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

• Status: Not yet recruiting
• Trial end date: 2025-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
• Treatments: Antibodies; Antibodies, Monoclonal; Betamethasone

Criteria

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.