Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Idiopathic Pulmonary Fibrosis IPF
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 544
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Participants will receive simtuzumab for up to 254 weeks. arm 2: Participants will receive simtuzumab placebo for up to 254 weeks.

Interventions: intervention 1: Simtuzumab intervention 2: Simtuzumab placebo
Intervention descriptions: intervention 1: 125 mg/mL single-dose vials administered subcutaneously once a week intervention 2: Simtuzumab placebo single-dose vials administered subcutaneously once a week

Protocol document: