study of jaktinib hydrochloride tablets in participants with idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: 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.


Eligibility criteria:
inclusion criteria: 1. written informed consent signed;at least 50 years of age;no gender limitation. 2. diagnosed idiopathic pulmonary fibrosis(see 2018.9 guidance that ast and ers and jrs and alat publish ); 3. fvc%≥45% normal predicted value; 4. dlco≥30% normal predicted value； 5. fev1 / fvc ≥0.7 exclusion criteria: 1. a plan of lung transplant after into group for one year. 2. in addition of ipf,other causes cause interstitial lung disease in patients； 3. patients with bleeding tendency (inr \> 2, pt or aptt \> 1.5 times normal) or cerebral hemorrhage in the past 1 year; 4. have used anticoagulant drugs within 1 month（except for low molecular weight heparin）; 5. an alcoholic or drug abuser; 6. expected survival ≤ one year; 7. patients who plan to undergo a operation within study period, such as major operations on chest and abdomen; 8. previous use of a jak inhibitor for more than 10 days or treatment failure; 9. suspected allergic to jaktinib dihydrochloride monohydrate , similar drugs (fedratinib,ruxolitinib)or their excipients; 10. patients with malignant tumors in the previous 5 years; 11. patients with other serious diseases that investigators believe may affect patient safety or compliance; 12. 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)； 13. patients hospitalized for deterioration or acute exacerbation of ipf within 1 month prior to screening; 14. patients who had not fully recovered from surgery within 1 month prior to screening; 15. participate in clinical trials of other new drugs or medical devices within 3 months before screening; 16. prednisone \> 15mg/ day or equivalent within 1 month prior to screening; 17. those who had used pirfenidone, nintedanib, azathioprine, cyclophosphamide, cyclosporine a or other immunosuppressive drugs within 1 month prior to screening; 18. 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; 19. patients with active tb in the 12 months prior to screening; 20. screening patients with arrhythmia requiring treatment, or with qtcb \>480ms; 21. 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. 22. 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; 23. patients with a history of progressive multifocal leukoencephalopathy in screening ; 24. 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; 25. 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; 26. subjects who cannot be treated and followed up according to the protocol; 27. any subject whom the investigator considers inappropriate for this clinical study.