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NCT Number: NCT07708181

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

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

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Key information

Conditions

Gout Arthritis Arthritis Arthritis, Gouty Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Gout Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SSGJ-613 100 mg Q12W

Drug

Participants will receive one s.c. injection of SSGJ-613 on Day 1、W12

SSGJ-613 200 mg Q12W

Drug

Participants will receive one s.c. injection of SSGJ-613 on Day 1、W12

SSGJ-613 100 mg Q4W

Drug

Participants will receive one s.c. injection of SSGJ-613 on Day 1、W4、W8、W12

Colchicine 0.5 MG

Drug

Participants will receive 0.5mg bid Colchicine for 24 weeks.

Primary outcomes

  1. Numbers of acute gout flares

    Time frame: 24 weeks

Secondary outcomes

  1. Numbers of acute gout flares

    Time frame: 12 weeks

  2. Proportions of subjects with at least 1 acute gout flare

    Time frame: 12、24、48weeks

  3. Time from randomization to first acute flare.

    Time frame: 12、24、48 Weeks

  4. Numbers of acute gout flares

    Time frame: 12、24 Weeks

Sponsors and collaborators

Lead sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 16, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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