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A Study of SSGJ-613 in Gout Participants Initiating Urate-Lowering Treatment
Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Summary
The purpose of this study is to determine the efficacy and safety of recombinant anti-interleukin-1β humanized monoclonal antibody injection in Chinese gout participants Initiating Urate-Lowering Treatment
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Trial to Evaluate the Efficacy and Safety of SSGJ-613 for Prophylaxis Against Acute Gouty Arthritis Flares in Subjects Initiating Urate-Lowering Treatment.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-08-02
Completion Date
2028-04-19
Last Updated
2026-07-16
Healthy Volunteers
No
Conditions
Interventions
SSGJ-613 100 mg Q12W
Participants will receive one s.c. injection of SSGJ-613 on Day 1、W12
SSGJ-613 200 mg Q12W
Participants will receive one s.c. injection of SSGJ-613 on Day 1、W12
SSGJ-613 100 mg Q4W
Participants will receive one s.c. injection of SSGJ-613 on Day 1、W4、W8、W12
Colchicine 0.5 mg
Participants will receive 0.5mg bid Colchicine for 24 weeks.