Phase
Condition
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
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
Centro Médico Dra de Salvo
Buenos Aires, C1426ABP
ArgentinaSite Not Available
Hospital Privado Centro Médico de Córdoba
Córdoba, X5016KEH
ArgentinaSite Not Available
CEMER Centro Médico de Enfermedades Respiratorias
Florida, B1602DQD
ArgentinaSite Not Available
Hospital Zonal Especializado de Agudos y Crónicos Dr. Antonio A. Cetrangolo
Luján, B6700CNR
ArgentinaSite Not Available
Instituto de Investigaciones Clínicas Mar Del Plata
Mar Del Plata, B7600FZN
ArgentinaSite Not Available
Fundacion Scherbovsky
Mendoza, 5500
ArgentinaSite Not Available
South Health Campus
Calgary, T3M 1M4
CanadaSite Not Available
Hôtel Dieu Du Centre Hospitalier de L'université de Montréal
Montréal, H2L 4M1
CanadaSite Not Available
McGill University Health Centre Research Institute
Montréal, QC H3S 1Y9
CanadaSite Not Available
Institut Universitaire de Cardiologie et de Pneumologie
Québec, G1V 4G5
CanadaSite Not Available
Toronto General Hospital
Toronto, M5G 2N2
CanadaSite Not Available
Pacific Lung Research Center
Vancouver, V6Z 1Y6
CanadaSite Not Available
Vancouver General Hospital
Vancouver, V5Z 1M9
CanadaSite Not Available
Dr Anil Dhar Professional Medicine Corporation
Windsor, N8W1L9
CanadaSite Not Available
Hôpital Nord AP-HM
Marseille, 13915
FranceSite Not Available
Centre Hospitalier Regional Universitaire Montpellier
Montpellier, 34295
FranceSite Not Available
Groupe Hospitalier Bichat Claude Bernard
Paris, 75018
FranceSite Not Available
CHU de Reims
Reims, 51092
FranceSite Not Available
Ruhrlandklinik
Essen, 45239
GermanySite Not Available
Praxis Dr. med. Claus Keller
Frankfurt, 60389
GermanySite Not Available
Universitätsmedizin Greifswald Klinik und Poliklinik für Innere Medizin B
Greifswald, 17475
GermanySite Not Available
Pneumologisches Forschungsinstitut
Großhansdorf, 22927
GermanySite Not Available
Lungenfachklinik Immenhausen
Immenhausen, 34376
GermanySite Not Available
Kliniken der Stadt Koln GmbH
Köln, 51109
GermanySite Not Available
Krankenhaus Bethanien - Klinik für Pneumologie und Allergologie
Solingen, 42699
GermanySite Not Available
Semmelweis Egyetem
Budapest, 1125
HungarySite Not Available
Veszprem Megyei Tudogyogyintezet
Farkasgyepű, 8582
HungarySite Not Available
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktató Kórház
Miskolc, 3529
HungarySite Not Available
Tüdőgyógyintézet Törökbálint
Törökbálint, 2045
HungarySite Not Available
Barzilai Medical Center
Ashkelon, 78278
IsraelSite Not Available
Lady Davis Carmel Medical Center
Haifa, 34362
IsraelSite Not Available
Hadassah University Hospital Ein Kerem
Jerusalem, 91120
IsraelSite Not Available
Meir Medical Center
Kfar Saba, 44281
IsraelSite Not Available
Rabin Medical Center - PPDS
Petah tikva, 49100
IsraelSite Not Available
Kaplan Medical Center
Reẖovot, 7661041
IsraelSite Not Available
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
Catania, Sicilia 95123
ItalySite Not Available
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
Ancona, 60020
ItalySite Not Available
Presidio Ospedaliero GB Morgagni L Pierantoni
Forlì, 47121
ItalySite Not Available
Ospedale S. Giuseppe Multimedica
Milano, 20123
ItalySite Not Available
Università Cattolica Del S Cuore
Roma, 00168
ItalySite Not Available
Azienda Ospedaliera Universitaria Senese
Siena, 53100
ItalySite Not Available
National Hospital Organization Ibarakihigashi National Hospital
Naka, Ibaraki 319-1113
JapanSite Not Available
Tenryu Hospital
Hamamatsu, Shizuoka 434-8511
JapanSite Not Available
Juntendo University Hospital
Bunkyo, 113-8431
JapanSite Not Available
Fukuoka University Hospital
Fukuoka, 814-0180
JapanSite Not Available
National Hospital Organization Kyushu Medical Center
Fukuoka, 810-8563
JapanSite Not Available
NHO Okinawa Hospital
Ginowan, 901-2214
JapanSite Not Available
Hamamatsu University School of Medicine
Hamamatsu, 431-3192
JapanSite Not Available
National Hospital Organization Himeji Medical Center
Himeji, 670-8520
JapanSite Not Available
Hiroshima Prefectural Hospital
Hiroshima, 734-8530
JapanSite Not Available
Kobe City Medical Center General Hospital
Hyōgo, 650-0047
JapanSite Not Available
Saiseikai Kumamoto Hospital
Kumamoto, 861-4101
JapanSite Not Available
Nagasaki University Hospital
Nagasaki, 852-8102
JapanSite Not Available
Nagoya University Hospital
Nagoya, 466-8560
JapanSite Not Available
Japanese Red Cross Okayama Hospital
Okayama, 700-8607
JapanSite Not Available
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakai, 591-8555
JapanSite Not Available
Tohoku Medical and Pharmaceutical Hospital
Sendai, 983-8512
JapanSite Not Available
Tosei General Hospital
Seto, 489-8642
JapanSite Not Available
Tokyo Medical University Hospital
Shinjuku-Ku, 160-0023
JapanSite Not Available
Tokushima University Hospital
Tokushima, 770-8503
JapanSite Not Available
Center Hospital of the National Center for Global Health and Medicine
Tokyo, 162-8655
JapanSite Not Available
Kanagawa Cardiovascular and Respiratory Center
Yokohama, 236-0051
JapanSite Not Available
Soon Chun Hyang University Hospital Bucheon
Bucheon, Gyeonggi-do 420-767
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do 463-707
Korea, Republic ofSite Not Available
Gachon University Gil Medical Center
Incheon, 405760
Korea, Republic ofSite Not Available
Asan Medical Center - PPDS
Seoul, 05505
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, 135-170
Korea, Republic ofSite Not Available
Soon Chun Hyang University Hospital Seoul
Seoul, 140-743
Korea, Republic ofSite Not Available
Instituto Nacional De Enfermedades (INER)
Ciudad de mexico, 14080
MexicoSite Not Available
Centro de Investigación Medico Biologica y de Terapia Avanzada S.C.
Guadalajara, 44130
MexicoSite Not Available
Hospital Universitatorio Dr. Jose Eleuterio González
Monterrey, 64460
MexicoSite Not Available
Unidad de Investigación Clínica En Medicina SC
Monterrey, 64718
MexicoSite Not Available
OLVG locatie Oost
Amsterdam, 1091 AC
NetherlandsSite Not Available
VU Medisch Centrum
Amsterdam, 1081 HV
NetherlandsSite Not Available
Martini Ziekenhuis
Groningen, 9700 RM
NetherlandsSite Not Available
Zuyderland Medisch Centrum
Heerlen, 6419 PC
NetherlandsSite Not Available
St. Antonius Ziekenhuis
Nieuwegein, 3425 CM
NetherlandsSite Not Available
Erasmus MC
Rotterdam, 3015 GD
NetherlandsSite Not Available
Greenlane Clinical Centre
Auckland, 1051
New ZealandSite Not Available
NZ Respiratory & Sleep Institute
Auckland, 1149
New ZealandSite Not Available
Christchurch Hospital
Christchurch, 8011
New ZealandSite Not Available
Waikato Hospital
Hamilton, 3204
New ZealandSite Not Available
Centrum Medycyny Oddechowej Mroz sp. j.
Białystok, 15-044
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne - PPDS
Gdańsk, 80-952
PolandSite Not Available
PULMAG Arkadiusz Brodowski, Grzegorz Gasior S. C.
Katowice, 40-753
PolandSite Not Available
GRAŻYNA JASIENIAK-PINIS ATOPIA Niepubliczny Zakład Opieki Zdrowotnej Poradnie Specjalistyczne
Kraków, 31-159
PolandSite Not Available
SP ZOZ Szpital Uniwersytecki w Krakowie
Kraków, 31-153
PolandSite Not Available
ETG Lublin
Lublin, 20-314
PolandSite Not Available
ETG Warszawa
Warszawa, 02-777
PolandSite Not Available
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Łódź, 90-153
PolandSite Not Available
Dr Ismail Abdullah Private Practice
Cape Town, 7764
South AfricaSite Not Available
Tygerberg Hospital
Cape Town, 7505
South AfricaSite Not Available
University of Cape Town Lung Institute (UCTLI)
Cape Town, 7700
South AfricaSite Not Available
Ethekwini Hospital
Durban, 4017
South AfricaSite Not Available
Gateway Private Hospital
Durban, 4091
South AfricaSite Not Available
Milpark Hospital
Johannesburg, 2193
South AfricaSite Not Available
University of Alabama at Birmingham
Birmingham, Alabama 35294
United StatesSite Not Available
Arizona Pulmonary Specialists
Phoenix, Arizona 85012
United StatesSite Not Available
University of Arizona College of Medicine
Tucson, Arizona 85724
United StatesSite Not Available
Cedars Sinai Medical Center
Los Angeles, California 90048
United StatesSite Not Available
Keck School of Medicine of USC
Los Angeles, California 90033
United StatesSite Not Available
UC Davis Medical Center
Sacramento, California 95816
United StatesSite Not Available
University of California, San Francisco Medical Center
San Francisco, California 94143
United StatesSite Not Available
St. Francis Medical Institute
Clearwater, Florida 33765
United StatesSite Not Available
University of Miami
Miami, Florida 33136
United StatesSite Not Available
Renstar Medical Research
Ocala, Florida 34470
United StatesSite Not Available
Central Florida Pulmonary Group PA
Orlando, Florida 32803
United StatesSite Not Available
Emory University
Atlanta, Georgia 30322
United StatesSite Not Available
Piedmont Healthcare
Atlanta, Georgia 30309
United StatesSite Not Available
University of Chicago Medical Center
Chicago, Illinois 60637
United StatesSite Not Available
Loyola University Medical Center
Maywood, Illinois 60153
United StatesSite Not Available
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesSite Not Available
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesSite Not Available
Brigham and Womens Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
University of Michigan Health System (UMHS)
Ann Arbor, Michigan 48109
United StatesSite Not Available
Spectrum Health Medical Group
Grand Rapids, Michigan 49546
United StatesSite Not Available
University of Minnesota Medical Center
Minneapolis, Minnesota 55455
United StatesSite Not Available
Cardio Pulmonary Associates
Chesterfield, Missouri 63017
United StatesSite Not Available
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03765
United StatesSite Not Available
Atlantic Respiratory Institute
Summit, New Jersey 07901
United StatesSite Not Available
Lovelace Scientific Resources Inc
Albuquerque, New Mexico 87108
United StatesSite Not Available
Albany Medical Center
Albany, New York 12208
United StatesSite Not Available
Columbia University Medical Center
New York, New York 10032
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 27710
United StatesSite Not Available
Ohio State University
Columbus, Ohio 43203
United StatesSite Not Available
Mercy Health - St. Vincent Medical Center
Toledo, Ohio 43608
United StatesSite Not Available
Temple Lung Center
Philadelphia, Pennsylvania 19140
United StatesSite Not Available
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Medical University of South Carolina - PPDS
Charleston, South Carolina 29425
United StatesSite Not Available
University of Vermont
Burlington, Vermont 05401
United StatesSite Not Available
Inova Fairfax Hospital
Falls Church, Virginia 22042
United StatesSite Not Available
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