A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Trial of the Efficacy and Safety of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis Followed by an Open-Label Extension
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 153
- 试验地点
- 2
- 主要终点
- Study Drug Dose Reductions
研究概览
简要总结
This trial is a randomized, double-blind, placebo-controlled study evaluating the safety and preliminary efficacy of inhaled Nintedanib Dry Powder Inhalation (DPI) in adults with idiopathic pulmonary fibrosis (IPF). Participants are randomized to receive either 2 mg BID, 4 mg BID, or matching placebo for 12 weeks, followed by a 24-week open-label extension in which all participants receive active treatment. The primary focus is on safety-particularly bronchospasm events, lung function changes (FEV1, FEV1/FVC), and adverse event rates and assessing the effectiveness of nintedanib DPI in treating 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40-80 years old when signing consent and entering screening.
- •Diagnosed with IPF based on current ATS/ERS/JRS/ALAT guidelines.
- •Either new to treatment or on a stable dose of pirfenidone and/or nerandomilast for at least 3 months before screening.
- •Weighs more than 40 kg (88 lb) at screening.
- •Women who can become pregnant:
- •Must have a negative pregnancy test at screening.
- •Must use an approved birth control method from screening until at least 1 month after the last study dose.
- •Men who can father a child and are sexually active with women who can become pregnant:
- •Must use an approved birth control method during treatment and for at least 3 months after the last study dose.
- •Must not donate sperm during treatment and for at least 3 months after the last study dose.
- •Willing to follow all study rules and restrictions.
- •Willing and able to attend study visits and complete study procedures.
- •Able to perform spirometry (lung function testing) as required by the study.
排除标准
- •Has a lung disease caused by something other than IPF.
- •Has a connective tissue or autoimmune disease (such as lupus, scleroderma, or rheumatoid arthritis).
- •Has another condition that significantly affects breathing.
- •Has serious heart or blood vessel disease.
- •Has a recent or current infection.
- •Was recently hospitalized for COVID-19, an IPF flare-up, or a lung infection.
- •Has a history of asthma (except childhood asthma that has resolved).
- •Has another medical condition or abnormal test result that may affect study participation or safety.
- •Cannot perform high-quality spirometry testing.
- •Has obstructive lung disease.
- •Has abnormal liver function tests.
- •Has moderate to severe liver disease.
- •Has severe kidney disease.
- •Has recently used high-dose steroids or other immune-suppressing medications.
- •Has active cancer or recent cancer treatment.
- •Is on, or expected to be added to, a transplant list.
- •Had major surgery recently or has planned procedures that could interfere with the study.
- •Has had a severe reaction to nintedanib or cannot take nintedanib safely.
- •Has recently used certain medications that may interact with the study drug.
- •Is currently using, or plans to use, prohibited medications during the study.
- •Has recently participated in another clinical trial.
- •Has current alcohol or drug abuse issues.
- •Donated a significant amount of blood recently.
- •Received a live vaccine recently.
- •Currently smokes, recently smoked, or quit smoking less than 1 year ago.
- •Requires more than 6 L/min of oxygen while at rest.
研究组 & 干预措施
Nintedanib DPI 2X day 1st dose
Inhalable
干预措施: Nintedanib Dry Powder Inhalation (Drug)
Placebo 2X day 1st dose
Inhalable
干预措施: Placebo (Drug)
Nintedanib DPI 2X day 2nd dose
2nd dose
干预措施: Nintedanib Dry Powder Inhalation (Drug)
Placebo 2X day 2nd dose
2nd dose
干预措施: Placebo (Drug)
结局指标
主要结局
Study Drug Dose Reductions
时间窗: From enrollment to the end of open-label treatment at 36 weeks
Rate of study drug dose reductions
Adverse Events
时间窗: From enrollment to the end of open-label treatment at 36 weeks
Rate of TEAEs
Safety and Efficacy
时间窗: From enrollment to the end of randomized treatment at 12 weeks
Safety and tolerability of different doses and to confirm an optimal dose of Nintedanib Dry Powder Inhalation (DPI)
Events of clinical bronchospasm
时间窗: From enrollment to the end of open-label treatment at 36 weeks
Events of clinical bronchospasm (e.g., treatment-emergent adverse event \[TEAE\] of wheezing or chest tightness immediately after inhalation)
FEV1 change
时间窗: From enrollment to the end of open-label treatment at 36 weeks
Change in forced expiratory volume in 1 second (FEV1) (mL)
Spirometry Change
时间窗: enrollment to end of open label at 36 weeks
Change in FEV1/forced vital capacity (FVC) ratio
Study Drug Discontinuation
时间窗: From enrollment to the end of open-label treatment at 36 weeks
Rate of study drug discontinuations
Related Adverse Events
时间窗: From enrollment to the end of open-label treatment at 36 weeks
Rate of treatment-related adverse events (TRAEs)
Serious Adverse Events
时间窗: From enrollment to the end of open-label treatment at 36 weeks
Rate of serious adverse events (SAEs)
次要结局
- Efficacy of Nintedanib DPI(From enrollment to the end of randomized treatment at 12 weeks)