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Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Study Purpose
This is a Phase 3 trial to evaluate the efficacy and safety of 30 milligrams (mg)/kilogram (kg) intravenous (IV) infusions of pamrevlumab administered every 3 weeks as compared to placebo in participants with Idiopathic Pulmonary Fibrosis (IPF). There is a 48-week randomized treatment phase followed by an optional, open-label extension phase.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 40 Years - 85 Years |
Gender | All |
Key
Inclusion Criteria:
1. Diagnosis of IPF as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) guidelines within the past 7 years prior to study participation. 2. High-resolution computed tomography (HRCT) scan at Screening, with ≥10% to <50% parenchymal fibrosis (reticulation) and <25% honeycombing. 3. FVCpp value >45% and <95% at Screening and Day 1 (prior to randomization). 4. Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥25% and ≤90%. 5. 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 of response to an approved IPF therapy, or choice to forego treatment with an approved IPF therapy after a full discussion with the Investigator regarding risks/benefits of such therapy. KeyExclusion Criteria:
1. Previous exposure to pamrevlumab. 2. Evidence of significant obstructive lung disease, as evidenced by spirometry or HRCT. 3. Female participants who are pregnant or nursing. 4. Smoking within 3 months of Screening and/or unwilling to avoid smoking throughout the study. 5. Interstitial lung disease other than IPF. 6. Sustained improvement in the severity of IPF during the 12 months prior to screening. 7. Other types of respiratory diseases that, in the opinion of the Investigator, would impact the primary protocol endpoint or otherwise preclude participation in the study, including diseases of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall. 8. Certain medical conditions, that, in the opinion of the Investigator, would impact the primary protocol endpoint or otherwise preclude participation in the study (such as, myocardial infarction/stroke, severe chronic heart failure, pulmonary hypertension, or cancers). 9. Acute IPF exacerbation during Screening or Randomization including hospitalization due to acute IPF exacerbation within 4 weeks prior to or during screening. 10. Use of any investigational drugs or unapproved therapies, or participation in any clinical 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 week prior to screening. 11. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies, or to any component of the excipient.Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04419558 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
FibroGen |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
Principal Investigator Affiliation | N/A |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Argentina, Brazil, China, Colombia, Czechia, Denmark, Dominican Republic, France, Georgia, Germany, Hungary, Ireland, Italy, Korea, Republic of, Lebanon, Mexico, Netherlands, Peru, Poland, Serbia, Spain, Switzerland, Ukraine, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Idiopathic Pulmonary Fibrosis |
The intent of this study is to evaluate the efficacy and safety of pamrevlumab as monotherapy in participants with IPF. Participants who are not being treated with approved IPF therapies (that is, nintedanib or pirfenidone) may be eligible for screening. Examples of reasons participants may not be treated with approved IPF therapies include but are not limited to:
- - Intolerant or not responsive to approved IPF therapies.
- - Ineligible to receive these therapies.
- - Participant voluntarily declines to receive approved IPF therapies after being fully informed of the potential benefits/risks.
Arms
Experimental: Pamrevlumab
Treatment phase: Pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks, for a total of up to 17 infusions over 48 weeks. Open-label extension phase: Pamrevlumab 30 mg/kg administered by intravenous infusion, every 3 weeks for up to 48 weeks
Experimental: Placebo
Pamrevlumab-matching placebo administered by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks
Interventions
Drug: - Pamrevlumab
Sterile solution for injection
Drug: - Placebo
Sterile solution for injection
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
UAB Lung Health Center
Birmingham, Alabama, 35294
Status
Recruiting
Address
UC San Francisco
San Francisco, California, 94143
Status
Recruiting
Address
National Jewish Health
Denver, Colorado, 80206
Status
Recruiting
Address
Yale University
New Haven, Connecticut, 06520
Status
Recruiting
Address
St. Francis Medical Center
Clearwater, Florida, 33765
Status
Recruiting
Address
Pulmonary Disease Specialists d/b/a PDS Research
Kissimmee, Florida, 34741
Status
Recruiting
Address
TGH/USF Center for Advanced Lung Disease and Lung Transplant
Tampa, Florida, 33606
Status
Recruiting
Address
Emory University/The Emory Clinic
Atlanta, Georgia, 30324
Status
Recruiting
Address
University of Iowa
Iowa City, Iowa, 52242
Status
Recruiting
Address
The University of Kansas Medical Center
Kansas City, Kansas, 66160
Status
Recruiting
Address
University of Maryland Medical Center
Baltimore, Maryland, 21201
Status
Recruiting
Address
The General Hospital Corporation d/b/a Massachusetts General Hospital
Boston, Massachusetts, 02114
Status
Recruiting
Address
Spectrum Health
Grand Rapids, Michigan, 49504
Status
Recruiting
Address
University of Minnesota
Minneapolis, Minnesota, 55455
Status
Recruiting
Address
Mayo Clinic
Rochester, Minnesota, 55905
Status
Recruiting
Address
Duke University Medical Center
Durham, North Carolina, 27710
Status
Recruiting
Address
PulmonIx, LLC
Greensboro, North Carolina, 27403
Status
Recruiting
Address
Ohio State University
Columbus, Ohio, 43221
Status
Recruiting
Address
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033
Status
Recruiting
Address
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Status
Recruiting
Address
Low Country Lung and Critical Care, PA
Charleston, South Carolina, 29406
Status
Recruiting
Address
The University of Vermont
Burlington, Vermont, 05405
Status
Recruiting
Address
University of Wisconsin Clinical Research
Madison, Wisconsin, 53706
International Sites
Status
Not yet recruiting
Address
Fundacion Respirar - Centro Médico Dra. De Salvo
Ciudad Autonoma De Buenos Aires (CABA), ,
Status
Not yet recruiting
Address
Centro de Investigacion Metabolica 'CINME'
Ciudad Autónoma de Buenos Aires, ,
Status
Not yet recruiting
Address
INSARES
Ciudad de Mendoza, ,
Status
Not yet recruiting
Address
Centro Medico de Enfermedades Respiratorias
Florida, ,
Status
Not yet recruiting
Address
Respira Salud Clinica Integral
Godoy Cruz, ,
Status
Not yet recruiting
Address
Instituto Ave Pulmo Fundacion Enfisema
Mar del Plata, ,
Status
Recruiting
Address
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
Status
Recruiting
Address
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande Do Sul, 90020-090
Status
Recruiting
Address
HSL-PUCRS Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
Porto Alegre, Rio Grande Do Sul, 90610-000
Status
Recruiting
Address
Hospital Dia do Pulmão
Blumenau, Santa Catarina, 89030-101
Status
Recruiting
Address
Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UPECLIN - UNESP
Botucatu, São Paulo, 18618-686
Status
Recruiting
Address
CEMEC - Centro Multidisciplinar de Estudos Clínicos LTDA EPP
Sao Bernardo do Campo, São Paulo, 09715-090
Status
Recruiting
Address
CPQuali Pesquisa Clínica Ltda.
São Paulo, , 01228-000
Status
Recruiting
Address
Hospital Alemao Oswaldo Cruz
São Paulo, , 01323-001
Status
Recruiting
Address
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
Status
Recruiting
Address
BeiJing Chao-Yang Hospital,Capital Medical University
Beijing, ,
Status
Recruiting
Address
Beijing Frindship hosiptal capital Medical University
Beijing, ,
Status
Recruiting
Address
China Japan Friendship hospital
Beijing, ,
Status
Recruiting
Address
Peking Union Medical College Hospital
Beijing, ,
Status
Recruiting
Address
Sichuan People's Hospital
Chengdu, ,
Status
Recruiting
Address
Guangdong Provincial People's Hospital
Guangzhou, ,
Status
Not yet recruiting
Address
Affiliated Hangzhou First People's Hospital,
Hangzhou, ,
Status
Recruiting
Address
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, ,
Status
Not yet recruiting
Address
The Second Xiangya Hospital of Central South University
Hunan, ,
Status
Not yet recruiting
Address
The First Hospital of Lanzhou University
Lanzhou, ,
Status
Not yet recruiting
Address
Shandong Provincal Qianfoshan Hospital
Shandong, ,
Status
Recruiting
Address
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, ,
Status
Recruiting
Address
Shanghai Oriental Hospital
Shanghai, ,
Status
Recruiting
Address
Shanghai Oriental Hospital
Shanghai, ,
Status
Recruiting
Address
The First Hospital of China Medical University
Shenyang, ,
Status
Not yet recruiting
Address
Shenzhen People's Hospital
Shenzhen, ,
Status
Recruiting
Address
General Hospital of Tianjin Medical University
Tianjing, ,
Status
Recruiting
Address
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, ,
Status
Recruiting
Address
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, ,
Status
Recruiting
Address
The Second Affiliated Hospital of Xi'an Jiaotong University
Xian, ,
Status
Recruiting
Address
General Hospital of Ningxia Medical University
Yinchuan, ,
Status
Recruiting
Address
Fundación Santa Fe de Bogotá
Bogota, , 110121
Status
Recruiting
Address
Fundación Neumológica Colombiana
Bogota, , 110131
Status
Not yet recruiting
Address
Caja de Compensación Familiar CAFAM
Bogota, , 111211
Status
Recruiting
Address
Healthy Medical Center S.A.S
Zipaquirá, , 250252
Status
Recruiting
Address
Fakultní nemocnice Brno
Brno, , 625 00
Status
Recruiting
Address
Nemocnice Jihlava
Jihlava, , 586 33
Status
Recruiting
Address
Nemocnice Na Bulovce, Klinika pneumologie
Prague, , 18081
Status
Recruiting
Address
Aarhus Universitets Hospital
Aarhus, , DK-8200
Status
Recruiting
Address
Odense University Hospital
Odense, , 5000
Status
Completed
Address
Centro de Obstetricia y Ginecologia
Santo Domingo, , 10205
Status
Completed
Address
Centro Medico Dominicano
Santo Domingo, , 456
Status
Recruiting
Address
University Hospital Avicenne
Bobigny, , 93000
Status
Recruiting
Address
Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel
Bron, , 69677
Status
Recruiting
Address
CHU de Caen
Caen, , 14033
Status
Recruiting
Address
Centre Memoire Ressources Recherche, Hopital F. MITTERRAND
Dijon, , 21079
Status
Recruiting
Address
C.H.R.U. de Montpellier - Hôpital Lapeyronie
Montpellier, , 34295
Status
Recruiting
Address
CHU de Nice Hôpital Pasteur
Nice, , 06000
Status
Recruiting
Address
Hôpital Bichat - Claude Bernard
Paris, , 75018
Status
Recruiting
Address
CHU de Reims Hopital Maison Blanche
Reims, , 51092
Status
Recruiting
Address
CHU de Rennes Hôpital Pontchaillou
Rennes, , 35033
Status
Recruiting
Address
Service de Néphrologie, Hôpital Bretonneau, CHRU de Tours
Tours, , 37044
Status
Recruiting
Address
Research Institute Of Clinical Medicine Todua Clinic
Tbilisi, , 0112
Status
Recruiting
Address
Clinic Diacor
Tbilisi, , 0159
Status
Recruiting
Address
Ruhrlandklinik-Universitaetsmedizin Essen
Essen, , 45239
Status
Recruiting
Address
Klinik Schillerhoehe
Gerlingen, , 70839
Status
Recruiting
Address
Agaplesion Evangelisches Krankenhaus Mittelhessen
Gießen, , 035398
Status
Recruiting
Address
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , 20246
Status
Recruiting
Address
University of Munich
Munich, , 81377
Status
Recruiting
Address
RoMed Klinikum Rosenheim
Rosenheim, , 83022
Status
Recruiting
Address
Institut fur Pneumologie an der Universitat zu Koln
Solingen, , 83022
Status
Recruiting
Address
Semmelweis University Clinic of Pulmonology
Budapest, , 1083
Status
Recruiting
Address
Orszagos Koranyi Tbc es Pulmonologiai Intezet, IV. Tudobelosztaly
Budapest, , 1121
Status
Recruiting
Address
Fejer Megyei Szent Gyorgy kh
Szekesfehervar, , 8000
Status
Recruiting
Address
Pulmonology Hospital
Törökbálint, , 2045
Status
Recruiting
Address
Royal College of Surgeons in Ireland
Dublin, , D09YD60
Status
Recruiting
Address
Gaspare Rodiloco Hospital
Catania, , 95123
Status
Recruiting
Address
Ospedale G.B.Morgagni L.Pierantoni - Azienda Unita Sanitaria Locale (AUSL) di Forli
Forli, , 47121
Status
Recruiting
Address
Ospedale San Giuseppe
Milan, , 20123
Status
Recruiting
Address
AOU Policlinico di Modena
Modena, , 41124
Status
Recruiting
Address
Monaldi Hospital
Naples, , 80131
Status
Recruiting
Address
Azienda Ospedaliera Universitaria di Padova
Padova, , 35128
Status
Recruiting
Address
IRCCS Fondazione San Matteo di Pavia
Pavia, , 27100
Status
Recruiting
Address
Agostina Gemelli University Polyclinic
Rome, , 00168
Status
Recruiting
Address
Azienda Ospedaliera Universitaria Senese, Policlinico "Le Scotte"
Siena, , 53100
Status
Recruiting
Address
Azienda Ospedaliera Citta' della Salute e delle Scienza di Torino
Torino, , 0126
Status
Recruiting
Address
Azienda Ospedaliero-Universitaria "Ospedali Riuniti di Ancona"
Torrette, , 60126
Status
Recruiting
Address
Myongji Hospital
Goyang-si, Gyeonggi-do, 10475
Status
Recruiting
Address
Soonchunhyang University Hospital Bucheon
Bucheon-si, , 14584
Status
Recruiting
Address
The Catholic University of Korea Bucheon St. Mary's Hospital
Bucheon, , 14647
Status
Recruiting
Address
Inje University Haeundae Paik Hospital
Busan, , 48108
Status
Recruiting
Address
Inje University Hospital Iisan Paik Hospital
Goyang, , 10380
Status
Recruiting
Address
Chonnam National University Hospital
Gwangju, , 61469
Status
Recruiting
Address
Gachon University Gil Medical Centre
Incheon, , 21565
Status
Recruiting
Address
Seoul National University Bundang Hospital
Seongnam, , 13620
Status
Recruiting
Address
Seoul National University Hospital
Seoul, , 03080
Status
Recruiting
Address
Kyunghee University Medical Center
Seoul, , 17104
Status
Recruiting
Address
Severance hospital
Seoul, , 3722
Status
Recruiting
Address
Soonchunhyang University Hospital Seoul
Seoul, , 4401
Status
Recruiting
Address
Asan Medical Center
Seoul, , 5505
Status
Not yet recruiting
Address
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, , 6591
Status
Recruiting
Address
The Catholic University of Korea, Yeouido ST. Mary's Hospital
Seoul, , 7345
Status
Recruiting
Address
Ulsan University Hospital
Ulsan, , 44033
Status
Recruiting
Address
American University of beirut medical center
Beirut, ,
Status
Recruiting
Address
Hotel Dieu De France
Beirut, ,
Status
Recruiting
Address
Rafik Hariri University Hospital (Clinical Research Unit)
Bir Hassan, ,
Status
Recruiting
Address
Instituto Nacional de Enfermedades Respiratorias INER
Mexico, , 14080
Status
Recruiting
Address
Unidad Medica para la Salud Integral (UMSI)
Mexico, , 66465
Status
Recruiting
Address
Medical Care and Research S.A. de C.V.
Mexico, , 97070
Status
Recruiting
Address
St. Lucas Clinical Research Center SA de CV
Mexico, , CP97217
Status
Recruiting
Address
Centro Regional para el estudio del Adulto Mayor, Servicio de Geriatria, Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, , 64460
Status
Recruiting
Address
Oaxaca Site Management Organization S.C. (OSMO)
Oaxaca, , 68000
Status
Recruiting
Address
Dept. of Pulmonary Diseases
Amsterdam, , 30.033
Status
Recruiting
Address
Catharina Hospital
Eindhoven, , 5623 EJ
Status
Recruiting
Address
Longarts - Opleider Longziekten Zuyderland MC
Heerlen, , 6419
Status
Recruiting
Address
St. Antonius Ziekenhuis BV
Nieuwegein, , 3435
Status
Recruiting
Address
Canisius-Wilhelmina Ziekenhuis
Nieuwegein, , 6533
Status
Recruiting
Address
Clinica Internacional
Lima, , 15001
Status
Recruiting
Address
Clinica San Pablo
Lima, , 150140
Status
Recruiting
Address
Clinica Providencia
Lima, , 15088
Status
Recruiting
Address
Hospital Nacional Cayetano Heredia / Servicio de Inmunología y Reumatología
Lima, , 15102
Status
Recruiting
Address
Centro de Investigacion Ricardo Palma
San Isidro, , 150131
Status
Recruiting
Address
Clinica La luz
Santa Beatriz, , 15046
Status
Recruiting
Address
Centrum Dentystyczno-Lekarskie Promedica Joanna Markiewicz
Bedzin, , 42-500
Status
Recruiting
Address
Centrum Medycyny Oddechowej Mroz SJ
Bialystok, , 15-044
Status
Recruiting
Address
Gornoslaskie Centrum Medyczne im. prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach
Katowice, , 40-635
Status
Recruiting
Address
University Hospital No1
Lodz, , 90-153
Status
Recruiting
Address
Instytut Gruzlicy i Chorob Pluc
Warsaw, , 01-138
Status
Recruiting
Address
Municipal Institute for Lung Diseases and Tuberculosis
Belgrade, , 11000
Status
Recruiting
Address
University Clinical Center of Serbia
Belgrade, , 11000
Status
Recruiting
Address
University Clinical Center of Nis
Nis, , 18000
Status
Recruiting
Address
Institute for Pulmonary Diseases of Vojvodina
Sremska Kamenica, , 21204
Status
Recruiting
Address
Hospital Universitario de Bellvitge
Barcelona, , 08907
Status
Recruiting
Address
Hospital Clinic de Barcelona
Barcelona, , 8036
Status
Recruiting
Address
Hospital Universitaio de La Princesa
Madrid, , 28006
Status
Recruiting
Address
Hospital General Universitario Gregorio Maranon
Madrid, , 28007
Status
Recruiting
Address
Hospital Clinico San Carlos-Madrid C/Martin Lagos s/n
Madrid, , 28040
Status
Recruiting
Address
Hospital Universitario Quironsalud Madrid
Madrid, , 28223
Status
Recruiting
Address
Hospital Universitario Marques de Valdecilla
Santander, , 39008
Status
Recruiting
Address
Hospital Universitario Nuestra Senora de Valme
Sevilla, , 41014
Status
Recruiting
Address
Universitätsklinik für Pneumologie
Bern, , 3010
Status
Recruiting
Address
Communal non-profit enterprise "City clinical hospital #16" of Dnipro Сit Сouncil
Dnipro, , 49069
Status
Recruiting
Address
Ivano-Frankivsk Regional Phthisiology-Pulmonology Center of Ivano-Frankivsk regional council
Ivano-Frankivsk, , 76018
Status
Recruiting
Address
National Institute of Phthisiology and Pulmonology named after F. G. Yanovskyi NAMS of Ukraine, Clinical and Functional Department
Kyiv, , 03680
Status
Recruiting
Address
National Institute of Phthisiology and Pulmonology named after F. G. Yanovskyi NAMS of Ukraine, Clinical and Functional Department
Kyiv, , 03680
Status
Recruiting
Address
Medway NHS Foundation Trust
Gillingham, Kent, ME7 5NY
Status
Recruiting
Address
Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust
Birmingham, , B15 2TH
Status
Recruiting
Address
Papworth Hospital NHS Foundation Trust, Advanced Heart Failure Unit
Cambridge, , CB2 0AY
Status
Recruiting
Address
The Princess Alexandra Hospital NHS Trust
Harlow, , CM20 1QX
Status
Recruiting
Address
Royal Brompton Hospital
London, , SW3 6NP
Status
Recruiting
Address
University College London
London, , WC1E 6JF
Status
Recruiting
Address
Manchester University NHS Foundation Trust
Manchester, , M23 9LT
Status
Recruiting
Address
Southampton General Hospital
Southampton, , SO16 6YD