A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
The primary objectives of this study are to determine the effect of simtuzumab (GS-6624) on progression-free survival (PFS) as determined by either a categorical decline in forced vital capacity (FVC) or all-cause mortality, in all participants enrolled or in a subset of participants who are classified as lysyl oxidase-like-2 (LOXL2) high based on a prespecified level in serum at baseline.
Key Inclusion Criteria:
Key Exclusion Criteria:
Significant diseases other than IPF
Obstructive lung disease
Aortic aneurysm greater than or equal to 3.5 cm in diameter
Treatment with immunosuppressive, cytotoxic, or antifibrotic drugs < 28 days prior to randomization are not permitted.
Individuals actively listed for lung transplant are excluded. However individuals at transplant centers with long waiting times (greater than 1 year) may be permitted to enter the study after discussion with Medical Monitor.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Los Angeles, California 90024, United States
Ostrava - Poruba, Severomoravsky Kraj 708 52, Czechia
Prague 4 - Krc, 140 59, Czechia
Grenoble, Auvergne-Rhône-Alpes 38043, France
Rennes, Brittany Region 35033, France
Tours, Centre-Val de Loire 37044, France
Marseille, Provence-Alpes-Côte d'Azur Region 13015, France
Freiburg im Breisgau, Baden-Wurttemberg 79106, Germany
Petach Tikvah, 49100, Israel
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-681, Poland
Zabrze, Silesian Voivodeship 41-803, Poland
Lódz, Łódź Voivodeship 90-153, Poland
Incheon, Gyeonggi-do 405-760, South Korea
Seoul, Gyeonggi-do 135-710, South Korea
Lausanne, Canton of Vaud CH 1011, Switzerland
Manchester, England M23 9LT, United Kingdom