FG-3019-049 (Fibrogen): A Phase 2a, Open-Label, Single-Arm Study to Evaluate the Safety, Tolerability, and Efficacy of FG-3019 in Subjects with Idiopathic Pulmonary Fibrosis

Status: Active - Enrolling.
PI:Danielle Antin-Ozeris, M.D.
Contact: Donna Carrano  (203) 737-5061
Jean Estrom       (203) 785-7324   

The overall objective of this study is to evaluate the safety of FG-3019 in subjects with IPF, and the efficacy of FG-3019 for attenuating fibrosis in these subjects.

Factors that allow someone to participate in a clinical trial.

• 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.

Factors that do not allow someone to participate in a clinical trial.

• 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.