CTRI/2023/02/050138招募中2 期
A Randomized, Double-blind, Four-Arm Active and Placebo-controlled Dose-Finding Trial to Evaluate the Efficacy, Tolerability, Safety and Dose Response of LYT-100 in Patients with Idiopathic Pulmonary Fibrosis (IPF).
PureTech LYT Inc0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Written, electronic, or oral informed consent from the patient prior to any study procedures in a manner approved by an IRB or Ethics Committee (EC)
- •2. Male or female, aged =40 to =80 at the time of informed consent
- •3. Able to perform and willing to comply with all study procedures and requirements
- •4. Treatment-naïve patients with physician diagnosed IPF based on ATS/ERS/JRS/ALAT 2018 guidelines
- •5. IPF on HRCT, performed within 12 months of Visit 1 as confirmed by central reader
- •6. The extent of fibrotic changes is greater than the extent of emphysema on the most recent HRCT scan as determined by the investigator
- •7. Diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin (Hb) [Visit 1] =30% and <90% of predicted normal where available at the study site
- •8. FVC =45% of predicted normal
- •9. Women of childbearing potential (WOCBP) must be non-pregnant and non-lactating, and must be abstinent from heterosexual intercourse throughout the study and for 90 days following last dose of study medication or agree to use one of the acceptable, highly effective methods of double contraception which is defined as male use of a condom AND one form of the following:
- •a. oral, intravaginal, or transdermal combined (estrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation
- •b. oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation
- •c. intrauterine device (IUD)
- •10. Male participants must be surgically sterile ( >30 days since vasectomy with no viable sperm), abstinent, or, if engaged in heterosexual relations, any female partner must be post-menopausal, surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or using an acceptable, highly effective contraceptive method from screening until study completion, including the follow-up period and for no less than 90 days after the last dose of study medication along with the use of male condom
- •11. Males will not donate sperm for at least 90 days after the last dose of study medication
- •12. Female partners of male patients and female patients will report pregnancy occurring within 90 days from cessation of study medication
排除标准
- •1. Patients who, in the judgement of the investigator, are unlikely to be able to fulfill study participation requirements
- •2. Significant clinical worsening (as per Investigator’s discretion) of IPF between Screening and Baseline Visits
- •3. AST, ALT >1.5 × ULN at Visit 1
- •4. Bilirubin >1.5 × ULN at Visit 1
- •5. Creatinine clearance <30 mL/min calculated by Cockcroft–Gault formula at Visit 1
- •[Note: Laboratory parameters from Visit 1 will be used to satisfy the laboratory threshold values as shown above. Visit 2 laboratory results may be available only after randomization. If the Visit 2 results no longer satisfy the entry criteria, the Investigator will determine whether it is justified that the patient remains on study drug. The justification for this decision needs to be documented.]
- •6. Patients with underlying chronic liver disease (Child Pugh A, B, or C hepatic impairment)
- •7. Current or prior treatment with nintedanib or pirfenidone
- •8. Other investigational therapy received within 1 month prior to randomization (Visit 2)
- •9. Significant pulmonary arterial hypertension (PAH) 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. PAH requiring subcutaneous or intravenous therapy with epoprostenol/treprostinil
- •10. Primary obstructive airway physiology (pre-bronchodilator forced expiratory volume in the first second [FEV1]/FVC <0.7 at Visit 1)
- •11. Known explanation for interstitial lung disease, including but not limited to radiation, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliterans organizing pneumonia, human immunodeficiency virus (HIV), viral hepatitis, and cancer
- •12. Diagnosis of any connective tissue disease, including but not limited to scleroderma/systemic sclerosis, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis
- •13. In the opinion of the Investigator, other clinically significant pulmonary abnormalities, including prior or current lung cancer (treated within the past 5 years)
- •14. Major extrapulmonary physiological restriction (e.g., chest wall abnormality, large pleural effusion)
- •15. Cardiovascular diseases, any of the following:
- •a. Uncontrolled hypertension, under treatment, within 3 months of Visit 1
- •b. Myocardial infarction within 6 months of Visit 1
- •c. Unstable cardiac angina within 6 months of Visit 1
- •16. Prior hospitalization for confirmed COVID-19, acute exacerbation of IPF or any lower respiratory tract infection within 3 months prior to enrollment
- •17. Known symptoms of dysphagia or known difficulty in swallowing capsules and/or total gastrectomy
- •18. Use of any of the following drugs within 2 weeks prior to Visit 2/baseline, during the screening period or planned during the duration of the study
- •a. Strong and moderate CYP1A2 inhibitors (i.e., ciprofloxacin, fluvoxamine, verapamil or enoxacin) and St John’s Wort or phenytoin (moderate inducers of CYP1A)
- •b. Drugs associated with substantial risk for prolongation of the QTc interval (including but not limited to moxifloxacin, quinidine, procainamide, amiodarone, sotalol)
- •c. Warfarin, imatinib, ambrisentan, azathioprine, cyclophosphamide, cyclosporin A, bosentan, methotrexate, sildenafil (exce
研究者
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