A Study to Evaluate the Efficacy,Safety,Tolerability,Pharmacokinetics,and Immunogenicty of Plonmarlimab in Subjects With Acute Gouty Arthritis
Sponsor: TJ Biopharma Co., Ltd. • ClinicalTrials.gov ID: NCT07453004
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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.
Interventions
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Plonmarlimab
(Drug)
single dose, intravenous infusion
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Compound betamethasone
(Drug)
single dose, intramuscular injection
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Plonmarlimab placebo
(Drug)
single dose, intravenous infusion
-
Compound betamethasone placebo
(Drug)
single dose, intramuscular injection
Eligibility criteria
Conditions
Locations
- The First Affiliated Hospital of Bengbu Medical University — Bengbu, Anhui, China
- The Second Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China
- Jiangmen Central Hospital — Jiangmen, Guangdong, China
- Zhongshan Hospital of Traditional Chinese Medicine — Zhongshan, Guangdong, China
- The first affiliated Hospital of Guilin Medical University — Guilin, Guangxi, China
- The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China
- The Second Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China
- Hebei Petro China Central Hospital — Langfang, Hebei, China
- The First Hospital of Hebei Medical University — Shijiazhuang, Hebei, China
- The First Affiliated Hospital of Henan University of Science and Technology — Luoyang, Henan, China
- Zhengzhou Central Hospital — Zhengzhou, Henan, China
- UnHospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China
- The central Hospital of Xiangtan — Xiangtan, Hunan, China
- Zhuzhou Central Hospital — Zhuzhou, Hunan, China
- Wuxi People's Hospital — Wuxi, Jiangsu, China
- Northern Jiangsu People's Hospital — Yangzhou, Jiangsu, China
- First Affiliated Hospital of Gannan Medical University — Ganzhou, Jiangxi, China
- PingXiang People's Hospital — Pingxiang, Jiangxi, China
- The People's Hospital of Jilin Province — Changchun, Jilin, China
- Shandong Medical and Pharmaceutical University Hospital — Binzhou, Shandong, China
- Jining NO.1 People's Hospital — Jining, Shandong, China
- Linyi People Hospital — Linyi, Shandong, China
- Zaozhuang Municipal Hospital — Zaozhuang, Shandong, China
- Renji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China
- Linfen Central Hospital — Linfen, Shanxi, China
- Shanxi Bethune Hospital — Taiyuan, Shanxi, China
- Chengdu fifth People's Hospital — Chengdu, Sichuan, China
- Mianyang Central Hospital — Mianyang, Sichuan, China
- The first People's Hospital of Yibin — Yibin, Sichuan, China
- Huzhou Third People's Hospital — Huzhou, Zhejiang, China
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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