Study of Jaktinib Hydrochloride Tablets in Participants With Idiopathic Pulmonary Fibrosis

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: Jaktinib Hydrochloride Tablets; Drug: Placebo

Detailed Description

This phase 2 study of Jaktinib Dihydrochloride Monohydrate, an oral inhibitor of JAK1 、JAK2 and JAK3, is to assess efficacy and safety in patients with idiopathic pulmonary fibrosis.The study is a randomised,multicentre,double-blind,placebo-controlled,study.

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xu Zuo Jun; Phone Number: 13671345136; Email: xuzj@hotmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Investigators: Study Chair: Jason Wu, Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: March 16, 2020
• First Posted (Actual): March 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 28, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Protective Agents; Respiratory System Agents; Antioxidants; Antidotes; Free Radical Scavengers; Expectorants; Acetylcysteine; N-monoacetylcystine
• Other Study ID Numbers: ZGJAK005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No