Zephyrus I: Evaluation of Efficacy and Safety of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
NCT ID: NCT03955146
Last Updated: 2024-09-19
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
393 participants
INTERVENTIONAL
2019-06-18
2023-08-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Main Study Cohort: Pamrevlumab
Participants will receive pamrevlumab 30 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion every 3 weeks for up to 48 weeks in the DB period.
Pamrevlumab
Pamrevlumab will be administered per dose and schedule specified in the arm description.
Main Study Cohort: Placebo
Participants will receive placebo matching to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks in the DB period.
Placebo
Placebo matching to pamrevlumab will be administered per schedule specified in the arm description.
Japan Extension Cohort: Pamrevlumab
Participants will receive pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
Pamrevlumab
Pamrevlumab will be administered per dose and schedule specified in the arm description.
Japan Extension Cohort: Placebo
Participants will receive placebo matching to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
Placebo
Placebo matching to pamrevlumab will be administered per schedule specified in the arm description.
OLE Period: Pamrevlumab/Pamrevlumab
Participants who receive pamrevlumab in the DB period will continue to receive the same dose of pamrevlumab for up to 48 weeks in the OLE period or until pamrevlumab is commercially available for the indication of IPF, or the sponsor decides to end the OLE period, whichever occurrs first.
Pamrevlumab
Pamrevlumab will be administered per dose and schedule specified in the arm description.
OLE Period: Placebo/Pamrevlumab
Participants who receive placebo matching to pamrevlumab in the DB period, will receive pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks in the OLE period or until pamrevlumab is commercially available for the indication of IPF, or the sponsor decides to end the OLE period, whichever occurrs first.
Pamrevlumab
Pamrevlumab will be administered per dose and schedule specified in the arm description.
Interventions
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Pamrevlumab
Pamrevlumab will be administered per dose and schedule specified in the arm description.
Placebo
Placebo matching to pamrevlumab will be administered per schedule specified in the arm description.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 and corrected by hemoglobin (Hb) value ≥25% and ≤90% at screening (determined locally).
5. 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.
Exclusion Criteria
2. Evidence of significant obstructive lung disease.
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. History of other types of respiratory diseases including diseases or disorders of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall.
8. 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.
9. Acute IPF exacerbation during screening or randomization.
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 (that is, 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.
40 Years
85 Years
ALL
No
Sponsors
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FibroGen
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham Hospital
Birmingham, Alabama, United States
Banner University Medical Center - Phoenix
Phoenix, Arizona, United States
Norton Thoracic Institute
Phoenix, Arizona, United States
Pulmonary Associates, PA - Research
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
J&L Research
Conway, Arkansas, United States
Loma Linda University Health
Loma Linda, California, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
UC Davis Medical Center
Sacramento, California, United States
University of California San Diego
San Diego, California, United States
Stanford University Medical Center
Stanford, California, United States
University of Colorado Denver
Aurora, Colorado, United States
National Jewish Health
Denver, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
St. Francis Medical Center
Clearwater, Florida, United States
University of Florida Pulmonary, Critical Care & Sleep Medicine Division
Gainesville, Florida, United States
University of Florida Health, Jacksonville
Jacksonville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Pulmonary Disease Specialist, PA d/b/a, PDS Research
Kissimmee, Florida, United States
University of South Florida
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Piedmont Healthcare, Inc.
Austell, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Loyola University of Chicago
Maywood, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
The University of Kansas Medical Center
Kansas City, Kansas, United States
University of Maryland, Baltimore
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Spectrum Health
Grand Rapids, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
The Lung Research Center, LLC
Chesterfield, Missouri, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Albany Medical College
Albany, New York, United States
Pulmonary Health Physicians, PC
Liverpool, New York, United States
Pulmonix, LLC
Greensboro, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Ohio State University
Columbus, Ohio, United States
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, United States
Legacy Research Institute
Portland, Oregon, United States
The Oregon Clinic
Portland, Oregon, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Lowcountry Lung and Critical Care, PA
Charleston, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Tennessee Comprehensive Lung and Sleep Center
Hendersonville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Houston Pulmonary Sleep, Allergy and Asthma Associates
Cypress, Texas, United States
Baylor Scott and White Research Institute
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Texas - Houston
Houston, Texas, United States
UT Health San Antonio
San Antonio, Texas, United States
Renovatio Clinical
The Woodlands, Texas, United States
University of Utah Health
Salt Lake City, Utah, United States
The University of Vermont
Burlington, Vermont, United States
University of Washington
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Fundacion Respirar - Centro Médico Dra. De Salvo
Ciudad Autonoma de Buenos Aires (caba), Buenos Aires, Argentina
Centro de Investigacion Metabolica 'CINME'
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Consultorios Medicos. Organización del Buen Ayre. SRL
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Centro Medico de Enfermedades Respiratorias
Florida, Buenos Aires, Argentina
Centro Platense en Investigaciones Respiratorias
La Plata, Buenos Aires, Argentina
Instituto ave Pulmo Fundacion enfisema
Mar del Plata, Buenos Aires, Argentina
Respira Salud Clinica Integral
Godoy Cruz, Mendoza Province, Argentina
INSARES
Mendoza, Mendoza Province, Argentina
Investigaciones en Patologias Respiratorias
San Miguel de Tucumán, Tucumán Province, Argentina
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Mater Health Services Adult Hospital
South Brisbane, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Centro Investigacion del Maule CIM
Talca, Maule Region, Chile
Instituto Nacional del Torax
Santiago, Santiago Metropolitan, Chile
CIMER
Santiago, Santiago Metropolitan, Chile
M y F estudios clinicos
Santiago, Santiago Metropolitan, Chile
Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
BeiJing Chao-Yang Hospital,Capital medical university
Beijing, Beijing Municipality, China
China-Japan friendship hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Shenzhen people's hospital
Shenzhen, Guangdong, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Henan Provincial chest hospital
Zhengzhou, Henan, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Union Hospital，Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
People's Hospital of Inner Mongolia Autonomous Region
Hohhot, Inner Mongolia, China
The second hospital of Dalian medical university
Dalian, Liaoning, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Huaxi Hospital of Sichuan University.
Chengdu, Sichuan, China
General Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
Queen Mary Hospital
Central, , Hong Kong
Tuen Mun Hospital
Hong Kong, , Hong Kong
Regional Clinical Hospital #3
Chelyabinsk, , Russia
Kazan State Medical University based on Republican Clinical Hospital
Kazan', , Russia
Clinical Hospital #3
Kemerovo, , Russia
Euromedservice, Clinical and Diagnostic Center
Moscow, , Russia
MONIKI
Moscow, , Russia
City Clinical Hospital #1 n.a. A.N. Kabanov
Omsk, , Russia
Vvedenskaya hospital
Saint Petersburg, , Russia
Medical Center "Reavita Med SPb"
Saint Petersburg, , Russia
FSBEI HE First Pavlov Medical University
Saint Petersburg, , Russia
Medical Association "NEW HOSPITAL"
Yekaterinburg, , Russia
Soonchunhyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, South Korea
The Catholic University of Korea, Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Inje University Busan Paik Hospital
Busan, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Centerx
Seoul, , South Korea
Taichung Veterans General Hospital
Taichung, , Taiwan
Taipei Medical University - Shuang-Ho Hospital, Ministry of Health and Welfare
Taipei, , Taiwan
Countries
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References
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Raghu G, Richeldi L, Fernandez Perez ER, De Salvo MC, Silva RS, Song JW, Ogura T, Xu ZJ, Belloli EA, Zhang X, Seid LL, Poole L; ZEPHYRUS-1 Study Investigators. Pamrevlumab for Idiopathic Pulmonary Fibrosis: The ZEPHYRUS-1 Randomized Clinical Trial. JAMA. 2024 Aug 6;332(5):380-389. doi: 10.1001/jama.2024.8693.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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FGCL-3019-091
Identifier Type: -
Identifier Source: org_study_id
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