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
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
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, Hong Kong, Korea, Republic of, 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:
Experimental: Pamrevlumab
Experimental: Placebo
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
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Research Center
Birmingham, Alabama, 35294
Status
Recruiting
Address
Research Center
Phoenix, Arizona, 85032
Status
Recruiting
Address
Research Center
Conway, Arkansas, 72032
Status
Recruiting
Address
Research Center
Los Angeles, California, 90095
Status
Recruiting
Address
Research Center
Aurora, Colorado, 80045
Status
Recruiting
Address
Research Center
Denver, Colorado, 80206
Status
Recruiting
Address
Research Center
New Haven, Connecticut, 06510
Status
Recruiting
Address
Research Center
Washington, District of Columbia, 20007
Status
Recruiting
Address
Research Center
Clearwater, Florida, 33765
Status
Recruiting
Address
Research Center
Gainesville, Florida, 32610
Status
Recruiting
Address
Research Center
Jacksonville, Florida, 32209
Status
Recruiting
Address
Research Center
Jacksonville, Florida, 32224
Status
Recruiting
Address
Research Center
Kissimmee, Florida, 34741
Status
Recruiting
Address
Research Center
Atlanta, Georgia, 30322
Status
Recruiting
Address
Research Center
Austell, Georgia, 30106
Status
Recruiting
Address
Research Center
Chicago, Illinois, 60611
Status
Recruiting
Address
Research Center
Maywood, Illinois, 60153
Status
Recruiting
Address
Research Center
Indianapolis, Indiana, 46202
Status
Recruiting
Address
Research Center
Kansas City, Kansas, 66160
Status
Recruiting
Address
Research Center
Louisville, Kentucky, 40292
Status
Recruiting
Address
Research Center
Baltimore, Maryland, 21201
Status
Recruiting
Address
Henry Ford Hospital
Detroit, Michigan, 48202
Status
Recruiting
Address
Research Center
Minneapolis, Minnesota, 55455
Status
Recruiting
Address
Research Center
Chesterfield, Missouri, 63017
Status
Recruiting
Address
Research Center
Lebanon, New Hampshire, 03756
Status
Recruiting
Address
Research Center
Albany, New York, 12208
Status
Recruiting
Address
Research Center
Greensboro, North Carolina, 27403
Status
Recruiting
Address
Research Center
Cincinnati, Ohio, 45267
Status
Recruiting
Address
Research Center
Columbus, Ohio, 43210
Status
Recruiting
Address
Research Center
Oklahoma City, Oklahoma, 73112
Status
Recruiting
Address
Research Center
Portland, Oregon, 97210
Status
Recruiting
Address
Research Center
Portland, Oregon, 97220
Status
Recruiting
Address
Research Center
Philadelphia, Pennsylvania, 19107
Status
Recruiting
Address
Research Center
Philadelphia, Pennsylvania, 19140
Status
Recruiting
Address
Research Center
Providence, Rhode Island, 02903
Status
Recruiting
Address
Research Center
Charleston, South Carolina, 29406
Status
Recruiting
Address
Research Center
Charleston, South Carolina, 29425
Status
Recruiting
Address
Research Center
Hendersonville, Tennessee, 37075
Status
Recruiting
Address
Research Center
Nashville, Tennessee, 37232
Status
Recruiting
Address
Research Center
Cypress, Texas, 77429
Status
Recruiting
Address
Research Center
Dallas, Texas, 75246
Status
Recruiting
Address
Research Center
Dallas, Texas, 75390
Status
Recruiting
Address
Research Center
Houston, Texas, 77030
Status
Recruiting
Address
Research Center
The Woodlands, Texas, 77380
Status
Recruiting
Address
Research Center
Burlington, Vermont, 05405
Status
Recruiting
Address
Research Center
Milwaukee, Wisconsin, 53226
Status
Recruiting
Address
Research Center
Bahia Blanca, Buenos Aires, B8000AAK
Status
Recruiting
Address
Research Center
Ciudad Autonoma De Buenos Aires (caba), Buenos Aires, 1426
Status
Recruiting
Address
Research Center
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1027AAP
Status
Recruiting
Address
Research Center
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425FVH
Status
Recruiting
Address
Research Center
Florida, Buenos Aires, B1602DQD
Status
Recruiting
Address
Research Center
La Plata, Buenos Aires, 1900
Status
Recruiting
Address
Research Center
Mar del Plata, Buenos Aires, B7602DCK
Status
Recruiting
Address
Research Center
Ciudad de Mendoza, Mendoza, M5500CCG
Status
Recruiting
Address
Research Center
Godoy Cruz, Provincia De Mendoza, M5501GCA
Status
Recruiting
Address
Research Center
San Miguel De Tucumán, Tucumán, T4000IAR
Status
Recruiting
Address
Research Center
Concord, New South Wales, 2139
Status
Recruiting
Address
Research Center
Westmead, New South Wales, 2145
Status
Recruiting
Address
Research Center
South Brisbane, Queensland, 4101
Status
Recruiting
Address
Research Center
Woolloongabba, Queensland, 4102
Status
Recruiting
Address
Research Center
Adelaide, South Australia, 5000
Status
Recruiting
Address
Research Center
Vina del Mar, Region De Valparaiso, 2520997
Status
Active, not recruiting
Address
Research Center
Central, ,
Status
Recruiting
Address
Research Center
Bucheon-si, Gyeonggi-do, 14584
Status
Recruiting
Address
Research Center
Bucheon-si, Gyeonggi-do, 14647
Status
Recruiting
Address
Research Center
Incheon, , 21565
Status
Recruiting
Address
Research Center
Seoul, , 2841
Status
Recruiting
Address
Research Center
Seoul, , 3080
Status
Recruiting
Address
Research Center
Seoul, , 5505
Status
Recruiting
Address
Research Center
Douliu, Yunlin County, 640
Status
Recruiting
Address
Research Center
Taipei city, Zhongzheng District, 10002
Status
Recruiting
Address
Research Center
Taichung, , 40201
Status
Recruiting
Address
Research Center
Taichung, , 40705
The Pulmonary Fibrosis Foundation rates among top charities in the U.S. The PFF has a three-star rating from Charity Navigator and is a Better Business Bureau accredited charity.