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

July 12, 2026 updated by: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

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.

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SSGJ-613 100 mg Q12W
Drug: SSGJ-613 100 mg Q12W
Participants will receive one s.c. injection of SSGJ-613 on Day 1、W12
Experimental: SSGJ-613 200 mg Q12W
Drug: SSGJ-613 200 mg Q12W
Participants will receive one s.c. injection of SSGJ-613 on Day 1、W12
Active Comparator: Colchicine 0.5mg
Drug: Colchicine 0.5 mg
Participants will receive 0.5mg bid Colchicine for 24 weeks.
Experimental: SSGJ-613 100 mg Q4W
Drug: SSGJ-613 100 mg Q4W
Participants will receive one s.c. injection of SSGJ-613 on Day 1、W4、W8、W12

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Numbers of acute gout flares
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Numbers of acute gout flares
Time Frame: 12 weeks
12 weeks
Proportions of subjects with at least 1 acute gout flare
Time Frame: 12、24、48weeks
12、24、48weeks
Time from randomization to first acute flare.
Time Frame: 12、24、48 Weeks
12、24、48 Weeks
Numbers of acute gout flares
Time Frame: 12、24 Weeks
12、24 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 2, 2026

Primary Completion (Estimated)

August 11, 2027

Study Completion (Estimated)

April 19, 2028

Study Registration Dates

First Submitted

July 12, 2026

First Submitted That Met QC Criteria

July 12, 2026

First Posted (Actual)

July 16, 2026

Study Record Updates

Last Update Posted (Actual)

July 16, 2026

Last Update Submitted That Met QC Criteria

July 12, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSGJ-613-PGF-II-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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