Gout FlaresNCT07616531
Efficacy and Safety of Scheduled Versus As-Needed Firsekibart Administration for the Prevention of Gout Recurrence: A Multicenter, Open-Label, Randomized Controlled Trial
A study testing Scheduled Firsekibart administration and As-Needed Firsekibart Administration in people with Gout Flares, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 11 sites in China.
Trial summary
Study Objective To compare the efficacy of continued scheduled dosing versus as-needed dosing in patients with acute gouty arthritis who remained recurrence-free after 24 weeks of treatment with Firsekibart. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gout Flares
- What is being tested?
- Scheduled Firsekibart administration and As-Needed Firsekibart Administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 11 sitesChina
- Study dates
- 1 May 2026to 28 Feb 2030
- Phase
- Interventional
- 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
- Age 18 to 75 years (inclusive), male or female;**
- Meet the 2015 ACR/EULAR Gout Classification Criteria;**
- Received initial treatment with Firsekibart 200 mg via subcutaneous injection for 24 weeks, and experienced no gout flares during this 24-week period;**
- Had≥2 gout flares within 1 year prior to the first administration of Firsekibart；
- Willing to comply with the protocol-defined urate-lowering therapy (ULT) during the study, meeting one of the following conditions:
- Patients currently receiving ULT with a stable regimen for≥14 days may continue their stable dosing; adjustments (including medication switch, dose reduction, or discontinuation) are permitted if the investigator assesses intolerance, poor efficacy, or achievement of target serum uric acid levels;
- For patients not on ULT or those on ULT but not stable for 14 days before enrollment, the investigator will decide whether to initiate ULT based on uric acid levels. In principle, allopurinol-naive patients should not be prescribed allopurinol in this study;
- Voluntarily signed the Informed Consent Form (ICF).
Who cannot join
- History of hypersensitivity to the study drug or similar classes of drugs;
- Systemic treatment with corticosteroids, or use of colchicine/NSAIDs within 24 weeks prior to enrollment;
- Confirmed active visceral bleeding, or severe bleeding tendency, or currently receiving anticoagulation therapy with heparin;
- Confirmed secondary gout;
- Confirmed or suspected rheumatoid arthritis, infectious/septic arthritis, or other conditions that may confound the assessment of affected joints (e.g., other joint pain including but not limited to neurological disorders, herpes zoster, etc.);
- Presence of infection requiring systemic treatment within 7 days prior to screening;
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- Received live or live-attenuated vaccines within 3 months prior to screening, or planned vaccination with such vaccines during the study;
- History of malignancy within 5 years prior to screening, except for adequately treated or excised cutaneous basal cell carcinoma or Stage I squamous cell carcinoma;
- History of systemic irradiation or total lymphoid irradiation; history of stem cell therapy or any type of bone marrow transplantation; history of solid organ transplantation; or long-term systemic use of immunosuppressants;
- History of severe immunodeficiency, including positive human immunodeficiency virus (HIV) antibody, or other acquired or congenital immunodeficiency diseases;
- History of clinically significant diseases, including:
- Chronic congestive heart failure (NYHA Class IV); History of echocardiography-confirmed ejection fraction (EF) < 30%; Myocardial infarction, acute coronary syndrome, viral myocarditis, or pulmonary embolism within 6 months; Coronary revascularization within 6 months; Severe arrhythmia requiring treatment with Class Ia or III antiarrhythmic drugs; History of sick sinus syndrome, Mobitz II and Complete Heart Block without a permanent pacemaker implanted; QTc interval≥480 ms on screening ECG ;
- Confirmed active tuberculosis infection;
- Receiving renal dialysis;
- Laboratory abnormalities at screening as follows:
- White blood cellcount or absolute neutrophil count below the lower limit of normal at the study site; Platelet count ≤100×10^9/L; Total bilirubin > 1.5 times ULN (Upper Limit of Normal); AST/ALT > 3 times ULN; Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m²; Triglycerides > 5.7 mmol/L;
- Pregnant or breastfeeding women;
- Women of childbearing potential who refuse to use highly effective contraception during the study;
- Use of any investigational drug or participation in other interventional clinical trials within 1 month prior to screening (participation in observational studies only is permitted);
- History of drug and/or alcohol abuse or psychiatric disorders;
- Any other conditions that, in the opinion of the investigator, may affect the evaluation of efficacy or safety in this study.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
China11 sites
Fuzhou University Affiliated Provincial Hospital
Fuzhou
Fei Gao, 0086-13665013469
The Second Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang
Kepeng Yang, 0086-17826873536, ykp1029@126.com
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
Huaxiang Wu, 0086-13757118395, wuhx8855@zju.edu.cn
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
Lijuan Wang, 0086-13567134447
Tongde Hospital of Zhejiang Province
Hangzhou
Qin Chen
Zhejiang Hospital
Hangzhou
Fang Yuan, 0086-18072963566
Changxin People's Hospital
Huzhou
Yingying Wang, 0086-13705790575
Jinhua Municipal Central Hospital
Jinhua
Li Hua, 0086-13758992315
Ningbo Medical Center Lihuili Hospital
Ningbo
Li Zhou, 0086-13858287828
The First People's Hospital of Wenlin
Wenzhou
Yongjun Chen, 0086-13958633696
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou
Hong Wang, 0086-13957756514
About this study
Study Objective To compare the efficacy of continued scheduled dosing versus as-needed dosing in patients with acute gouty arthritis who remained recurrence-free after 24 weeks of treatment with Firsekibart.
Primary Endpoint The proportion of patients experiencing at least one gout recurrence within 24 weeks after randomization.
Read more
Secondary Endpoints The mean number of gout recurrences within 24 weeks after randomization;The duration of the first gout recurrence;The proportion of patients experiencing at least one gout recurrence within 12 weeks after randomization;Time to first gout recurrence after randomization;Patient treatment satisfaction at 24 weeks after randomization, assessed using a Likert scale.
Study Design and Methods Patients with acute gouty arthritis who had received Firsekibart as initial treatment and experienced no recurrence during the first 24 weeks of treatment were eligible for enrollment and randomization in this study. Eligible patients were randomized to either a scheduled dosing group or an as-needed dosing group.
In the scheduled dosing group, patients received study treatment immediately after enrollment. In the as-needed dosing group, patients entered an observation period after enrollment and received study treatment only in the event of recurrence.
During the study, gout recurrence was recorded using patient diary cards. Telephone follow-up was conducted every 4 weeks to confirm recurrence status. On-site visits were performed at Weeks 12 and 24, as well as at the time of gout recurrence, for collection of efficacy-related assessments. Adverse events (AEs) and serious adverse events (SAEs) were followed until 12 weeks after the last dose of study drug.
Treatment Arms Scheduled Dosing Group (Intervention Group): Firsekibart 200 mg was administered by subcutaneous injection on the day of randomization.
As-Needed Dosing Group (Control Group): Patients were observed after randomization. If recurrence occurred, patients were required to return to the hospital within 4 days and receive Firsekibart 200 mg by subcutaneous injection.
- Conditions
- Gout Flares
- Being tested
- Scheduled Firsekibart administration, As-Needed Firsekibart Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scheduled Firsekibart administrationDrug
A 200 mg subcutaneous injection of Firsekibart will be administered on the day of randomization or the day of gout flare.
As-Needed Firsekibart AdministrationDrug
Following randomization, patients will remain under continuous observation. In the event of recurrence, patients should return to the hospital within 4 days to receive a 200 mg subcutaneous injection of Firsekibart.
| Study group | Role | What they receive |
|---|---|---|
| Regular dosing group | Experimental | Not described Receives: Drug: Scheduled Firsekibart administration |
| On-demand dosing group | Other | Not described Receives: Drug: As-Needed Firsekibart Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients experiencing at least one gout recurrence within 24 weeks after randomization.
Measured: 24 weeks after randomization
Secondary outcomes (6)
Mean number of gout flares over 24 weeks after randomization.
Measured: 24 weeks after randomization
Time to resolution of the first gout flare
Measured: 24 weeks after randomization.
Time to first gout flare
Measured: 24 weeks after randomization
Proportion of patients with at least one gout flare
Measured: 24 weeks after randomization
Patient treatment satisfaction scores
Measured: 24 weeks after randomization
Incidence of adverse events and serious adverse events.
Measured: 24 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 May 2026 (estimated)
- Primary completion28 Feb 2029 (estimated)
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gout FlaresStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616531
- Sponsor's protocol ID
- 20260160
- Status last verified
- Mar 2026
- First submitted
- 24 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Scheduled Versus As-Needed Firsekibart Administration for the Prevention of Gout Recurrence: A Multicenter, Open-Label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07616531
- Acronym / sponsor ID
- 20260160
- Conditions
- Gout Flares
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 1 Jun 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.
Study Objective To compare the efficacy of continued scheduled dosing versus as-needed dosing in patients with acute gouty arthritis who remained recurrence-free after 24 weeks of treatment with Firsekibart.
Primary Endpoint The proportion of patients experiencing at least one gout recurrence within 24 weeks after randomization.
Secondary Endpoints The mean number of gout recurrences within 24 weeks after randomization;The duration of the first gout recurrence;The proportion of patients experiencing at least one gout recurrence within 12 weeks after randomization;Time to first gout recurrence after randomization;Patient treatment satisfaction at 24 weeks after randomization, assessed using a Likert scale.
Study Design and Methods Patients with acute gouty arthritis who had received Firsekibart as initial treatment and experienced no recurrence during the first 24 weeks of treatment were eligible for enrollment and randomization in this study. Eligible patients were randomized to either a scheduled dosing group or an as-needed dosing group.
In the scheduled dosing group, patients received study treatment immediately after enrollment. In the as-needed dosing group, patients entered an observation period after enrollment and received study treatment only in the event of recurrence.
During the study, gout recurrence was recorded using patient diary cards. Telephone follow-up was conducted every 4 weeks to confirm recurrence status. On-site visits were performed at Weeks 12 and 24, as well as at the time of gout recurrence, for collection of efficacy-related assessments. Adverse events (AEs) and serious adverse events (SAEs) were followed until 12 weeks after the last dose of study drug.
Treatment Arms Scheduled Dosing Group (Intervention Group): Firsekibart 200 mg was administered by subcutaneous injection on the day of randomization.
As-Needed Dosing Group (Control Group): Patients were observed after randomization. If recurrence occurred, patients were required to return to the hospital within 4 days and receive Firsekibart 200 mg by subcutaneous injection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular dosing group | Experimental | Drug: Scheduled Firsekibart administration |
| On-demand dosing group | Other | Drug: As-Needed Firsekibart Administration |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 to 75 years (inclusive), male or female;**
- Meet the 2015 ACR/EULAR Gout Classification Criteria;**
- Received initial treatment with Firsekibart 200 mg via subcutaneous injection for 24 weeks, and experienced no gout flares during this 24-week period;**
- Had≥2 gout flares within 1 year prior to the first administration of Firsekibart；
- Willing to comply with the protocol-defined urate-lowering therapy (ULT) during the study, meeting one of the following conditions:
Key exclusion criteria (21 listed)
- History of hypersensitivity to the study drug or similar classes of drugs;
- Systemic treatment with corticosteroids, or use of colchicine/NSAIDs within 24 weeks prior to enrollment;
- Confirmed active visceral bleeding, or severe bleeding tendency, or currently receiving anticoagulation therapy with heparin;
- Confirmed secondary gout;
- Confirmed or suspected rheumatoid arthritis, infectious/septic arthritis, or other conditions that may confound the assessment of affected joints (e.g., other joint pain including but not limited to neurological disorders, herpes zoster, etc.);
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 |
|---|---|---|
| Scheduled Firsekibart administrationA 200 mg subcutaneous injection of Firsekibart will be administered on the day of randomization or the day of gout flare. | Drug | Regular dosing group |
| As-Needed Firsekibart AdministrationFollowing randomization, patients will remain under continuous observation. In the event of recurrence, patients should return to the hospital within 4 days to receive a 200 mg subcutaneous injection of Firsekibart. | Drug | On-demand dosing group |
Primary outcome
The proportion of patients experiencing at least one gout recurrence within 24 weeks after randomization.
Time frame: 24 weeks after randomization
6 secondary outcomes
Mean number of gout flares over 24 weeks after randomization.
Time frame: 24 weeks after randomization
Time to resolution of the first gout flare
Time frame: 24 weeks after randomization.
Time to first gout flare
Time frame: 24 weeks after randomization
Proportion of patients with at least one gout flare
Time frame: 24 weeks after randomization
Patient treatment satisfaction scores
Time frame: 24 weeks after randomization
Incidence of adverse events and serious adverse events.
Time frame: 24 weeks after randomization
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 1 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scheduled Firsekibart administration and As-Needed Firsekibart Administration in people with Gout Flares, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 11 sites 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 8 inclusion and 21 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 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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.
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?
Contact Huaxiang Wu (0086-13757118395, wuhx8855@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients experiencing at least one gout recurrence within 24 weeks after randomization. (time frame: 24 weeks after randomization). 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 1 Jun 2026.