NCT05671835已完成2 期
REVERT-IPF: A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis
Tvardi Therapeutics, Incorporated56 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年5月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 56
- 主要终点
- Number of Participants with an Adverse Event (AE)
研究概览
简要总结
The primary objective of this study is to evaluate the safety and tolerability of oral daily administration of TTI-101 over a 12-week treatment duration in participants with idiopathic pulmonary fibrosis (IPF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with IPF based on either the 2018 American Thoracic Society (ATS)/ European Respiratory Society (ERS)/ Japanese Respiratory Society (JRS)/ Latin American Thoracic Association (ALAT) International Diagnostic Guidelines or on the 2022 updated guidelines within 7 years prior to the date of informed consent.
- •Chest high-resolution computed tomography scan (HRCT) performed within 12 months prior to providing informed consent meeting requirements for IPF diagnosis based on 2018 or 2022 ATS/ERS/JRS/ALAT guidelines and confirmed by central review.
- •Greater than 40% of predicted forced vital capacity (FVC) and a ratio of forced expiratory volume in 1 second (FEV1)/FVC ≥0.7 measured pre-bronchodilator during screening confirmed by central review.
- •A predicted diffusing capacity of the lungs for carbon monoxide (DLCO) (hemoglobin [Hb] corrected) ≥25% during screening confirmed by central review.
- •Oxygen saturation (SpO2) ≥88% with up to 4L O2/min by pulse oximetry at rest.
- •If currently receiving nintedanib, dose must have been stable for ≥3 months prior to randomization. If participant has previously discontinued nintedanib, there is a 6-week washout period required before screening can begin.
- •Has a life expectancy of at least 12 months.
排除标准
- •Unresolved respiratory tract infection within 4 weeks (including coronavirus disease 2019 [COVID-19] infections) or an acute exacerbation of IPF within 3 months prior to screening.
- •Planned surgery during the study.
- •The investigator judges that there has been 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.
- •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 ability to do pulmonary function tests (PFTs), or otherwise preclude participation in the study.
- •Likely to have lung transplantation during the study. Note: Participant may be on a lung transplant list if the investigator anticipates the participant will be able to complete the study prior to transplant.
- •Clinically relevant and uncontrolled cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic, or psychiatric disorders that may interfere with the participant's ability to complete this study according to the investigator's judgment, or logistical challenges that, in the opinion of the investigator, preclude adequate participation in the study.
- •History or difficulty of swallowing, malabsorption, or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the study drug.
- •Receiving steroids (excluding topical steroids) in excess of a mean of 10 mg/day of prednisolone or its equivalent within 2 weeks prior to randomization.
- •Received pirfenidone within 3 months prior to randomization.
- •Smoking or vaping of any kind within 3 months of screening.
研究组 & 干预措施
Placebo
Placebo Comparator
Participants will receive a matching placebo BID for 12 weeks.
干预措施: Placebo (Drug)
TTI-101 800 mg/day
Experimental
Participants will receive 800 mg/day of TTI-101 BID for 12 weeks.
干预措施: TTI-101 (Drug)
TTI-101 400 mg/day
Experimental
Participants will receive 400 mg/day of TTI-101 twice daily (BID) for 12 weeks.
干预措施: TTI-101 (Drug)
结局指标
主要结局
Number of Participants with an Adverse Event (AE)
时间窗: 16 weeks
Incidence of AEs, including serious AEs assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) V.5.0. Clinically significant changes between baseline and postbaseline laboratory assessments, electrocardiograms, vital signs, and physical examinations will be recorded as AEs.
次要结局
- Time of Maximum Observed Plasma Concentration (tmax) of TTI-101(Day 1 to Week 12)
- Maximum Observed Plasma Concentration (Cmax) of TTI-101(Day 1 to Week 12)
- Area Under the Plasma Concentration-time Curve Over a Dosing Interval (AUC[0-τ]) of TTI-101(Day 1 to Week 12)
- Trough Plasma Concentration (Cτ) of TTI-101(Day 1 to Week 12)
研究者
研究点 (56)
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