A Study of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout
NCT ID: NCT06169891
Last Updated: 2023-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
500 participants
INTERVENTIONAL
2023-12-31
2025-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SSGJ-613 200 mg
SSGJ-613 200 mg subcutaneous (s.c) once. The s.c. injection could be administered into the abdomen or thigh. Randomized patients will receive one s.c. injection of SSGJ-613 and placebo matching compound betamethasone injection (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection is recommended to be administered deeply into the gluteal muscle.
Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg
one s.c. injection of SSGJ-613 once, on Day 1.
Placebo
Participants will receive Placebo matching Compound Betamethasone Injection to maintain the blinding of the Investigational Medicinal Products.
Compound Betamethasone Injection 1 mL
Compound betamethasone injection 1 mL intramuscularly (i.m) once. The i.m. injection is recommended to be administered deeply into the gluteal muscle. Randomized patients will receive compound betamethasone injection 1 mL i.m. once and placebo matching SSGJ-613 s.c. once, on Day 1.
Compound Betamethasone Injection
1 mL i.m. once on Day 1
Placebo
Participants will receive Placebo matching SSGJ-613 to maintain the blinding of the Investigational Medicinal Products.
Interventions
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Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg
one s.c. injection of SSGJ-613 once, on Day 1.
Placebo
Participants will receive Placebo matching Compound Betamethasone Injection to maintain the blinding of the Investigational Medicinal Products.
Compound Betamethasone Injection
1 mL i.m. once on Day 1
Placebo
Participants will receive Placebo matching SSGJ-613 to maintain the blinding of the Investigational Medicinal Products.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Hejian Zou, MD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Huanshan Hospital Fudan University-Rheumatology
Qinghong Zhou, MD
Role: STUDY_DIRECTOR
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Central Contacts
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Other Identifiers
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SSGJ-613-AG-III-01
Identifier Type: -
Identifier Source: org_study_id