A Phase 2, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of FG-3019 in Subjects With Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- FibroGen
- 入组人数
- 90
- 试验地点
- 18
- 主要终点
- To determine the safety and tolerability of FG-3019 administered at doses of 15 mg/kg (Cohort 1 and Cohort 1-EX) and 30 mg/kg (Cohort 2 and Cohort 2-EX) every 3 wks for 45 weeks, and every 3 weeks thereafter for three additional treatment years.
研究概览
简要总结
To evaluate the safety and tolerability of FG-3019 in subjects with Idiopathic Pulmonary Fibrosis (IPF) and the efficacy of FG-3019 for attenuating fibrosis in these subjects.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
FG-3019 administered at dose of 30 mg/kg (Cohort 2 ) by IV infusion every 3 weeks for 45 weeks in the target population.(first treatment year and first extended treatment year) and every 3 weeks thereafter for three additional extended treatment years.
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Cohort 1/1-EX
Subjects with moderate to severe idiopathic pulmonary fibrosis (IPF) who have evidence of disease progression
干预措施: FG-3019 (Drug)
Cohort 2/2-EX
Subjects with mild to moderate idiopathic pulmonary fibrosis (IPF) who have evidence of disease progression
干预措施: FG-3019 (Drug)
结局指标
主要结局
To determine the safety and tolerability of FG-3019 administered at doses of 15 mg/kg (Cohort 1 and Cohort 1-EX) and 30 mg/kg (Cohort 2 and Cohort 2-EX) every 3 wks for 45 weeks, and every 3 weeks thereafter for three additional treatment years.
时间窗: Cohort 1: Up to 60 weeks, Cohort 1-EX (original subjects): up to 109 weeks, Cohort 1-EX (subjects who complete Week 48-EX and continue in the trial): up to 151 weeks, Cohort 2: up to 58 weeks, Cohort 2-EX: up to 202 weeks
次要结局
- To evaluate the effect of FG-3019 on the extent of pulmonary fibrosis in subjects with IPF.(Cohort 1: Up to 60 weeks, Cohort 1-EX (original subjects): up to 109 weeks, Cohort 1-EX (subjects who complete Week 48-EX and continue in the trial): up to 151 weeks, Cohort 2: up to 58 weeks, Cohort 2-EX: up to 202 weeks)
- To evaluate the effect of FG-3019 on pulmonary function in subjects with IPF.(Cohort 1: Up to 60 weeks, Cohort 1-EX (original subjects): up to 109 weeks, Cohort 1-EX (subjects who complete Week 48-EX and continue in the trial): up to 151 weeks, Cohort 2: up to 58 weeks, Cohort 2-EX: up to 202 weeks)
- To evaluate the effect of FG-3019 on dyspnea in subjects with IPF.(Cohort 1: Up to 60 weeks, Cohort 1-EX (original subjects): up to 109 weeks, Cohort 1-EX (subjects who complete Week 48-EX and continue in the trial): up to 151 weeks, Cohort 2: up to 58 weeks, Cohort 2-EX: up to 202 weeks)