Long-Term Safety Study of GS-6624 in Adults With Idiopathic Pulmonary Fibrosis (IPF)

A Phase 2, Long-Term Safety Study of GS-6624 in Adult Subjects With Idiopathic Pulmonary Fibrosis (IPF)

The primary objective of this study is to evaluate the long term safety and tolerability of simtuzumab (GS-6624) in participants with idiopathic pulmonary fibrosis (IPF) who had previously participated in Gilead clinical trial AB0024-201.

Key Inclusion Criteria:

• Previous participation in Phase 1 Gilead clinical trial
• Diagnosis of idiopathic pulmonary fibrosis
• Females of childbearing potential and non-vasectomized males must agree to use highly effective methods of contraception
• Females must discontinue nursing
• Comply with study requirements
• Have adequate organ function

Key Exclusion Criteria:

• History or evidence of clinically significant disorder, condition or disease that would pose a risk or interfere with the study
• Pregnant or lactating
• Clinically significant heart, hepatic or renal disease
• History of cancer within 5 years of screening
• Infection that is not controlled despite antibiotics or other treatment
• History of bleeding diathesis within the last 6 months of Day 1
• Known history of human immunodeficiency virus, hepatitis B or C
• Concern's for subjects compliance
• Other conditions that might put the subject at high risk for treatment complications or reduce the chance to obtain data required
• Placed on a lung transplant list
• Previous participation in an idiopathic pulmonary fibrosis clinical trial other than for simtuzumab

Note: Other protocol defined Inclusion/Exclusion criteria may apply