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.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07708181

Enrollment

200

Registered

2026-07-16

Start date

2026-08-02

Completion date

2028-04-19

Last updated

2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gout Arthritis

Keywords

Gout Arthritis

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

Interventions

DRUGSSGJ-613 100 mg Q12W

Participants will receive one s.c. injection of SSGJ-613 on Day 1、W12

DRUGSSGJ-613 200 mg Q12W

Participants will receive one s.c. injection of SSGJ-613 on Day 1、W12

DRUGSSGJ-613 100 mg Q4W

Participants will receive one s.c. injection of SSGJ-613 on Day 1、W4、W8、W12

DRUGColchicine 0.5 mg

Participants will receive 0.5mg bid Colchicine for 24 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Numbers of acute gout flares	24 weeks

Secondary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 21, 2026