NCT07453004

A Study to Evaluate the Efficacy,Safety,Tolerability,Pharmacokinetics,and Immunogenicty of Plonmarlimab in Subjects With Acute Gouty Arthritis

A Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Phase II Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Punarlimab in Subjects With Acute Gouty Arthritis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: TJ Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Gouty Arthritis

Interventions

Type	Name	Description
DRUG	Plonmarlimab	single dose, intravenous infusion
DRUG	Compound betamethasone	single dose, intramuscular injection
DRUG	Plonmarlimab placebo	single dose, intravenous infusion
DRUG	Compound betamethasone placebo	single dose, intramuscular injection

Timeline

• Start date: 2026-03-26
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2026-03-05
• Last updated: 2026-04-03

Locations

1 site across 1 country: China