A Study of SSGJ-613 in Gout Participants Initiating Urate-Lowering Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SSGJ-613 100 mg Q12W, SSGJ-613 200 mg Q12W, SSGJ-613 100 mg Q4W, Colchicine 0.5 mg.
- Who it may be relevant to
- Registry conditions: Gout Arthritis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2, Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Trial to Evaluate the Efficacy and Safety of SSGJ-613 for Prophylaxis Against Acute Gouty Arthritis Flares in Subjects Initiating Urate-Lowering Treatment.
Overview
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
Interventions
- Drug SSGJ-613 100 mg Q12W
Participants will receive one s.c. injection of SSGJ-613 on Day 1、W12 - Drug SSGJ-613 200 mg Q12W
Participants will receive one s.c. injection of SSGJ-613 on Day 1、W12 - Drug SSGJ-613 100 mg Q4W
Participants will receive one s.c. injection of SSGJ-613 on Day 1、W4、W8、W12 - Drug Colchicine 0.5 mg
Participants will receive 0.5mg bid Colchicine for 24 weeks.
Primary outcome measures
- Numbers of acute gout flares [Time frame: 24 weeks]
Secondary outcome measures (4)
- Numbers of acute gout flares [Time frame: 12 weeks]
- Proportions of subjects with at least 1 acute gout flare [Time frame: 12、24、48weeks]
- Time from randomization to first acute flare. [Time frame: 12、24、48 Weeks]
- Numbers of acute gout flares [Time frame: 12、24 Weeks]
Eligibility criteria
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.
- ≥4 acute gout flares within 1 year prior to screening
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07708181 · SSGJ-613-PGF-II-02