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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.The sponsor's other registered studies.
- 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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07708181
- Acronym / sponsor ID
- SSGJ-613-PGF-II-02
- Conditions
- Gout Arthritis
- Keywords
- Gout Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Aug 2026 (estimated)
- Primary completion
- 11 Aug 2027 (estimated)
- Study completion
- 19 Apr 2028 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SSGJ-613 100 mg Q12WParticipants will receive one s.c. injection of SSGJ-613 on Day 1、W12 | Drug | SSGJ-613 100 mg Q12W |
| SSGJ-613 200 mg Q12WParticipants will receive one s.c. injection of SSGJ-613 on Day 1、W12 | Drug | SSGJ-613 200 mg Q12W |
| SSGJ-613 100 mg Q4WParticipants will receive one s.c. injection of SSGJ-613 on Day 1、W4、W8、W12 | Drug | SSGJ-613 100 mg Q4W |
| Colchicine 0.5 mgParticipants will receive 0.5mg bid Colchicine for 24 weeks. | Drug | Colchicine 0.5mg |
Primary outcome
Numbers of acute gout flares
Time frame: 24 weeks
4 secondary outcomes
Numbers of acute gout flares
Time frame: 12 weeks
Proportions of subjects with at least 1 acute gout flare
Time frame: 12、24、48weeks
Time from randomization to first acute flare.
Time frame: 12、24、48 Weeks
Numbers of acute gout flares
Time frame: 12、24 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
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..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of acute gout flares (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.