jRCT2051210169暂停不适用
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 34
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 40age old over 至 85age old under（—）
- 性别
- All
入选标准
- •Age 40 to 85 years, inclusive, at screening initiation.
- •Diagnosis of IPF as defined by ATS/ERS/JRS/ALAT guidelines (Raghu 2018).
- •IPF diagnosis within the past 7 years, with onset defined as the date of the first recorded diagnosis of IPF by HRCT and/or surgical biopsy (SLB) or other appropriate tissue sample (e.g., cryobiopsy) in the medical history.
- •Interstitial pulmonary fibrosis defined by HRCT scan at screening, with evidence of >10% to <50% parenchymal fibrosis (reticulation) and <25% honeycombing, within the whole lung. NOTE: this requires confirmation by an Independent Radiology Imaging Review Group, prior to randomization. If a recent HRCT scan (within 3 months prior to screening) is available, it can be utilized for screening purposes, provided it is submitted and evaluated by the Independent Radiology Imaging Review Group, is adhering to the imaging parameters detailed in the Imaging Core Manual (ICM), and is using the same accredited scanner as the on-study HRCT scans.
- •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 Hb value >25% and <90% at screening (determined locally). If a DLCO is available within 3 months prior to screening, it can be utilized for screening purposes.
- •Both FVC and DLCO testing must be representative of the IPF underlying disease (i.e. have been obtained in absence of an acute respiratory event [e.g. lung infection, cold] or other events that are known to affect PFT testing results (e.g., broken rib, chest pain, other).
- •Not currently receiving treatment for IPF with an approved therapy (i.e., 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. NOTE:no subject should discontinue approved therapy for the purpose of enrolling in this study.
- •Male subjects with partners of childbearing potential and female subjects of childbearing potential (including those <1 year postmenopausal) must use a highly effective method of contraception per Clinical Trial Facilitation Group (CTFG) recommendation (see protocol section 5.2.3 for details) during the conduct of the study, and for 3 months after the last dose of study drug. Women not of childbearing potential are defined as:
- •a. Post-menopausal women (defined as at least 12 months with no menses without an alternative medical cause); in women < 45 years of age, a high follicle stimulating hormone (FSH) level in the post-menopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy; OR
- •b. Have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 6 weeks prior to screening; OR
- •c. Have a congenital or acquired condition that prevents childbearing.
- •Able to understand and sign a written informed consent form.
排除标准
- •Previous exposure to pamrevlumab.
- •Evidence of significant obstructive lung disease by any of the following criteria: (1) forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio <0.70, or (2) extent of emphysema greater than the extent of fibrosis on HRCT. NOTE: this requires confirmation by an Independent Radiology Imaging Review Group, prior to randomization.
- •Female subjects who are pregnant or nursing.
- •Smoking within 3 months of screening and/or unwilling to avoid smoking throughout the study.
- •Interstitial lung disease (ILD) other than IPF, including but not limited to any of the other types of idiopathic interstitial pneumonias; lung diseases related to exposure to fibrogenic agents or other environmental toxins or drugs; other types of occupational lung diseases; granulomatous lung diseases; pulmonary vascular diseases; systemic diseases, including vasculitis, infectious diseases and connective tissue diseases. In cases of uncertain diagnosis, serological testing and/or review by multi-disciplinary team should be performed to confirm diagnosis of IPF vs. other types of ILD.
- •Sustained improvement in the severity of IPF during the 12 months prior to screening, based on changes in FVC, DLCO, and/or HRCT scans of the chest.
- •History of other types of respiratory diseases, including diseases or disorders of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall that, in the opinion of the Investigator, would impact the primary protocol endpoint or otherwise preclude the subjects participation in the study.
- •Medical conditions (e.g. MI/stroke within the past 6 month), or logistical challenges that in the opinion of the Investigator preclude the subjects adequate participation in the study.
- •Poorly controlled chronic heart failure (NYHA Class 3 or above); clinical diagnosis of cor pulmonale requiring specific treatment; or severe pulmonary arterial hypertension requiring specific treatment that, in the opinion of the Investigator, would preclude the subjects participation in the study.
- •Clinically important abnormal laboratory tests (including serum creatinine >1.5 multiplied by upper limit of normal [ULN], hemoglobin (Hb) <10 g/dL, white blood cells <3,000/mm3, platelets less than 100,000/mm3, serum total bilirubin >1.5 multiplied by ULN, serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 multiplied by ULN, or serum alkaline phosphatase >2 multiplied by ULN.
- •Ongoing acute IPF exacerbation, or suspicion of such process during screening or randomization, including hospitalization due to acute IPF exacerbation within 4 weeks prior to or during screening.
- •High likelihood of lung transplantation (in the opinion of the Investigator) within 6 months after Day
- •Use of any investigational drugs or unapproved therapies, or participation in a clinical trial with an investigational new drug, within 30 days prior to screening. Or use of approved IPF therapies (i.e., pirfenidone or nintedanib) within 1 week prior to screening.
- •Daily use of PDE-5 inhibitor drugs (e.g. sildenafil, tadalafil) except for treatment of severe pulmonary artery hypertension.
- •Any current malignancy (this does not include localized cancer such as basal or squamous cell carcinoma of skin). Any history of malignancy likely to result in mortality, or requiring significant medical or surgical intervention within the next year.
- •History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies, or to any component of the excipient.
- •Any condition (other than IPF) that is likely to result in the death of the patient within the next year.
- •The Investigator judges that the subject will be unable to fully participate in the study and complete it for any reason, including inability to comply with study procedures and treatment, addiction, or any other relevant medical or psychiatric conditions.
结局指标
主要结局
-
Change in FVC (L) from baseline at Week 48
次要结局
- Time to disease progression
- Time to composite of clinical outcomes
研究者
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