Actively Recruiting
A Study to Evaluate the Efficacy,Safety,Tolerability,Pharmacokinetics,and Immunogenicty of Plonmarlimab in Subjects With Acute Gouty Arthritis
Led by TJ Biopharma Co., Ltd. · Updated on 2026-04-03
170
Participants Needed
1
Research Sites
92 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Evaluate the Efficacy,Safety,Tolerability,Pharmacokinetics,and Immunogenicty of Plonmarlimab in Subjects With Acute Gouty Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Willingness to participate and sign informed consent
- Meet the 2015 ACR/EULAR gout classification criteria
- Experienced three or more acute gout flare episodes in the past 12 months
- Experienced an acute gout flare within 5 days before receiving study treatment
- Contraindicated, intolerant, or inadequately responsive to colchicine and/or NSAIDs
- Baseline pain score of 50 mm or higher on the Visual Analogue Scale in the most affected joint
- May or may not be on urate-lowering therapy; if so, dose must be stable for at least 2 weeks before baseline
- No pregnancy plans from screening until 90 days after dosing and agree to use effective contraception
You will not qualify if you...
- Secondary gout caused by other causes such as chemotherapy
- Hypersensitivity to study drug components or similar biologics
- Contraindications to compound betamethasone therapy
- Presence of other rheumatic diseases that could affect results
- Significant pulmonary diseases impairing lung function
- Recent serious cardiovascular diseases or abnormal heart rhythms
- History of cancer within 5 years except certain skin cancers
- Clinically significant unstable or uncontrolled diseases unrelated to gout
- Active or recurrent infections including tuberculosis, HIV, hepatitis, and others
- Abnormal liver or kidney function beyond specified limits
- Blood disorders or abnormal blood test results
- Planned surgery or medical procedures affecting eligibility
- History of organ transplantation
- Pregnant or breastfeeding women
- Participation in other interventional clinical trials within 3 months
- Recent live vaccine administration
- Inability to receive intramuscular injections
- Drug or alcohol abuse within specified timeframes
- Any condition that increases risk or complicates study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
L
Lina Qin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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