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A Study of SSGJ-613 in Gout Participants Initiating Urate-Lowering Treatment

NCT07708181 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-07-20

No results posted yet for this study

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

Conditions

  • Gout Arthritis

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.

Sponsors & Collaborators

  • Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-02
Primary Completion
2027-08-11
Completion
2028-04-19

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07708181 on ClinicalTrials.gov