SSGJ ‐613 Alleviates Pain and Reduces the Risk of Acute Flares in Patients With Gout: A Randomized, Double‐Blind, Phase II Study

OBJECTIVES: This phase II trial aimed to evaluate the efficacy and safety of SSGJ-613, a fully human anti-interleukin 1β monoclonal antibody, compared with compound betamethasone (CB) in Chinese patients with acute gouty arthritis. METHODS: In this multicenter, double-blind, double-dummy, active-controlled study, 90 adults with gout according to the 2015 American College of Rheumatology (ACR) criteria and who had experienced an acute gouty arthritis flare within 7 days were randomized (1:1:1) to receive a single subcutaneous injection of SSGJ-613 (200 mg or 300 mg) or intramuscular CB. The primary endpoint was the change from baseline in visual analog scale (VAS) pain scores at 72 h post-dosing. Safety was evaluated through monitoring of adverse events and laboratory parameters. RESULTS: The mean changes from baseline in VAS scores at 72 h were comparable between SSGJ-613200 mg (-45.8 mm), 300 mg (-40.4 mm), and CB (-48.2 mm) groups. However, SSGJ-613 significantly reduced the risk of new flares: 16.7% (200 mg) and 14.3% (300 mg) of patients experienced new flares versus 54.8% with CB (p = 0.0037 and p = 0.0019, respectively). The safety profile of SSGJ-613 was similar to CB, with no drug-related serious adverse events reported. CONCLUSION: A single injection of SSGJ-613 demonstrated rapid pain relief comparable to corticosteroid therapy at 72 h and provided superior protection against gout flare recurrence over 12 weeks in Chinese patients, supporting its potential as an effective treatment option for acute gouty arthritis with prolonged therapeutic benefits. CLINICAL TRIALS: NCT06169891.