Gout ArthritisPhase 2NCT07708181
A Study of SSGJ-613 in Gout Participants Initiating Urate-Lowering Treatment
A Phase 2 study testing SSGJ-613 100 mg Q12W, SSGJ-613 200 mg Q12W and SSGJ-613 100 mg Q4W in people with Gout Arthritis, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd..
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gout Arthritis
- What is being tested?
- SSGJ-613 100 mg Q12W, SSGJ-613 200 mg Q12W and SSGJ-613 100 mg Q4W
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 2 Aug 2026to 19 Apr 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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
- Conditions
- Gout Arthritis
- Being tested
- SSGJ-613 100 mg Q12W, SSGJ-613 200 mg Q12W, SSGJ-613 100 mg Q4W, Colchicine 0.5 mg
- Keywords
- Gout Arthritis
- Medical subject headings
- Arthritis, Gouty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSGJ-613 100 mg Q12WDrug
Participants will receive one s.c. injection of SSGJ-613 on Day 1、W12
SSGJ-613 200 mg Q12WDrug
Participants will receive one s.c. injection of SSGJ-613 on Day 1、W12
SSGJ-613 100 mg Q4WDrug
Participants will receive one s.c. injection of SSGJ-613 on Day 1、W4、W8、W12
Colchicine 0.5 mgDrug
Participants will receive 0.5mg bid Colchicine for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| SSGJ-613 100 mg Q12W | Experimental | Not described Receives: Drug: SSGJ-613 100 mg Q12W |
| SSGJ-613 200 mg Q12W | Experimental | Not described Receives: Drug: SSGJ-613 200 mg Q12W |
| Colchicine 0.5mg | Active comparator | Not described Receives: Drug: Colchicine 0.5 mg |
| SSGJ-613 100 mg Q4W | Experimental | Not described Receives: Drug: SSGJ-613 100 mg Q4W |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of acute gout flares
Measured: 24 weeks
Secondary outcomes (4)
Numbers of acute gout flares
Measured: 12 weeks
Proportions of subjects with at least 1 acute gout flare
Measured: 12、24、48weeks
Time from randomization to first acute flare.
Measured: 12、24、48 Weeks
Numbers of acute gout flares
Measured: 12、24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start2 Aug 2026 (estimated)
- Primary completion11 Aug 2027 (estimated)
- Study completion19 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gout ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708181
- Sponsor's protocol ID
- SSGJ-613-PGF-II-02
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No