drugset / Trial / NCT07453004
A Study to Evaluate the Efficacy,Safety,Tolerability,Pharmacokinetics,and Immunogenicty of Plonmarlimab in Subjects With Acute Gouty Arthritis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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.
Timeline
- Start
- 2026-03-26
- Primary completion
- 2027-12-31
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | BETAMETHASONE DIPROPIONATE | Small molecule | 7 mg | Intramuscular |
| Subject | Plonmarlimab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Plonmarlimab | Monoclonal antibody | 6 mg/kg | Intravenous |