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NCT07708181
A Study of SSGJ-613 in Gout Participants Initiating Urate-Lowering Treatment
Conditions: Gout Arthritis
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 200
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
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Source: ClinicalTrials.gov (NCT07708181). StuddyBuddy aggregates publicly available trial information.
