A Randomized, Open-label, Active-Controlled Phase II Trial to Evaluate the Efficacy and Safety of SSGJ-613 for Prophylaxis Against Acute Gouty Arthritis Flares in Subjects Initiating Urate-Lowering Treatment.

SSGJ-613-PGF-II-01

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.

2024-03-30

2024-06-01

2024-12-01

Recruiting

Early phase I

150

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. * ≥2 acute gout flares within 1 year prior to screening. * Willingness to initiate urate-lowering treatment or to initiate urate-lowering treatment within 7 days prior to administration. 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}

2024-04-10