Safety, Tolerability, and Efficacy Study of Idiopathic Pulmonary Fibrosis

Major Changes: FGCL-3019-049 Protocol Amendment 3 offers long-term extension of treatment with FG-3019 to eligible Cohort 1-EX (approximately 14 subjects) and Cohort 2 (approximately 28 subjects) subjects who complete the Week 48-EX and Week 48 assessments described in Protocol Amendment 2, respectively. A subject is eligible for long-term extension of treatment if the investigator, after discussion with the Fibrogen Medical Monitor, believes that the subject would benefit from continued treatment with FG-3019.

Main Inclusion Criteria:

• Age 35 to 80 years, inclusive.
• Clinical diagnosis of IPF by high resolution computed tomography (HRCT) scan (and in some cases by surgical lung biopsy) and reduced lung function (forced vital capacity).
• History of IPF of 5 years duration or less.
• Evidence of progression of IPF within the last 3-12 months for Cohort 1, or within the last 18 months for Cohort 2 before screening.
• Women of childbearing potential, and men, must be willing to use a medically acceptable method of contraception during the trial and 3 months after the last dose of study drug.

Main Exclusion Criteria:

• Women who are pregnant or nursing.
• History of any other types of lung or heart disease and any other medical conditions that, in the opinion of the investigator, would preclude the subject's participation in the study.
• Clinically important abnormal laboratory tests.
• Upper or lower respiratory tract infection of any type within 4 weeks of the first screening visit.
• Acute exacerbation of IPF within 3 months of the first screening visit.
• Use of certain medications within 4 weeks of the first screening visit.
• Receipt of an investigational drug within 6 weeks of the first screening visit.
• History of cancer of any type in the 5 years preceding the first screening visit, excluding non-melanomatous skin cancer, localized bladder cancer, or in situ cervical cancer.
• Trauma or surgical procedures requiring hospitalization within 4 weeks of the first screening visit.
• Planned elective surgery during the study including 4 weeks following the final dose of study drug.
• History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies.
• Inability to cooperate with study personnel or history of non-compliance to a medical regimen.
• Previous treatment with FG-3019.