Study of Jaktinib Hydrochloride Tablets in Participants With Idiopathic Pulmonary Fibrosis

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized, Double-Blind,Placebo-controlled,Phase 2 Study of Jaktinib Hydrochloride Tablets in Participants With Idiopathic Pulmonary Fibrosis

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Drug: Jaktinib Hydrochloride Tablets
* Drug: Jaktinib Hydrochloride Tablets
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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, nidanib, 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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jaktinib 50mg BID<br>Patients receive the dose of Jaktinib Hydrochloride Tablets orally 50mg twice daily (BID) for 24 weeks. | Drug: Jaktinib Hydrochloride Tablets<br>* Patients were administered Jaktinib taken orally as tablets twice daily<br>* Other names: Jaktinib;|
| Experimental: Jaktinib 75mg BID<br>Patients receive the dose of Jaktinib Hydrochloride Tablets orally 75mg twice daily (BID) for 24 weeks. | Drug: Jaktinib Hydrochloride Tablets<br>* Patients were administered Jaktinib taken orally as tablets twice daily<br>* Other names: Jaktinib;|
| Placebo Comparator: Placebo<br>Patients receive the dose of placebo orally twice daily (BID) for 24 weeks. | Drug: Placebo<br>* Patients were administered Placebo taken orally as tablets twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in forced vital capacity (FVC) [ Time Frame: 24 weeks ] | Changes in FVC from 24 weeks to baseline | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free time [ Time Frame: the onset of disease or death from any cause ] | The time from a random date to 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 | 
| Non-worsening survival time: [ Time Frame:the time from randomization to the first acute exacerbation ]; | acute aggravation events should meet all the following conditions: (1) acute exacerbation or aggravation of respiratory distress within 1 month;Chest CT showed new bilateral ground glass shadows or pulmonary interstitial fibrosis with pulmonary consolidation;(3) exclude heart failure, fluid retention and infection caused by acute dyspnea | from randomization to one month | 
| K-BILD Scale: absolute value of change from baseline [ Time Frame: 24 weeks ] | absolute value of change from baseline at 24 weeks | 24 weeks | 
| mMRC Dyspnea scale：absolute value of change from baseline [ Time Frame: 24 weeks ] | absolute value of change from baseline at 24 weeks | 24 weeks | 
| Survival rate: [ Time Frame: 6 months, 12 months, 24 months ] | Survival rate | 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] | The severity and incidence of all adverse events and adverse reactions | within 28 days after the signing of the informed consent |