Acute GoutPhase 3NCT06169891
A Study of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout
A Phase 3 study testing Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg and Compound Betamethasone Injection in people with Acute Gout, 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-IL-1β humanized monoclonal antibody injection in Chinese participants with acute gout. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Gout
- What is being tested?
- Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg and Compound Betamethasone Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Nov 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 ≤35 kg/m2.
- Meeting the American College of Rheumatology (ACR) 2015 criteria for the classification of acute arthritis of primary gout.
- History of ≥ 3 gout flares within the 12 months prior to study randomization.
- Onset of current acute gout flare within 4 days prior to study screening.
- Screening pain intensity of the Target Joint ≥ 50 mm on the 0-100 mm VAS.
- Contraindicated, intolerant or lack efficacy to NSAIDs and/or colchicine.
- Accept uric acid lowering treatment according to the requirements of the protocol.
Who cannot join
- Gout caused by radiotherapy/chemotherapy, lead, organ transplantation, tumors, etc.
- Evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis.
- Presence of severe renal function impairment.
- Intolerance of subcutaneous and intramuscular injection.
- Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment.
- History of malignant tumor within 5 years before screening.
- Live vaccinations within 8 weeks prior to the start of the study.
- Use of forbidden therapy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Trial to Evaluate the Efficacy and Safety of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout
The purpose of this study is to determine the efficacy and safety of recombinant anti-IL-1β humanized monoclonal antibody injection in Chinese participants with acute gout.
Read the detailed description
Study SSGJ-613-AG-III-01 is a phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group study examining the effect of recombinant anti-IL-1β humanized monoclonal antibody injection versus compound betamethasone injection in Chinese adult patients with frequent flares of acute gouty arthritis who are contraindicated, intolerant, or lack efficacy to non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine. The entire treatment period is 48 weeks, consisting of a double-blind treatment period of 24 weeks and an open treatment period of 24 weeks.
- Conditions
- Acute Gout
- Being tested
- Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg, Placebo, Compound Betamethasone Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mgDrug
Also called SSGJ-613 200 mg
one s.c. injection of SSGJ-613 once, on Day 1.
PlaceboOther
Also called 0.9% sodium chloride injection
Participants will receive Placebo matching Compound Betamethasone Injection to maintain the blinding of the Investigational Medicinal Products.
Compound Betamethasone InjectionDrug
1 mL i.m. once on Day 1
PlaceboOther
Also called PBO
Participants will receive Placebo matching SSGJ-613 to maintain the blinding of the Investigational Medicinal Products.
| Study group | Role | What they receive |
|---|---|---|
| SSGJ-613 200 mg | Experimental | SSGJ-613 200 mg subcutaneous (s.c) once. The s.c. injection could be administered into the abdomen or thigh. Randomized patients will receive one s.c. injection of SSGJ-613 and placebo matching compound betamethasone injection (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection is recommended to be administered deeply into the gluteal muscle. Receives: Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg; Other: Placebo |
| Compound Betamethasone Injection 1 mL | Active comparator | Compound betamethasone injection 1 mL intramuscularly (i.m) once. The i.m. injection is recommended to be administered deeply into the gluteal muscle. Randomized patients will receive compound betamethasone injection 1 mL i.m. once and placebo matching SSGJ-613 s.c. once, on Day 1. Receives: Drug: Compound Betamethasone Injection; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change in Pain Intensity in the Target Joint From Baseline to 72 Hours Post Dose as Measured on a 0-100 mm Visual Analog Scale (VAS)
The change in pain intensity from baseline to 72 hours post dose as measured on a 0-100 mm Visual Analog Scale (VAS): 0= no pain and 100= severe pain. Change from baseline = (post-baseline measurement - baseline).
Measured: 72 hours post-dose
Time to First New Flare
The Kaplan Meier method was used to estimate the median time and 95% CI of the first new flares within 12 weeks after the first administration of each group, as well as the event incidence and 95% CI at 12 weeks.
Measured: 12 weeks
Secondary outcomes (10)
The Change in Pain Intensity in the Target Joint From Baseline to 6, 24, 48 Hours and 7 Days Post Dose as Measured on a 0-100 mm Visual Analog Scale (VAS)
The change in pain intensity from baseline to 6, 12, 48 hours and 7 days post dose as measured on a 0-100 mm Visual Analog Scale (VAS): 0= no pain and 100= severe pain. Change from baseline = (post-baseline measurement - baseline).
Measured: At 6, 24, 48 hours and 7 Days post-dose
The Time to At Least 50% Reduction of Baseline Pain Intensity in the Target Joint after study drug administration
The time to at least 50% reduction in Pain intensity from baseline as measured by Visual Analog Scale (VAS) for each treatment group, is estimated using the Kaplan Meier method. Participants scored their pain intensity in the target joint on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100).
Measured: Up to 48 weeks
The Time to Complete Pain Remission of Baseline Pain Intensity in the Target Joint after study drug administration
The time to complete pain remission in Pain intensity from baseline as measured by a 5-point Likert scale for each treatment group, is estimated using the Kaplan Meier method. Participants scored their pain intensity in the target joint on a 5-point Likert scale: None, mild, moderate, severe, extremely severe.
Measured: Up to 48 weeks
Percentage of Participants with Complete Pain Remission of the Target Joint within 12 weeks after study drug administration
Participants scored their pain intensity in the target joint on a 5-point Likert scale: None, mild, moderate, severe, extremely severe.
Measured: 12 weeks
Time to first use of Rescue Medication
The Kaplan Meier method was used to estimate the median time and 95% CI of the first use of Rescue Medication.
Measured: Within 7 days after the first administration, within 7 days after the last acute attack of gout during the double blind treatment period
Percentage of Participants Taking Rescue Medication After Study Drug Administration and Categories and Dosages of Rescue Medication
Measured: 12 weeks, 24 weeks, 48 weeks
Likert scores for target joint pain
Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme).
Measured: 7 days, 12 weeks, 24 weeks
Time to First New Flare
The Kaplan Meier method was used to estimate the median time and 95% CI of the first new flares after the first administration of each group, as well as the event incidence and 95% CI.
Measured: 24 weeks, 48 weeks
Percentage of Participants with at least 1 new gout flare
Measured: 12 weeks, 24 weeks, 48 weeks
Number of new gout flares
Measured: 12 weeks, 24 weeks, 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study startDec 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute GoutStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hejian Zou, MD, Principal investigator, Shanghai Huanshan Hospital Fudan University-RheumatologyQinghong Zhou, MD, Study director, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169891
- Sponsor's protocol ID
- SSGJ-613-AG-III-01
- Status last verified
- Dec 2023
- First submitted
- 30 Nov 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xue Y, Zhu X, Zhang B, Li Y, Gou W, Dai L, Zhang N, Tang L, Zhang Z, Dong L, Yang X, Xu J, Li Z, Yang J, Lou J, Liu Y, Zou H. SSGJ-613 Alleviates Pain and Reduces the Risk of Acute Flares in Patients With Gout: A Randomized, Double-Blind, Phase II Study. Int J Rheum Dis. 2026 Aug;29(8):e70798. doi: 10.1111/1756-185x.70798.
PubMed 42530081
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Trial to Evaluate the Efficacy and Safety of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout
- ClinicalTrials.gov ID
- NCT06169891
- Acronym / sponsor ID
- SSGJ-613-AG-III-01
- Conditions
- Acute Gout
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 14 Dec 2023 (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-IL-1β humanized monoclonal antibody injection in Chinese participants with acute gout.
Detailed description
Study SSGJ-613-AG-III-01 is a phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group study examining the effect of recombinant anti-IL-1β humanized monoclonal antibody injection versus compound betamethasone injection in Chinese adult patients with frequent flares of acute gouty arthritis who are contraindicated, intolerant, or lack efficacy to non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine. The entire treatment period is 48 weeks, consisting of a double-blind treatment period of 24 weeks and an open treatment period of 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SSGJ-613 200 mg | Experimental | Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg, Other: PlaceboSSGJ-613 200 mg subcutaneous (s.c) once. The s.c. injection could be administered into the abdomen or thigh. Randomized patients will receive one s.c. injection of SSGJ-613 and placebo matching compound betamethasone injection (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection is recommended to be administered deeply into the gluteal muscle. |
| Compound Betamethasone Injection 1 mL | Active comparator | Drug: Compound Betamethasone Injection, Other: PlaceboCompound betamethasone injection 1 mL intramuscularly (i.m) once. The i.m. injection is recommended to be administered deeply into the gluteal muscle. Randomized patients will receive compound betamethasone injection 1 mL i.m. once and placebo matching SSGJ-613 s.c. once, on Day 1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Must be 18 Years to 75 Years, both male and female.
- BMI ≤35 kg/m2.
- Meeting the American College of Rheumatology (ACR) 2015 criteria for the classification of acute arthritis of primary gout.
- History of ≥ 3 gout flares within the 12 months prior to study randomization.
- Onset of current acute gout flare within 4 days prior to study screening.
Key exclusion criteria (8 listed)
- Gout caused by radiotherapy/chemotherapy, lead, organ transplantation, tumors, etc.
- Evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis.
- Presence of severe renal function impairment.
- Intolerance of subcutaneous and intramuscular 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 |
|---|---|---|
| Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mgAlso: SSGJ-613 200 mgone s.c. injection of SSGJ-613 once, on Day 1. | Drug | SSGJ-613 200 mg |
| PlaceboAlso: 0.9% sodium chloride injectionParticipants will receive Placebo matching Compound Betamethasone Injection to maintain the blinding of the Investigational Medicinal Products. | Other | SSGJ-613 200 mg |
| Compound Betamethasone Injection1 mL i.m. once on Day 1 | Drug | Compound Betamethasone Injection 1 mL |
| PlaceboAlso: PBOParticipants will receive Placebo matching SSGJ-613 to maintain the blinding of the Investigational Medicinal Products. | Other | Compound Betamethasone Injection 1 mL |
Primary outcome
The Change in Pain Intensity in the Target Joint From Baseline to 72 Hours Post Dose as Measured on a 0-100 mm Visual Analog Scale (VAS)
Time frame: 72 hours post-dose
The change in pain intensity from baseline to 72 hours post dose as measured on a 0-100 mm Visual Analog Scale (VAS): 0= no pain and 100= severe pain. Change from baseline = (post-baseline measurement - baseline).
Time to First New Flare
Time frame: 12 weeks
The Kaplan Meier method was used to estimate the median time and 95% CI of the first new flares within 12 weeks after the first administration of each group, as well as the event incidence and 95% CI at 12 weeks.
10 secondary outcomes
The Change in Pain Intensity in the Target Joint From Baseline to 6, 24, 48 Hours and 7 Days Post Dose as Measured on a 0-100 mm Visual Analog Scale (VAS)
Time frame: At 6, 24, 48 hours and 7 Days post-dose
The Time to At Least 50% Reduction of Baseline Pain Intensity in the Target Joint after study drug administration
Time frame: Up to 48 weeks
The Time to Complete Pain Remission of Baseline Pain Intensity in the Target Joint after study drug administration
Time frame: Up to 48 weeks
Percentage of Participants with Complete Pain Remission of the Target Joint within 12 weeks after study drug administration
Time frame: 12 weeks
Time to first use of Rescue Medication
Time frame: Within 7 days after the first administration, within 7 days after the last acute attack of gout during the double blind treatment period
Percentage of Participants Taking Rescue Medication After Study Drug Administration and Categories and Dosages of Rescue Medication
Time frame: 12 weeks, 24 weeks, 48 weeks
Likert scores for target joint pain
Time frame: 7 days, 12 weeks, 24 weeks
Time to First New Flare
Time frame: 24 weeks, 48 weeks
Percentage of Participants with at least 1 new gout flare
Time frame: 12 weeks, 24 weeks, 48 weeks
Number of new gout flares
Time frame: 12 weeks, 24 weeks, 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Derived from this study: PubMed 42530081Xue Y, Zhu X, Zhang B, Li Y, Gou W, Dai L, Zhang N, Tang L, Zhang Z, Dong L, Yang X, Xu J, Li Z, Yang J, Lou J, Liu Y, Zou H. SSGJ-613 Alleviates Pain and Reduces the Risk of Acute Flares in Patients With Gout: A Randomized, Double-Blind, Phase II Study. Int J Rheum Dis. 2026 Aug;29(8):e70798. doi: 10.1111/1756-185x.70798.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Hejian Zou, MD principal investigator
Shanghai Huanshan Hospital Fudan University-Rheumatology
Qinghong Zhou, MD study director
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg and Compound Betamethasone Injection in people with Acute Gout, 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 8 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 14 Dec 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qinghong Zhou, MD (+86 18911301578, zhouqinghong@3sbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Change in Pain Intensity in the Target Joint From Baseline to 72 Hours Post Dose as Measured on a 0-100 mm Visual Analog Scale (VAS) (time frame: 72 hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06169891, which also lists 1 linked publication.
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 14 Dec 2023.