Phase
Condition
Lung Injury
Scar Tissue
Cystic Fibrosis
Treatment
N/AClinical Study ID
Ages > 40 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female subject aged ≥40 years on the day of signing the Informed Consent Form (ICF).
- A diagnosis of IPF within 5 years prior to the screening visit, as per applicableAmerican Thoracic Society (ATS)/European Respiratory Society (ERS)/JapaneseRespiratory Society (JRS)/Latin American Thoracic Association (ALAT) guidelines at thetime of diagnosis.
- Chest high-resolution computed tomography (HRCT) historically performed within 12months prior to the screening visit and according to the minimum requirements for IPFdiagnosis by central review based on subject's HRCT only (if no lung biopsy (LB)available), or based on both HRCT and LB (with application of the different criteriain either situation). If an evaluable HRCT <12 months prior to screening is notavailable, an HRCT can be performed at screening to determine eligibility, accordingto the same requirements as the historical HRCT.
- Subjects receiving local standard of care for the treatment of IPF, defined as eitherpirfenidone or nintedanib at a stable dose for at least two months before screening,and during screening; or neither pirfenidone or nintedanib (for any reason). A stabledose is defined as the highest dose tolerated by the subject during those two months.
- The extent of fibrotic changes is greater than the extent of emphysema on the mostrecent HRCT scan (investigator-determined).
- Meeting all of the following criteria during the screening period: FVC ≥45% predictedof normal, Forced expiratory volume in 1 second (FEV1)/FVC ≥0.7, diffusing capacity ofthe lung for carbon monoxide (DLCO) corrected for Hb ≥30% predicted of normal.
- Estimated minimum life expectancy of at least 30 months for non IPF related disease inthe opinion of the investigator.
- Male subjects and female subjects of childbearing potential agree to use highlyeffective contraception/preventive exposure measures from the time of first dose ofinvestigational medicinal product (IMP) (for the male subject) or the signing of theICF (for the female subject), during the study, and until 90 days (male) or 30 days (female) after the last dose of IMP.
- Able to walk at least 150 meters during the 6-Minute Walk Test (6MWT) at screeningVisit 1; without having a contraindication to perform the 6MWT or without a conditionputting the subject at risk of falling during the test (investigator's discretion).The use of a cane is allowed, the use of a stroller is not allowed at all for anycondition. At Visit 2, for the oxygen titration test, resting oxygen saturation (SpO2)should be ≥88% with maximum 6 L O2/minute; during the walk, SpO2 should be ≥83% with 6L O2/minute or ≥88% with 0, 2 or 4 L O2/minute.
Exclusion
Exclusion Criteria:
- History of malignancy within the past 5 years (except for carcinoma in situ of theuterine cervix, basal cell carcinoma of the skin that has been treated with noevidence of recurrence, prostate cancer that has been medically managed through activesurveillance or watchful waiting, squamous cell carcinoma of the skin if fullyresected, and Ductal Carcinoma In Situ).
- Clinically significant abnormalities detected on ECG of either rhythm or conduction, aQT interval corrected for heart rate using Fridericia's formula (QTcF) >450 ms, or aknown long QT syndrome. Patients with implantable cardiovascular devices (e.g.pacemaker) affecting the QT interval time may be enrolled in the study based uponinvestigator judgment following cardiologist consultation if deemed necessary, andonly after discussion with the medical monitor.
- Acute IPF exacerbation within 6 months prior to screening and/or during the screeningperiod. The definition of an acute IPF exacerbation is as follows: Previous orconcurrent diagnosis of IPF; Acute worsening or development of dyspnea typically < 1month duration; Computed tomography with new bilateral ground-glass opacity and/orconsolidation superimposed on a background pattern consistent with usual interstitialpneumonia pattern and deterioration not fully explained by cardiac failure or fluidoverload.
- Lower respiratory tract infection requiring treatment within 4 weeks prior toscreening and/or during the screening period.
- Interstitial lung disease associated with known primary diseases (e.g. sarcoidosis andamyloidosis), exposures (e.g. radiation, silica, asbestos, and coal dust), or drugs (e.g. amiodarone).
- Diagnosis of severe pulmonary hypertension (investigator- determined).
- Unstable cardiovascular, pulmonary (other than IPF), or other disease within 6 monthsprior to screening or during the screening period (e.g. acute coronary disease, heartfailure, and stroke).
- Had gastric perforation within 3 months prior to screening or during screening, and/orunderwent major surgery within 3 months prior to screening, during screening or havemajor surgery planned during the study period.
- History of nintedanib-related increase in ALT and/or AST of >5 x upper limit of thenormal range (ULN) and increased susceptibility to elevated LFT; moderate to severehepatic impairment (Child-Pugh B or C) and/or abnormal liver function test (LFT) atscreening, defined as aspartate aminotransferase (AST), and/or alanineaminotransferase (ALT), and/or total bilirubin ≥1.5 x upper limit of the normal range (ULN), and/or gamma glutamyl transferase (GGT) ≥3 x ULN. Retesting is allowed once forabnormal LFT.
- Abnormal renal function defined as estimated creatinine clearance, calculatedaccording to Cockcroft-Gault calculation (CCr) <30 mL/min. Retesting is allowed once.
- Use of any of the following therapies within 4 weeks prior to screening and during thescreening period, or planned during the study: warfarin, imatinib, ambrisentan,azathioprine, cyclophosphamide, cyclosporine A, bosentan, methotrexate, sildenafil (except for occasional use), prednisone at steady dose >10 mg/day or equivalent.
Study Design
Connect with a study center
Royal Adelaide Hospital
Adelaide, 5000
AustraliaSite Not Available
Flinders Medical Centre
Bedford Park, 5042
AustraliaSite Not Available
Box Hill Hospital
Box Hill, VIC 3128
AustraliaSite Not Available
Corte Royal Prince Alfred Hospital
Camperdown, NSW 2050
AustraliaSite Not Available
Lung Research Queensland
Chermside, QLD 4060
AustraliaSite Not Available
Concord Repatriation General Hospital
Concord, NSW 2139
AustraliaSite Not Available
St Vincent's Hospital Sydney
Darlinghurst, NSW 2010
AustraliaSite Not Available
Austin Health
Heidelberg, 3084
AustraliaSite Not Available
Respiratory Clinical Trials Pty Ltd
Kent Town, SA 5067
AustraliaSite Not Available
The Alfred Hospital
Melbourne, VIC 3004
AustraliaSite Not Available
ZNA Middelheim
Antwerp, 2020
BelgiumSite Not Available
Cliniques Universitaires Saint-Luc
Brussels, 1200
BelgiumSite Not Available
Hôpital Erasme
Brussels, 1070
BelgiumSite Not Available
UZ Leuven
Leuven, 3000
BelgiumSite Not Available
CHU UCL Namur asbl - Site Godinne
Yvoir, 5530
BelgiumSite Not Available
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90035-074
BrazilSite Not Available
Faculdade de Medicina Do ABC
Santo André, 09060-870
BrazilSite Not Available
Hospital Clínico Regional de Concepción Dr Guillermo Grant Benavente
Concepción, 4070038
ChileSite Not Available
Centro de Investigación Curico
Curicó, 3341643
ChileSite Not Available
Centro Respiratorio Integral LTDA. (CENRESIN)
Quillota, 2260000
ChileSite Not Available
Centro de Investigaciones Medicas Respiratorias CIMER
Santiago, 7500692
ChileSite Not Available
Hospital Dr Sotero Del Rio
Santiago, 8207257
ChileSite Not Available
Instituto Nacional Torax
Santiago, 7500691
ChileSite Not Available
Centro de Investigacion del Maule
Talca, 3465584
ChileSite Not Available
Hospital Carlos Van Buren
Valparaíso, 2352499
ChileSite Not Available
CINVEC- Estudos Clínicos Quinta Región Limitada
Viña Del Mar, 2520024
ChileSite Not Available
Fakultni nemocnice Brno
Brno, 62500
CzechiaSite Not Available
Fakultni nemocnice Ostrava
Ostrava, 708 52
CzechiaSite Not Available
Nemocnice Na Bulovce
Praha, 180 81
CzechiaSite Not Available
Thomayerova nemocnice
Praha, 14059
CzechiaSite Not Available
Aarhus Universitetshospital
Aarhus, 8200
DenmarkSite Not Available
Gentofte Hospital
Hellerup, 2900
DenmarkSite Not Available
Odense Universitetshospital
Odense, 5000
DenmarkSite Not Available
Zentralklinik Bad Berka GmbH
Bad Berka, 99437
GermanySite Not Available
Evangelische Lungenklinik
Berlin, 13125
GermanySite Not Available
Fachkrankenhaus Coswig
Coswig, 01640
GermanySite Not Available
Medizinische Hochschule Hannover
Hannover, 30625
GermanySite Not Available
Thorax Klinik
Heidelberg, 69126
GermanySite Not Available
Universitatsklinikum Leipzig
Leipzig, 04103
GermanySite Not Available
Klinikum Rosenheim
Rosenheim, 83022
GermanySite Not Available
Attikon University General Hospital
Athens, 12464
GreeceSite Not Available
Sotiria Chest Hospital of Athens
Athens, 11527
GreeceSite Not Available
University General Hospital of Heraklion
Iraklio, 71110
GreeceSite Not Available
University General Hospital of Larissa
Larissa, 41110
GreeceSite Not Available
Georgios Papanikolaou General Hospital of Thessaloniki
Thessaloníki, 57010
GreeceSite Not Available
Tenryu Hospital
Hamamatsu, 434-8511
JapanSite Not Available
Saiseikai Kumamoto Hospital
Kumamoto, 861-4193
JapanSite Not Available
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakai, 591-8555
JapanSite Not Available
Tosei General Hospital
Seto, 489-0065
JapanSite Not Available
Center Hospital of the National Center for Global Health and Medicine
Tokyo, 162-0052
JapanSite Not Available
National Hospital Organization Kyushu Medical Center
Tokyo, 810-8563
JapanSite Not Available
Kanagawa Cardiovascular and Respiratory Center
Yokohama, 236-0051
JapanSite Not Available
Hospital Chancay y Servicios Basicos de Salud
Chancay, 15131
PeruSite Not Available
Hospital Nacional Guillermo Almenara Irigoyen ESSALUD
Lima,
PeruSite Not Available
Clinica Internacional - PPDS
Lima Cercado,
PeruSite Not Available
Clinica Ricardo Palma - PPDS
San Isidro,
PeruSite Not Available
Clinica Providencia (Inverconsult Sociedad Anonima)
San Miguel,
PeruSite Not Available
Clinica San Pablo
Santiago De Surco,
PeruSite Not Available
CHUVI - H.U. Alvaro Cunquerio
Vigo, Pontevedra 36312
SpainSite Not Available
Hospital Clinical de Barcelona
Barcelona, 03036
SpainSite Not Available
Hospital Universitario de Bellvitge, Hospitalet De Llobregat
Barcelona, 08097
SpainSite Not Available
Hospital Clinico San Carlos
Madrid, 28040
SpainSite Not Available
Hospital Universitario de La Princesa
Madrid, 28006
SpainSite Not Available
Clinica Universidad Navarra
Pamplona, 31008
SpainSite Not Available
Hospital Universitario Marques de Valdecilla
Santander, 39008
SpainSite Not Available
Consorcio Hospital General Universitario de Valencia
Valencia, 46014
SpainSite Not Available
Kaohsiung Medical University Hospital
Kaohsiung City, 807
TaiwanSite Not Available
Far Eastern Memorial Hospital
New Taipei City, 220
TaiwanSite Not Available
Taipei Medical University Shuang Ho Hospital
New Taipei City, 23561
TaiwanSite Not Available
National Taiwan University Hospital
Taipei, 10002
TaiwanSite Not Available
Süreyyapaşa Göğüs Hastalıkları Ve Göğüs Cerrahisi Eğitim Ve Araştırma Hastanesi
Istanbul, 34854
TurkeySite Not Available
Mersin Üniversitesi Tıp Fakültesi Hastanesi Göğüs Hastalıkları Polikinliği
Mersin, 33169
TurkeySite Not Available
Ege Universitesi Tıp Fakultesi Hastanesi Gögus Hastalıkları Anabilim Dalı
İzmir, 35100
TurkeySite Not Available
Uludag Universitesi Tıp Fakultesi Hastanesi Gögüs Hastalıkları Anabilim Dalı
İzmir, 35100
TurkeySite Not Available
Birmingham Heartlands Hospital
Birmingham, B9 5SS
United KingdomSite Not Available
Southmead Hospital
Bristol, BS10 5NB
United KingdomSite Not Available
Papworth Hospital
Cambridge, CB233RE
United KingdomSite Not Available
Castle Hill Hospital
Cottingham, HU16 5JQ
United KingdomSite Not Available
Royal Devon and Exeter Hospital NHS Trust
Exeter, EX2 5DW
United KingdomSite Not Available
Aintree University Hospital NHS Foundation Trust
Liverpool, L9 7AL
United KingdomSite Not Available
Royal Brompton Hospital
London, SW3 6NP
United KingdomSite Not Available
Wythenshawe Hospital - PPDS
Manchester, M23 9LT
United KingdomSite Not Available
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle, NE14LP
United KingdomSite Not Available
Nottingham City Hospital
Nottingham, NG5 1PB
United KingdomSite Not Available
Northern General Hospital
Sheffield, S5 7AU
United KingdomSite Not Available
Pulmonary Associates
Phoenix, Arizona 85006
United StatesSite Not Available
Mayo Clinic Arizona - PPDS
Scottsdale, Arizona 85259
United StatesSite Not Available
Atria Clinical Research - BTC - PPDS
Little Rock, Arkansas 72209
United StatesSite Not Available
David Geffen School of Medicine at UCLA
Los Angeles, California 90095
United StatesSite Not Available
Respire Research
Palm Springs, California 92262
United StatesSite Not Available
University of California San Diego
San Diego, California 92037
United StatesSite Not Available
Stanford University Medical Center
Stanford, California 94305
United StatesSite Not Available
University of Colorado
Aurora, Colorado 80045
United StatesSite Not Available
National Jewish Health
Denver, Colorado 80206
United StatesSite Not Available
Western Connecticut Medical Group
Danbury, Connecticut 06810
United StatesSite Not Available
Yale University School of Medicine
New Haven, Connecticut 06510
United StatesSite Not Available
MedStar Georgetown University Hospital
Washington, District of Columbia 20007
United StatesSite Not Available
PAB Clinical Research - ClinEdge - PPDS
Brandon, Florida 33511
United StatesSite Not Available
St. Francis Medical Institute - BTC - PPDS
Clearwater, Florida 33765
United StatesSite Not Available
North Florida/South Georgia Veterans Health System-NAVREF-PPDS
Gainesville, Florida 32608
United StatesSite Not Available
University of Florida
Gainesville, Florida 32610
United StatesSite Not Available
Advanced Pulmonary Research Institute
Loxahatchee Groves, Florida 33470
United StatesSite Not Available
Northwestern Memorial Hospital
Chicago, Illinois 60611
United StatesSite Not Available
Pulmonary and Infections Disease Associates
Council Bluffs, Iowa 51503
United StatesSite Not Available
University of Louisville
Louisville, Kentucky 40202
United StatesSite Not Available
Tulane Medical Center
New Orleans, Louisiana 70112
United StatesSite Not Available
University of Maryland Medical Center
Baltimore, Maryland 21201
United StatesSite Not Available
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts 02135
United StatesSite Not Available
Massachusetts General Hospital, Division of Pulmonary and Critical Care Medicine
Boston, Massachusetts 02114
United StatesSite Not Available
Henry Ford Health System
Dearborn, Michigan 48124
United StatesSite Not Available
Minnesota Lung Center
Minneapolis, Minnesota 55407
United StatesSite Not Available
Mayo Clinic - PPDS
Rochester, Minnesota 55905
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Creighton University
Omaha, Nebraska 68131
United StatesSite Not Available
University of Rochester Medical Center - PPDS
Rochester, New York 14642
United StatesSite Not Available
PulmonIx LLC
Greensboro, North Carolina 27403
United StatesSite Not Available
UC Health Department of Internal Medicine, Pulmonary, Critical Care & Sleep Medicine
Cincinnati, Ohio 45267
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195-0001
United StatesSite Not Available
The Oregon Clinic
Portland, Oregon 97220
United StatesSite Not Available
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania 17033
United StatesSite Not Available
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Rhode Island Hospital
Providence, Rhode Island 02903
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesSite Not Available
University of Texas Southwestern Medical Center
Dallas, Texas 75390
United StatesSite Not Available
Houston Methodist Hospital
Houston, Texas 77030
United StatesSite Not Available
Metroplex Pulmonary and Sleep Medicine Center
McKinney, Texas 75069
United StatesSite Not Available
University of Texas Health Science Center San Antonio
San Antonio, Texas 78229
United StatesSite Not Available
University of Utah Medical Care
Salt Lake City, Utah 84108
United StatesSite Not Available
University of Virginia
Charlottesville, Virginia 22908
United StatesSite Not Available
Western Washington Medical Group
Everett, Washington 98208
United StatesSite Not Available
University of Washington Medical Center
Seattle, Washington 98195
United StatesSite Not Available
University of Wisconsin
Madison, Wisconsin 53792
United StatesSite Not Available
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