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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

About this trial

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

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • SSGJ-613 100 mg Q12W
  • SSGJ-613 200 mg Q12W
  • SSGJ-613 100 mg Q4W
  • Colchicine 0.5 mg

Treatment groups

200 Participants
are divided into 4 treatment groups

Locations

This trial has no locations