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

Suzhou Zelgen Biopharmaceuticals Co.,Ltd1 site in 1 country91 target enrollmentSeptember 8, 2020

ConditionsIdiopathic Pulmonary Fibrosis

InterventionsJaktinib Hydrochloride Tablets Placebo

DrugsJaktinib Hydrochloride Tablets Placebo

Overview

Phase: Phase 2
Intervention: Jaktinib Hydrochloride Tablets
Conditions: Idiopathic Pulmonary Fibrosis
Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Enrollment: 91
Locations: 1
Primary Endpoint: Changes in forced vital capacity (FVC) [ Time Frame: 24 weeks ]
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 8, 2020

End Date

June 9, 2022

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Responsible Party

Sponsor

Eligibility Criteria

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;

Arms & Interventions

Jaktinib 50mg BID

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

Intervention: Jaktinib Hydrochloride Tablets

Jaktinib 75mg BID

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

Intervention: Jaktinib Hydrochloride Tablets

Placebo

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

Intervention: Placebo

Outcomes

Primary Outcomes

Changes in forced vital capacity (FVC) [ Time Frame: 24 weeks ]

Time Frame: 24 weeks

Changes in FVC from 24 weeks to baseline

Secondary Outcomes

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)
mMRC Dyspnea scale：absolute value of change from baseline [ Time Frame: 24 weeks ](24 weeks)
Survival rate: [ Time Frame: 6 months, 12 months, 24 months ](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](within 28 days after the signing of the informed consent)
Non-worsening survival time: [ Time Frame:the time from randomization to the first acute exacerbation ];(from randomization to one month)
K-BILD Scale: absolute value of change from baseline [ Time Frame: 24 weeks ](24 weeks)