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This is a multi center,randomized,double-blind,double-dummy,active-controlled study,and planned enrollment of 120-170 subjects,an interim analysis will be conducted after first 60 subjects complete the 72 -hour pain Visual Analogue Scale(VAS) assessment following their initial dose.Based on the analysis result,the sample size may be adjusted, and 1or 2 group(s)of the investigational drug will be selected to continue enrollment along with the active comparator group.The goal is to evaluate the efficacy of plonmarlimab in subjects with acute gouty arthristis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1-Plonmarlimab 3mg/kg | Experimental | Plonmarlimab 3mg/kg, Single dose, Intravenous infusion |
|
| Group2-Plonmarlimab 6mg/kg | Experimental | Plonmarlimab 6mg/kg, Single dose, Intravenous infusion |
|
| Group3-Compound betamethasone | Active Comparator | Compound betamethasone 7 mg, single dose, intramuscular injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plonmarlimab | Drug | single dose, intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale(VAS) score | The change from baseline in the subject's self-assessed Visual Analogue Scale (VAS) score for pain intensity in the most severely affected joint at baseline, assessed at 72 hours after the initial dose. | 72 hours after the initial dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lina Qin | Contact | 18600672907 | lina.qin@tjbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | China |
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| Compound betamethasone | Drug | single dose, intramuscular injection |
|
| Plonmarlimab placebo | Drug | single dose, intravenous infusion |
|
| Compound betamethasone placebo | Drug | single dose, intramuscular injection |
|
| ID | Term |
|---|---|
| C000711830 | plonmarlimab |
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