A Phase Ib/II Study of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout
Acute Gout
About this trial
This is an interventional treatment trial for Acute Gout
Eligibility Criteria
Inclusion Criteria:
- Must be 18 Years to 65 Years, both male and female
- Meeting the American College of Rheumatology (ACR) 2015 criteria for the classification of acute arthritis of primary gout.
- Presence of acute gout flare for no longer than 7 days
- Baseline pain intensity > or = to 50 mm on the 0-100 mm VAS
- Contraindicated for, intolerant or unresponsive to NSAIDs, colchicine or both
Exclusion Criteria:
- Secondary gout (such as gout caused by chemotherapy, transplant gout, 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 3 months prior to the start of the study
- Use of forbidden therapy
Sites / Locations
- Site 02Recruiting
- Site 03
- Site 01Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
SSGJ-613 100 mg (phase Ib)
SSGJ-613 200 mg (phase Ib)
SSGJ-613 300 mg (phase Ib)
SSGJ-613 200 mg (phase II)
SSGJ-613 300 mg (phase II)
Compound Betamethasone Injection 1 mL (phase II)
Dose Arm 1 (phase Ib): SSGJ-613 100 mg subcutaneous (s.c) once. The s.c. injection could be administered into the abdomen or thigh.
Dose Arm 2 (phase Ib): SSGJ-613 200 mg subcutaneous (s.c) once. The s.c. injection could be administered into the abdomen or thigh.
Dose Arm 3 (phase Ib): SSGJ-613 300 mg subcutaneous (s.c) once. The s.c. injection could be administered into the abdomen or thigh.
Dose Arm 4 (phase II): 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.
Dose Arm 5 (phase II): SSGJ-613 300 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.
Dose Arm 6 (phase II): 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.