Status:
UNKNOWN
A Study of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout
Lead Sponsor:
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Conditions:
Acute Gout
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06169891
Start Date
December 1 2023
End Date
November 1 2025
Last Update
December 14 2023
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