A Study of SSGJ-613 in Gout Participants Initiating Urate-Lowering Treatment
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.
1 other identifier
interventional
200
0 countries
N/A
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2026
CompletedFirst Posted
Study publicly available on registry
July 16, 2026
CompletedStudy Start
First participant enrolled
August 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 11, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 19, 2028
July 20, 2026
July 1, 2026
1 year
July 12, 2026
July 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Numbers of acute gout flares
24 weeks
Secondary Outcomes (4)
Numbers of acute gout flares
12 weeks
Proportions of subjects with at least 1 acute gout flare
12、24、48weeks
Time from randomization to first acute flare.
12、24、48 Weeks
Numbers of acute gout flares
12、24 Weeks
Study Arms (4)
SSGJ-613 100 mg Q12W
EXPERIMENTALSSGJ-613 200 mg Q12W
EXPERIMENTALColchicine 0.5mg
ACTIVE COMPARATORSSGJ-613 100 mg Q4W
EXPERIMENTALInterventions
Participants will receive one s.c. injection of SSGJ-613 on Day 1、W12
Participants will receive one s.c. injection of SSGJ-613 on Day 1、W12
Participants will receive one s.c. injection of SSGJ-613 on Day 1、W4、W8、W12
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2026
First Posted
July 16, 2026
Study Start
August 2, 2026
Primary Completion (Estimated)
August 11, 2027
Study Completion (Estimated)
April 19, 2028
Last Updated
July 20, 2026
Record last verified: 2026-07