RT Journal Article SR Electronic T1 Phase 2 trial of FG-3019, anti-CTGF monoclonal antibody, in idiopathic pulmonary fibrosis (IPF): Preliminary safety and efficacy results JF European Respiratory Journal JO Eur Respir J FD European Respiratory Society SP 2819 VO 40 IS Suppl 56 A1 Ganesh Raghu A1 Mary Beth Scholand A1 Joao de Andrade A1 Lisa Lancaster A1 Jonathan Goldin A1 Seth Porter A1 Thomas Neff A1 Frank Valone A1 John Stauffer YR 2012 UL http://erj.ersjournals.com/content/40/Suppl_56/2819.abstract AB Introduction: Connective tissue growth factor (CTGF) is implicated in the pathogenesis of IPF and is a potential novel therapeutic target.Objectives: To evaluate the safety, tolerability, and efficacy of FG-3019 in subjects with IPF.Methods: Phase 2 prospective, open label study of FG-3019 (15 mg/kg IV every 3 weeks for 45 weeks) in subjects with well-defined IPF (duration ≤5 years, evidence of disease progression during the preceding year, FVC 45−85% predicted, DLCO ≥ 30% predicted, and 10−50% parenchymal fibrosis by HRCT). Treatment response was assessed by changes in extent of parenchymal disease (HRCT and FVC).Results: 54 subjects (males 83%, mean age 67 years, median FVC % predicted 63.2%) were enrolled. Quantified HRCT scores of whole lung fibrosis (QLF) and all abnormal interstitial lung disease (QILD) at week 24 showed decreases from baseline greater than analytical variability (±2%) in 6 (24%) and 8 (32%) of 25 subjects, respectively. Changes in both QLF and QILD score were significantly correlated with changes in FVC % predicted (for QILD, r=-0.55, p=0.004). Mean decreases in FVC % predicted were less than in historical controls. Safety findings to date include 13 SAEs (none drug-related), 1 acute exacerbation, 9 respiratory-related hospitalizations, and 3 deaths (all related to IPF).Conclusions: FG-3019, a novel anti-fibrotic agent, is well tolerated by subjects with IPF. No drug-related SAEs have been reported to date. Promising results of measurement of quantified lung fibrosis scores and FVC warrant pursuing the clinical trial with a higher dose of FG-3019 to further assess safety and efficacy in subjects with IPF.