Study of Jaktinib Hydrochloride Tablets in Participants With Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04312594
• Other study ID #: ZGJAK005
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 8, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 91
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• Jaktinib Hydrochloride Tablets
Patients were administered Jaktinib taken orally as tablets twice daily
• Jaktinib Hydrochloride Tablets
Patients were administered Jaktinib taken orally as tablets twice daily
• Placebo
Patients were administered Placebo taken orally as tablets twice daily

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in forced vital capacity (FVC) [ Time Frame: 24 weeks ]	Changes in FVC from 24 weeks to baseline	24 weeks
Secondary	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
Secondary	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
Secondary	K-BILD Scale: absolute value of change from baseline [ Time Frame: 24 weeks ]	absolute value of change from baseline at 24 weeks	24 weeks
Secondary	mMRC Dyspnea scale:absolute value of change from baseline [ Time Frame: 24 weeks ]	absolute value of change from baseline at 24 weeks	24 weeks
Secondary	Survival rate: [ Time Frame: 6 months, 12 months, 24 months ]	Survival rate	6 months, 12 months, 24 months
Secondary	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