2024-511330-13-00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 100 Inc.7 个研究点 分布在 2 个国家目标入组 14 人开始时间: 2024年5月17日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 14
- 试验地点
- 7
- 主要终点
- Rate of decline in FVC (in mL) over Part A (26 weeks)
研究概览
简要总结
To obtain clinical data establishing the safety, tolerability, efficacy, and dosing regimen of LYT-100 in patients with IPF
研究设计
- 分配方式
- Randomized
- 主要目的
- Part B Follow Up
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Written or electronic informed consent from the participant prior to any study procedures in a manner approved by an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Human Research Ethics Committee (HREC)
- •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 postmenopausal, surgically sterile (eg, 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 (males) and 30 days (females) after the last dose of study medication along with the use of male condom
- •Males will not donate sperm for at least 90 days after the last dose of study medication
- •Female partners of male participants and female participants will report pregnancy occurring within 30 days from cessation of study medication
- •Part B: Signed informed consent for Part B prior to any study-mandated procedures
- •Part B: Participant must have completed Part A of the study through Day 183 of treatment
- •Part B: In the opinion of the investigator, the participant is a good candidate for continued treatment
- •Male or female, age of ≥40 years at the time of informed consent
- •Able to perform and willing to comply with all study procedures and requirements
- •Treatment-naïve patients or those with <6 months of exposure to nintedanib with physician-diagnosed IPF based on American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) 2018 guidelines
- •IPF on high-resolution computed tomography (HRCT), performed within 12 months of Visit 1 as confirmed by central readers
- •The extent of fibrotic changes is greater than the extent of emphysema on the most recent HRCT scan as determined by the investigator and the central reader
- •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.
- •FVC ≥45% of predicted normal
- •Women of childbearing potential (WOCBP) must be non-pregnant and non-lactating, and must be abstinent from heterosexual intercourse throughout the study and for 30 days following last dose of study medication or agree to use 1 of the acceptable, highly effective methods of double contraception which is defined as male use of a condom AND 1 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)
排除标准
- •Participants who, in the judgement of the investigator, are unlikely to be able to fulfill study participation requirements
- •Part B: Participants must not meet any exclusion criteria listed for Part A
- •Part B: Participants who discontinued study medication and started receiving commercially available antifibrotic medication during Part A will not be eligible for Part B
- •Primary obstructive airway physiology (pre-bronchodilator forced expiratory volume in the first second [FEV1]/FVC <0.7 at Visit 1)
- •Part B: Participants whose treatment assignment is unblinded during Part A will not be eligible for Part B
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 × upper limit of normal (ULN) at Visit 1
- •Part B: Any known factor or disease that interferes with treatment compliance, study conduct, or interpretation of the results, as judged by the investigator
- •Total bilirubin >1.5 × ULN at Visit
- •Exceptions may be made on a case-by-case basis for participants with Gilbert’s syndrome in consultation with the medical monitor
- •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 participant remains on study drug. The justification for this decision needs to be documented.]
- •Participants with underlying chronic liver disease (Child-Pugh B or C hepatic impairment)
- •Current or prior treatment with pirfenidone
- •Use of any of the following drugs within 2 weeks prior to Visit 2/baseline or planned during the duration of the study: a. Strong and moderate CYP1A2 inhibitors (ie, ciprofloxacin, fluvoxamine, enoxacin, methoxsalen, mexiletine, vemurafenib) and phenytoin, rifampin, and terifluonmide (inducers of CYP1A2) b. Medications associated with substantial risk for prolongation of the QTc interval including but not limited to moxifloxacin, quinidine, procainamide, sotalol, amiodarone (discontinued at least 90 days from V2) c. Immunosuppressant medications such as azathioprine, cyclophosphamide, cyclosporin A, metho-trexate, prednisone at a steady dose >10mg/day or equivalent (Prednisone should be at a stable dose for at least 90 days prior to V2). d. Medications used to treat PH such as endothelin receptor antagonists (eg, ambrisentan, bosentan, and macitentan), phosphodiesterase-5 inhibitors (sildenafil and tadalafil used to treat erectile dys-function are allowed), guanylate cyclase stimulators (eg, riociguat), prostacyclin analogs (eg, epo-prostenol, treprostnil, iloprost), or prostacyclin receptor agonists (eg, selexipag) e. Warfarin, as it may worsen IPF f. Vaccination with a live vaccine is not permitted during the period from 4 weeks prior to Screening to 4 weeks after the last dose. The medical monitor should be consulted if there is any question about a particular vaccine.
- •Other investigational therapy received within 1 month prior to randomization (Visit 2)
- •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 inhaled, subcutaneous, or intravenous therapy with epoprostenol/treprostinil d. In the principal investigator's opinion, the study participant’s symptoms are more related to their PH than to their IPF
- •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
- •Major surgical procedures during Screening or study periods, with the exception of pre-planned procedures that will not interfere with study participation
- •Diagnosis of any connective tissue disease, including but not limited to scleroderma/systemic sclerosis, Sjogren’s disease, mixed connective tissue diseases, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis
- •In the opinion of the investigator, other clinically significant pulmonary abnormalities, including prior or current lung cancer (treated within the past 5 years)
- •Major extrapulmonary physiological restriction (eg, chest wall abnormality, large pleural effusion)
- •Cardiovascular diseases, any of the following: a. Uncontrolled hypertension, 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
- •Prior hospitalization within 3 months prior to Visit 1 for confirmed COVID-19, acute exacerbation of IPF, or any lower respiratory tract infection
- •Known symptoms of dysphagia or known difficulty in swallowing capsules or tablets and/or total gastrectomy
- •Significant clinical worsening (as per Investigator’s discretion) of IPF between Screening and Baseline Visits
- •A current immunosuppressive condition (eg, HIV)
- •Active alcohol or drug abuse
- •Use of smoked (burnt) tobacco products or vaping/e-cigarettes
- •Other disease (including malignancy) that may interfere with testing procedures or in the judgement of the investigator may interfere with study participation or may put the participant at risk when participating in this study
- •Participants with a documented hypersensitivity to LYT-100
- •Participants with a documented lactose or galactose intolerance
结局指标
主要结局
Rate of decline in FVC (in mL) over Part A (26 weeks)
Rate of decline in FVC (in mL) over Part A (26 weeks)
次要结局
- Rate of decline in FVC % predicted (FVCpp) over Part A (Week 26)
- Time to IPF progression through 26 weeks (the end of Part A), as defined by a decline from baseline in FVCpp of 5% or greater, or death
- Time to hospitalization due to respiratory cause (as determined by the investigator) or all cause mortality through 26 weeks
- Time to hospitalization due to respiratory cause (as determined by the investigator) through 26 weeks
- Time to all-cause mortality through 26 weeks
- Change from baseline to Week 26 in King's Brief Interstitial Lung Disease Questionnaire (K-BILD) total score
- Change from baseline to Week 26 in St. George’s Respiratory Questionnaire – IPF Version (SGRQ-I)
- Change from baseline to Week 26 in EuroQol 5-Dimensional Quality of Life Questionnaire (EQ-5D)
- Change in serum biomarkers from baseline through Week 26
- Number and duration of respiratory hospitalizations or pulmonary exacerbations (as determined by the investigator) through 26 weeks
- Rate of hospitalization due to respiratory cause (as determined by the investigator) through 26 weeks
- Part B: Rate of decline in FVCpp from the end of Part A (Week 26) to the end of Part B Period 1 (Week 52) Change in FVCpp from the end of Part A (Week 26) to the end of Part B Period 1 (Week 52)
- Part B: Rate of decline in FVC (in mL) from the end of Part A (Week 26) to the end of Part B Period 1 (Week 52) using the values obtained from spirometry assessments
- Part B: Time to IPF progression in Part B, as defined by a decline from the end of Part A (Week 26) to the end of Part B Period 1 (Week 52) in FVCpp of 5% or greater, or death
- Part B: Time to hospitalization due to respiratory cause (as determined by the investigator) from the start of Part B (Week 26) through the end of Part B Period 1 (Week 52)
- Part B: Time to all-cause mortality from the start of Part B (Week 26) through the end of Part B Period 1 (Week 52)
- Part B: Time to hospitalization due to respiratory cause (as determined by the investigator) or all-cause mortality from the start of Part B (Week 26) through the end of Part B Period 1 (Week 52)
- Part B: Total duration on assigned dose from the start of Part B through the end of Part B Period 1 (Week 52)
- Part B: Change in EQ-5D from the end of Part A (Week 26) through the end of Part B Period 1 (Week 52)
- Part B: Change in serum and plasma biomarkers from the end of Part A (Week 26) through the end of Part B Period 1 (Week 52)
- Part B: Number and duration of respiratory hospitalizations or pulmonary exacerbations(as determined by the investigator) from the start of Part B (Week 26) through the end of Part B Period 1 (Week 52)
- Part B: Rate of hospitalization due to respiratory cause (as determined by the investigator) from the start of Part B (Week 26) through the end of Part B Period 1 (Week 52)
研究者
Sarah Santipadri
Scientific
Puretech Lyt 100 Inc.
研究点 (7)
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