Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF)

FibroGen Inc.0 个研究点目标入组 7 人开始时间: 2024年7月18日最近更新: 2024年8月19日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 7

研究概览研究设计入排标准研究者记录与标识符相似试验

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
主要目的: Treatment
盲法: Blinded (masking used)

入排标准

年龄范围: 40 至 85（—）
性别: All

入选标准

•1. Age 40 to 85 years, inclusive, at screening initiation.
•2. Diagnosis of IPF as defined by ATS/ERS/JRS/ALAT guidelines (Raghu 2018).
•3. 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 samples (e.g., cryobiopsy) in the medical history.
•4. 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.
•5. FVCpp value =50% and =80% at Screening and Day 1.
•6. Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted and corrected by Hb value =30% and =90% at Screening (determined locally).
•7. 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]).
•8. Previously treated with an approved IPF therapy (i.e., pirfenidone or nintedanib) but discontinued at least 1 week prior to screening, unless neither treatment is available in the host country. NOTE: no subject should discontinue approved therapy for the purpose of enrolling in this study.
•9. Male subjects with partners of childbearing potential and female subjects of childbearing potential (including those <1 year postmenopausal) must use double barrier contraception methods 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.
•10. Able to understand and sign a written informed consent form.

排除标准

•1. Previous exposure to pamrevlumab.
•2. 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.
•3. Female subjects who are pregnant or nursing.
•4. Smoking within 3 months of Screening and/or unwilling to avoid smoking throughout the study.
•5. Interstitial lung disease (ILD) other than IPF, including but not limited to any of the other types of idiopathic interstitial pneumonia; 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 (i.e. TB) and connective tissue diseases. In cases of uncertain diagnosis, serological testing and/or review by the multi-disciplinary team should be performed to confirm the diagnosis of IPF vs. other types of ILD.
•6. 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.
•7. 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 subject’s participation in the study.
•8. Medical conditions (e.g. MI/stroke within the past 6 months), or logistical challenges that in the opinion of the Investigator preclude the subject’s adequate participation in the study.
•9. 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 subject’s participation in the study.
•10. Clinically important abnormal laboratory tests (including serum creatinine =1.5 x 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 x ULN, serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =2 x ULN, or serum alkaline phosphatase =2 x ULN.
•11. Ongoing acute IPF exacerbation, or suspicion of such process by the Investigator, during Screening or Randomization.
•12. High likelihood of lung transplantation (in the opinion of the Investigator) within 6 months after Day 1.
•13. 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.
•14. Daily use of PDE-5 inhibitor drugs (e.g. sildenafil, tadalafil) except for treatment of severe pulmonary artery hypertension.
•15. Any current malignancy (this does not include localized cancer such as basal or squamous cell carcinoma of the skin). Any history of malignancy likely to result in mortality, or requiring significant medical or surgical intervention within the next year.
•16. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies.
•17. Any condition (other than IPF) that is likely to result in the death of the patient within the next year.

研究者

发起方

FibroGen Inc.

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