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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05321069
Other study ID # 1305-0014
Secondary ID 2022-001091-34
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date September 19, 2022
Est. completion date November 15, 2024

Study information

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

Clinical Trial Summary

This study is open to adults with a lung disease called Idiopathic Pulmonary Fibrosis (IPF). People can join the study if they are 40 years or older. If they already take nintedanib or pirfenidone for their IPF, they can continue treatment throughout the study. 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1177
Est. completion date November 15, 2024
Est. primary completion date August 5, 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Inclusion criteria 1. Patients =40 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 Idiopathic Pulmonary Fibrosis (IPF) 4. 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. 5. Forced Vital Capacity (FVC) =45% of predicted normal at Visit 1. 6. Diffusing Capacity (of Lung) for Carbon Monoxide (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 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 Idiopathic Pulmonary Fibrosis (IPF) 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. Confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) not fully recovered according to investigator judgement within the 4 weeks prior to randomization (Visit 2). 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.

Study Design


Intervention

Drug:
BI 1015550
BI 1015550
Placebo
Placebo

Locations

Country Name City State
Argentina Consultorios Médicos del Buen Ayre Buenos Aires
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 Instituto Ave Pulmo Mar del Plata
Argentina INSARES Mendoza
Argentina Centro Respiratorio de Quilmes Quilmes
Australia Royal Prince Alfred Hospital Camperdown New South Wales
Australia Canberra Hospital Canberra Australian Capital Territory
Australia Lung Research Queensland Chermside Queensland
Australia The Prince Charles Hospital Chermside Queensland
Australia Lung Research Victoria Footscray Victoria
Australia Austin Hospital Heidelberg Victoria
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
Australia Princess Alexandra Hospital Woolloongabba Queensland
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 Clinic Floridsdorf 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 CEMEC - Centro Multidisciplinar de Estudos Clínicos São Bernardo do Campo
Brazil Hospital Alemao Oswaldo Cruz Sao Paulo
Canada University of Alberta Hospital (University of Alberta) Edmonton Alberta
Canada QEII Health Sciences Centre Halifax Nova Scotia
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 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 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 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 Anhui Provincial Hospital Hefei
China The First hospital of Jiaxing Jiaxing
China Jinhua Municipal Central Hospital Jinhua
China Nanjing Drum Tower Hospital Nanjing
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 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
Croatia University Hospital Dubrava Zagreb
Denmark Aarhus University Hospital Aarhus N
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
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 Bicêtre Le Kremlin-Bicêtre
France INS Coeur Poumon Lille
France HOP Nord Marseille
France HOP Nord Laennec Nantes Cedex 01
France HOP Pasteur Nice
France HOP Bichat Paris
France HOP Paris Saint-Joseph Paris
France HOP Tenon 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
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 Klinikum Nürnberg Nürnberg
Germany Krankenhaus Bethanien gGmbH Solingen
Germany Helios Hanseklinikum Stralsund Stralsund
Germany Robert-Bosch-Krankenhaus GmbH Stuttgart
Germany Universitätsklinikum Tübingen Tübingen
Germany Petrus-Krankenhaus Wuppertal
Greece Univ. Gen. Hosp. of Ioannina Ioannina
Greece Univ. Gen. Hosp. of Patras Patras
Greece Hospital of Heraklion (PAGNI) Voutes
Hungary Koranyi National Institute For Pulmonolgy Budapest
Hungary University of Debrecen Clinical Centre Debrecen
Ireland Connolly Hospital Blanchardstown Dublin 15
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 Azienda Ospedaliera Policlinico di Modena Modena
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)
Japan Tosei General Hospital Aichi, Seto
Japan Fujita Health University Hospital Aichi, Toyoake
Japan Chiba University Hospital Chiba, Chiba
Japan IUHW Narita Hospital Chiba, Narita
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 Kurume University Hospital Fukuoka, Kurume
Japan Fukushima Medical University Hospital Fukushima, Fukushima
Japan Tsuboi Hospital Fukushima, Koriyama
Japan Hiroshima Prefectural Hospital Hiroshima, Hiroshima
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 Kanagawa Cardiovascular and Respiratory Center Kanagawa, Yokohama
Japan Saiseikai Kumamoto Hospital Kumamoto, Kumamoto
Japan Nagasaki University Hospital Nagasaki, Nagasaki
Japan Kindai University Hospital Osaka, Osakasayama
Japan National Hospital Organization Kinki-Chuo Chest Medical Center Osaka, Sakai
Japan Saitama Red Cross Hospital Saitama, Saitama
Japan Shimane University Hospital Shimane, Izumo
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 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 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 de Investigacion Integral MEDIVEST S.C Chihuahua
Mexico Centro Respiratorio de Mexico Ciudad de Mexico
Mexico Soltmed Smo Ciudad de Mexico
Mexico Centro de Prevención y Rehabilitación de Enfermedades Pulmon Monterrey
Mexico Oaxaca Site Management Organization, S.C. Oaxaca
Netherlands Zuyderland Medisch Centrum Heerlen
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 Alergopneuma Medical Center Swidnik
Poland Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa Warsaw
Portugal ULS de Coimbra, E.P.E. Coimbra
Portugal USLM, EPE - Hospital Pedro Hispano Matosinhos
Puerto Rico Allianze Pulmonary Research LLC Guaynabo
Singapore National University Hospital Singapore
Singapore Singapore General Hospital Singapore
Singapore Tan Tock Seng Hospital Singapore
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 Universitario Lucus Augusti Lugo
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 Son Espases Palma de Mallorca
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
Spain Hospital General Universitario de Valencia Valencia
Sweden Universitetssjukhuset, Linköping Linköping
Sweden Akademiska sjukhuset Uppsala
Switzerland University Hospital Basel Basel
Taiwan Chang-Hua Christian Hospital Changhua
Taiwan Kaohsiung Chang Gung Memorial Hospital Kaohsiung
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung
Taiwan Far Eastern Memorial Hospital New Taipei City
Taiwan Taichung Veterans General Hospital Taichung
Taiwan NCKUH Tainan
Taiwan National Taiwan University Hospital Taipei
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
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 Royal Brompton Hospital London
United Kingdom Wythenshawe Hospital Manchester
United Kingdom Churchill Hospital Oxford
United States University of Michigan Health System Ann Arbor Michigan
United States Piedmont Healthcare Atlanta Georgia
United States University of Alabama at Birmingham Birmingham Alabama
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 Lowcountry Lung and Critical Care Charleston South Carolina
United States The Lung Research Center, LLC Chesterfield Missouri
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 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 Minnesota Lung Center and Sleep Institute Edina Minnesota
United States Evanston Hospital Pulmonary Clinic Evanston Illinois
United States Clinical Trials Center of Middle Tennessee, LLC Franklin Tennessee
United States University of Florida Health Shands Hospital Gainesville Florida
United States The University of Texas Health Science Center at Houston Houston Texas
United States University of Kansas Medical Center Kansas City Kansas
United States Clinical Research Specialists LLC Kissimmee Florida
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
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 Louisville Pulmonary Care Louisville Kentucky
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 Northern Westchester Hospital Mount Kisco New York
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 Weill Cornell Medicine New York New York
United States Christiana Hospital Newark Delaware
United States Infinity Medical Research North Dartmouth Massachusetts
United States Creighton University Omaha Nebraska
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 Georgetown University Washington District of Columbia
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,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Norway,  Poland,  Portugal,  Puerto Rico,  Singapore,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Thailand,  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 IPF exacerbation, first hospitalization for respiratory cause, or death (whichever occurs first) over the duration of the trial Key secondary endpoint up to 30 months
Secondary Time to first acute Idiopathic Pulmonary Fibrosis (IPF) exacerbation or death over the duration of trial up to 30 months
Secondary Time to hospitalization for respiratory cause or death over the duration of trial up to 30 months
Secondary Time to absolute decline in FVC % predicted of >10% from baseline or death over the duration of the trial up to 30 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 30 months
Secondary Time to death over the duration of trial up to 30 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 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 Fatigue 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 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
See also
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Withdrawn NCT01524068 - A MultiCenter Study of Combined PEX, Rituximab, and Steroids in Acute Idiopathic Pulmonary Fibrosis Exacerbations Phase 2
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Completed NCT01110694 - Prospective Observation of Fibrosis in the Lung Clinical Endpoints Study
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