A Study of SSGJ-613 in Gout Participants Initiating Urate-Lowering Treatment

Starting soon · Phase 2

Conditions studied: Gout Arthritis

In brief

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

Key facts

Study ID

NCT07708181

Run by

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

People needed

200

Starts

2026-08-02

Expected to finish

2028-04-19

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must be 18 Years to 75 Years, both male and female.
• BMI ≤40 kg/m2.
• Meeting the American College of Rheumatology (ACR) 2015 criteria for the classification of gouty arthritis.
• ≥4 acute gout flares within 1 year prior to screening

You may not qualify if…

• Gout caused by radiotherapy/chemotherapy, organ transplantation, tumors, etc.
• Evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis.
• Presence of severe renal function impairment.
• Intolerance of subcutaneous injection.
• Known presence or suspicion of active or recurrent bacterial, fungal, or viral infection at the time of enrollment.
• Live vaccinations within 8 weeks prior to the start of the study.
• Use of forbidden therapy.

Full record on ClinicalTrials.gov

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