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

Recruiting Phase 2 Interventional Study
Acute Gouty Arthritis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
170 (estimated)
Sponsor
TJ Biopharma Co., Ltd. · Industry
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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 s…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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. * …
Contacts

Lina Qin

18600672907

lina.qin@tjbio.com

CONTACT