A Phase 2 interventional study of Jaktinib Hydrochloride Tablets and Jaktinib Hydrochloride Tablets in Idiopathic Pulmonary Fibrosis, sponsored by Suzhou Zelgen Biopharmaceuticals Co.,Ltd. Completed at 1 site in China. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-12-12.
Sponsored by Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Phase 2, Interventional, and Treatment
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.
680 studies on the registry are indexed under Pulmonary Fibrosis; 119 are open to participants now.
This study's enrollment of 91 is above the median of 50 across 419 interventional studies indexed under Pulmonary Fibrosis.
Browse Pulmonary Fibrosis studies →Suzhou Zelgen Biopharmaceuticals Co.,Ltd is the lead sponsor of 82 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive the dose of Jaktinib Hydrochloride Tablets orally 50mg twice daily (BID) for 24 weeks.
Drug: Jaktinib Hydrochloride Tablets
Patients receive the dose of Jaktinib Hydrochloride Tablets orally 75mg twice daily (BID) for 24 weeks.
Drug: Jaktinib Hydrochloride Tablets
Patients receive the dose of placebo orally twice daily (BID) for 24 weeks.
Drug: Placebo
Patients were administered Jaktinib taken orally as tablets twice daily
Also known as: Jaktinib
Patients were administered Jaktinib taken orally as tablets twice daily
Also known as: Jaktinib
Patients were administered Placebo taken orally as tablets twice daily
Changes in forced vital capacity (FVC) [ Time Frame: 24 weeks ]
Changes in FVC from 24 weeks to baseline
Time frame: 24 weeks
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;
Time frame: 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
Time frame: 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
Time frame: 24 weeks
mMRC Dyspnea scale:absolute value of change from baseline [ Time Frame: 24 weeks ]
absolute value of change from baseline at 24 weeks
Time frame: 24 weeks
Survival rate: [ Time Frame: 6 months, 12 months, 24 months ]
Survival rate
Time frame: 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
Time frame: within 28 days after the signing of the informed consent
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Suzhou Zelgen Biopharmaceuticals Co.,Ltd