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Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pamrevlumab
Placebo
Sponsored by
FibroGen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring Idiopathic Pulmonary Fibrosis, IPF, Idiopathic Interstitial Pneumonia, Interstitial Lung Disease, Lung Fibrosis

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.
  4. Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥25% and ≤90%.
  5. Previously treated with an approved IPF therapy (such as, pirfenidone or nintedanib) but discontinued at least 1 week prior to screening, unless neither treatment is available in the host country.

Key Exclusion 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.
  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. Recent use of any investigational drugs or unapproved therapies, or participation in any clinical trial.
  11. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies, or to any component of the excipient.

Sites / Locations

  • UAB Lung Health Center
  • UC San Francisco
  • National Jewish Health
  • Yale University
  • St. Francis Medical Center
  • Pulmonary Disease Specialists d/b/a PDS Research
  • TGH/USF Center for Advanced Lung Disease and Lung Transplant
  • Emory University/The Emory Clinic
  • University of Iowa
  • The University of Kansas Medical Center
  • University of Maryland Medical Center
  • The General Hospital Corporation d/b/a Massachusetts General Hospital
  • Spectrum Health
  • University of Minnesota
  • Mayo Clinic
  • Duke University Medical Center
  • PulmonIx, LLC
  • Ohio State University
  • Penn State Milton S Hershey Medical Center
  • University of Pennsylvania
  • Low Country Lung and Critical Care, PA
  • The University of Vermont
  • University of Wisconsin Clinical Research
  • Fundacion Respirar - Centro Médico Dra. De Salvo
  • Hospital das Clínicas da UFMG - Centro de Pesquisas Clínicas do Hospital das Clínicas da Universidade Federal de Minas Gerais - CPC HC/UFMG
  • Irmandade da Santa Casa de Misericórdia de Porto Alegre
  • HSL-PUCRS Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
  • Hospital Dia do Pulmão
  • Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UPECLIN - UNESP
  • CEMEC - Centro Multidisciplinar de Estudos Clínicos LTDA EPP
  • CPQuali Pesquisa Clínica Ltda.
  • Hospital Alemao Oswaldo Cruz
  • INCOR - Instituto do Coração Centro de Pesquisa Prof. Dr. Fulvio Pileggi Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP
  • BeiJing Chao-Yang Hospital,Capital Medical University
  • Beijing Frindship hosiptal capital Medical University
  • China Japan Friendship hospital
  • Peking Union Medical College Hospital
  • Sichuan People's Hospital
  • Guangdong Provincial People's Hospital
  • The Second Affiliated Hospital of Zhejiang University School of Medicine
  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
  • Shanghai Oriental Hospital
  • The First Hospital of China Medical University
  • General Hospital of Tianjin Medical University
  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • The Second Affiliated Hospital of Xi'an Jiaotong University
  • General Hospital of Ningxia Medical University
  • Fundación Santa Fe de Bogotá
  • Fundación Neumológica Colombiana
  • Healthy Medical Center S.A.S
  • Fakultní nemocnice Brno
  • Nemocnice Jihlava
  • Nemocnice Na Bulovce, Klinika pneumologie
  • Aarhus Universitets Hospital
  • Odense University Hospital
  • Centro de Obstetricia y Ginecologia
  • Centro Medico Dominicano
  • University Hospital Avicenne
  • Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel
  • CHU de Caen
  • Centre Memoire Ressources Recherche, Hopital F. MITTERRAND
  • C.H.R.U. de Montpellier - Hôpital Lapeyronie
  • CHU de Nice Hôpital Pasteur
  • Hôpital Bichat - Claude Bernard
  • CHU de Reims Hopital Maison Blanche
  • CHU de Rennes Hôpital Pontchaillou
  • Service de Néphrologie, Hôpital Bretonneau, CHRU de Tours
  • Research Institute Of Clinical Medicine Todua Clinic
  • Clinic Diacor
  • Ruhrlandklinik-Universitaetsmedizin Essen
  • Klinik Schillerhoehe
  • Agaplesion Evangelisches Krankenhaus Mittelhessen
  • Universitätsklinikum Hamburg-Eppendorf
  • University of Munich
  • RoMed Klinikum Rosenheim
  • Institut fur Pneumologie an der Universitat zu Koln
  • Semmelweis University Clinic of Pulmonology
  • Orszagos Koranyi Tbc es Pulmonologiai Intezet, IV. Tudobelosztaly
  • Fejer Megyei Szent Gyorgy kh
  • Pulmonology Hospital
  • Royal College of Surgeons in Ireland
  • Gaspare Rodiloco Hospital
  • Ospedale G.B.Morgagni L.Pierantoni - Azienda Unita Sanitaria Locale (AUSL) di Forli
  • Ospedale San Giuseppe
  • AOU Policlinico di Modena
  • Monaldi Hospital
  • Azienda Ospedaliera Universitaria di Padova
  • IRCCS Fondazione San Matteo di Pavia
  • Agostina Gemelli University Polyclinic
  • Azienda Ospedaliera Universitaria Senese, Policlinico "Le Scotte"
  • Azienda Ospedaliera Citta' della Salute e delle Scienza di Torino
  • Azienda Ospedaliero-Universitaria "Ospedali Riuniti di Ancona"
  • Myongji Hospital
  • Soonchunhyang University Hospital Bucheon
  • The Catholic University of Korea Bucheon St. Mary's Hospital
  • Inje University Haeundae Paik Hospital
  • Inje University Hospital Iisan Paik Hospital
  • Chonnam National University Hospital
  • Gachon University Gil Medical Centre
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Kyunghee University Medical Center
  • Severance hospital
  • Soonchunhyang University Hospital Seoul
  • Asan Medical Center
  • The Catholic University of Korea, Yeouido ST. Mary's Hospital
  • Ulsan University Hospital
  • American University of beirut medical center
  • Hotel Dieu De France
  • Rafik Hariri University Hospital (Clinical Research Unit)
  • Instituto Nacional de Enfermedades Respiratorias INER
  • Unidad Medica para la Salud Integral (UMSI)
  • Medical Care and Research S.A. de C.V.
  • St. Lucas Clinical Research Center SA de CV
  • Centro Regional para el estudio del Adulto Mayor, Servicio de Geriatria, Hospital Universitario Dr Jose Eleuterio Gonzalez
  • Oaxaca Site Management Organization S.C. (OSMO)
  • Dept. of Pulmonary Diseases
  • Catharina Hospital
  • Longarts - Opleider Longziekten Zuyderland MC
  • St. Antonius Ziekenhuis BV
  • Canisius-Wilhelmina Ziekenhuis
  • Clinica Internacional
  • Clinica San Pablo
  • Clinica Providencia
  • Hospital Nacional Cayetano Heredia / Servicio de Inmunología y Reumatología
  • Centro de Investigacion Ricardo Palma
  • Clinica La luz
  • Centrum Dentystyczno-Lekarskie Promedica Joanna Markiewicz
  • Centrum Medycyny Oddechowej Mroz SJ
  • Gornoslaskie Centrum Medyczne im. prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach
  • University Hospital No1
  • Instytut Gruzlicy i Chorob Pluc
  • Municipal Institute for Lung Diseases and Tuberculosis
  • University Clinical Center of Serbia
  • University Clinical Center of Nis
  • Institute for Pulmonary Diseases of Vojvodina
  • Hospital Universitario de Bellvitge
  • Hospital Clinic de Barcelona
  • Hospital Universitaio de La Princesa
  • Hospital General Universitario Gregorio Maranon
  • Hospital Clinico San Carlos-Madrid C/Martin Lagos s/n
  • Hospital Universitario Quironsalud Madrid
  • Hospital Universitario Marques de Valdecilla
  • Hospital Universitario Nuestra Senora de Valme
  • Universitätsklinik für Pneumologie
  • Communal non-profit enterprise "City clinical hospital #16" of Dnipro Сit Сouncil
  • Ivano-Frankivsk Regional Phthisiology-Pulmonology Center of Ivano-Frankivsk regional council
  • National Institute of Phthisiology and Pulmonology named after F. G. Yanovskyi NAMS of Ukraine, Clinical and Functional Department
  • Medway NHS Foundation Trust
  • Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust
  • Papworth Hospital NHS Foundation Trust, Advanced Heart Failure Unit
  • The Princess Alexandra Hospital NHS Trust
  • Royal Brompton Hospital
  • University College London
  • Manchester University NHS Foundation Trust
  • Southampton General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pamrevlumab

Placebo

Arm Description

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

Pamrevlumab-matching placebo administered by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks

Outcomes

Primary Outcome Measures

Change From Baseline in Forced Vital Capacity (FVC) at Week 48

Secondary Outcome Measures

Time to Disease Progression
Defined as absolute FVC percent predicted (FVCpp) decline of ≥10% or death, whichever occurs first
Change from Baseline to Week 48 in Quantitative Lung Fibrosis (QLF) Volume
Time to Any Component of the Clinical Composite Endpoint, Whichever Occurs First: Acute IPF Exacerbation, Respiratory Hospitalization, or Death
Time to First Acute IPF Exacerbation
Time to All-Cause Mortality
Time to First Respiratory Hospitalization

Full Information

First Posted
June 3, 2020
Last Updated
April 17, 2023
Sponsor
FibroGen
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1. Study Identification

Unique Protocol Identification Number
NCT04419558
Brief Title
Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Official Title
Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 30, 2020 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FibroGen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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 NOTE: No participant should discontinue an approved IPF therapy for the purpose of enrolling in this study. During the 48-week treatment phase of the study, co-administration of an approved IPF therapy (such as, pirfenidone or nintedanib) is acceptable if clinically indicated in the Investigator's opinion, after assessment of potential risks/benefits of such combination with blinded study treatment. Participants who complete the 48-week study will be eligible for an optional, open-label extension phase with continued access to pamrevlumab, regardless of their randomized assignment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
Idiopathic Pulmonary Fibrosis, IPF, Idiopathic Interstitial Pneumonia, Interstitial Lung Disease, Lung Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
During the Open-label extension phase, all participants will receive pamrevlumab in an open-label manner. No unblinding of participant's treatment assignment in the treatment phase (main study) will occur for purposes of open-label extension participation.
Allocation
Randomized
Enrollment
372 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pamrevlumab
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Pamrevlumab-matching placebo administered by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks
Intervention Type
Drug
Intervention Name(s)
Pamrevlumab
Other Intervention Name(s)
FG-3019
Intervention Description
Sterile solution for injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sterile solution for injection
Primary Outcome Measure Information:
Title
Change From Baseline in Forced Vital Capacity (FVC) at Week 48
Time Frame
Baseline, Week 48
Secondary Outcome Measure Information:
Title
Time to Disease Progression
Description
Defined as absolute FVC percent predicted (FVCpp) decline of ≥10% or death, whichever occurs first
Time Frame
Up to Week 48
Title
Change from Baseline to Week 48 in Quantitative Lung Fibrosis (QLF) Volume
Time Frame
Baseline, Week 48
Title
Time to Any Component of the Clinical Composite Endpoint, Whichever Occurs First: Acute IPF Exacerbation, Respiratory Hospitalization, or Death
Time Frame
Up to Week 48
Title
Time to First Acute IPF Exacerbation
Time Frame
Up to Week 48
Title
Time to All-Cause Mortality
Time Frame
Up to Week 48
Title
Time to First Respiratory Hospitalization
Time Frame
Up to Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 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. 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 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. Key Exclusion Criteria: Previous exposure to pamrevlumab. Evidence of significant obstructive lung disease, as evidenced by spirometry or HRCT. Female participants who are pregnant or nursing. Smoking within 3 months of Screening and/or unwilling to avoid smoking throughout the study. Interstitial lung disease other than IPF. Sustained improvement in the severity of IPF during the 12 months prior to screening. 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. 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). Acute IPF exacerbation during Screening or Randomization including hospitalization due to acute IPF exacerbation within 4 weeks prior to or during screening. 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. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies, or to any component of the excipient.
Facility Information:
Facility Name
UAB Lung Health Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
UC San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
St. Francis Medical Center
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Pulmonary Disease Specialists d/b/a PDS Research
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
TGH/USF Center for Advanced Lung Disease and Lung Transplant
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Emory University/The Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30324
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
The University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
The General Hospital Corporation d/b/a Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49504
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
PulmonIx, LLC
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
Penn State Milton S Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Low Country Lung and Critical Care, PA
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
The University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Facility Name
University of Wisconsin Clinical Research
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53706
Country
United States
Facility Name
Fundacion Respirar - Centro Médico Dra. De Salvo
City
Ciudad Autonoma De Buenos Aires (CABA)
Country
Argentina
Facility Name
Hospital das Clínicas da UFMG - Centro de Pesquisas Clínicas do Hospital das Clínicas da Universidade Federal de Minas Gerais - CPC HC/UFMG
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-100
Country
Brazil
Facility Name
Irmandade da Santa Casa de Misericórdia de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90020-090
Country
Brazil
Facility Name
HSL-PUCRS Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Hospital Dia do Pulmão
City
Blumenau
State/Province
Santa Catarina
ZIP/Postal Code
89030-101
Country
Brazil
Facility Name
Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UPECLIN - UNESP
City
Botucatu
State/Province
São Paulo
ZIP/Postal Code
18618-686
Country
Brazil
Facility Name
CEMEC - Centro Multidisciplinar de Estudos Clínicos LTDA EPP
City
Sao Bernardo do Campo
State/Province
São Paulo
ZIP/Postal Code
09715-090
Country
Brazil
Facility Name
CPQuali Pesquisa Clínica Ltda.
City
São Paulo
ZIP/Postal Code
01228-000
Country
Brazil
Facility Name
Hospital Alemao Oswaldo Cruz
City
São Paulo
ZIP/Postal Code
01323-001
Country
Brazil
Facility Name
INCOR - Instituto do Coração Centro de Pesquisa Prof. Dr. Fulvio Pileggi Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
BeiJing Chao-Yang Hospital,Capital Medical University
City
Beijing
Country
China
Facility Name
Beijing Frindship hosiptal capital Medical University
City
Beijing
Country
China
Facility Name
China Japan Friendship hospital
City
Beijing
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China
Facility Name
Sichuan People's Hospital
City
Chengdu
Country
China
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
Country
China
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
Country
China
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
Country
China
Facility Name
Shanghai Oriental Hospital
City
Shanghai
Country
China
Facility Name
The First Hospital of China Medical University
City
Shenyang
Country
China
Facility Name
General Hospital of Tianjin Medical University
City
Tianjing
Country
China
Facility Name
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
Country
China
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
Country
China
Facility Name
The Second Affiliated Hospital of Xi'an Jiaotong University
City
Xian
Country
China
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
Country
China
Facility Name
Fundación Santa Fe de Bogotá
City
Bogota
ZIP/Postal Code
110121
Country
Colombia
Facility Name
Fundación Neumológica Colombiana
City
Bogota
ZIP/Postal Code
110131
Country
Colombia
Facility Name
Healthy Medical Center S.A.S
City
Zipaquirá
ZIP/Postal Code
250252
Country
Colombia
Facility Name
Fakultní nemocnice Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Nemocnice Jihlava
City
Jihlava
ZIP/Postal Code
586 33
Country
Czechia
Facility Name
Nemocnice Na Bulovce, Klinika pneumologie
City
Prague
ZIP/Postal Code
18081
Country
Czechia
Facility Name
Aarhus Universitets Hospital
City
Aarhus
ZIP/Postal Code
DK-8200
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Centro de Obstetricia y Ginecologia
City
Santo Domingo
ZIP/Postal Code
10205
Country
Dominican Republic
Facility Name
Centro Medico Dominicano
City
Santo Domingo
ZIP/Postal Code
456
Country
Dominican Republic
Facility Name
University Hospital Avicenne
City
Bobigny
ZIP/Postal Code
93000
Country
France
Facility Name
Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
CHU de Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Centre Memoire Ressources Recherche, Hopital F. MITTERRAND
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
C.H.R.U. de Montpellier - Hôpital Lapeyronie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU de Nice Hôpital Pasteur
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
Hôpital Bichat - Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
CHU de Reims Hopital Maison Blanche
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
CHU de Rennes Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Service de Néphrologie, Hôpital Bretonneau, CHRU de Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Research Institute Of Clinical Medicine Todua Clinic
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
Clinic Diacor
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Ruhrlandklinik-Universitaetsmedizin Essen
City
Essen
ZIP/Postal Code
45239
Country
Germany
Facility Name
Klinik Schillerhoehe
City
Gerlingen
ZIP/Postal Code
70839
Country
Germany
Facility Name
Agaplesion Evangelisches Krankenhaus Mittelhessen
City
Gießen
ZIP/Postal Code
035398
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
University of Munich
City
Munich
ZIP/Postal Code
81377
Country
Germany
Facility Name
RoMed Klinikum Rosenheim
City
Rosenheim
ZIP/Postal Code
83022
Country
Germany
Facility Name
Institut fur Pneumologie an der Universitat zu Koln
City
Solingen
ZIP/Postal Code
83022
Country
Germany
Facility Name
Semmelweis University Clinic of Pulmonology
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Orszagos Koranyi Tbc es Pulmonologiai Intezet, IV. Tudobelosztaly
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
Fejer Megyei Szent Gyorgy kh
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Pulmonology Hospital
City
Törökbálint
ZIP/Postal Code
2045
Country
Hungary
Facility Name
Royal College of Surgeons in Ireland
City
Dublin
ZIP/Postal Code
D09YD60
Country
Ireland
Facility Name
Gaspare Rodiloco Hospital
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Ospedale G.B.Morgagni L.Pierantoni - Azienda Unita Sanitaria Locale (AUSL) di Forli
City
Forli
ZIP/Postal Code
47121
Country
Italy
Facility Name
Ospedale San Giuseppe
City
Milan
ZIP/Postal Code
20123
Country
Italy
Facility Name
AOU Policlinico di Modena
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Monaldi Hospital
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
IRCCS Fondazione San Matteo di Pavia
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Agostina Gemelli University Polyclinic
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Senese, Policlinico "Le Scotte"
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Azienda Ospedaliera Citta' della Salute e delle Scienza di Torino
City
Torino
ZIP/Postal Code
0126
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria "Ospedali Riuniti di Ancona"
City
Torrette
ZIP/Postal Code
60126
Country
Italy
Facility Name
Myongji Hospital
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
10475
Country
Korea, Republic of
Facility Name
Soonchunhyang University Hospital Bucheon
City
Bucheon-si
ZIP/Postal Code
14584
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Bucheon St. Mary's Hospital
City
Bucheon
ZIP/Postal Code
14647
Country
Korea, Republic of
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Facility Name
Inje University Hospital Iisan Paik Hospital
City
Goyang
ZIP/Postal Code
10380
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Centre
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Kyunghee University Medical Center
City
Seoul
ZIP/Postal Code
17104
Country
Korea, Republic of
Facility Name
Severance hospital
City
Seoul
ZIP/Postal Code
3722
Country
Korea, Republic of
Facility Name
Soonchunhyang University Hospital Seoul
City
Seoul
ZIP/Postal Code
4401
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
5505
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Yeouido ST. Mary's Hospital
City
Seoul
ZIP/Postal Code
7345
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
ZIP/Postal Code
44033
Country
Korea, Republic of
Facility Name
American University of beirut medical center
City
Beirut
Country
Lebanon
Facility Name
Hotel Dieu De France
City
Beirut
Country
Lebanon
Facility Name
Rafik Hariri University Hospital (Clinical Research Unit)
City
Bir Hassan
Country
Lebanon
Facility Name
Instituto Nacional de Enfermedades Respiratorias INER
City
Mexico
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Unidad Medica para la Salud Integral (UMSI)
City
Mexico
ZIP/Postal Code
66465
Country
Mexico
Facility Name
Medical Care and Research S.A. de C.V.
City
Mexico
ZIP/Postal Code
97070
Country
Mexico
Facility Name
St. Lucas Clinical Research Center SA de CV
City
Mexico
ZIP/Postal Code
CP97217
Country
Mexico
Facility Name
Centro Regional para el estudio del Adulto Mayor, Servicio de Geriatria, Hospital Universitario Dr Jose Eleuterio Gonzalez
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Oaxaca Site Management Organization S.C. (OSMO)
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Facility Name
Dept. of Pulmonary Diseases
City
Amsterdam
ZIP/Postal Code
30.033
Country
Netherlands
Facility Name
Catharina Hospital
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Longarts - Opleider Longziekten Zuyderland MC
City
Heerlen
ZIP/Postal Code
6419
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis BV
City
Nieuwegein
ZIP/Postal Code
3435
Country
Netherlands
Facility Name
Canisius-Wilhelmina Ziekenhuis
City
Nieuwegein
ZIP/Postal Code
6533
Country
Netherlands
Facility Name
Clinica Internacional
City
Lima
ZIP/Postal Code
15001
Country
Peru
Facility Name
Clinica San Pablo
City
Lima
ZIP/Postal Code
150140
Country
Peru
Facility Name
Clinica Providencia
City
Lima
ZIP/Postal Code
15088
Country
Peru
Facility Name
Hospital Nacional Cayetano Heredia / Servicio de Inmunología y Reumatología
City
Lima
ZIP/Postal Code
15102
Country
Peru
Facility Name
Centro de Investigacion Ricardo Palma
City
San Isidro
ZIP/Postal Code
150131
Country
Peru
Facility Name
Clinica La luz
City
Santa Beatriz
ZIP/Postal Code
15046
Country
Peru
Facility Name
Centrum Dentystyczno-Lekarskie Promedica Joanna Markiewicz
City
Bedzin
ZIP/Postal Code
42-500
Country
Poland
Facility Name
Centrum Medycyny Oddechowej Mroz SJ
City
Bialystok
ZIP/Postal Code
15-044
Country
Poland
Facility Name
Gornoslaskie Centrum Medyczne im. prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach
City
Katowice
ZIP/Postal Code
40-635
Country
Poland
Facility Name
University Hospital No1
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Instytut Gruzlicy i Chorob Pluc
City
Warsaw
ZIP/Postal Code
01-138
Country
Poland
Facility Name
Municipal Institute for Lung Diseases and Tuberculosis
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Clinical Center of Nis
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Institute for Pulmonary Diseases of Vojvodina
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
Hospital Universitario de Bellvitge
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
Hospital Universitaio de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Clinico San Carlos-Madrid C/Martin Lagos s/n
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Quironsalud Madrid
City
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitario Nuestra Senora de Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Universitätsklinik für Pneumologie
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Communal non-profit enterprise "City clinical hospital #16" of Dnipro Сit Сouncil
City
Dnipro
ZIP/Postal Code
49069
Country
Ukraine
Facility Name
Ivano-Frankivsk Regional Phthisiology-Pulmonology Center of Ivano-Frankivsk regional council
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
National Institute of Phthisiology and Pulmonology named after F. G. Yanovskyi NAMS of Ukraine, Clinical and Functional Department
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
Medway NHS Foundation Trust
City
Gillingham
State/Province
Kent
ZIP/Postal Code
ME7 5NY
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Papworth Hospital NHS Foundation Trust, Advanced Heart Failure Unit
City
Cambridge
ZIP/Postal Code
CB2 0AY
Country
United Kingdom
Facility Name
The Princess Alexandra Hospital NHS Trust
City
Harlow
ZIP/Postal Code
CM20 1QX
Country
United Kingdom
Facility Name
Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
Facility Name
University College London
City
London
ZIP/Postal Code
WC1E 6JF
Country
United Kingdom
Facility Name
Manchester University NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

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