NCT04312594已完成2 期
A Multicenter, Randomized, Double-Blind,Placebo-controlled,Phase 2 Study of Jaktinib Hydrochloride Tablets in Participants With Idiopathic Pulmonary Fibrosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Changes in forced vital capacity (FVC) [ Time Frame: 24 weeks ]
研究概览
简要总结
This is a multi-center, randomized, double-blinded, and placebo-controlled phase II study to evaluate the efficacy and safety of Jaktinib Hydrochloride Tablets in Participants With Idiopathic Pulmonary Fibrosis.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent signed;at least 50 years of age;no gender limitation.
- •Diagnosed idiopathic pulmonary fibrosis(see 2018.9 guidance that AST and ERS and JRS and ALAT publish );
- •FVC%≥45% normal predicted value;
- •DLCO≥30% normal predicted value；
- •FEV1 / FVC ≥0.7
排除标准
- •A plan of lung transplant after into group for one year.
- •In addition of IPF,Other causes cause interstitial lung disease in patients；
- •Patients with bleeding tendency (INR > 2, PT or APTT > 1.5 times normal) or cerebral hemorrhage in the past 1 year;
- •Have used anticoagulant drugs within 1 month（Except for low molecular weight heparin）;
- •An alcoholic or drug abuser;
- •Expected survival ≤ one year;
- •Patients who plan to undergo a operation within study period, such as major operations on chest and abdomen;
- •Previous use of a JAK inhibitor for more than 10 days or treatment failure;
- •Suspected allergic to Jaktinib Dihydrochloride Monohydrate , similar drugs (Fedratinib,Ruxolitinib)or their excipients;
- •Patients with malignant tumors in the previous 5 years;
- •Patients with other serious diseases that investigators believe may affect patient safety or compliance;
- •Any significant clinical or laboratory abnormalities that the investigator considers to affect safety assessment, such as: a. uncontrolled diabetes (13.9 tendency > / L), b. had high blood pressure and antihypertensive drug treatment under two or unable to descend to the ranges (systolic blood pressure < 160 mmHg, diastolic pressure < 100 mmHg), c. peripheral neuropathy (NCI - CTC AE v5.0 standard grade 2 or above)；
- •Patients hospitalized for deterioration or acute exacerbation of IPF within 1 month prior to screening;
- •patients who had not fully recovered from surgery within 1 month prior to screening;
- •Participate in clinical trials of other new drugs or medical devices within 3 months before screening;
- •Prednisone > 15mg/ day or equivalent within 1 month prior to screening;
- •Those who had used pirfenidone, Nintedanib, azathioprine, cyclophosphamide, cyclosporine A or other immunosuppressive drugs within 1 month prior to screening;
- •A history of congestive heart failure, uncontrolled or unstable angina or myocardial infarction, cerebrovascular accident or pulmonary embolism occurred within 6 month prior to screening;
- •Patients with active TB in the 12 months prior to screening;
- •Screening patients with arrhythmia requiring treatment, or with QTcB >480ms;
- •At the time of screening, there was evidence of severe impairment of organ function : including ALT and AST > 2.5uln;DBIL and TBIL > 2.0 ULN;Serum creatinine > was 1.5 ULN.
- •Evidence of active and uncontrolled viral infections such as HIV, HBV (HBsAg positive, hbv-dna positive or ≥10000 copies /ml), HCV (anti-hcv antibody or hcv-rna positive), or bacterial, viral, parasitic or fungal infections requiring treatment with any clinical symptoms;
- •patients with a history of progressive multifocal leukoencephalopathy in Screening ;
- •Patients with epilepsy or using antipsychotics(Sleep medicine,for diazepam expect) for treatment of mental illness( schizophrenia,depressed,mania,anxiety,and so on) at the time of screening;
- •Women who are planning to become pregnant or who are pregnant or breast-feeding and who are unable to use effective contraception throughout the trial period;Male patients who did not use condoms during administration and within 1 month after the last dose;
- •Subjects who cannot be treated and followed up according to the protocol;
- •Any subject whom the investigator considers inappropriate for this clinical study.
研究组 & 干预措施
Jaktinib 50mg BID
Experimental
Patients receive the dose of Jaktinib Hydrochloride Tablets orally 50mg twice daily (BID) for 24 weeks.
干预措施: Jaktinib Hydrochloride Tablets (Drug)
Jaktinib 75mg BID
Experimental
Patients receive the dose of Jaktinib Hydrochloride Tablets orally 75mg twice daily (BID) for 24 weeks.
干预措施: Jaktinib Hydrochloride Tablets (Drug)
Placebo
Placebo Comparator
Patients receive the dose of placebo orally twice daily (BID) for 24 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in forced vital capacity (FVC) [ Time Frame: 24 weeks ]
时间窗: 24 weeks
Changes in FVC from 24 weeks to baseline
次要结局
- Progression-free time [ Time Frame: the onset of disease or death from any cause ](From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months)
- mMRC Dyspnea scale：absolute value of change from baseline [ Time Frame: 24 weeks ](24 weeks)
- Survival rate: [ Time Frame: 6 months, 12 months, 24 months ](6 months, 12 months, 24 months)
- The severity and incidence of all adverse events and adverse reactions[ Time Frame: within 28 days after the signing of the informed consent](within 28 days after the signing of the informed consent)
- Non-worsening survival time: [ Time Frame:the time from randomization to the first acute exacerbation ];(from randomization to one month)
- K-BILD Scale: absolute value of change from baseline [ Time Frame: 24 weeks ](24 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
A Study of CM310 in Subjects With Chronic PruritusChronic Pruritus of Unknown OriginNCT05452343Keymed Biosciences Co.Ltd50
尚未招募
2 期
Study of CM326 in Participants With Chronic Rhinosinusitis With Nasal PolyposisChronic Rhinosinusitis With Nasal PolypsNCT06372678Keymed Biosciences Co.Ltd90
已完成
2 期
Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ICP-488 in Patients with Moderate to Severe Plaque PsoriasisModerate to Severe Plaque PsoriasisNCT06109818Beijing InnoCare Pharma Tech Co., Ltd.129
尚未招募
2 期
Evaluate the Safety and Efficacy of HDM1002 Tablets in Overweight and Obese AdultsOverweight and ObesityNCT06500299Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.180
已完成
2 期
A Clinical Study of TQC2731 Injection in the Treatment of Chronic Rhinosinusitis With Nasal PolypsChronic SinusitisNasal PolypsNCT06036927Chia Tai Tianqing Pharmaceutical Group Co., Ltd.80