Learn about Research & Clinical Trials
Evaluation of Efficacy and Safety of Pamrevlumab in Patients With Idiopathic Pulmonary Fibrosis
Study Purpose
This is a Phase 3 trial to evaluate the efficacy and safety of 30 mg/kg intravenous (IV) infusions of pamrevlumab administered every 3 weeks as compared to placebo in subjects with Idiopathic Pulmonary Fibrosis
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 ATS/ERS/JRS/ALAT guidelines (Raghu 2018) within the past 7 years prior to study participation. 2. HRCT scan at Screening, with ā„10% to <50% parenchymal fibrosis (reticulation) and <25% honeycombing. 3. FVCpp value >45% and <95% 4. Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted ā„25% and ā¤90% at screening (determined locally). 5. Not currently receiving treatment for IPF with an approved therapy (i.e., pirfenidone or nintedanib) for any reason, including prior intolerance to an approved IPF therapy. KeyExclusion Criteria:
1. Previous exposure to pamrevlumab. 2. Evidence of significant obstructive lung disease. 3. Female subjects 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 including diseases of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall. 8. Certain medical conditions, including recent (e.g. MI/stroke, or severe chronic heart failure or pulmonary hypertension, or cancers. 9. Acute IPF exacerbation during Screening or Randomization. 10. Recent use of any investigational drugs or unapproved therapies, or approved or participation in any clinical trial. 11. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies.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. |
NCT03955146 |
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, Australia, Chile, China, Hong Kong, Japan, Korea, Republic of, Russian Federation, Taiwan, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Idiopathic Pulmonary Fibrosis |
This is a Phase 3, randomized, double-blind, placebo-controlled, multi-center trial to evaluate the efficacy and safety of pamrevlumab in subjects with idiopathic pulmonary fibrosis (IPF). Subjects who are not being treated with approved IPF therapies (i.e., nintedanib or pirfenidone) may be eligible for screening. Examples of reasons subjects 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.
- - Subject voluntarily declines to receive approved IPF therapies after being fully informed of the potential benefits/risks.
- - 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 subject 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.
Arms
Experimental: Pamrevlumab
Experimental: Placebo
Interventions
Drug: - Pamrevlumab
Pamrevlumab: 30 mg/kg by intravenous infusion every 3 weeks for a total of 17 infusions over 48 weeks
Drug: - Placebo
Placebo: 30 mg/kg by intravenous infusion every 3 weeks for a total of 17 infusions over 48 weeks
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
Active, not recruiting
Address
University of Alabama at Birmingham Hospital
Birmingham, Alabama, 35294
Status
Active, not recruiting
Address
Banner University Medical Center - Phoenix
Phoenix, Arizona, 85006
Status
Active, not recruiting
Address
Norton Thoracic Institute
Phoenix, Arizona, 85013
Status
Active, not recruiting
Address
Pulmonary Associates, PA - Research
Phoenix, Arizona, 85032
Status
Active, not recruiting
Address
University of Arizona
Tucson, Arizona, 85724
Status
Active, not recruiting
Address
J&L Research
Conway, Arkansas, 72032
Status
Active, not recruiting
Address
Loma Linda University Health
Loma Linda, California, 92354
Status
Active, not recruiting
Address
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
Status
Active, not recruiting
Address
UC Davis Medical Center
Sacramento, California, 95817
Status
Completed
Address
University of California San Diego
San Diego, California, 92103
Status
Active, not recruiting
Address
Stanford University Medical Center
Stanford, California, 94305
Status
Active, not recruiting
Address
University of Colorado Denver
Aurora, Colorado, 80045
Status
Active, not recruiting
Address
National Jewish Health
Denver, Colorado, 80207
Status
Active, not recruiting
Address
Yale University School of Medicine
New Haven, Connecticut, 06510
Status
Active, not recruiting
Address
Medstar Georgetown University Hospital
Washington, District of Columbia, 20007
Status
Active, not recruiting
Address
St. Francis Medical Center
Clearwater, Florida, 33765
Status
Active, not recruiting
Address
University of Florida Pulmonary, Critical Care & Sleep Medicine Division
Gainesville, Florida, 32610
Status
Active, not recruiting
Address
University of Florida Health, Jacksonville
Jacksonville, Florida, 32209
Status
Active, not recruiting
Address
Mayo Clinic
Jacksonville, Florida, 32224
Status
Active, not recruiting
Address
Pulmonary Disease Specialist, PA d/b/a, PDS Research
Kissimmee, Florida, 34741
Status
Active, not recruiting
Address
University of South Florida
Tampa, Florida, 33606
Status
Active, not recruiting
Address
Emory University
Atlanta, Georgia, 30322
Status
Active, not recruiting
Address
Piedmont Healthcare, Inc.
Austell, Georgia, 30106
Status
Active, not recruiting
Address
Northwestern University
Chicago, Illinois, 60612
Status
Active, not recruiting
Address
Loyola University of Chicago
Maywood, Illinois, 60153
Status
Active, not recruiting
Address
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Status
Active, not recruiting
Address
The University of Kansas Medical Center
Kansas City, Kansas, 66160
Status
Active, not recruiting
Address
University of Maryland, Baltimore
Baltimore, Maryland, 21201
Status
Active, not recruiting
Address
University of Michigan
Ann Arbor, Michigan, 48109
Status
Active, not recruiting
Address
Henry Ford Hospital
Detroit, Michigan, 48202
Status
Active, not recruiting
Address
Spectrum Health
Grand Rapids, Michigan, 49546
Status
Active, not recruiting
Address
University of Minnesota
Minneapolis, Minnesota, 55455
Status
Active, not recruiting
Address
The Lung Research Center, LLC
Chesterfield, Missouri, 63017
Status
Active, not recruiting
Address
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Status
Active, not recruiting
Address
Albany Medical College
Albany, New York, 12208
Status
Active, not recruiting
Address
Pulmonary Health Physicians, PC
Liverpool, New York, 13088
Status
Active, not recruiting
Address
Pulmonix, LLC
Greensboro, North Carolina, 27403
Status
Active, not recruiting
Address
University of Cincinnati
Cincinnati, Ohio, 45267
Status
Active, not recruiting
Address
Ohio State University
Columbus, Ohio, 43221
Status
Completed
Address
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, 73112
Status
Active, not recruiting
Address
Legacy Research Institute
Portland, Oregon, 97210
Status
Active, not recruiting
Address
The Oregon Clinic
Portland, Oregon, 97220
Status
Active, not recruiting
Address
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Status
Active, not recruiting
Address
Temple University
Philadelphia, Pennsylvania, 19140
Status
Active, not recruiting
Address
Rhode Island Hospital
Providence, Rhode Island, 02903
Status
Active, not recruiting
Address
Lowcountry Lung and Critical Care, PA
Charleston, South Carolina, 29406
Status
Active, not recruiting
Address
Medical University of South Carolina
Charleston, South Carolina, 29425
Status
Active, not recruiting
Address
Tennessee Comprehensive Lung and Sleep Center
Hendersonville, Tennessee, 37075
Status
Active, not recruiting
Address
Vanderbilt University Medical Center
Nashville, Tennessee, 37204
Status
Active, not recruiting
Address
Houston Pulmonary Sleep, Allergy and Asthma Associates
Cypress, Texas, 77429
Status
Active, not recruiting
Address
Baylor Scott and White Research Institute
Dallas, Texas, 75246
Status
Active, not recruiting
Address
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Status
Active, not recruiting
Address
Baylor College of Medicine
Houston, Texas, 77030
Status
Active, not recruiting
Address
University of Texas - Houston
Houston, Texas, 77030
Status
Active, not recruiting
Address
UT Health San Antonio
San Antonio, Texas, 78229
Status
Active, not recruiting
Address
Renovatio Clinical
The Woodlands, Texas, 77380
Status
Active, not recruiting
Address
University of Utah Health
Salt Lake City, Utah, 84108
Status
Active, not recruiting
Address
The University of Vermont
Burlington, Vermont, 05405
Status
Active, not recruiting
Address
University of Washington
Seattle, Washington, 98195
Status
Active, not recruiting
Address
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
International Sites
Status
Active, not recruiting
Address
Fundacion Respirar - Centro MĆ©dico Dra. De Salvo
Ciudad Autonoma De Buenos Aires (caba), Buenos Aires, 1426
Status
Active, not recruiting
Address
Centro de Investigacion Metabolica 'CINME'
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1027AAP
Status
Active, not recruiting
Address
Consultorios Medicos. OrganizaciĆ³n del Buen Ayre. SRL
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425FVH
Status
Active, not recruiting
Address
Centro Medico de Enfermedades Respiratorias
Florida, Buenos Aires, B1602DQD
Status
Active, not recruiting
Address
Centro Platense en Investigaciones Respiratorias
La Plata, Buenos Aires, 1900
Status
Active, not recruiting
Address
Instituto ave Pulmo Fundacion enfisema
Mar del Plata, Buenos Aires, B7602DCK
Status
Active, not recruiting
Address
INSARES
Ciudad de Mendoza, Mendoza, M5500CCG
Status
Active, not recruiting
Address
Respira Salud Clinica Integral
Godoy Cruz, Provincia De Mendoza, M5501GCA
Status
Active, not recruiting
Address
Investigaciones en Patologias Respiratorias
San Miguel De TucumƔn, TucumƔn, T4000IAR
Status
Active, not recruiting
Address
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050
Status
Active, not recruiting
Address
Westmead Hospital
Westmead, New South Wales, 2145
Status
Active, not recruiting
Address
Mater Health Services Adult Hospital
South Brisbane, Queensland, 4101
Status
Active, not recruiting
Address
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Status
Active, not recruiting
Address
Box Hill Hospital
Box Hill, Victoria, 3128
Status
Completed
Address
The Alfred Hospital
Melbourne, Victoria, 3004
Status
Active, not recruiting
Address
Centro Investigacion del Maule CIM
Talca, Region Del Maule, 3465586
Status
Active, not recruiting
Address
Instituto Nacional del Torax
Santiago, Region Metropolitana, 7500691
Status
Active, not recruiting
Address
CIMER
Santiago, Region Metropolitana, 7500692
Status
Active, not recruiting
Address
M y F estudios clinicos
Santiago, Region Metropolitana, 7750495
Status
Active, not recruiting
Address
Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000
Status
Active, not recruiting
Address
BeiJing Chao-Yang Hospital,Capital medical university
Beijing, Beijing, 100020
Status
Active, not recruiting
Address
China-Japan friendship hospital
Beijing, Beijing, 100029
Status
Active, not recruiting
Address
Peking Union Medical College Hospital
Beijing, Beijing, 100730
Status
Active, not recruiting
Address
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510000
Status
Active, not recruiting
Address
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Status
Active, not recruiting
Address
Shenzhen people's hospital
Shenzhen, Guangdong, 518020
Status
Active, not recruiting
Address
Henan Provincial People's Hospital
Zhengzhou, Henan, 450000
Status
Active, not recruiting
Address
Henan Provincial chest hospital
Zhengzhou, Henan, 450003
Status
Active, not recruiting
Address
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Status
Active, not recruiting
Address
Union Hospitalļ¼Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Status
Active, not recruiting
Address
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Status
Active, not recruiting
Address
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 10010
Status
Active, not recruiting
Address
People's Hospital of Inner Mongolia Autonomous Region
Hohhot, Inner Mongolia, 10020
Status
Active, not recruiting
Address
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210000
Status
Active, not recruiting
Address
The second hospital of Dalian medical university
Dalian, Liaoning, 116001
Status
Active, not recruiting
Address
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
Status
Active, not recruiting
Address
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
Status
Active, not recruiting
Address
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai, 200025
Status
Active, not recruiting
Address
Shanghai Pulmonary Hospital of Tongji University
Shanghai, Shanghai, 200433
Status
Active, not recruiting
Address
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shanxi, 710004
Status
Active, not recruiting
Address
Huaxi Hospital of Sichuan University.
ChenDu, Sichuan, 6100141
Status
Active, not recruiting
Address
General Hospital of Tianjin Medical University
Tianjin, Tianjin, 300052
Status
Active, not recruiting
Address
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310006
Status
Active, not recruiting
Address
Queen Mary Hospital
Central, ,
Status
Active, not recruiting
Address
Princess Margaret Hospital
Hong Kong, ,
Status
Completed
Address
Tuen Mun Hospital
Hong Kong, ,
Status
Recruiting
Address
Tosei General Hospital
Seto-shi, Aichi, 489-8642
Status
Recruiting
Address
University of Fukui Hospital
Yoshida-gun, Fukui, 910-1193
Status
Recruiting
Address
National Hospital Organization Kyushu Medical Center
Fukuoka-shi, Fukuoka, 810-8563
Status
Recruiting
Address
Kurume University Hospital
Kurume-shi, Fukuoka, 830-0011
Status
Recruiting
Address
Hiroshima Prefectural Hospital
Hiroshima-shi, Hiroshima, 734-8530
Status
Recruiting
Address
National Hospital Organization Himeji Medical Center
Himeji-shi, Hyogo, 670-8520
Status
Recruiting
Address
Kobe City Medical Center General Hospital
Kobe, Hyogo, 650-0047
Status
Recruiting
Address
Kanagawa Cardiovascular and Respiratory Center
Yokohama, Kanagawa, 236-0051
Status
Recruiting
Address
Saiseikai Kumamoto Hospital
Kumamoto city, Kumamoto, 861- 4193
Status
Recruiting
Address
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakai-city, Osaka, 591-8555
Status
Recruiting
Address
Saitama Prefectural Cardiovascular and Respiratory Center
Kumagaya-shi, Saitama, 360-0197
Status
Recruiting
Address
Hamamatsu University Hospital
Hamamatsu city, Shizuoka, 431-3192
Status
Recruiting
Address
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431
Status
Recruiting
Address
Toho University Omori Medical Center
Ota-ku, Tokyo, 143-8541
Status
Recruiting
Address
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, 160-0023
Status
Recruiting
Address
Center Hospital of the National Center for Global Health and Medicine
Shinjuku-ku, Tokyo, 162-8655
Status
Recruiting
Address
Kyoto University Hospital
Kyoto, , 606-8507
Status
Active, not recruiting
Address
Soonchunhyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, 14579
Status
Active, not recruiting
Address
The Catholic University of Korea, Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggi-do, 14647
Status
Active, not recruiting
Address
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Status
Active, not recruiting
Address
Ajou University Hospital
Suwon-si, Gyeonggi-do, 16499
Status
Active, not recruiting
Address
Inje University Busan Paik Hospital
Busan, , 47392
Status
Active, not recruiting
Address
Gachon University Gil Medical Center
Incheon, , 21565
Status
Active, not recruiting
Address
Korea University Anam Hospital
Seoul, , 2841
Status
Active, not recruiting
Address
Seoul National University Hospital
Seoul, , 3080
Status
Active, not recruiting
Address
Asan Medical Center
Seoul, , 5505
Status
Active, not recruiting
Address
Samsung Medical Centerx
Seoul, , 6351
Status
Active, not recruiting
Address
Regional Clinical Hospital #3
Chelyabinsk, , 454106
Status
Active, not recruiting
Address
Medical Association "NEW HOSPITAL"
Ekaterinburg, , 620109
Status
Completed
Address
Kazan State Medical University based on Republican Clinical Hospital
Kazan, , 420029
Status
Active, not recruiting
Address
Clinical Hospital #3
Kemerovo, , 650000
Status
Active, not recruiting
Address
Euromedservice, Clinical and Diagnostic Center
Moscow, , 115419
Status
Active, not recruiting
Address
MONIKI
Moscow, , 129110
Status
Active, not recruiting
Address
City Clinical Hospital #1 n.a. A.N. Kabanov
Omsk, , 644112
Status
Completed
Address
FSBEI HE First Pavlov Medical University
Saint-Petersburg, , 197022
Status
Active, not recruiting
Address
Vvedenskaya hospital
St. Petersburg, , 191180
Status
Active, not recruiting
Address
Medical Center "Reavita Med SPb"
St. Petersburg, , 194354
Status
Active, not recruiting
Address
Taichung Veterans General Hospital
Taichung, , 40705
Status
Active, not recruiting
Address
Taipei Medical University - Shuang-Ho Hospital, Ministry of Health and Welfare
Taipei, , 23561