Phase
Condition
Idiopathic Pulmonary Fibrosis
Lung Injury
Cystic Fibrosis
Treatment
Pamrevlumab
Placebo
Clinical Study ID
Ages 40-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Diagnosis of IPF as defined by American Thoracic Society/European RespiratorySociety/Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) guidelines within the past 7 years prior to study participation.
High-resolution computed tomography (HRCT) scan at Screening, with ≥10% to <50%parenchymal fibrosis (reticulation) and <25% honeycombing.
FVCpp value >45% and <95% at Screening and Day 1 (prior to randomization).
Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥25%and ≤90%.
Not currently receiving treatment for IPF with an approved therapy for IPF (such as,pirfenidone or nintedanib) for any reason, including prior intolerance or lack ofresponse to an approved IPF therapy, or choice to forego treatment with an approvedIPF therapy after a full discussion with the Investigator regarding risks/benefitsof such therapy.
Exclusion
Key Exclusion Criteria:
Previous exposure to pamrevlumab.
Evidence of significant obstructive lung disease, as evidenced by spirometry orHRCT.
Female participants who are pregnant or nursing.
Smoking within 3 months of Screening and/or unwilling to avoid smoking throughoutthe study.
Interstitial lung disease other than IPF.
Sustained improvement in the severity of IPF during the 12 months prior toscreening.
Other types of respiratory diseases that, in the opinion of the Investigator, wouldimpact the primary protocol endpoint or otherwise preclude participation in thestudy, including diseases of the airways, lung parenchyma, pleural space,mediastinum, diaphragm, or chest wall.
Certain medical conditions, that, in the opinion of the Investigator, would impactthe primary protocol endpoint or otherwise preclude participation in the study (suchas, myocardial infarction/stroke, severe chronic heart failure, pulmonaryhypertension, or cancers).
Acute IPF exacerbation during Screening or Randomization including hospitalizationdue to acute IPF exacerbation within 4 weeks prior to or during screening.
Use of any investigational drugs or unapproved therapies, or participation in anyclinical trial with an investigational new drug within 30 days prior to screening.Or use of approved IPF therapies (such as, pirfenidone or nintedanib) within 1 weekprior to screening.
History of allergic or anaphylactic reaction to human, humanized, chimeric or murinemonoclonal antibodies, or to any component of the excipient.
Study Design
Study Description
Connect with a study center
Fundacion Respirar - Centro Médico Dra. De Salvo
Ciudad Autonoma De Buenos Aires (CABA),
ArgentinaSite Not Available
Centro de Investigacion Metabolica 'CINME'
Ciudad Autónoma de Buenos Aires,
ArgentinaSite Not Available
INSARES
Ciudad de Mendoza,
ArgentinaSite Not Available
Centro Medico de Enfermedades Respiratorias
Florida,
ArgentinaSite Not Available
Respira Salud Clinica Integral
Godoy Cruz,
ArgentinaSite Not Available
Instituto Ave Pulmo Fundacion Enfisema
Mar del Plata,
ArgentinaSite Not Available
Centro Medico de Enfermedades Respiratorias
Miguel Bergna,
ArgentinaSite Not Available
Hospital das Clínicas da UFMG - Centro de Pesquisas Clínicas do Hospital das Clínicas da Universidade Federal de Minas Gerais - CPC HC/UFMG
Belo Horizonte, Minas Gerais 30130-100
BrazilSite Not Available
HSL-PUCRS Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
Porto Alegre, Rio Grande Do Sul 90610-000
BrazilSite Not Available
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande Do Sul 90020-090
BrazilSite Not Available
Hospital Dia do Pulmão
Blumenau, Santa Catarina 89030-101
BrazilSite Not Available
Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UPECLIN - UNESP
Botucatu, São Paulo 18618-686
BrazilSite Not Available
CEMEC - Centro Multidisciplinar de Estudos Clínicos LTDA EPP
Sao Bernardo do Campo, São Paulo 09715-090
BrazilSite Not Available
CPQuali Pesquisa Clínica Ltda.
São Paulo, 01228-000
BrazilSite Not Available
Hospital Alemao Oswaldo Cruz
São Paulo, 01323-001
BrazilSite Not Available
INCOR - Instituto do Coração Centro de Pesquisa Prof. Dr. Fulvio Pileggi Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP
São Paulo, 05403-000
BrazilSite Not Available
BeiJing Chao-Yang Hospital,Capital Medical University
Beijing,
ChinaSite Not Available
Beijing Frindship hosiptal capital Medical University
Beijing,
ChinaSite Not Available
China Japan Friendship hospital
Beijing,
ChinaSite Not Available
Peking Union Medical College Hospital
Beijing,
ChinaSite Not Available
Sichuan People's Hospital
Chengdu,
ChinaSite Not Available
Guangdong Provincial People's Hospital
Guangzhou,
ChinaSite Not Available
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou,
ChinaSite Not Available
The Second Xiangya Hospital of Central South University
Hunan,
ChinaSite Not Available
The First Hospital of Lanzhou University
Lanzhou,
ChinaSite Not Available
Shandong Provincal Qianfoshan Hospital
Shandong,
ChinaSite Not Available
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai,
ChinaSite Not Available
Shanghai Oriental Hospital
Shanghai,
ChinaSite Not Available
The First Hospital of China Medical University
Shenyang,
ChinaSite Not Available
Shenzhen People's Hospital
Shenzhen,
ChinaSite Not Available
General Hospital of Tianjin Medical University
Tianjing,
ChinaSite Not Available
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan,
ChinaSite Not Available
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan,
ChinaSite Not Available
The Second Affiliated Hospital of Xi'an Jiaotong University
Xian,
ChinaSite Not Available
General Hospital of Ningxia Medical University
Yinchuan,
ChinaSite Not Available
Fundación Neumológica Colombiana
Bogota, 110131
ColombiaSite Not Available
Fundación Santa Fe de Bogotá
Bogota, 110121
ColombiaSite Not Available
Healthy Medical Center S.A.S
Zipaquirá, 250252
ColombiaSite Not Available
Fakultní nemocnice Brno
Brno, 625 00
CzechiaSite Not Available
Nemocnice Jihlava
Jihlava, 586 33
CzechiaSite Not Available
Nemocnice Na Bulovce, Klinika pneumologie
Prague, 18081
CzechiaSite Not Available
Aarhus Universitets Hospital
Aarhus, DK-8200
DenmarkSite Not Available
Odense University Hospital
Odense, 5000
DenmarkSite Not Available
Centro Medico Dominicano
Santo Domingo, 456
Dominican RepublicSite Not Available
Centro de Obstetricia y Ginecologia
Santo Domingo, 10205
Dominican RepublicSite Not Available
University Hospital Avicenne
Bobigny, 93000
FranceSite Not Available
Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel
Bron, 69677
FranceSite Not Available
CHU de Caen
Caen, 14033
FranceSite Not Available
Centre Memoire Ressources Recherche, Hopital F. MITTERRAND
Dijon, 21079
FranceSite Not Available
APHM-Hôpital NORD
Marseille, 13015
FranceSite Not Available
C.H.R.U. de Montpellier - Hôpital Lapeyronie
Montpellier, 34295
FranceSite Not Available
CHU de Nice Hôpital Pasteur
Nice, 06000
FranceSite Not Available
Hôpital Bichat - Claude Bernard
Paris, 75018
FranceSite Not Available
CHU de Reims Hopital Maison Blanche
Reims, 51092
FranceSite Not Available
CHU de Rennes Hôpital Pontchaillou
Rennes, 35033
FranceSite Not Available
Service de Néphrologie, Hôpital Bretonneau, CHRU de Tours
Tours, 37044
FranceSite Not Available
Clinic Diacor
Tbilisi, 0159
GeorgiaSite Not Available
Research Institute Of Clinical Medicine Todua Clinic
Tbilisi, 0112
GeorgiaSite Not Available
Studienkoordination Prüfstelle der GWT am Fachkrankenhaus Coswig GmbH
Coswig, 1640
GermanySite Not Available
Ruhrlandklinik-Universitaetsmedizin Essen
Essen, 45239
GermanySite Not Available
Klinik Schillerhoehe
Gerlingen, 70839
GermanySite Not Available
Agaplesion Evangelisches Krankenhaus Mittelhessen
Gießen, 035398
GermanySite Not Available
Research Center
Greifenstein, 35753
GermanySite Not Available
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
GermanySite Not Available
University of Munich
Munich, 81377
GermanySite Not Available
RoMed Klinikum Rosenheim
Rosenheim, 83022
GermanySite Not Available
Institut fur Pneumologie an der Universitat zu Koln
Solingen, 83022
GermanySite Not Available
Orszagos Koranyi Tbc es Pulmonologiai Intezet, IV. Tudobelosztaly
Budapest, 1121
HungarySite Not Available
Semmelweis University Clinic of Pulmonology
Budapest, 1083
HungarySite Not Available
Petz Aldar County Teaching Hospital
Gyor, 9023
HungarySite Not Available
Miskolci Semmelweis Ignác Health Centre and Educational Clinic Nonprofit Ltd.
Miskolc, H-3529
HungarySite Not Available
Fejer Megyei Szent Gyorgy kh
Szekesfehervar, 8000
HungarySite Not Available
Pulmonology Hospital
Törökbálint, 2045
HungarySite Not Available
Royal College of Surgeons in Ireland
Dublin, D09YD60
IrelandSite Not Available
A.O.U Ospedali Riuniti Umberto I G.M. Lancisi G. Salesi
Ancona, 60126
ItalySite Not Available
Gaspare Rodiloco Hospital
Catania, 95123
ItalySite Not Available
Ospedale G.B.Morgagni L.Pierantoni - Azienda Unita Sanitaria Locale (AUSL) di Forli
Forli, 47121
ItalySite Not Available
Ospedale San Giuseppe
Milan, 20123
ItalySite Not Available
AOU Policlinico di Modena
Modena, 41124
ItalySite Not Available
Monaldi Hospital
Naples, 80131
ItalySite Not Available
Azienda Ospedaliera Universitaria di Padova
Padova, 35128
ItalySite Not Available
IRCCS Fondazione San Matteo di Pavia
Pavia, 27100
ItalySite Not Available
Agostina Gemelli University Polyclinic
Rome, 00168
ItalySite Not Available
Azienda Ospedaliera Universitaria Senese, Policlinico "Le Scotte"
Siena, 53100
ItalySite Not Available
Azienda Ospedaliera Citta' della Salute e delle Scienza di Torino
Torino, 0126
ItalySite Not Available
Azienda Ospedaliero-Universitaria "Ospedali Riuniti di Ancona"
Torrette, 60126
ItalySite Not Available
Myongji Hospital
Goyang-si, Gyeonggi-do 10475
Korea, Republic ofSite Not Available
The Catholic University of Korea Bucheon St. Mary's Hospital
Bucheon, 14647
Korea, Republic ofSite Not Available
Soonchunhyang University Hospital Bucheon
Bucheon-si, 14584
Korea, Republic ofSite Not Available
Inje University Haeundae Paik Hospital
Busan, 48108
Korea, Republic ofSite Not Available
Inje University Hospital Iisan Paik Hospital
Goyang, 10380
Korea, Republic ofSite Not Available
Chonnam National University Hospital
Gwangju, 61469
Korea, Republic ofSite Not Available
Gachon University Gil Medical Centre
Incheon, 21565
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Seongnam, 13620
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul, 5505
Korea, Republic ofSite Not Available
Kyunghee University Medical Center
Seoul, 17104
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Severance hospital
Seoul, 3722
Korea, Republic ofSite Not Available
Soonchunhyang University Hospital Seoul
Seoul, 4401
Korea, Republic ofSite Not Available
The Catholic University of Korea, Yeouido ST. Mary's Hospital
Seoul, 7345
Korea, Republic ofSite Not Available
Ulsan University Hospital
Ulsan, 44033
Korea, Republic ofSite Not Available
American University of beirut medical center
Beirut,
LebanonSite Not Available
Hotel Dieu De France
Beirut,
LebanonSite Not Available
Rafik Hariri University Hospital (Clinical Research Unit)
Bir Hassan,
LebanonSite Not Available
Instituto Nacional de Enfermedades Respiratorias INER
Mexico, 14080
MexicoSite Not Available
Medical Care and Research S.A. de C.V.
Mexico, 97070
MexicoSite Not Available
St. Lucas Clinical Research Center SA de CV
Mexico, CP97217
MexicoSite Not Available
Unidad Medica para la Salud Integral (UMSI)
Mexico, 66465
MexicoSite Not Available
Centro Regional para el estudio del Adulto Mayor, Servicio de Geriatria, Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, 64460
MexicoSite Not Available
Oaxaca Site Management Organization S.C. (OSMO)
Oaxaca, 68000
MexicoSite Not Available
Dept. of Pulmonary Diseases
Amsterdam, 30.033
NetherlandsSite Not Available
Catharina Hospital
Eindhoven, 5623 EJ
NetherlandsSite Not Available
Longarts - Opleider Longziekten Zuyderland MC
Heerlen, 6419
NetherlandsSite Not Available
Canisius-Wilhelmina Ziekenhuis
Nieuwegein, 6533
NetherlandsSite Not Available
St. Antonius Ziekenhuis BV
Nieuwegein, 3435
NetherlandsSite Not Available
Clinica Internacional
Lima, 15001
PeruSite Not Available
Clinica Providencia
Lima, 15088
PeruSite Not Available
Clinica San Pablo
Lima, 150140
PeruSite Not Available
Hospital Nacional Cayetano Heredia / Servicio de Inmunología y Reumatología
Lima, 15102
PeruSite Not Available
Centro de Investigacion Ricardo Palma
San Isidro, 150131
PeruSite Not Available
Clinica La luz
Santa Beatriz, 15046
PeruSite Not Available
Centrum Dentystyczno-Lekarskie Promedica Joanna Markiewicz
Bedzin, 42-500
PolandSite Not Available
Centrum Medycyny Oddechowej Mroz SJ
Bialystok, 15-044
PolandSite Not Available
Gornoslaskie Centrum Medyczne im. prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach
Katowice, 40-635
PolandSite Not Available
University Hospital No1
Lodz, 90-153
PolandSite Not Available
Instytut Gruzlicy i Chorob Pluc
Warsaw, 01-138
PolandSite Not Available
Municipal Institute for Lung Diseases and Tuberculosis
Belgrade, 11000
SerbiaSite Not Available
University Clinical Center of Serbia
Belgrade, 11000
SerbiaSite Not Available
University Clinical Center of Nis
Nis, 18000
SerbiaSite Not Available
Institute for Pulmonary Diseases of Vojvodina
Sremska Kamenica, 21204
SerbiaSite Not Available
Hospital Clinic de Barcelona
Barcelona, 8036
SpainSite Not Available
Hospital Universitario de Bellvitge
Barcelona, 08907
SpainSite Not Available
Hospital Clinico San Carlos-Madrid C/Martin Lagos s/n
Madrid, 28040
SpainSite Not Available
Hospital General Universitario Gregorio Maranon
Madrid, 28007
SpainSite Not Available
Hospital Universitaio de La Princesa
Madrid, 28006
SpainSite Not Available
Hospital Universitario Quironsalud Madrid
Madrid, 28223
SpainSite Not Available
Hospital Universitario Marques de Valdecilla
Santander, 39008
SpainSite Not Available
Hospital Universitario Nuestra Senora de Valme
Sevilla, 41014
SpainSite Not Available
Universitätsklinik für Pneumologie
Bern, 3010
SwitzerlandSite Not Available
Communal non-profit enterprise "City clinical hospital #16" of Dnipro Сit Сouncil
Dnipro, 49069
UkraineSite Not Available
Ivano-Frankivsk Regional Phthisiology-Pulmonology Center of Ivano-Frankivsk regional council
Ivano-Frankivsk, 76018
UkraineSite Not Available
Municipal Institution of health care "Kharkiv City Clinical Hospital №13", Pulmonology Department №1
Kharkiv, 61035
UkraineSite Not Available
National Institute of Phthisiology and Pulmonology named after F. G. Yanovskyi NAMS of Ukraine, Clinical and Functional Department
Kyiv, 03680
UkraineSite Not Available
Medway NHS Foundation Trust
Gillingham, Kent ME7 5NY
United KingdomSite Not Available
Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH
United KingdomSite Not Available
Southmead Hospital
Bristol, BS10 5NB
United KingdomSite Not Available
Papworth Hospital NHS Foundation Trust, Advanced Heart Failure Unit
Cambridge, CB2 0AY
United KingdomSite Not Available
Royal Devon and Exeter NHS Foundation Trust
Exeter, EX2 5DW
United KingdomSite Not Available
The Princess Alexandra Hospital NHS Trust
Harlow, CM20 1QX
United KingdomSite Not Available
Royal Brompton Hospital
London, SW3 6NP
United KingdomSite Not Available
University College London
London, WC1E 6JF
United KingdomSite Not Available
Manchester University NHS Foundation Trust
Manchester, M23 9LT
United KingdomSite Not Available
Southampton General Hospital
Southampton, SO16 6YD
United KingdomSite Not Available
UAB Lung Health Center
Birmingham, Alabama 35294
United StatesSite Not Available
UC San Francisco
San Francisco, California 94143
United StatesSite Not Available
National Jewish Health
Denver, Colorado 80206
United StatesSite Not Available
Yale University
New Haven, Connecticut 06520
United StatesSite Not Available
St. Francis Medical Center
Clearwater, Florida 33765
United StatesSite Not Available
University of Florida Pulmonary, Critical Care & Sleep Medicine Division
Gainesville, Florida 32610
United StatesSite Not Available
Mayo Clinic
Jacksonville, Florida 32224
United StatesSite Not Available
Pulmonary Disease Specialists d/b/a PDS Research
Kissimmee, Florida 34741
United StatesSite Not Available
TGH/USF Center for Advanced Lung Disease and Lung Transplant
Tampa, Florida 33606
United StatesSite Not Available
Emory University/The Emory Clinic
Atlanta, Georgia 30324
United StatesSite Not Available
University of Iowa
Iowa City, Iowa 52242
United StatesSite Not Available
The University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesSite Not Available
University of Maryland Medical Center
Baltimore, Maryland 21201
United StatesSite Not Available
The General Hospital Corporation d/b/a Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Spectrum Health
Grand Rapids, Michigan 49504
United StatesSite Not Available
University of Minnesota
Minneapolis, Minnesota 55455
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 27710
United StatesSite Not Available
PulmonIx, LLC
Greensboro, North Carolina 27403
United StatesSite Not Available
Ohio State University
Columbus, Ohio 43221
United StatesSite Not Available
The Oregon Clinic, PC
Portland, Oregon 97232
United StatesSite Not Available
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania 17033
United StatesSite Not Available
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Low Country Lung and Critical Care, PA
Charleston, South Carolina 29406
United StatesSite Not Available
The University of Vermont
Burlington, Vermont 05405
United StatesSite Not Available
University of Virginia
Charlottesville, Virginia 22903
United StatesSite Not Available
University of Wisconsin Clinical Research
Madison, Wisconsin 53706
United StatesSite Not Available
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