A Study of SSGJ-613 in Gout Participants Initiating Urate... | NCT07708181

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

NCT07708181

Sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Status

Not yet recruiting

Last Update Posted

Jul 16, 2026Actual

Enrollment

200Estimated

Phase

Phase 2

Conditions

Gout Arthritis

Interventions

SSGJ-613 100 mg Q12W
SSGJ-613 200 mg Q12W
SSGJ-613 100 mg Q4W
Colchicine 0.5 mg

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2, 2026Estimated

Primary Completion Date

Aug 11, 2027Estimated

Completion Date

Apr 19, 2028Estimated

First Submitted Date

Jul 12, 2026

First Submission Date that Met QC Criteria

Jul 12, 2026

First Posted Date

Jul 16, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2026

Last Update Posted Date

Jul 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
SSGJ-613 100 mg Q12W	Experimental	Drug: SSGJ-613 100 mg Q12W
SSGJ-613 200 mg Q12W	Experimental	Drug: SSGJ-613 200 mg Q12W
Colchicine 0.5mg	Active Comparator	Drug: Colchicine 0.5 mg
SSGJ-613 100 mg Q4W	Experimental	Drug: SSGJ-613 100 mg Q4W

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SSGJ-613 100 mg Q12W	Drug	Participants will receive one s.c. injection of SSGJ-613 on Day 1、W12	SSGJ-613 100 mg Q12W

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Numbers of acute gout flares		24 weeks

Secondary Outcomes

Measure	Description	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.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015210	Arthritis, Gouty

Ancestor Terms

ID	Term
D006073	Gout
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003078	Colchicine

Ancestor Terms

ID	Term
D000470	Alkaloids
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided