Study of Jaktinib Hydrochloride Tablets in Participants With Idiopathic Pulmonary Fibrosis

NCT ID: NCT04312594

Last Updated: 2024-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-08
• Study Completion Date: 2022-06-09

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.

Conditions

Idiopathic Pulmonary Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Jaktinib 50mg BID

Patients receive the dose of Jaktinib Hydrochloride Tablets orally 50mg twice daily (BID) for 24 weeks.

Group Type: EXPERIMENTAL

Jaktinib Hydrochloride Tablets

Intervention Type: DRUG

Patients were administered Jaktinib taken orally as tablets twice daily

Jaktinib 75mg BID

Patients receive the dose of Jaktinib Hydrochloride Tablets orally 75mg twice daily (BID) for 24 weeks.

Group Type: EXPERIMENTAL

Jaktinib Hydrochloride Tablets

Intervention Type: DRUG

Patients were administered Jaktinib taken orally as tablets twice daily

Placebo

Patients receive the dose of placebo orally twice daily (BID) for 24 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Patients were administered Placebo taken orally as tablets twice daily

Interventions

Jaktinib Hydrochloride Tablets

Patients were administered Jaktinib taken orally as tablets twice daily

Intervention Type: DRUG

Jaktinib Hydrochloride Tablets

Patients were administered Jaktinib taken orally as tablets twice daily

Intervention Type: DRUG

Placebo

Patients were administered Placebo taken orally as tablets twice daily

Intervention Type: DRUG

Other Intervention Names

Jaktinib; Jaktinib

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason Wu

Role: STUDY_CHAIR

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

ZGJAK005

Identifier Type: -

Identifier Source: org_study_id