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

ConditionAcute 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Plonmarlimab
Drug
single dose, intravenous infusion
Compound betamethasone
Drug
single dose, intramuscular injection
Plonmarlimab placebo
Drug
single dose, intravenous infusion
Compound betamethasone placebo
Drug
single dose, intramuscular injection

Treatment groups

170 Participants

are divided into 3 treatment groups

Group A: Group1-Plonmarlimab 3mg/kgExperimental treatment 2 interventions

Group B: Group2-Plonmarlimab 6mg/kgExperimental treatment 2 interventions

Group C: Group3-Compound betamethasoneActive comparator 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame

72 hours after the initial dose.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

TJ Biopharma Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

Apply now