	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai
China	Shanghai Chest Hospital	Shanghai
China	Shanghai Huadong Hospital	Shanghai
China	Shanghai Pulmonary Hospital	Shanghai
China	Zhongshan Hospital Fudan University	Shanghai
China	China Shenyang Chest Hospital	Shenyang
China	Shenzhen People's Hospital	Shenzhen
China	The University of Hong Kong-Shenzhen Hospital	Shenzhen
China	People's Hospital of Sichuan Province	Sichuan
China	The First Affiliated Hospital of Soochow University	Suzhou
China	Tianjin Medical University General Hospital	Tianjin
China	The First Affiliated Hospital of Wenzhou Med College	Wenxzhou
China	Renmin Hospital of Wuhan University	Wuhan
China	Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T	Wuhan
China	Wuhan Union Hospital	Wuhan
China	Wuxi People's Hospital	Wuxi
China	Second Affiliated Hospital of Xi'an JiaoTong University	Xi'an
China	Affiliated Hospital, Xuzhou Medical college	Xuzhou
China	Yichang NO.1 People's Hospital	Yichang
China	General Hospital of Ningxia Medical University	Yinchuan
China	Yuncheng Central Hospital	Yuncheng
Croatia	Solmed Clinic	Zagreb
Croatia	University hospital center Zagreb	Zagreb
Croatia	University Hospital Dubrava	Zagreb
Czechia	University Thomayer's Hospital	Praha 4
Denmark	Herlev and Gentofte Hospital	Hellerup
Denmark	Odense University Hospital	Odense
Estonia	North Estonia Medical Centre Foundation, Tallinn	Tallinn
Finland	HYKS Keuhkosairauksien tutkimusyksikkö	Helsinki
Finland	Oulun yliopistollinen keskussairaala	Oulu
Finland	Tampere University Hospital	Tampere
Finland	TYKS	Turku
France	HOP d'Angers	Angers
France	HOP Avicenne	Bobigny
France	HOP de la Cavale Blanche	Brest
France	HOP Louis Pradel	Bron
France	HOP Côte de Nacre	Caen
France	HOP François Mitterrand	Dijon
France	HOP Michallon	La Tronche
France	HOP Calmette	Lille
France	HOP Nord	Marseille
France	HOP Arnaud de Villeneuve	Montpellier
France	HOP Nord Laennec	Nantes Cedex 01
France	HOP Pasteur	Nice
France	HOP Bichat	Paris
France	HOP Européen G. Pompidou	Paris
France	HOP Haut-Lévêque	Pessac
France	HOP Maison Blanche	Reims
France	HOP Pontchaillou	Rennes
France	HOP Charles Nicolle	Rouen
France	HOP Civil	Strasbourg
France	HOP Foch	Suresnes
France	HOP Larrey	Toulouse
France	HOP Bretonneau	Tours
Georgia	LLC Diacor	Tbilisi
Georgia	National Center for Tuberculosis and Lung Diseases, Tbilisi	Tbilisi
Germany	CIMS Studienzentrum Bamberg GmbH	Bamberg
Germany	Vivantes Netzwerk für Gesundheit GmbH	Berlin
Germany	Universitätsklinikum Bonn AöR	Bonn
Germany	Klinikum Chemnitz gGmbH	Chemnitz
Germany	Fachkrankenhaus Coswig GmbH	Coswig
Germany	Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH	Essen
Germany	Velocity Clinical Research Germany GmbH	Großhansdorf
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Klinikum Region Hannover GmbH	Hannover
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg	Heidelberg
Germany	Lungenklinik Hemer	Hemer
Germany	Lungenfachklinik Immenhausen	Immenhausen
Germany	Klinikum Konstanz	Konstanz
Germany	Klinikum der Universität München - Campus Großhadern	München
Germany	Westfälische Wilhelms-Universität Münster	Münster
Germany	Klinikum Nürnberg	Nürnberg
Germany	Krankenhaus Bethanien gGmbH	Solingen
Germany	Helios Hanseklinikum Stralsund	Stralsund
Germany	Robert-Bosch-Krankenhaus GmbH	Stuttgart
Germany	Universitätsklinikum Tübingen	Tübingen
Greece	General Hospital of Athens "Laiko"	Athens
Greece	Univ. Gen. Hosp. of Ioannina	Ioannina
Greece	Univ. Gen. Hosp. of Patras	Patras
Greece	General Hospital of Thessaloniki "Hippokrateio"	Thessaloniki
Greece	Hospital of Heraklion (PAGNI)	Voutes
Hungary	Koranyi National Institute For Pulmonolgy	Budapest
Hungary	Semmelweis University	Budapest
Hungary	University of Debrecen Clinical Centre	Debrecen
India	Hindustan Hospital	Coimbatore
India	Bhatia Hospital	Mumbai
India	P.D. Hinduja National Hospital	Mumbai
India	Jehangir Clinical Development Centre Pvt. Ltd.	Pune
Ireland	Mater Misericordiae University Hospital	Dublin
Israel	Soroka Univ. Medical Center	Beer Sheva
Israel	Lady Davis Carmel Medical Center	Haifa
Israel	Shaare Zedek Medical Center, Jerusalem 91031	Jerusalem
Israel	Shamir Medical Center (Assaf Harofeh)	Ramat Gan
Israel	Sourasky Medical Center	Tel Aviv
Italy	ASST degli Spedali Civili di Brescia	Brescia
Italy	A.O.U. Policlinico Vittorio Emanuele	Catania
Italy	A. O. Universitaria Careggi	Firenze
Italy	Ospedale Colonnello D Avanzo	Foggia
Italy	Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli	Forli'
Italy	Osp. S. Giuseppe Fatebenefratelli	Milano
Italy	Ospedale San Paolo	Milano
Italy	Azienda Ospedaliera Policlinico di Modena	Modena
Italy	A.O. San Gerardo di Monza	Monza
Italy	Osp. dei Colli Monaldi-Cotugno	Napoli
Italy	Azienda Ospedaliera Universitaria di Padova	Padova
Italy	Pol. Universitario Tor Vergata	Roma
Italy	Poli Univ A. Gemelli	Roma
Italy	A.O.U. Senese Policlinico Santa Maria alle Scotte	Siena
Italy	Ospedali Riuniti di Ancona	Torrette Di Ancona (Ancona)
Italy	Ospedale di Cattinara	Trieste
Japan	Tosei General Hospital	Aichi, Seto
Japan	Fujita Health University Hospital	Aichi, Toyoake
Japan	University of Fukui Hospital	Fukui, Yoshida-gun
Japan	Kyushu University Hospital	Fukuoka, Fukuoka
Japan	National Hospital Organization Kyushu Medical Center	Fukuoka, Fukuoka
Japan	Aso Co.,Ltd Iizuka Hospital	Fukuoka, Iizuka
Japan	Hospital of the University of Occupational and Environmental Health	Fukuoka, Kitakyushu
Japan	Kurume University Hospital	Fukuoka, Kurume
Japan	Fukushima Medical University Hospital	Fukushima, Fukushima
Japan	Tsuboi Hospital	Fukushima, Koriyama
Japan	Hiroshima Prefectural Hospital	Hiroshima, Hiroshima
Japan	Hokkaido University Hospital	Hokkaido, Sapporo
Japan	Sapporo Medical University Hospital	Hokkaido, Sapporo
Japan	National Hospital Organization Himeji Medical Center	Hyogo, Himeji
Japan	Kobe City Hospital Organization Kobe City Medical Center West Hospital	Hyogo, Kobe
Japan	Kobe City Medical Center General Hospital	Hyogo, Kobe
Japan	Kagawa University Hospital	Kagawa, Kita-gun
Japan	Kanagawa Cardiovascular and Respiratory Center	Kanagawa, Yokohama
Japan	Saiseikai Kumamoto Hospital	Kumamoto, Kumamoto
Japan	Kyoto University Hospital	Kyoto, Kyoto
Japan	Tohoku University Hospital	Miyagi, Sendai
Japan	Nagasaki University Hospital	Nagasaki, Nagasaki
Japan	Kindai University Hospital	Osaka, Osakasayama
Japan	National Hospital Organization Kinki-Chuo Chest Medical Center	Osaka, Sakai
Japan	Osaka Medical and Pharmaceutical University Hospital	Osaka, Takatsuki
Japan	Saitama Red Cross Hospital	Saitama, Saitama
Japan	Hamamatsu University Hospital	Shizuoka, Hamamatsu
Japan	Jichi Medical University Hospital	Tochigi, Shimotsuke
Japan	Tokushima University Hospital	Tokushima, Tokushima
Japan	Juntendo University Hospital	Tokyo, Bunkyo-ku
Japan	Nippon Medical School Hospital	Tokyo, Bunkyo-ku
Japan	Tokyo Medical and Dental University Hospital	Tokyo, Bunkyo-ku
Japan	Toranomon Hospital	Tokyo, Minato-ku
Japan	Kyorin University Hospital	Tokyo, Mitaka
Japan	Toho University Omori Medical Center	Tokyo, Ota-ku
Japan	Center Hospital of the National Center for Global Health and Medicine	Tokyo, Shinjuku-ku
Japan	Keio University Hospital	Tokyo, Shinjuku-ku
Japan	Tokyo Medical University Hospital	Tokyo, Shinjuku-ku
Japan	Wakayama Medical University Hospital	Wakayama, Wakayama
Korea, Republic of	The Catholic University of Korea, Bucheon St.Mary's Hospital	Bucheon
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Kyung Hee University Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	Soonchunhyang University Hospital Seoul	Seoul
Malaysia	Hospital Sultan Idris Shah Serdang	Kajang
Malaysia	Institut Perubatan Respiratori	Kuala Lumpur
Malaysia	Sarawak General Hospital	Kuching
Malaysia	Hospital Pulau Pinang	Pulau Pinang
Mexico	Centro Respiratorio de Mexico	Cdmx
Mexico	Centro de Investigacion Integral MEDIVEST S.C	Chihuahua
Mexico	Soltmed Smo	Ciudad de Mexico
Mexico	CREPID Aire y Salud Integral	Coyoacan
Mexico	Centro de Investigacion Farmacologica del Bajío, S.C.	Guanajuato
Mexico	Centro de Prevención y Rehabilitación de Enfermedades Pulmon	Monterrey
Mexico	Oaxaca Site Management Organization, S.C.	Oaxaca
Mexico	Asociación Mexicana para la Investigacion Clínica, A.C(AMIC)	Pachuca
Netherlands	Zuyderland Medisch Centrum	Heerlen
Netherlands	Leids Universitair Medisch Centrum (LUMC)	Leiden
Netherlands	St. Antonius ziekenhuis, locatie Nieuwegein	Nieuwegein
Netherlands	Erasmus Medisch Centrum	Rotterdam
New Zealand	Waikato Hospital	Hamilton
New Zealand	Greenlane Clinical Centre	One Tree Hill, Auckland
New Zealand	Middlemore Clinical Trials	Papatoetoe
New Zealand	Tauranga Hospital	Tauranga South
Norway	Haukeland Universitetssykehus	Bergen
Norway	Akershus Universitetssykehus HF	Lørenskog
Norway	Oslo Universitetssykehus HF, Rikshospitalet	Oslo
Poland	University Clinical Center, Gdansk	Gdansk
Poland	Leszek Giec Upper-Silesian Med.Cent.Silesian Med.Univ.	Katowice
Poland	Alergopneuma Medical Center	Swidnik
Poland	Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa	Warsaw
Poland	University Clinical Center of the Medical University of Warsaw	Warsaw
Portugal	ULS Braga	Braga
Portugal	ULS de São José, E.P.E.	Lisboa
Portugal	USLM, EPE - Hospital Pedro Hispano	Matosinhos
Portugal	ULS de Gaia/Espinho, EPE	Vila Nova de Gaia
Puerto Rico	Allianze Pulmonary Research LLC	Guaynabo
Saudi Arabia	King Fahad Specialist Hospital - Research Center	Dammam
Saudi Arabia	King Abdullah International Medical Research Center	Riyadh
Saudi Arabia	King Faisal Specialist Hospital and Research Center	Riyadh
Serbia	University Clinical Center of Serbia	Belgrade
Serbia	University Clinical Center of Kragujevac	Kragujevac
Serbia	University Clinical Center Nis	Nis
Serbia	Inst. for Pulm. Diseases of Vojvodine, Clinic f. Pulm. Oncol	Sremska Kamenica
Singapore	National University Hospital	Singapore
Singapore	Singapore General Hospital	Singapore
Slovenia	Hospital Golnik - Univ. Clinic of Pulmonary and Allergic Diseases	Golnik
South Africa	Busamed Paardevlei Private Hospital	Cape Town
South Africa	Melomed Gatesville Hospital	Cape Town
South Africa	KwaPhila Health Solutions	Durban
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital de Basurto	Bilbao
Spain	Hospital Universitario Virgen de la Arrixaca	El Palmar
Spain	Hospital de Galdakao	Galdakao
Spain	Hospital Universitari de Girona Doctor Josep Trueta	Girona
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hospital de Bellvitge	L'Hospitalet de Llobregat
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital La Princesa	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Infanta Leonor	Madrid
Spain	Hospital Virgen de la Victoria	Malaga
Spain	Hospital Central de Asturias	Oviedo
Spain	Hospital Quirónsalud Madrid	Pozuelo de Alarcón
Spain	Hospital Universitario Marqués de Valdecilla	Santander
Spain	Hospital Clínico de Santiago	Santiago de Compostela
Spain	Hospital Nuestra Señora de Valme	Sevilla
Spain	Hospital Virgen del Rocío	Sevilla
Sweden	Akademiska sjukhuset	Uppsala
Switzerland	University Hospital Basel	Basel
Switzerland	University Hospital Bern/Inselspital Bern	Bern
Taiwan	Chang-Hua Christian Hospital	Changhua
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	NCKUH	Tainan
Taiwan	Taipei Veterans General Hospital	Taipei
Thailand	Siriraj Hospital	Bangkok Noi
Thailand	Songklanagarind Hospital	Hat Yai
Thailand	Srinagarind Hospital	Khon Kaen
Thailand	Central Chest Institute of Thailand	Muang
Thailand	Maharat Nakhonchiangmai Hospital	Muang
Thailand	Ramathibodi Hospital	Ratchatewi
Turkey	Ankara Universitesi Tip Fakultesi	Ankara
Turkey	Gulhane Training and Research Hospital	Ankara
Turkey	Akdeniz Universitesi Tip Fakultesi	Antalya
Turkey	Uludag Universitesi Tip Fakultesi	Bursa
Turkey	Istanbul Universitesi Istanbul Tip Fakultesi	Istanbul
Turkey	Gazi Universitesi Tip Fakultesi	Yenimahalle/ANKARA
United Kingdom	Aberdeen Royal Infirmary	Aberdeen
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	Southmead Hospital	Bristol
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	Royal Devon and Exeter Hospital	Exeter
United Kingdom	Royal Lancaster Infirmary	Lancaster
United Kingdom	St James's University Hospital	Leeds
United Kingdom	Guy's Hospital	London
United Kingdom	Royal Brompton Hospital	London
United Kingdom	Altnagelvin Area Hospital	Londonderry
United Kingdom	Wythenshawe Hospital	Manchester
United Kingdom	Churchill Hospital	Oxford
United Kingdom	Southampton General Hospital	Southampton
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead	Atlanta	Georgia
United States	The Emory Clinic	Atlanta	Georgia
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	St. Elizabeth's Medical Center	Boston	Massachusetts
United States	University of Vermont	Burlington	Vermont
United States	Lowcountry Lung and Critical Care	Charleston	South Carolina
United States	University of Cincinnati	Cincinnati	Ohio
United States	St. Francis Medical Institute	Clearwater	Florida
United States	Cleveland Clinic	Cleveland	Ohio
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Stony Brook University Medical Center	Commack	New York
United States	Baylor University Medical Center	Dallas	Texas
United States	Premier Pulmonary Critical Care and Sleep Medicine	Denison	Texas
United States	National Jewish Health	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	Infinity Medical Research, Inc.	East Providence	Rhode Island
United States	Evanston Hospital Pulmonary Clinic	Evanston	Illinois
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Clinical Trials Center of Middle Tennessee, LLC	Franklin	Tennessee
United States	University of Florida Health Shands Hospital	Gainesville	Florida
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Clinical Research Specialists LLC	Kissimmee	Florida
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	University of California Los Angeles	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	Advanced Pulmonary Research Institute	Loxahatchee Groves	Florida
United States	University of Wisconsin	Madison	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	Intermountain Medical Center	Murray	Utah
United States	Vanderbilt University Medical Center - Vanderbilt Lung Institute at 100 Oaks	Nashville	Tennessee
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Tulane University Hospital and Clinic	New Orleans	Louisiana
United States	Columbia University Medical Center-New York Presbyterian Hospital	New York	New York
United States	Lenox Hill Hospital	New York	New York
United States	NewYork-Presbyterian/Weill Cornell Medical Center	New York	New York
United States	Christiana Hospital	Newark	Delaware
United States	Infinity Medical Research	North Dartmouth	Massachusetts
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Jefferson Health Honickman Center	Philadelphia	Pennsylvania
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	The Oregon Clinic	Portland	Oregon
United States	Renown Regional Medical Center	Reno	Nevada
United States	Mayo Clinic, Rochester	Rochester	Minnesota
United States	Beaumont Health	Royal Oak	Michigan
United States	University of California Davis	Sacramento	California
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of Utah Health Sciences Center	Salt Lake City	Utah
United States	UT Health San Antonio	San Antonio	Texas
United States	Destin Pulmonary Critical Care	Santa Rosa Beach	Florida
United States	Virginia Mason Medical Center	Seattle	Washington
United States	University of Arizona	Tucson	Arizona
United States	Southeastern Research Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Chile,  China,  Croatia,  Czechia,  Denmark,  Estonia,  Finland,  France,  Georgia,  Germany,  Greece,  Hungary,  India,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Norway,  Poland,  Portugal,  Puerto Rico,  Saudi Arabia,  Serbia,  Singapore,  Slovenia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change from baseline in Forced Vital Capacity (FVC) (mL) at Week 52		at baseline, at week 52
Secondary	Time to the first occurrence of any of the components of the composite endpoint: time to first acute ILD exacerbation, first hospitalization for respiratory cause, or death (whichever occurs first) over the duration of the trial	Key secondary endpoint	up to 31 months
Secondary	Time to first acute Interstitial Lung Disease (ILD) exacerbation or death over the duration of trial		up to 31 months
Secondary	Time to hospitalization for respiratory cause or death over the duration of trial		up to 31 months
Secondary	Time to absolute decline in Forced vital capacity (FVC) % predicted of >10% from baseline or death over the duration of the trial		up to 31 months
Secondary	Time to absolute decline in Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) % predicted of >15% from baseline or death over the duration of the trial		up to 31 months
Secondary	Time to death over the duration of trial		up to 31 months
Secondary	Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Dyspnea domain score at Week 52	The L-PF is a 49-item questionnaire with two modules: Symptoms (28 items) and Impact (21 items).; The Symptom score has three domain scores: dyspnea, cough, and fatigue, as well as a total symptom score.; Items have response options on a five-option numeric rating score with an anchor of 0 "Not at all" to 4 "Extremely", with higher numbers indicating a greater impairment.	at baseline, at week 52
Secondary	Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Cough domain score at Week 52	The L-PF is a 44-item questionnaire divided into two modules: Symptoms (23 items) and Impacts (21 items).; The Symptoms module assesses shortness of breath, cough and fatigue in the past 24 hours.; Items have response options on a five-option numeric rating score with an anchor of 0 "Not at all" to 4 "Extremely", with higher numbers indicating a greater impairment.	at baseline, at week 52
Secondary	Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Fatigue domain score at Week 52	The L-PF is a 44-item questionnaire divided into two modules: Symptoms (23 items) and Impacts (21 items).; The Symptoms module assesses shortness of breath, cough and fatigue in the past 24 hours.; Items have response options on a five-option numeric rating score with an anchor of 0 "Not at all" to 4 "Extremely", with higher numbers indicating a greater impairment.	at baseline, at week 52
Secondary	Absolute change from baseline in FVC % predicted at Week 52		at baseline, at week 52
Secondary	Absolute change from baseline in DLCO % predicted at Week 52		at baseline, at week 52

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