University of Alabama at Birmingham Hospital |
Birmingham, Alabama, United States, 35294 |
Principal Investigator: Tracy Luckhardt |
Pulmonary Associates, PA - Research |
Phoenix, Arizona, United States, 85032 |
Principal Investigator: Mark Gotfried |
J&L Research |
Conway, Arkansas, United States, 72032 |
Principal Investigator: Ladly Abraham |
David Geffen School of Medicine at UCLA |
Los Angeles, California, United States, 90095 |
Principal Investigator: John Belperio |
University of Colorado Denver |
Aurora, Colorado, United States, 80045 |
Principal Investigator: Joyce Lee |
National Jewish Health |
Denver, Colorado, United States, 80207 |
Principal Investigator: Evans Fernandez |
Yale University School of Medicine |
New Haven, Connecticut, United States, 06510 |
Principal Investigator: Danielle Antin-Ozerkis |
Medstar Georgetown University Hospital |
Washington, District of Columbia, United States, 20007 |
Principal Investigator: Cristina Reichner |
St. Francis Medical Center |
Clearwater, Florida, United States, 33765 |
Principal Investigator: Frank Averill |
University of Florida Pulmonary, Critical Care & Sleep Medicine Division |
Gainesville, Florida, United States, 32610 |
Principal Investigator: Chirstopher Harden |
University of Florida Health, Jacksonville |
Jacksonville, Florida, United States, 32209 |
Principal Investigator: Vandana Seeram |
Mayo Clinic |
Jacksonville, Florida, United States, 32224 |
Principal Investigator: Tarik Haddad |
Pulmonary Disease Specialist, PA d/b/a, PDS Research |
Kissimmee, Florida, United States, 34741 |
Principal Investigator: Thomas O'Brien |
Emory University |
Atlanta, Georgia, United States, 30322 |
Principal Investigator: Srihari Veeraraghavan |
Piedmont Healthcare, Inc. |
Austell, Georgia, United States, 30106 |
Principal Investigator: Amy Hajari Case |
Northwestern University |
Chicago, Illinois, United States, 60612 |
Principal Investigator: Jane Dematte |
Loyola University of Chicago |
Maywood, Illinois, United States, 60153 |
Principal Investigator: Bradford Bemiss |
Indiana University School of Medicine |
Indianapolis, Indiana, United States, 46202 |
Principal Investigator: Ryan Boente |
The University of Kansas Medical Center |
Kansas City, Kansas, United States, 66160 |
Principal Investigator: Mark Hamblin |
University of Louisville |
Louisville, Kentucky, United States, 40202 |
Principal Investigator: Sally Suliman |
University of Maryland, Baltimore |
Baltimore, Maryland, United States, 21201 |
Principal Investigator: Edward Britt |
Henry Ford Hospital |
Detroit, Michigan, United States, 48202 |
Principal Investigator: Krishna Thavarajah |
University of Minnesota |
Minneapolis, Minnesota, United States, 55455 |
Principal Investigator: Kim Hyun |
The Lung Research Center, LLC |
Chesterfield, Missouri, United States, 63017 |
Principal Investigator: Neil Ettinger |
Dartmouth-Hitchcock Medical Center |
Lebanon, New Hampshire, United States, 03756 |
Principal Investigator: Richard Enelow |
Albany Medical College |
Albany, New York, United States, 12208 |
Principal Investigator: Scott Beegle |
Pulmonix, LLC |
Greensboro, North Carolina, United States, 27403 |
Principal Investigator: Murali Ramaswamy |
University of Cincinnati |
Cincinnati, Ohio, United States, 45267 |
Principal Investigator: Nishant Gupta |
Ohio State University |
Columbus, Ohio, United States, 43221 |
Principal Investigator: Nitin Bhatt |
INTEGRIS Baptist Medical Center |
Oklahoma City, Oklahoma, United States, 73112 |
Principal Investigator: Alan Betensley |
Legacy Research Institute |
Portland, Oregon, United States, 97210 |
Principal Investigator: Catherine Markin |
The Oregon Clinic |
Portland, Oregon, United States, 97220 |
Principal Investigator: David Hotchkin |
Temple University |
Philadelphia, Pennsylvania, United States, 19140 |
Principal Investigator: Gerard Criner |
Rhode Island Hospital |
Providence, Rhode Island, United States, 02903 |
Principal Investigator: Barry Shea |
Lowcountry Lung and Critical Care, PA |
Charleston, South Carolina, United States, 29406 |
Principal Investigator: Thomas D. Kaelin, Jr |
Medical University of South Carolina |
Charleston, South Carolina, United States, 29425 |
Principal Investigator: Terrill Huggins |
Tennessee Comprehensive Lung and Sleep Center |
Hendersonville, Tennessee, United States, 37075 |
Principal Investigator: Clyde Southwell |
Vanderbilt University Medical Center |
Nashville, Tennessee, United States, 37204 |
Principal Investigator: Lisa Lancaster |
Houston Pulmonary Sleep, Allergy and Asthma Associates |
Cypress, Texas, United States, 77429 |
Principal Investigator: Dileep Puppala |
Baylor Scott and White Research Institute |
Dallas, Texas, United States, 75246 |
Principal Investigator: Yolanda Mageto |
University of Texas Southwestern Medical Center |
Dallas, Texas, United States, 75390 |
Principal Investigator: John Fitzgerald |
University of Texas - Houston |
Houston, Texas, United States, 77030 |
Principal Investigator: Rodeo Abrencillo |
Renovatio Clinical |
The Woodlands, Texas, United States, 77380 |
Principal Investigator: Ather Siddiqi |
The University of Vermont |
Burlington, Vermont, United States, 05405 |
Principal Investigator: Prema Menon |
Medical College of Wisconsin |
Milwaukee, Wisconsin, United States, 53226 |
Principal Investigator: Vijaya Ramalingam |
Centro de Investigación Clínica Aplicada - Hospital Regional Español Bahía Blanca |
Bahia Blanca, Buenos Aires, Argentina, B8000AAK |
Principal Investigator: Jorge Alfredo Draghi |
Fundacion Respirar - Centro Médico Dra. De Salvo |
Ciudad Autonoma De Buenos Aires (caba), Buenos Aires, Argentina, 1426 |
Principal Investigator: Maria De Salvo |
Centro de Investigacion Metabolica 'CINME' |
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1027AAP |
Principal Investigator: Maria Otaola |
Consultorios Medicos. Organización del Buen Ayre. SRL |
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1425FVH |
Principal Investigator: Gaston De Stefano |
Centro Medico de Enfermedades Respiratorias |
Florida, Buenos Aires, Argentina, B1602DQD |
Principal Investigator: Miguel Bergna |
Centro Platense en Investigaciones Respiratorias |
La Plata, Buenos Aires, Argentina, 1900 |
Principal Investigator: Gabriel Ricardo Garcia |
Instituto ave Pulmo Fundacion enfisema |
Mar del Plata, Buenos Aires, Argentina, B7602DCK |
Principal Investigator: Luis Arturo Wehbe |
INSARES |
Ciudad de Mendoza, Mendoza, Argentina, M5500CCG |
Principal Investigator: Pedro Carlos Elias |
Respira Salud Clinica Integral |
Godoy Cruz, Provincia De Mendoza, Argentina, M5501GCA |
Principal Investigator: Alejandro Chirino |
Investigaciones en Patologias Respiratorias |
San Miguel De Tucumán, Tucumán, Argentina, T4000IAR |
Principal Investigator: Ramon Rojas |
Westmead Hospital |
Westmead, New South Wales, Australia, 2145 |
Principal Investigator: JOHN WHEATLEY |
Mater Health Services Adult Hospital |
South Brisbane, Queensland, Australia, 4101 |
Principal Investigator: SIMON BOWLER |
Princess Alexandra Hospital |
Woolloongabba, Queensland, Australia, 4102 |
Principal Investigator: GREGORY KEIR |
Royal Adelaide Hospital |
Adelaide, South Australia, Australia, 5000 |
Principal Investigator: MARK HOLMES |
Centro de Investigacion Clinica V Region CINVEC |
Vina del Mar, Region De Valparaiso, Chile, 2520997 |
Principal Investigator: Manuel Barros |
Nemocnice Jihlava |
Jihlava, Czechia, 625 00 |
Principal Investigator: Martina Doubkova |
Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel |
Bron, France, 69677 |
Principal Investigator: Julie Traclet |
C.H.R.U. de Montpellier - Hôpital Lapeyronie |
Montpellier, France, 34295 |
Principal Investigator: Arnaud Bourdin |
CHU de Nice Hôpital Pasteur |
Nice, France, 06000 |
Principal Investigator: Charles Marquette |
Hôpital Bichat - Claude Bernard |
Paris, France, 75018 |
Principal Investigator: Bruno Crestani |
CHU de Reims Hopital Maison Blanche |
Reims, France, 51092 |
Principal Investigator: Francois Lebargy |
CHU de Rennes Hôpital Pontchaillou |
Rennes, France, 35033 |
Principal Investigator: Stephane Jouneau Jouneau |
Ruhrlandklinik-Universitaetsmedizin Essen |
Essen, Germany, 45239 |
Principal Investigator: Francesco Bonella |
Agaplesion Evangelisches Krankenhaus Mittelhessen |
Gießen, Germany, 035398 |
Principal Investigator: Andreas Gunther |
Universitätsklinikum Hamburg-Eppendorf |
Hamburg, Germany, 20246 |
Principal Investigator: Tim Oqueka |
Queen Mary Hospital |
Central, Hong Kong |
Principal Investigator: David-Chi-leung Lam |
Petz Aldar County Teaching Hospital |
Gyor, Hungary, 9023 |
Principal Investigator: Zsuzsanna Szalai |
Fejer Megyei Szent Gyorgy kh |
Szekesfehervar, Hungary, 8000 |
Principal Investigator: Zsolt Papai-Szekely |
Gaspare Rodiloco Hospital |
Catania, Italy, 95123 |
Principal Investigator: Carlo Vancheri |
AOU Policlinico di Modena |
Modena, Italy, 41124 |
Principal Investigator: Dario Andrisani Andrisani |
Monaldi Hospital |
Naples, Italy, 80131 |
Principal Investigator: Alessandro Zamparelli |
IRCCS Fondazione San Matteo di Pavia |
Pavia, Italy, 27100 |
Principal Investigator: Tiberio Oggionni |
Soonchunhyang University Bucheon Hospital |
Bucheon-si, Gyeonggi-do, Korea, Republic of, 14579 |
Principal Investigator: CHOONSIK PARK |
The Catholic University of Korea, Bucheon St. Mary's Hospital |
Bucheon-si, Gyeonggi-do, Korea, Republic of, 14647 |
Principal Investigator: SOOK-HEE |
Gachon University Gil Medical Center |
Incheon, Korea, Republic of, 21565 |
Principal Investigator: SUNGHWAN JEONG |
Korea University Anam Hospital |
Seoul, Korea, Republic of, 2841 |
Principal Investigator: EUN-JOO LEE |
Seoul National University Hospital |
May 16, 2019
|
May 17, 2019
|
June 4, 2021
|
June 27, 2019
|
December 31, 2022 (Final data collection date for primary outcome measure)
|
Change in FVC (L) [ Time Frame: Baseline to Week 48 ]
|
Change in FVC (L) [ Time Frame: Baseline to Week 52 ]
|
|
- Time to disease progression defined as absolute FVCpp decline of ≥10% or death, whichever occurs first. [ Time Frame: Baseline to Week 48 ]
- Change in FVCpp (absolute and relative) [ Time Frame: Baseline to Week 48 ]
- Time to composite of clinical outcomes: respiratory hospitalization or death or absolute FVCpp decline ≥10%, whichever occurs first [ Time Frame: Baseline to Week 48 ]
- Time to first respiratory hospitalizations during study [ Time Frame: Baseline to Week 48 ]
- Change in Quantitative Lung Fibrosis (QLF) volume [ Time Frame: Baseline to Week 48 ]
- Change in St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: Baseline to Week 48 ]
The SGRQ is a 50-item questionnaire developed to measure health status (quality of life). Scores are calculated for three domains: Symptoms, Activity and Impacts. The total score (summed weights) can range from 0 to 100 with a lower score denoting a better health status.
- Change in University of California San Diego - Shortness of Breath Questionnaire (UCSD-SOBQ) [ Time Frame: Baseline to Week 48 ]
The UCSD SOBQ is a 24-item questionnaire developed to measure breathlessness associated with activities of daily living, on a scale between zero and five where 0 is not at all breathless and 5 is maximally breathless or too breathless to do the activity. The responses to all items are summed up to provide the overall score that can range from 0 (best outcome) to 120 (worst outcome).
- Change in Leicester Cough Questionnaire (LCQ) [ Time Frame: Baseline to Week 48 ]
The LCQ is a self-reporting quality of life measure of chronic cough. It consists of 19 items with a 7 point likert response scale (range from 1 to 7). Each item is developed to assess symptoms during cough and impact of cough on three main domains: physical, psychological and social. Scores are calculated as a mean of each domain and the total score is calculated by adding every domain score.
- Time to all-cause mortality during study [ Time Frame: Baseline to Week 48 ]
- Time to first acute IPF exacerbations during study [ Time Frame: Baseline to Week 48 ]
|
- Change in FVC percent predicted (FVCpp) [ Time Frame: Baseline to Week 52 ]
- Subjects with FVCpp decline of 10% or more or death during study [ Time Frame: Baseline to Week 52 ]
- Composite clinical outcomes including the following: respiratory hospitalization + death + acute IPF exacerbations + FVCpp decline ≥10% [ Time Frame: Baseline to Week 52 ]
- Change in St. George's Respiratory Questionnaire (SGRQ) score [ Time Frame: Baseline to Week 52 ]
The St. George's Respiratory Questionnaire (SGRQ) is a 50-item questionnaire developed to measure health status (quality of life). Scores are calculated for three domains: Symptoms, Activity and Impacts. The total score (summed weights) can range from 0 to 100 with a lower score denoting a better health status.
- Change in QLF volume [ Time Frame: Baseline to Week 52 ]
- Change in University of California San Diego - Shortness of Breath Questionnaire (UCSD-SOBQ) [ Time Frame: Baseline to Week 52 ]
The University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) is a 24-item questionnaire developed to measure breathlessness associated with activities of daily living, on a scale between zero and five where 0 is not at all breathless and 5 is maximally breathless or too breathless to do the activity. The responses to all items are summed up to provide the overall score that can range from 0 (best outcome) to 120 (worst outcome).
- Mortality rate [ Time Frame: Baseline to Week 52 ]
- Acute IPF exacerbations [ Time Frame: Baseline to Week 52 ]
|
Not Provided
|
Not Provided
|
|
Evaluation of Efficacy and Safety of Pamrevlumab in Patients With Idiopathic Pulmonary Fibrosis
|
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
|
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
|
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
NOTE: No subject should discontinue an approved IPF therapy for the purpose of enrolling in this study.
Approximately 340 eligible subjects will be randomized at a 1:1 ratio to Arm A or Arm B, respectively:
Arm A: pamrevlumab, 30 mg/kg IV, Day 1 and every 3 weeks thereafter
Arm B: Matching placebo IV, Day 1 and every 3 weeks thereafter
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 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
During the treatment period, co-administration of an approved IPF therapy (i.e., 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.
Subjects who discontinue study treatment for any reason should be encouraged to remain in the study and be followed for all study visits and assessments.
Subjects who complete the study will be eligible for an open-label, extension with pamrevlumab.
|
Interventional
|
Phase 3
|
Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
|
Idiopathic Pulmonary Fibrosis
|
|
|
Not Provided
|
|
Recruiting
|
340
|
565
|
January 31, 2023
|
December 31, 2022 (Final data collection date for primary outcome measure)
|
Key Inclusion Criteria:
- Diagnosis of IPF as defined by ATS/ERS/JRS/ALAT guidelines (Raghu 2018) within the past 7 years prior to study participation.
- HRCT scan at Screening, with ≥10% to <50% parenchymal fibrosis (reticulation) and <25% honeycombing.
- FVCpp value >45% and <95%
- Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥25% and ≤90% at screening (determined locally).
- 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.
Key Exclusion Criteria:
- Previous exposure to pamrevlumab.
- Evidence of significant obstructive lung disease.
- Female subjects 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.
- Other types of respiratory diseases including diseases of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall.
- Certain medical conditions, including recent (e.g. MI/stroke, or severe chronic heart failure or pulmonary hypertension, or cancers.
- Acute IPF exacerbation during Screening or Randomization.
- Recent use of any investigational drugs or unapproved therapies, or approved or participation in any clinical trial.
- History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies.
|
Sexes Eligible for Study: |
All |
|
40 Years to 85 Years (Adult, Older Adult)
|
No
|
Contact: Gustavo Lorente |
650-273-2264 |
Zephyrus@Fibrogen.com |
|
|
Argentina, Australia, Chile, Czechia, France, Germany, Hong Kong, Hungary, Italy, Korea, Republic of, Lebanon, Netherlands, Peru, Spain, Taiwan, United States
|
|
|
NCT03955146
|
FGCL-3019-091
|
Yes
|
Studies a U.S. FDA-regulated Drug Product: |
Yes |
Studies a U.S. FDA-regulated Device Product: |
No |
|
Plan to Share IPD: |
Undecided |
|
FibroGen
|
FibroGen
|
Not Provided
|
Not Provided
|
FibroGen
|
June 2021
|
|