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
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.
• Subjects aged ≥18 years, regardless of gender.
• Subjects are willing to participate in this study and voluntarily sign the informed consent form.
• Meet the 2015 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) gout classification criteria.
• Experienced ≥3 episodes of acute gout flare within the 12 months prior to baseline (determination of an acute gout flare based on patient history, referral records, etc., will be made by the investigator).
• Subjects have experienced an acute gout flare within 5 days prior to administration of the investigational product (determination of an acute gout flare based on patient history, referral records, etc., will be made by the investigator).
• Contraindicated, intolerant, or inadequately responsive to colchicine and/or non-steroidal anti-inflammatory drugs (NSAIDs) (determination based on patient history, referral records, etc., will be made by the investigator).
• Baseline pain intensity assessment in the most severely affected joint by the subject using a 0-100 mm Visual Analogue Scale (VAS) is ≥50 mm.
• Subjects may or may not be receiving urate-lowering therapy. If planning to continue urate-lowering therapy during the study, it must have been at a stable dose for ≥2 weeks prior to baseline.
• Subjects (including their partners) have no pregnancy plans from the screening period until 90 days after dosing and voluntarily agree to use effective contraception.