Back to resultsZephyrus I: Evaluation of Efficacy and Safety 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
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
Key Inclusion Criteria:
- Diagnosis of IPF as defined by American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japan Radiological Society (JRS)/Latin American Thoracic Association (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 and corrected by hemoglobin (Hb) value ≥25% and ≤90% at screening (determined locally).
- Not currently receiving treatment for IPF with an approved therapy (that is, 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.
- 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.
- History of other types of respiratory diseases including diseases or disorders of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall.
- Medical conditions (for example, myocardial infarction [MI]/stroke within the past 6 month), or logistical challenges that in the opinion of the Investigator preclude the participant's adequate participation in the study.
- Acute IPF exacerbation during screening or randomization.
- 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 (that is, 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.
Sites / Locations
- University of Alabama at Birmingham Hospital
- Banner University Medical Center - Phoenix
- Norton Thoracic Institute
- Pulmonary Associates, PA - Research
- University of Arizona
- J&L Research
- Loma Linda University Health
- David Geffen School of Medicine at UCLA
- UC Davis Medical Center
- University of California San Diego
- Stanford University Medical Center
- University of Colorado Denver
- National Jewish Health
- Yale University School of Medicine
- Medstar Georgetown University Hospital
- St. Francis Medical Center
- University of Florida Pulmonary, Critical Care & Sleep Medicine Division
- University of Florida Health, Jacksonville
- Mayo Clinic
- Pulmonary Disease Specialist, PA d/b/a, PDS Research
- University of South Florida
- Emory University
- Piedmont Healthcare, Inc.
- Northwestern University
- Loyola University of Chicago
- Indiana University School of Medicine
- The University of Kansas Medical Center
- University of Maryland, Baltimore
- University of Michigan
- Henry Ford Hospital
- Spectrum Health
- University of Minnesota
- The Lung Research Center, LLC
- Dartmouth-Hitchcock Medical Center
- Albany Medical College
- Pulmonary Health Physicians, PC
- Pulmonix, LLC
- University of Cincinnati
- Ohio State University
- INTEGRIS Baptist Medical Center
- Legacy Research Institute
- The Oregon Clinic
- Penn State Milton S. Hershey Medical Center
- Temple University
- Rhode Island Hospital
- Lowcountry Lung and Critical Care, PA
- Medical University of South Carolina
- Tennessee Comprehensive Lung and Sleep Center
- Vanderbilt University Medical Center
- Houston Pulmonary Sleep, Allergy and Asthma Associates
- Baylor Scott and White Research Institute
- University of Texas Southwestern Medical Center
- Baylor College of Medicine
- University of Texas - Houston
- UT Health San Antonio
- Renovatio Clinical
- University of Utah Health
- The University of Vermont
- University of Washington
- Medical College of Wisconsin
- Fundacion Respirar - Centro Médico Dra. De Salvo
- Centro de Investigacion Metabolica 'CINME'
- Consultorios Medicos. Organización del Buen Ayre. SRL
- Centro Medico de Enfermedades Respiratorias
- Centro Platense en Investigaciones Respiratorias
- Instituto ave Pulmo Fundacion enfisema
- INSARES
- Respira Salud Clinica Integral
- Investigaciones en Patologias Respiratorias
- Royal Prince Alfred Hospital
- Westmead Hospital
- Mater Health Services Adult Hospital
- Royal Adelaide Hospital
- Box Hill Hospital
- The Alfred Hospital
- Centro Investigacion del Maule CIM
- Instituto Nacional del Torax
- CIMER
- M y F estudios clinicos
- Second Affiliated Hospital of Anhui Medical University
- BeiJing Chao-Yang Hospital,Capital medical university
- China-Japan friendship hospital
- Peking Union Medical College Hospital
- Nanfang Hospital of Southern Medical University
- The First Affiliated Hospital of Guangzhou Medical University
- Shenzhen people's hospital
- Henan Provincial People's Hospital
- Henan Provincial chest hospital
- Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
- Union Hospital，Tongji Medical College of Huazhong University of Science and Technology
- The Second Xiangya Hospital of Central South University
- Affiliated Hospital of Inner Mongolia Medical University
- People's Hospital of Inner Mongolia Autonomous Region
- The second hospital of Dalian medical university
- The First Hospital of China Medical University
- General Hospital of Ningxia Medical University
- Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
- The Second Affiliated Hospital of Xi'an Jiaotong University
- Huaxi Hospital of Sichuan University.
- General Hospital of Tianjin Medical University
- Hangzhou First People's Hospital
- Queen Mary Hospital
- Tuen Mun Hospital
- Soonchunhyang University Bucheon Hospital
- The Catholic University of Korea, Bucheon St. Mary's Hospital
- Seoul National University Bundang Hospital
- Ajou University Hospital
- Inje University Busan Paik Hospital
- Gachon University Gil Medical Center
- Korea University Anam Hospital
- Seoul National University Hospital
- Asan Medical Center
- Samsung Medical Centerx
- Regional Clinical Hospital #3
- Medical Association "NEW HOSPITAL"
- Kazan State Medical University based on Republican Clinical Hospital
- Clinical Hospital #3
- Euromedservice, Clinical and Diagnostic Center
- MONIKI
- City Clinical Hospital #1 n.a. A.N. Kabanov
- FSBEI HE First Pavlov Medical University
- Vvedenskaya hospital
- Medical Center "Reavita Med SPb"
- Taichung Veterans General Hospital
- Taipei Medical University - Shuang-Ho Hospital, Ministry of Health and Welfare
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Pamrevlumab
Placebo
Arm Description
Pamrevlumab 30 mg/kg by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks
Placebo matching to pamrevlumab 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
Time to disease progression was defined as absolute percent predicted FVC (FVCpp) decline of ≥10% or death, whichever occurs first.
Change From Baseline in Quantitative Lung Fibrosis (QLF) Volume at Week 48
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 During Study
Time to All-cause Mortality During Study
Time to First Respiratory Hospitalizations During Study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03955146
Brief Title
Zephyrus I: Evaluation of Efficacy and Safety of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Official Title
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
June 18, 2019 (Actual)
Primary Completion Date
March 20, 2023 (Actual)
Study Completion Date
May 14, 2024 (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 IPF.
Detailed Description
This is a Phase 3, randomized, double-blind, placebo-controlled, multi-center trial to evaluate the efficacy and safety of pamrevlumab 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.
The study consists of the following study periods:
Main (double blind, placebo-controlled) phase:
Screening period: Up to 6 weeks
Treatment period: 48 weeks
Optional, open-label extension (OLE) phase of pamrevlumab:
o Access to pamrevlumab will be available until the last participant completes 48 weeks of treatment in the OLE phase, or pamrevlumab is commercially available for the indication of IPF, or the Sponsor decides to end the OLE phase, whichever occurs first.
Follow-up period/final safety assessments:
28 days after last dose
60 days after last dose: follow-up phone call, for a final safety assessment
During the treatment period, co-administration of an approved IPF therapy (that is, pirfenidone or nintedanib) is acceptable if clinically indicated in the Investigator's opinion, provided that the Investigator assesses the potential risks/benefits of combining approved IPF therapies with blinded study treatment.
Participants who discontinue study treatment for any reason should be encouraged to remain in the study and be followed for all study visits and assessments.
Participants who complete the Week 48 visit of the main study (regardless of the number of study drug infusions received) will be eligible to participate in the optional OLE phase of the study that offers continuing access to pamrevlumab regardless of randomization assignment in the main study.
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
Allocation
Randomized
Enrollment
356 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pamrevlumab
Arm Type
Experimental
Arm Description
Pamrevlumab 30 mg/kg by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Placebo matching to pamrevlumab 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
Pamrevlumab will be administered per dose and schedule specified in the arm description.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching to pamrevlumab will be administered per schedule specified in the arm description.
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
Time to disease progression was defined as absolute percent predicted FVC (FVCpp) decline of ≥10% or death, whichever occurs first.
Time Frame
Baseline to Week 48
Title
Change From Baseline in Quantitative Lung Fibrosis (QLF) Volume at Week 48
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
Baseline to Week 48
Title
Time to First Acute IPF Exacerbation During Study
Time Frame
Baseline to Week 48
Title
Time to All-cause Mortality During Study
Time Frame
Baseline to Week 48
Title
Time to First Respiratory Hospitalizations During Study
Time Frame
Baseline 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 (ATS)/European Respiratory Society (ERS)/Japan Radiological Society (JRS)/Latin American Thoracic Association (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 and corrected by hemoglobin (Hb) value ≥25% and ≤90% at screening (determined locally).
Not currently receiving treatment for IPF with an approved therapy (that is, 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.
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.
History of other types of respiratory diseases including diseases or disorders of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall.
Medical conditions (for example, myocardial infarction [MI]/stroke within the past 6 month), or logistical challenges that in the opinion of the Investigator preclude the participant's adequate participation in the study.
Acute IPF exacerbation during screening or randomization.
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 (that is, 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
University of Alabama at Birmingham Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Banner University Medical Center - Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Norton Thoracic Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Pulmonary Associates, PA - Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
J&L Research
City
Conway
State/Province
Arkansas
ZIP/Postal Code
72032
Country
United States
Facility Name
Loma Linda University Health
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
David Geffen School of Medicine at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80207
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Medstar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
St. Francis Medical Center
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
University of Florida Pulmonary, Critical Care & Sleep Medicine Division
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University of Florida Health, Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Pulmonary Disease Specialist, PA d/b/a, PDS Research
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Piedmont Healthcare, Inc.
City
Austell
State/Province
Georgia
ZIP/Postal Code
30106
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Loyola University of Chicago
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
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, Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
The Lung Research Center, LLC
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Pulmonary Health Physicians, PC
City
Liverpool
State/Province
New York
ZIP/Postal Code
13088
Country
United States
Facility Name
Pulmonix, LLC
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
INTEGRIS Baptist Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Legacy Research Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
The Oregon Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97220
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
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Lowcountry Lung and Critical Care, PA
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Tennessee Comprehensive Lung and Sleep Center
City
Hendersonville
State/Province
Tennessee
ZIP/Postal Code
37075
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Facility Name
Houston Pulmonary Sleep, Allergy and Asthma Associates
City
Cypress
State/Province
Texas
ZIP/Postal Code
77429
Country
United States
Facility Name
Baylor Scott and White Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
UT Health San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Renovatio Clinical
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
University of Utah Health
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
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 Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Fundacion Respirar - Centro Médico Dra. De Salvo
City
Ciudad Autonoma De Buenos Aires (caba)
State/Province
Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Centro de Investigacion Metabolica 'CINME'
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1027AAP
Country
Argentina
Facility Name
Consultorios Medicos. Organización del Buen Ayre. SRL
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1425FVH
Country
Argentina
Facility Name
Centro Medico de Enfermedades Respiratorias
City
Florida
State/Province
Buenos Aires
ZIP/Postal Code
B1602DQD
Country
Argentina
Facility Name
Centro Platense en Investigaciones Respiratorias
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
1900
Country
Argentina
Facility Name
Instituto ave Pulmo Fundacion enfisema
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
B7602DCK
Country
Argentina
Facility Name
INSARES
City
Ciudad de Mendoza
State/Province
Mendoza
ZIP/Postal Code
M5500CCG
Country
Argentina
Facility Name
Respira Salud Clinica Integral
City
Godoy Cruz
State/Province
Provincia De Mendoza
ZIP/Postal Code
M5501GCA
Country
Argentina
Facility Name
Investigaciones en Patologias Respiratorias
City
San Miguel De Tucumán
State/Province
Tucumán
ZIP/Postal Code
T4000IAR
Country
Argentina
Facility Name
Royal Prince Alfred Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Mater Health Services Adult Hospital
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Centro Investigacion del Maule CIM
City
Talca
State/Province
Region Del Maule
ZIP/Postal Code
3465586
Country
Chile
Facility Name
Instituto Nacional del Torax
City
Santiago
State/Province
Region Metropolitana
ZIP/Postal Code
7500691
Country
Chile
Facility Name
CIMER
City
Santiago
State/Province
Region Metropolitana
ZIP/Postal Code
7500692
Country
Chile
Facility Name
M y F estudios clinicos
City
Santiago
State/Province
Region Metropolitana
ZIP/Postal Code
7750495
Country
Chile
Facility Name
Second Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
Facility Name
BeiJing Chao-Yang Hospital,Capital medical university
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
China-Japan friendship hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Nanfang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
Shenzhen people's hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Facility Name
Henan Provincial chest hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Facility Name
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Union Hospital，Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Facility Name
Affiliated Hospital of Inner Mongolia Medical University
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
10010
Country
China
Facility Name
People's Hospital of Inner Mongolia Autonomous Region
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
10020
Country
China
Facility Name
The second hospital of Dalian medical university
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116001
Country
China
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
Facility Name
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
The Second Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710004
Country
China
Facility Name
Huaxi Hospital of Sichuan University.
City
ChenDu
State/Province
Sichuan
ZIP/Postal Code
6100141
Country
China
Facility Name
General Hospital of Tianjin Medical University
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Hangzhou First People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Facility Name
Queen Mary Hospital
City
Central
Country
Hong Kong
Facility Name
Tuen Mun Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Soonchunhyang University Bucheon Hospital
City
Bucheon-si
State/Province
Gyeonggi-do
ZIP/Postal Code
14579
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Bucheon St. Mary's Hospital
City
Bucheon-si
State/Province
Gyeonggi-do
ZIP/Postal Code
14647
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon-si
State/Province
Gyeonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Inje University Busan Paik Hospital
City
Busan
ZIP/Postal Code
47392
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
2841
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
3080
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
5505
Country
Korea, Republic of
Facility Name
Samsung Medical Centerx
City
Seoul
ZIP/Postal Code
6351
Country
Korea, Republic of
Facility Name
Regional Clinical Hospital #3
City
Chelyabinsk
ZIP/Postal Code
454106
Country
Russian Federation
Facility Name
Medical Association "NEW HOSPITAL"
City
Ekaterinburg
ZIP/Postal Code
620109
Country
Russian Federation
Facility Name
Kazan State Medical University based on Republican Clinical Hospital
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Clinical Hospital #3
City
Kemerovo
ZIP/Postal Code
650000
Country
Russian Federation
Facility Name
Euromedservice, Clinical and Diagnostic Center
City
Moscow
ZIP/Postal Code
115419
Country
Russian Federation
Facility Name
MONIKI
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
Facility Name
City Clinical Hospital #1 n.a. A.N. Kabanov
City
Omsk
ZIP/Postal Code
644112
Country
Russian Federation
Facility Name
FSBEI HE First Pavlov Medical University
City
Saint-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Vvedenskaya hospital
City
St. Petersburg
ZIP/Postal Code
191180
Country
Russian Federation
Facility Name
Medical Center "Reavita Med SPb"
City
St. Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Taipei Medical University - Shuang-Ho Hospital, Ministry of Health and Welfare
City
Taipei
ZIP/Postal Code
23561
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35204752
Citation
Rayego-Mateos S, Morgado-Pascual JL, Lavoz C, Rodrigues-Diez RR, Marquez-Exposito L, Tejera-Munoz A, Tejedor-Santamaria L, Rubio-Soto I, Marchant V, Ruiz-Ortega M. CCN2 Binds to Tubular Epithelial Cells in the Kidney. Biomolecules. 2022 Feb 3;12(2):252. doi: 10.3390/biom12020252.
Results Reference
derived
Learn more about this trial
Zephyrus I: Evaluation of Efficacy and Safety of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
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