EUCTR2021-006820-41-GR进行中（未招募）1 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.0 个研究点目标入组 240 人开始时间: 2022年9月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
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
- 性别
- All
入选标准
- •1. Written or electronic informed consent from the participant prior to
- •any study procedures in a manner approved by an IRB, IEC, or HREC
- •2. Male or female, age of =40 years at the time of informed consent
- •3. Able to perform and willing to comply with all study procedures and
- •requirements
- •4. Treatment-naïve patients or those with <6 months of exposure to
- •nintedanib with physician-diagnosed IPF based on ATS/ ERS/JRS/ALAT
- •2018 guidelines
- •5. IPF on high-resolution computed tomography (HRCT), performed
- •within 12 months of Visit 1 as confirmed by central readers
- •6. 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
- •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 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)
- •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 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 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 participants and female participants will
- •report pregnancy occurring within 90 days from cessation of study
- •1. Signed informed consent for Part B prior to any study-mandated
- •2. Participant must have completed Part A of the study, through Day 183
- •of treatment
- •3. In the opinion of the investigator, the participant is a good candidate
- •for continued treatment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) yes
- 另有 1 项未显示
排除标准
- •1.Participants 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 or ALT>1.5 × ULN at Visit 1
- •4.Total bilirubin>1.5 × ULN at Visit 1. Exceptions may be made on a
- •case-by-case basis for participants with Gilbert's syndrome in
- •consultation with the medical monitor
- •5.Creatinine clearance <30 mL/min calculated by Cockcroft–Gault
- •formula at Visit 1
- •6.Participants with underlying chronic liver disease (Child-Pugh B or C
- •hepatic impairment)
- •7.Current or prior treatment with pirfenidone
- •8.Other investigational therapy received within 1 month prior to
- •randomization visit (Visit 2)
- •9.Significant pulmonary hypertension (PH) defined by any of the
- •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 inhaled requiring 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
- •10.Primary obstructive airway physiology (pre-bronchodilator 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, HIV, viral hepatitis, and
- •12.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
- •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 (eg, chest wall abnormality, large pleural effusion)
- •15.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
- •16.Prior hospitalization within 3 months prior to Visit 1 for
- •confirmed COVID-19, acute exacerbation of IPF, or any lower
- •respiratory tract infection
- •17.Known symptoms of dysphagia or known difficulty in swallowing
- •capsules or tablets and/or total gastrectomy
- •18.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 teriflunomide (inducers of CYP1A2)
- 另有 11 项未显示
研究者
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