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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTJ Biopharma Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

Secondary gout caused by various etiologies (e.g., gout induced by chemotherapy, judged by the investigator based on the subject's medical history, referral records, etc.).

History of hypersensitivity to any component of the investigational product or to similar biological agents.

Contraindication to compound betamethasone therapy.

Presence of other rheumatic diseases besides gout that may interfere with interpretation of results, including but not limited to rheumatoid arthritis, infectious/suppurative arthritis, traumatic arthritis, etc.

Trial design

Treatments tested in this trial

  • Plonmarlimab
  • Compound betamethasone
  • Plonmarlimab placebo
  • Compound betamethasone placebo

Treatment groups

170 Participants
are divided into 3 treatment groups

Sponsors and collaborators