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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jaktinib 50mg BID | Experimental | Patients receive the dose of Jaktinib Hydrochloride Tablets orally 50mg twice daily (BID) for 24 weeks. |
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| Jaktinib 75mg BID | Experimental | Patients receive the dose of Jaktinib Hydrochloride Tablets orally 75mg twice daily (BID) for 24 weeks. |
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| Placebo | Placebo Comparator | Patients receive the dose of placebo orally twice daily (BID) for 24 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jaktinib Hydrochloride Tablets | Drug | Patients were administered Jaktinib taken orally as tablets twice daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in forced vital capacity (FVC) [ Time Frame: 24 weeks ] | Changes in FVC from 24 weeks to baseline | 24 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Wu | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Jaktinib Hydrochloride Tablets | Drug | Patients were administered Jaktinib taken orally as tablets twice daily |
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| Placebo | Drug | Patients were administered Placebo taken orally as tablets twice daily |
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| 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 scaleļ¼absolute 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 |