A Study of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout

A Phase 3, Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Trial to Evaluate the Efficacy and Safety of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout

The purpose of this study is to determine the efficacy and safety of recombinant anti-IL-1β humanized monoclonal antibody injection in Chinese participants with acute gout.

Study SSGJ-613-AG-III-01 is a phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group study examining the effect of recombinant anti-IL-1β humanized monoclonal antibody injection versus compound betamethasone injection in Chinese adult patients with frequent flares of acute gouty arthritis who are contraindicated, intolerant, or lack efficacy to non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine. The entire treatment period is 48 weeks, consisting of a double-blind treatment period of 24 weeks and an open treatment period of 24 weeks.

Inclusion Criteria:

• Must be 18 Years to 75 Years, both male and female.
• BMI ≤35 kg/m2.
• Meeting the American College of Rheumatology (ACR) 2015 criteria for the classification of acute arthritis of primary gout.
• History of ≥ 3 gout flares within the 12 months prior to study randomization.
• Onset of current acute gout flare within 4 days prior to study screening.
• Screening pain intensity of the Target Joint ≥ 50 mm on the 0-100 mm VAS.
• Contraindicated, intolerant or lack efficacy to NSAIDs and/or colchicine.
• Accept uric acid lowering treatment according to the requirements of the protocol.

Exclusion Criteria:

• Gout caused by radiotherapy/chemotherapy, lead, organ transplantation, tumors, etc.
• Evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis.
• Presence of severe renal function impairment.
• Intolerance of subcutaneous and intramuscular injection.
• Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment.
• History of malignant tumor within 5 years before screening.
• Live vaccinations within 8 weeks prior to the start of the study.
• Use of forbidden therapy.