CTIS2022-502954-15-00招募中1 期
A 26-Week, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Efficacy, Safety, and Tolerability of Axatilimab in Subjects with Idiopathic Pulmonary Fibrosis (IPF) - SNDX-6352-0506
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 224
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1.Male or female subject aged =40 years on the day of signing the Informed Consent Form (ICF)., 10. Subject is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol., 11. Subject and Investigator considered all medicinal treatment options and/or possibly lung transplantation prior to considering participation in the study., 2. Documented diagnosis of IPF per the 2018 American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society Clinical Practice Guideline (Raghu 2018)., 3. HRCT confirming the diagnosis of IPF based on radiographic findings, as follows: Chest HRCT performed within 12 months prior to Screening Visit 1 and according to the minimum requirements for IPF diagnosis by central review based on subject's HRCT only (if no lung biopsy is available) or based on both HRCT and lung biopsy (with application of the different criteria in either situation). If an evaluable HRCT <12 months prior to Screening is not available, an HRCT can be performed at Screening Visit 1 to determine eligibility, according to the same requirements as the historical HRCT. If a subject has an indeterminate usual interstitial pneumonia (UIP) pattern and their HRCT is >6 months old, if in the opinion of the Investigator their disease has progressed, an additional HRCT may be obtained and reviewed for eligibility., 4. Subjects are eligible if they meet either of the following criteria: a. UIP or probable UIP pattern determined by at least 2 reviewers (see Appendix 3), or b. Indeterminate UIP with an accompanying biopsy supporting UIP or probable UIP histopathology pattern. The pathology report from a locally certified pathologist will provide documentation of histopathologic criteria (see Appendix 3)., 5. Meeting one of the following criteria for background IPF medication use: a.Subjects may be treatment-naïve to nintedanib or pirfenidone for reasons such as contraindication to nintedanib or pirfenidone or subject refusal. (Note: Initiation of nintedanib or pirfenidone and consideration of other therapies for IPF should be discussed by Investigator before study enrollment.) b.Subjects receiving pirfenidone or nintedanib for IPF must have been at a stable dose for at least 12 weeks before Screening. c.If subjects have previously taken and discontinued nintedanib or pirfenidone for any reason (eg, side effect, no therapeutic benefit, refusal of these medications by the subject), they must have discontinued such treatment =4 weeks prior to Screening Visit 1. Note: Discontinuation of nintedanib or pirfenidone for the sole purpose of enrollment in this study is not allowed., 6. Meeting all of the following criteria during the Screening Period: a. FVC =45% of predicted normal at Screening Visit 1 or Visit 2, b. Forced expiratory volume in 1 second (FEV1)/FVC =0.7 at Screening Visit 1 or Visit 2, c. DLCO =30% and =90% of predicted, corrected for hemoglobin at Screening Visit 1, d. Acceptability: Subject can perform acceptable PFTs (ie, meet ATS/ERS acceptability criteria [Appendix 2] at Screening Visits 1, 2, and 3). e. Repeatability: Subject can perform technically acceptable PFTs meeting repeatability criteria for FVC at Screening Visits 1, 2, and 3 (Appendix 2)., 7. Estimated minimum life expectancy of at least 12 months for non-IPF-related disease in the opinion of the Investigator., 8. Male s
排除标准
- •1. History of malignancy within the past 5 years (except for carcinoma in situ of the uterine cervix, basal cell carcinoma of the skin that has been treated with no evidence of recurrence, prostate cancer that has been medically managed through active surveillance or watchful waiting, squamous cell carcinoma of the skin if fully resected, non-invasive ductal carcinoma in situ of the breast, and melanoma in situ)., 10. Acute respiratory or systemic bacterial, viral, or fungal infection requiring systemic treatment either during Screening or prior to Screening and not successfully resolved 4 weeks prior to Screening Visit 1., 11. Class IV New York Heart Association chronic heart failure., 12. Significant pulmonary hypertension (PH) defined by any of the following: a. Previous clinical or echocardiographic evidence of significant right heart failure b. History of right heart catheterization showing a cardiac index =2 L/min/m² c. PH requiring parenteral therapy with epoprostenol/treprostinil, 13. Cardiopulmonary rehabilitation program based on exercise training that has been completed within 6 weeks prior to Screening or planned to start within the first 6 weeks of the subject's enrollment in this study., 14. History of cigarette smoking or vaping within the previous 3 months., 15. Recent history (<6 months) of alcohol or substance abuse disorder., 16. Unstable cardiovascular, pulmonary (other than IPF), or other disease within 6 months prior to Screening or during the Screening Period (eg, acute coronary disease, heart failure, and stroke)., 17. Major surgery within 3 months prior to Screening, during screening or have major surgery planned during the study period., 18. Alanine aminotransferase and/or aspartate aminotransferase (AST) >2 x upper limit of normal (ULN) or total bilirubin =1.5 x ULN. Retesting is allowed once., 19. Moderate to severe hepatic impairment (Child-Pugh B or C)., 2. Abnormalities detected on ECG of either rhythm or conduction that in the opinion of the Investigator are clinically significant. Note: • Subjects with implantable cardiovascular devices (eg, pacemaker) affecting the QT interval time may be enrolled in the study based upon Investigator judgment following cardiologist consultation if deemed necessary. • Atrial fibrillation that has been clinically stable for at least 6 months and that has been appropriately treated with anticoagulants and controlled with a rate control strategy (eg, selective beta blocker, calcium channel blocker, digoxin or ablation therapy) for at least 6 months is allowed for inclusion. In such subjects, if atrial fibrillation is present at Visit 1, resting ventricular rate must be <100 beats per minute., 20. Amylase or lipase >1.5 x ULN; creatine phosphokinase (CPK) >2 x ULN. Retesting is allowed once., 21. Abnormal renal function defined as estimated creatinine clearance of <30 mL/min, calculated according to the Chronic Kidney Disease Epidemiology Collaboration formula (Inker 2021). Retesting is allowed once., 22. History of acute pancreatitis in the prior 12 months or =2 episodes in past 3 years., 23. Subject with acquired immune deficiency syndrome., 24. A history of tuberculosis in the prior 6 months, or subjects with active or latent tuberculosis, confirmed by a positive test during Screening (interferon gamma release assay). [The interferon gamma release assay may be substituted with local tuberculosis test or local tuberculosis test results determined within 6 months prior to
研究者
相似试验
进行中（未招募）
1 期
A 26-Week Randomized, Double-blind, Placebo-controlled, Dose-ranging Phase 2 Study to Assess the Safety and Efficacy of SAR425899 in Patients with Type 2 Diabetes Mellitusutritional and metabolic diseasesMedDRA version: 19.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2016-001328-77-HUsanofi-aventis recherche & développement296
进行中（未招募）
1 期
A Study to Assess the Safety and Efficacy of SAR425899 in Patients with Type 2 Diabetes Mellitusutritional and metabolic diseasesMedDRA version: 19.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2016-001328-77-ESsanofi-aventis recherche & développement270
进行中（未招募）
1 期
A Study to Assess the Safety and Efficacy of SAR425899 in Patients with Type 2 Diabetes Mellitusutritional and metabolic diseasesMedDRA version: 19.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2016-001328-77-CZsanofi-aventis recherche & développement270
进行中（未招募）
1 期
A Study to Assess the Safety and Efficacy of SAR425899 in Patients with Type 2 Diabetes Mellitusutritional and metabolic diseasesMedDRA version: 20.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2016-001328-77-DEsanofi-aventis recherche & développement270
进行中（未招募）
1 期
A study to evaluate the effect of omalizumab on asthma impairment in patients with persistent allergic asthmaAllergic asthmaEUCTR2017-001799-41-Outside-EU/EEAovartis Pharmaceutical Corporation266