Study of Jaktinib Hydrochloride Tablets in Participants With Idiopathic Pulmonary Fibrosis

Phase 2

Completed

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: Jaktinib Hydrochloride Tablets; Drug: Placebo

• Registration Number: NCT04312594
• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-27
• Study First Submitted QC: 2020-03-16
• Study First Posted: 2020-03-18
• Study Start: 2020-09-08
• Primary Completion: 2022-06-09
• Study Completion: 2022-06-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Jaktinib 75mg BID	Jaktinib Hydrochloride Tablets	Patients receive the dose of Jaktinib Hydrochloride Tablets orally 75mg twice daily (BID) for 24 weeks.
Placebo	Placebo	Patients receive the dose of placebo orally twice daily (BID) for 24 weeks.
Jaktinib 50mg BID	Jaktinib Hydrochloride Tablets	Patients receive the dose of Jaktinib Hydrochloride Tablets orally 50mg twice daily (BID) for 24 weeks.

Primary Outcome Measures

Name	Time	Method
Changes in forced vital capacity (FVC) [ Time Frame: 24 weeks ]	24 weeks	Changes in FVC from 24 weeks to baseline

Secondary Outcome Measures

Name	Time	Method
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	The time from a random date to the onset of disease or death from any cause;
Non-worsening survival time: [ Time Frame:the time from randomization to the first acute exacerbation ];	from randomization to one month	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
K-BILD Scale: absolute value of change from baseline [ Time Frame: 24 weeks ]	24 weeks	absolute value of change from baseline at 24 weeks
mMRC Dyspnea scale：absolute value of change from baseline [ Time Frame: 24 weeks ]	24 weeks	absolute value of change from baseline at 24 weeks
Survival rate: [ Time Frame: 6 months, 12 months, 24 months ]	6 months, 12 months, 24 months	Survival rate
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	The severity and incidence of all adverse events and adverse reactions

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China