FibroGen initiates phase III ZEPHYRUS-2 trial of pamrevlumab for the treatment of idiopathic pulmonary fibrosis.

FibroGen, Inc.announced dosing of the first patient in the ZEPHYRUS-2 Phase III clinical study of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF) , a chronic, progressive, and fatal lung disease. ZEPHYRUS-2 is a 52-week randomized, double-blind, placebo-controlled, multi-center Phase III trial designed to evaluate the efficacy and safety of pamrevlumab in subjects with IPF who were previously treated with an approved therapy but who discontinued that therapy.The primary endpoint of the study is disease progression defined as a change from baseline in forced vital capacity (FVC) percent predicted decline ?10% or death. Secondary endpoints include change in quantitative lung fibrosis (QLF) and patient-reported outcomes. Approximately 340 subjects will be enrolled into the global study. Subjects who complete the 52-week study may be eligible for rollover into a separate study offering open-label, extension treatment with pamrevlumab. For more information about ZEPHYRUS-2 please visit www.clinicaltrials.gov (NCT04419558). The Phase III clinical development program for pamrevlumab for IPF consists of two studies, ZEPHYRUS and ZEPHYRUS-2. ZEPHYRUS is an ongoing randomized, double-blind, placebo-controlled, multi-center Phase III trial designed to evaluate the efficacy and safety of pamrevlumab in subjects with IPF over a 52-week period. The primary endpoint of the study is the change in forced vital capacity (FVC) from baseline. For more information about ZEPHYRUS please visit www.clinicaltrials.gov (NCT03955146).