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)

Status: Completed
Location: See all (333) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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.

• 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.

Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
California
Cedars-Sinai Medical Center
Los Angeles
University of California Los Angeles
Los Angeles
University of Southern California
Los Angeles
University of California Davis
Sacramento
Colorado
National Jewish Health
Denver
Connecticut
Yale University School of Medicine
New Haven
Washington, D.c.
Georgetown University
Washington D.c.
Delaware
Christiana Hospital
Newark
Florida
St. Francis Medical Institute
Clearwater
University of Florida Health Shands Hospital
Gainesville
Clinical Research Specialists LLC
Kissimmee
Advanced Pulmonary Research Institute
Loxahatchee Groves
Destin Pulmonary Critical Care
Santa Rosa Beach
Georgia
Piedmont Healthcare-Atlanta-57055
Atlanta
Illinois
Evanston Hospital Pulmonary Clinic
Evanston
Kansas
University of Kansas Medical Center
Kansas City
Kentucky
Louisville Pulmonary Care
Louisville
Louisiana
Tulane University Hospital and Clinic
New Orleans
Massachusetts
Brigham and Women's Hospital
Boston
Massachusetts General Hospital
Boston
St. Elizabeth's Medical Center
Boston
Infinity Medical Research
North Dartmouth
Michigan
University of Michigan Health System
Ann Arbor
Beaumont Health
Royal Oak
Minnesota
Minnesota Lung Center and Sleep Institute
Edina
University of Minnesota
Minneapolis
Mayo Clinic, Rochester
Rochester
Missouri
The Lung Research Center, LLC
Chesterfield
Washington University School of Medicine
St Louis
North Carolina
Duke University Medical Center
Durham
Southeastern Research Center-Winston-Salem-61365
Winston-salem
Nebraska
Creighton University
Omaha
University of Nebraska Medical Center
Omaha
New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon
Nevada
Renown Regional Medical Center
Reno
New York
Northern Westchester Hospital
Mount Kisco
Columbia University Medical Center-New York Presbyterian Hospital
New York
Weill Cornell Medicine-New York-59955
New York
Ohio
University of Cincinnati
Cincinnati
Cleveland Clinic
Cleveland
The Ohio State University Wexner Medical Center
Columbus
Oregon
The Oregon Clinic
Portland
Pennsylvania
Jefferson Health Honickman Center
Philadelphia
Temple University Hospital
Philadelphia
University of Pennsylvania
Philadelphia
Allegheny General Hospital
Pittsburgh
South Carolina
Lowcountry Lung and Critical Care
Charleston
Tennessee
Clinical Trials Center of Middle Tennessee, LLC
Franklin
Vanderbilt University Medical Center - Vanderbilt Lung Institute at 100 Oaks
Nashville
Texas
Premier Pulmonary Critical Care and Sleep Medicine
Denison
The University of Texas Health Science Center at Houston
Houston
UT Health San Antonio
San Antonio
Utah
University of Utah Health Sciences Center
Salt Lake City
Washington
Virginia Mason Medical Center
Seattle
Wisconsin
University of Wisconsin
Madison
Other Locations
Argentina
Centro de Investigaciones Metabolicas (CINME)-C.A.B.A-61553
C.a.b.a
CEDIC - Centro de Investigacion Clinica
Caba
Hospital Italiano de Buenos Aires
Caba
Consultorios Médicos del Buen Ayre
Capital Federal
Instituto Ave Pulmo
Mar Del Plata
INSARES
Mendoza
Centro Respiratorio de Quilmes
Quilmes
Australia
Royal Prince Alfred Hospital
Camperdown
Canberra Hospital
Canberra
Lung Research Queensland
Chermside
The Prince Charles Hospital
Chermside
Lung Research Victoria
Footscray
Austin Hospital
Heidelberg
The Alfred Hospital
Melbourne
Fiona Stanley Hospital
Murdoch
Mater Hospital Brisbane
South Brisbane
Trialswest
Spearwood
Westmead Hospital
Westmead
Princess Alexandra Hospital
Woolloongabba
Austria
LKH Klagenfurt am Woerthersee
Klagenfurt
Krems University Hospital
Krems
Hospital Elisabethinen Linz
Linz
LKH Salzburg University Hospital
Salzburg
AKH - Medical University of Vienna
Vienna
Clinic Floridsdorf
Vienna
Klinikum Wels - Grieskirchen GmbH
Wels
Belgium
Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim
Antwerp
Cliniques Universitaires Saint-Luc
Brussels
ULB Hopital Erasme
Brussels
UNIV UZ Gent
Ghent
UZ Leuven
Leuven
Centre Hospitalier Universitaire de Liège
Liège
Yvoir - UNIV UCL de Mont-Godinne
Yvoir
Brazil
Serviços Medicos Respirar Sul Fluminense
Barra Mansa
Hospital das Clinicas da Universidade Federal HC-UFMG
Belo Horizonte,minas Gerais
Edumed - Educacao e Saude SA
Curitiba
CLARE - Clinica de Pneumologia
Goiânia
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre
Instituto D´Or de Pesquisa e Ensino - Bahia
Salvador
CEMEC - Centro Multidisciplinar de Estudos Clínicos
São Bernardo Do Campo
Hospital Alemao Oswaldo Cruz
São Paulo
Canada
University of Alberta Hospital (University of Alberta)
Edmonton
QEII Health Sciences Centre
Halifax
St. Joseph's Healthcare Hamilton
Hamilton
Kelowna Respirology & Allergy Research
Kelowna
Dr. Georges-L.-Dumont University Hospital Centre
Moncton
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal
McGill University Health Centre (MUHC)
Montreal
IUCPQ (Laval University)
Québec
CIC Mauricie Inc.
Trois-rivières
St. Paul's Hospital (Vancouver)
Vancouver
Vancouver General Hospital
Vancouver
Dr. Syed Anees Medicine Professional Corporation
Windsor
Chile
Instituto Nacional del Tórax
Providencia, Santiago De Chile
Centro de Investigación del Maule
Talca
China
China-Japan Friendship Hospital
Beijing
Chinese PLA General Hospital
Beijing
Peking Union Medical College Hospital
Beijing
The Second Xiangya Hospital Of Central South University
Changsha
West China Hospital of Sichuan University
Chengdu
First Affiliated Hospital of Guangzhou Medical University
Guangzhou
NanFang Hosptial
Guangzhou
Hangzhou First People's Hospital
Hangzhou
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou
Anhui Provincial Hospital
Hefei
The First hospital of Jiaxing
Jiaxing
Jinhua Municipal Central Hospital
Jinhua
Nanjing Drum Tower Hospital
Nanjing
The First Affiliated Hospital of Ningbo University
Ningbo
Huadong Hospital affiliated to Fudan University
Shanghai
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Shanghai Chest Hospital
Shanghai
Shanghai Pulmonary Hospital
Shanghai
Zhongshan Hospital Affiliated to Fudan University
Shanghai
China Shenyang Chest Hospital
Shenyang
Shenzhen People's Hospital
Shenzhen
The University of Hong Kong-Shenzhen Hospital
Shenzhen
People's Hospital of Sichuan Province
Sichuan
The First Affiliated Hospital of Soochow University
Suzhou
Tianjin Medical University General Hospital
Tianjin
Renmin Hospital of Wuhan University
Wuhan
Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
Wuhan
Wuhan Union Hospital
Wuhan
Wuxi People's Hospital
Wuxi
Second Affiliated Hospital of Xi'an JiaoTong University
Xi'an
Affiliated Hospital, Xuzhou Medical college
Xuzhou
Yichang NO.1 People's Hospital
Yichang
Croatia
University Hospital Dubrava
Zagreb
Denmark
Aarhus University Hospital
Aarhus N
Herlev and Gentofte Hospital
Hellerup
Odense University Hospital
Odense
Estonia
North Estonia Medical Centre Foundation, Tallinn
Tallinn
Finland
HYKS Keuhkosairauksien tutkimusyksikkö
Helsinki
Oulun yliopistollinen keskussairaala
Oulu
France
HOP d'Angers
Angers
HOP Avicenne
Bobigny
HOP de la Cavale Blanche
Brest
HOP Louis Pradel
Bron
HOP CHU Caen
Caen
HOP François Mitterrand
Dijon
HOP Michallon
La Tronche
HOP Bicêtre
Le Kremlin-bicêtre
INS Coeur Poumon
Lille
HOP Nord
Marseille
HOP Nord Laennec
Nantes
HOP Pasteur
Nice
HOP Bichat
Paris
HOP Paris Saint-Joseph
Paris
HOP Tenon
Paris
HOP Haut-Lévêque
Pessac
HOP Robert Debré
Reims
HOP Pontchaillou
Rennes
HOP Charles Nicolle
Rouen
HOP Civil
Strasbourg
HOP Foch
Suresnes
HOP Larrey
Toulouse
HOP Bretonneau
Tours
Germany
Velocity Clinical Research Germany GmbH, Ahrensburg
Ahrensburg
CIMS Studienzentrum Bamberg GmbH
Bamberg
Vivantes Netzwerk für Gesundheit GmbH
Berlin
Universitätsklinikum Bonn AöR
Bonn
Klinikum Chemnitz gGmbH
Chemnitz
Fachkrankenhaus Coswig GmbH
Coswig
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen
Universitätsklinikum Hamburg, Eppendorf
Hamburg
Klinikum Region Hannover GmbH
Hanover
Medizinische Hochschule Hannover
Hanover
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg
Lungenklinik Hemer
Hemer
Lungenfachklinik Immenhausen
Immenhausen
Klinikum Konstanz
Konstanz
Klinikum der Universität München - Campus Großhadern
München
Klinikum Nürnberg
Nuremberg
Krankenhaus Bethanien gGmbH
Solingen
Helios Hanseklinikum Stralsund
Stralsund
Robert-Bosch-Krankenhaus GmbH
Stuttgart
Universitätsklinikum Tübingen
Tübingen
Petrus-Krankenhaus
Wuppertal
Greece
Univ. Gen. Hosp. of Ioannina
Ioannina
Univ. Gen. Hosp. of Patras
Pátrai
Hospital of Heraklion (PAGNI)
Voútai
Hungary
Koranyi National Institute For Pulmonolgy
Budapest
University of Debrecen Clinical Centre
Debrecen
Ireland
Connolly Hospital Blanchardstown
Dublin
Italy
A.O.U. Policlinico Vittorio Emanuele
Catania
A. O. Universitaria Careggi
Florence
Ospedale Colonnello D Avanzo
Foggia
Ospedale G.B. Morgagni
Forlì
Ospedale Classificato San Giuseppe
Milan
Azienda Ospedaliera Policlinico di Modena
Modena
Azienda Ospedaliera Universitaria di Padova
Padua
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma
Pol. Universitario Tor Vergata
Roma
A.O.U. Senese Policlinico Santa Maria alle Scotte
Siena
Ospedali Riuniti di Ancona
Torrette Di Ancona (ancona)
Japan
Tosei General Hospital
Aichi, Seto
Fujita Health University Hospital
Aichi, Toyoake
Chiba University Hospital
Chiba, Chiba
IUHW Narita Hospital
Chiba, Narita
University of Fukui Hospital
Fukui, Yoshida-gun
Kyushu University Hospital
Fukuoka, Fukuoka
National Hospital Organization Kyushu Medical Center
Fukuoka, Fukuoka
Aso Co.,Ltd Iizuka Hospital
Fukuoka, Iizuka
Kurume University Hospital
Fukuoka, Kurume
Fukushima Medical University Hospital
Fukushima, Fukushima
Tsuboi Hospital
Fukushima, Koriyama
Hiroshima Prefectural Hospital
Hiroshima, Hiroshima
Sapporo Medical University Hospital
Hokkaido, Sapporo
National Hospital Organization Himeji Medical Center
Hyogo, Himeji
Kobe City Hospital Organization Kobe City Medical Center West Hospital
Hyogo, Kobe
Kobe City Medical Center General Hospital
Hyogo, Kobe
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, Yokohama
Saiseikai Kumamoto Hospital
Kumamoto, Kumamoto
Nagasaki University Hospital
Nagasaki, Nagasaki
Kindai University Hospital
Osaka, Osakasayama
National Hospital Organization Kinki-Chuo Chest Medical Center
Osaka, Sakai
Saitama Red Cross Hospital
Saitama, Saitama
Shimane University Hospital
Shimane, Izumo
Hamamatsu University Hospital
Shizuoka, Hamamatsu
Jichi Medical University Hospital
Tochigi, Shimotsuke
Tokushima University Hospital
Tokushima, Tokushima
Juntendo University Hospital
Tokyo, Bunkyo-ku
Toranomon Hospital
Tokyo, Minato-ku
Kyorin University Hospital
Tokyo, Mitaka
Toho University Omori Medical Center
Tokyo, Ota-ku
National Center for Global Health and Medicine
Tokyo, Shinjuku-ku
Tokyo Medical University Hospital
Tokyo, Shinjuku-ku
Wakayama Medical University Hospital
Wakayama, Wakayama
Malaysia
Hospital Sultan Idris Shah Serdang
Kajang
Institut Perubatan Respiratori
Kuala Lumpur
Sarawak General Hospital
Kuching
Hospital Pulau Pinang-Pulau Pinang-21953
Pulau Pinang
Mexico
Centro de Investigacion Integral MEDIVEST S.C
Chihuahua City
Centro Respiratorio de Mexico
Mexico City
Soltmed Smo
Mexico City
Centro de Prevención y Rehabilitación de Enfermedades Pulmon
Monterrey
Oaxaca Site Management Organization, S.C.
Oaxaca City
Netherlands
Zuyderland Medisch Centrum
Heerlen
St. Antonius ziekenhuis, locatie Nieuwegein
Nieuwegein
Erasmus Medisch Centrum-ROTTERDAM-50697
Rotterdam
New Zealand
Waikato Hospital
Hamilton
Greenlane Clinical Centre
One Tree Hill, Auckland
Middlemore Clinical Trials
Papatoetoe
Tauranga Hospital
Tauranga South
Norway
Haukeland Universitetssykehus
Bergen
Akershus Universitetssykehus HF
Lørenskog
Oslo Universitetssykehus HF, Rikshospitalet
Oslo
Poland
University Clinical Center, Gdansk
Gdansk
Alergopneuma Medical Center
Świdnik
Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa
Warsaw
Portugal
ULS de Coimbra, E.P.E.
Coimbra
USLM, EPE - Hospital Pedro Hispano
Matosinhos Municipality
Puerto Rico
Allianze Pulmonary Research LLC
Guaynabo
Republic of Korea
The Catholic University of Korea, Bucheon St.Mary's Hospital
Bucheon-si
Seoul National University Bundang Hospital
Seongnam
Asan Medical Center
Seoul
Kyung Hee University Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital
Seoul
Soonchunhyang University Hospital Seoul
Seoul
Singapore
National University Hospital-Singapore-42005
Singapore
Singapore General Hospital
Singapore
Tan Tock Seng Hospital
Singapore
South Africa
Busamed Paardevlei Private Hospital
Cape Town
Melomed Gatesville Hospital
Cape Town
KwaPhila Health Solutions
Durban
Spain
Hospital General Universitario de Alicante
Alicante
Hospital Clínic de Barcelona
Barcelona
Hospital del Mar
Barcelona
Hospital Vall d'Hebron
Barcelona
Hospital de Basurto
Bilbao
Hospital Universitario Virgen de la Arrixaca
El Palmar
Hospital de Galdakao
Galdakao
Hospital Universitari de Girona Doctor Josep Trueta
Girona
Hospital Universitario Virgen de las Nieves
Granada
Hospital de Bellvitge
L'hospitalet De Llobregat
Hospital Universitario Lucus Augusti
Lugo
Hospital General Universitario Gregorio Marañón
Madrid
Hospital La Princesa
Madrid
Hospital Ramón y Cajal
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Infanta Leonor
Madrid
Hospital Virgen de la Victoria
Málaga
Hospital Central de Asturias
Oviedo
Hospital Son Espases
Palma De Mallorca
Hospital Quirónsalud Madrid
Pozuelo De Alarcón
Hospital Universitario Marqués de Valdecilla
Santander
Hospital Clínico de Santiago
Santiago De Compostela
Hospital Nuestra Señora de Valme
Seville
Hospital Virgen del Rocío
Seville
Hospital General Universitario de Valencia
Valencia
Sweden
Universitetssjukhuset, Linköping
Linköping
Akademiska sjukhuset
Uppsala
Switzerland
Universitätsspital Basel
Basel
Taiwan
Chang-Hua Christian Hospital
Changhua
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Taichung Veterans General Hospital
Taichung
NCKUH
Tainan City
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Thailand
Siriraj Hospital
Bangkok Noi
Songklanagarind Hospital
Hat Yai
Srinagarind Hospital
Khon Kaen
Central Chest Institute of Thailand
Muang
Maharat Nakhonchiangmai Hospital
Muang
Ramathibodi Hospital
Ratchatewi
United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham
Southmead Hospital
Bristol
Royal Infirmary of Edinburgh
Edinburgh
Royal Devon and Exeter Hospital, Wonford
Exeter
Royal Lancaster Infirmary
Lancaster
St James's University Hospital
Leeds
Royal Brompton Hospital
London
Wythenshawe Hospital
Manchester
Churchill Hospital
Oxford
Time Frame
Start Date: 2022-10-06
Completion Date: 2024-12-17
Participants
Target number of participants: 1177
Treatments
Experimental: Nerandomilast 9 mg BID
Participants received 9 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.
Experimental: Nerandomilast 18 mg BID
Participants received 18 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.
Placebo_comparator: Placebo
Participants received placebo matching 9 mg or 18 mg nerandomilast film-coated tablets orally twice daily, with doses given at least 12 hours apart and each taken with 250 mL of water.
Sponsors
Leads: Boehringer Ingelheim

This content was sourced from clinicaltrials.gov

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