NCT02550873已完成2 期
A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 18
- 主要终点
- Change From Baseline in Forced Vital Capacity (FVC) [% Predicted]
研究概览
简要总结
This study is a Phase 2, randomized, double-blind, placebo controlled, pilot study designed to evaluate the efficacy and safety of PRM-151 administered through Week 24 to subjects with IPF.
详细描述
PRM-151 is an anti-fibrotic immunomodulator being developed for treatment of fibrotic diseases.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is aged 40-80 years.
- •Has IPF satisfying the American Thoracic Society/European Respiratory Society /Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) diagnostic criteria (Raghu, Collard et al. 2011). In the absence of a surgical lung biopsy, high-resolution computed tomography (HRCT) must be "consistent with "usual interstitial pneumonia" (UIP) defined as meeting either criteria A, B, and C, or criteria A and C, or criteria B and C below:
- •Definite honeycomb lung destruction with basal and peripheral predominance.
- •Presence of reticular abnormality AND traction bronchiectasis consistent with fibrosis, with basal and peripheral predominance.
- •Atypical features are absent, specifically nodules and consolidation. Ground glass opacity, if present, is less extensive than reticular opacity pattern.
- •If on pirfenidone or nintedanib, subject must have been on a stable dose of pirfenidone or nintedanib for at least 3 months without increase in forced vital capacity (FVC)% predicted on two consecutive pulmonary function tests (PFTs), including screening PFTs. Subjects may not be on both pirfenidone and nintedanib.
- •If not currently receiving pirfenidone or nintedanib, subject must have been off pirfenidone or nintedanib for ≥ 4 weeks before baseline.
- •Has a FVC ≥ 50% and ≤ 90% of predicted.
- •Has a DLCO ≥ 25% and ≤ 90% of predicted.
- •Minimum distance on 6-Minute Walk Test (6MWT) of 150 meters.
- •Has a forced expiratory volume in 1 second (FEV1)/FVC ratio > 0.
- •Women of child bearing potential (WCBP), defined as a sexually mature woman not surgically sterilized or not post-menopausal for at least 24 consecutive months if ≤ 55 years or 12 months if > 55 years, must have a negative serum pregnancy test within four weeks prior to the first dose of study drug and must agree to use adequate methods of birth control throughout the study. Adequate methods of contraception are defined in the protocol.
- •Has a life expectancy of at least 9 months
- •According to the investigator's best judgment, can comply with the requirements of the protocol.
- •Has provided written informed consent to participate in the study.
排除标准
- •Has emphysema ≥ 50% on HRCT or the extent of emphysema is greater than the extent of fibrosis according to reported results from the most recent HRCT.
- •Has a history of cigarette smoking within the previous 3 months.
- •Has received investigational therapy for IPF within 4 weeks before baseline.
- •Is receiving systemic corticosteroids equivalent to prednisone > 10 mg/day or equivalent within 2 weeks of baseline.
- •Received azathioprine, cyclophosphamide, or cyclosporine A within 4 weeks of baseline.
- •Has a history of a malignancy within the previous 5 years, with the exception of basal cell skin neoplasms. In addition, a malignant diagnosis or condition first occurring prior to 5 years must be considered cured, inactive, and not under current treatment.
- •Has any concurrent condition other than IPF that, in the Investigator's opinion, is unstable and/or would impact the likelihood of survival for the study duration or the subject's ability to complete the study as designed, or may influence any of the safety or efficacy assessments included in the study.
- •Has baseline resting oxygen saturation of < 89% on room air or supplemental oxygen.
- •Is unable to refrain from use of the following:
- •Short acting bronchodilators on the day of and within 12 hours of pulmonary function, DLCO, and 6 minute walk assessments.
- •Long acting bronchodilators on the day of and within 24 hours of these assessments.
- •Has a known post bronchodilator (short acting beta agonist [SABA] - albuterol or salbutamol) increase in FEV1 of >10% and in FVC of >7.5%.
研究组 & 干预措施
Placebo
Placebo Comparator
Dosing Every 4 weeks
干预措施: placebo (Other)
PRM-151 10mg / kg
Experimental
Dosing Every 4 Weeks
干预措施: PRM-151 (Biological)
结局指标
主要结局
Change From Baseline in Forced Vital Capacity (FVC) [% Predicted]
时间窗: 0 to 28 weeks
Determine the effect size of PRM-151 relative to placebo in change from Baseline to Week 28 in mean FVC% predicted, pooling subjects on a stable dose of pirfenidone or nintedanib with subjects not on other treatment for IPF.
次要结局
- Change From Baseline in Total Lung Volume on High-resolution Computed Tomography (HRCT)(0 to 28 weeks)
- Change From Baseline in Volume of Normal Lung on HRCT(0 to 28 weeks)
- Number of Subjects With a Decline in FVC [% Predicted] of ≥ 5% and ≥ 10% From Baseline to Week 28.(0 to 28 weeks)
- Number of Subjects With an Increase in FVC of ≥ 100 mL and ≥ 200 mL From Baseline to Week 28(0 to 28 weeks)
- Change From Baseline in Volume of Interstitial Lung Abnormalities (ILA) on HRCT(0 to 28 weeks)
- Correlation Between Mean Change From Baseline in FVC [% Predicted] and Mean Change From Baseline in ILA(0 to 28 weeks)
- Number of Subjects With a Decline in FVC of ≥ 100 mL and ≥ 200 mL From Baseline to Week 28.(0 to 28 weeks)
- Change From Baseline in % Predicted Diffusion Capacity of Carbon Monoxide (DLCO).(0 to 28 weeks)
- Percentage of Subjects Reporting Respiratory Decline SAEs [Safety and Tolerability](0 to 28 weeks)
- All Cause Mortality(0 to 28 weeks)
- Mortality Due to Respiratory Deterioration(0 to 28 weeks)
- Change From Baseline in 6-Minute Walk Distance (6MWD)(0 to 28 weeks)
- Percentage of Subjects Reporting Serious Adverse Events (SAEs)(0 to 28 weeks)
- Percentage of Subjects With Infusion Related Reactions(0 to 28 weeks)
- Mortality Due to Disease Related Events(0 to 28 weeks)
- Change From Baseline in % of Total Lung Volume of ILA on HRCT(0 to 28 weeks)
- Change From Baseline in % of Normal Lung on HRCT (%)(0 to 28 weeks)
- Number of Subjects With an Increase in FVC [% Predicted] of ≥ 5% and ≥10% From Baseline to Week 28.(0 to 28 weeks)
- Number of Subjects With Stable Disease, Defined as a Change in FVC [% Predicted] of < 5% From Baseline to Week 28.(0 to 28 weeks)
- Number of Subjects With Stable Disease, Defined as a Change in FVC of < 100 mL From Baseline to Week 28.(0 to 28 weeks)
- Percentage of Subjects Discontinuing Study Drug Due to AEs(0 to 28 weeks)
- Percentage of Subjects Reporting Respiratory Decline AEs(0 to 28 weeks)
- Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs)(0 to 28 weeks)
研究者
研究点 (18)
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进行中（未招募）
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A study to test intravenous PRM-151 for safety and to see how PRM-151 acts in the body and blood of people with idiopathic pulmonary fibrosis (IPF) - a disorder where lung tissue becomes damaged and scarred making it difficult to breathe.Idiopathic Pulmonary Fibrosis (IPF)MedDRA version: 18.1 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2014-004782-24-ESPromedior, Inc.117