title: FG-3019 anti-connective tissue growth factor monoclonal antibody: results of an open-label clinical trial in idiopathic pulmonary fibrosis.
abstract: FG-3019 is a fully human monoclonal antibody that interferes with the action of connective tissue growth factor, a central mediator in the pathogenesis of fibrosis.This open-label phase 2 trial evaluated the safety and efficacy of two doses of FG-3019 administered by intravenous infusion every 3 weeks for 45 weeks in patients with idiopathic pulmonary fibrosis (IPF). Subjects had a diagnosis of IPF within the prior 5 years defined by either usual interstitial pneumonia (UIP) pattern on a recent high-resolution computed tomography (HRCT) scan, or a possible UIP pattern on HRCT scan and a recent surgical lung biopsy showing UIP pattern. Pulmonary function tests were performed every 12 weeks, and changes in the extent of pulmonary fibrosis were measured by quantitative HRCT scans performed at baseline and every 24 weeks.FG-3019 was safe and well-tolerated in IPF patients participating in the study. Changes in fibrosis were correlated with changes in pulmonary function.Further investigation of FG-3019 in IPF with a placebo-controlled clinical trial is warranted and is underway.
authors.affiliation: University of Washington, Seattle, WA, USA graghu@u.washington.edu.
authors.forename: Ganesh
authors.initials: G
authors.lastname: Raghu
authors.affiliation: University of Utah, Salt Lake City, UT, USA.
authors.forename: Mary Beth
authors.initials: MB
authors.lastname: Scholand
authors.affiliation: University of Alabama at Birmingham, Birmingham, AL, USA.
authors.forename: João
authors.initials: J
authors.lastname: de Andrade
authors.affiliation: Vanderbilt University, Nashville, TN, USA.
authors.forename: Lisa
authors.initials: L
authors.lastname: Lancaster
authors.affiliation: University of Vermont, Burlington, VT, USA.
authors.forename: Yolanda
authors.initials: Y
authors.lastname: Mageto
authors.affiliation: David Geffen School of Medicine, Los Angeles, CA, USA.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Goldin
authors.affiliation: National Jewish Health, Denver, CO, USA.
authors.forename: Kevin K
authors.initials: KK
authors.lastname: Brown
authors.affiliation: University of Michigan Health System, USA.
authors.forename: Kevin R
authors.initials: KR
authors.lastname: Flaherty
authors.affiliation: Via Christi Clinic, Wichita, KS, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Wencel
authors.affiliation: Pulmonary Function and Clinical Trial Consultant, Rochester, MN, USA.
authors.forename: Jack
authors.initials: J
authors.lastname: Wanger
authors.affiliation: FibroGen, Inc., San Francisco, CA, USA.
authors.forename: Thomas
authors.initials: T
authors.lastname: Neff
authors.affiliation: FibroGen, Inc., San Francisco, CA, USA.
authors.forename: Frank
authors.initials: F
authors.lastname: Valone
authors.affiliation: FibroGen, Inc., San Francisco, CA, USA.
authors.forename: John
authors.initials: J
authors.lastname: Stauffer
authors.affiliation: FibroGen, Inc., San Francisco, CA, USA.
authors.forename: Seth
authors.initials: S
authors.lastname: Porter
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D001706:Biopsy; D015331:Cohort Studies; D055513:Connective Tissue Growth Factor / Q000037:antagonists & inhibitors*; D003937:Diagnosis, Differential; D018450:Disease Progression; D006801:Humans; D054990:Idiopathic Pulmonary Fibrosis / Q000628:therapy*; D008168:Lung / Q000000981:diagnostic imaging / Q000473:pathology; D017563:Lung Diseases, Interstitial / Q000000981:diagnostic imaging / Q000628:therapy; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D061214:Patient Safety; D012129:Respiratory Function Tests; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D055513:Connective Tissue Growth Factor; C560078:pamrevlumab