Gout ArthritisPhase 2NCT06270225
A Study of SSGJ-613 in Gout Subjects Initiating Urate-Lowering Treatment.
A Phase 2 study testing Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg, Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg and Colchicine 0.5 mg in people with Gout Arthritis, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.
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?
- Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg, Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg and Colchicine 0.5 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2024to Dec 2024
- Phase
- Phase 2
- 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 ≤40 kg/m2.
- Meeting the American College of Rheumatology (ACR) 2015 criteria for the classification of gouty arthritis.
- ≥2 acute gout flares within 1 year prior to screening.
- Willingness to initiate urate-lowering treatment or to initiate urate-lowering treatment within 7 days prior to administration.
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
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Huashan Hospital Fudan University-Rheumatology
Shanghai, Shanghai Municipality, 200040
About this study
Official title: A Randomized, Open-label, Active-Controlled Phase II 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
- Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg, Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg, Colchicine 0.5 mg
- Medical subject headings
- Arthritis, Gouty
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 100 mgDrug
Also called SSGJ-613 100mg
Subjects will receive one s.c. injection of SSGJ-613 on Day 1.
Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mgDrug
Also called SSGJ-613 200mg
Subjects will receive one s.c. injection of SSGJ-613 on Day 1.
Colchicine 0.5 mgDrug
Subjects will receive 0.5mg/d Colchicine for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| SSGJ-613 100 mg | Experimental | Subjects will receive 100mg SSGJ-613 on Day 1. Receives: Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg |
| SSGJ-613 200 mg | Experimental | Subjects will receive 200mg SSGJ-613 on Day 1. Receives: Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg |
| Colchicine 0.5mg | Active comparator | Subjects will receive 0.5mg/d Colchicine for 12 weeks. Receives: Drug: Colchicine 0.5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of acute gout flares
Measured: 12 weeks
Secondary outcomes (10)
Numbers of acute gout flares
Measured: 24 weeks
Proportions of subjects with at least 1 acute gout flare
Measured: 12 weeks
Proportions of subjects with at least 1 acute gout flare
Measured: 24 weeks
Time from randomization to first acute flare.
Measured: 24 weeks
Duration of acute gout flares.
Measured: 12 weeks
Duration of acute gout flares.
Measured: 24 weeks
Subject's overall assessment of response to treatment
Response to treatment will be assessed by the subjects using a five-point Likert scale: 1-very good, 2-good, 3-fair, 4-poor, and 5-very poor.
Measured: 24 weeks
Investigator's overall assessment of response to treatment
Response to treatment will be assessed by the Investigators using a five-point Likert scale: 1-very good, 2-good, 3-fair, 4-poor, and 5-very poor.
Measured: 24 weeks
36-item Short Form Survey (SF-36)
36-Item Short Form Survey (SF-36) will be used to assess the health and functional changes of the subjects. It comprises 36 items that measure perceived health on eight scales (i.e., physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health) with higher scores (range 0-100) reflecting better perceived health.
Measured: 24 weeks
Adverse events (AE)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start30 Mar 2024
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (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
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hejian Zou, MD, Principal investigator, Shanghai Huashan Hospital Fudan University-RheumatologyQinghong Zhou, Study director, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270225
- Sponsor's protocol ID
- SSGJ-613-PGF-II-01
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 5 Aug 2024
- 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 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Active-Controlled Phase II 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
- NCT06270225
- Acronym / sponsor ID
- SSGJ-613-PGF-II-01
- Conditions
- Gout Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Mar 2024 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 21 Feb 2024 (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
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SSGJ-613 100 mg | Experimental | Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mgSubjects will receive 100mg SSGJ-613 on Day 1. |
| SSGJ-613 200 mg | Experimental | Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mgSubjects will receive 200mg SSGJ-613 on Day 1. |
| Colchicine 0.5mg | Active comparator | Drug: Colchicine 0.5 mgSubjects will receive 0.5mg/d Colchicine for 12 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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.
- ≥2 acute gout flares within 1 year prior to screening.
- Willingness to initiate urate-lowering treatment or to initiate urate-lowering treatment within 7 days prior to administration.
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 |
|---|---|---|
| Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mgAlso: SSGJ-613 100mgSubjects will receive one s.c. injection of SSGJ-613 on Day 1. | Drug | SSGJ-613 100 mg |
| Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mgAlso: SSGJ-613 200mgSubjects will receive one s.c. injection of SSGJ-613 on Day 1. | Drug | SSGJ-613 200 mg |
| Colchicine 0.5 mgSubjects will receive 0.5mg/d Colchicine for 12 weeks. | Drug | Colchicine 0.5mg |
Primary outcome
Numbers of acute gout flares
Time frame: 12 weeks
10 secondary outcomes
Numbers of acute gout flares
Time frame: 24 weeks
Proportions of subjects with at least 1 acute gout flare
Time frame: 12 weeks
Proportions of subjects with at least 1 acute gout flare
Time frame: 24 weeks
Time from randomization to first acute flare.
Time frame: 24 weeks
Duration of acute gout flares.
Time frame: 12 weeks
Duration of acute gout flares.
Time frame: 24 weeks
Subject's overall assessment of response to treatment
Time frame: 24 weeks
Investigator's overall assessment of response to treatment
Time frame: 24 weeks
36-item Short Form Survey (SF-36)
Time frame: 24 weeks
Adverse events (AE)
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
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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 Huashan Hospital Fudan University-Rheumatology
Qinghong Zhou study director
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg, Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg and Colchicine 0.5 mg in people with Gout Arthritis, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.
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 5 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: status not confirmed, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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: 12 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 5 Aug 2024.