A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- FibroGen
- 入组人数
- 356
- 试验地点
- 125
- 主要终点
- DB Period (Japan Extension Cohort): Change From Baseline in FVC at Week 48
研究概览
简要总结
This is a Phase 3 trial to evaluate the efficacy and safety of 30 milligrams (mg)/kilogram (kg) intravenous (IV) infusions of pamrevlumab administered every 3 weeks as compared to placebo in participants with IPF.
详细描述
This is a Phase 3, randomized, double-blind, placebo-controlled, multi-center trial to evaluate the efficacy and safety of pamrevlumab in participants with IPF.
Participants who are not being treated with approved IPF therapies (that is, nintedanib or pirfenidone) may be eligible for screening. Examples of reasons participants may not be treated with approved IPF therapies include but are not limited to:
- Intolerant or not responsive to approved IPF therapies
- Ineligible to receive these therapies
- Participant voluntarily declines to receive approved IPF therapies after being fully informed of the potential benefits/risks
NOTE: No participant should discontinue an approved IPF therapy for the purpose of enrolling in this study.
The study consists of the following study periods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of IPF as defined by American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japan Radiological Society (JRS)/Latin American Thoracic Association (ALAT) guidelines within the past 7 years prior to study participation.
- •High-resolution computed tomography (HRCT) scan at screening, with ≥10% to <50% parenchymal fibrosis (reticulation) and <25% honeycombing.
- •FVCpp value >45% and <95% at screening and Day 1 (prior to randomization).
- •Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted and corrected by hemoglobin (Hb) value ≥25% and ≤90% at screening (determined locally).
- •Not currently receiving treatment for IPF with an approved therapy (that is, pirfenidone or nintedanib) for any reason, including prior intolerance or lack of response to an approved IPF therapy, or choice to forego treatment with an approved IPF therapy after a full discussion with the Investigator regarding risks/benefits of such therapy.
排除标准
- •Previous exposure to pamrevlumab.
- •Evidence of significant obstructive lung disease.
- •Female participants who are pregnant or nursing.
- •Smoking within 3 months of screening and/or unwilling to avoid smoking throughout the study.
- •Interstitial lung disease other than IPF.
- •Sustained improvement in the severity of IPF during the 12 months prior to screening.
- •History of other types of respiratory diseases including diseases or disorders of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall.
- •Medical conditions (for example, myocardial infarction [MI]/stroke within the past 6 month), or logistical challenges that in the opinion of the Investigator preclude the participant's adequate participation in the study.
- •Acute IPF exacerbation during screening or randomization.
- •Use of any investigational drugs or unapproved therapies, or participation in any clinical trial with an investigational new drug within 30 days prior to screening. Or use of approved IPF therapies (that is, pirfenidone or nintedanib) within 1 week prior to screening.
- •History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies, or to any component of the excipient.
研究组 & 干预措施
Main Study Cohort: Pamrevlumab
Participants will receive pamrevlumab 30 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion every 3 weeks for up to 48 weeks in the DB period.
干预措施: Pamrevlumab (Drug)
Main Study Cohort: Placebo
Participants will receive placebo matching to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks in the DB period.
干预措施: Placebo (Drug)
Japan Extension Cohort: Pamrevlumab
Participants will receive pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
干预措施: Pamrevlumab (Drug)
Japan Extension Cohort: Placebo
Participants will receive placebo matching to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
干预措施: Placebo (Drug)
OLE Period: Pamrevlumab/Pamrevlumab
Participants who receive pamrevlumab in the DB period will continue to receive the same dose of pamrevlumab for up to 48 weeks in the OLE period or until pamrevlumab is commercially available for the indication of IPF, or the sponsor decides to end the OLE period, whichever occurrs first.
干预措施: Pamrevlumab (Drug)
OLE Period: Placebo/Pamrevlumab
Participants who receive placebo matching to pamrevlumab in the DB period, will receive pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks in the OLE period or until pamrevlumab is commercially available for the indication of IPF, or the sponsor decides to end the OLE period, whichever occurrs first.
干预措施: Pamrevlumab (Drug)
结局指标
主要结局
DB Period (Japan Extension Cohort): Change From Baseline in FVC at Week 48
时间窗: Baseline, Week 48
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC was the volume of air that could forcibly be blown out after full inspiration in the upright position, measured in liters.
DB Period (Main Study Cohort): Change From Baseline in FVC at Week 48
时间窗: Baseline, Week 48
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC was the volume of air that could forcibly be blown out after full inspiration in the upright position, measured in liters. Least square (LS) mean and standard error (SE) were calculated using mixed model for repeated measures (MMRM).
次要结局
- DB Period (Main Study Cohort): Time to Disease Progression(Up to Week 48)
- DB Period (Main Study Cohort): Time to First Occurrence of Any Component of the Clinical Composite Endpoint(Up to Week 48)
- DB Period (Main Study Cohort and Japan Extension Cohort): Change From Baseline in Quantitative Lung Fibrosis (QLF) Volume at Week 48(Baseline, Week 48)
- DB Period (Main Study Cohort): Time to First Acute IPF Exacerbation(Up to Week 48)
- DB Period (Main Study Cohort): Time to All-Cause Mortality(Up to Week 48)
- DB Period (Main Study Cohort): Time to First Respiratory Hospitalizations(Up to Week 48)