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The purpose of this study is to evaluate the efficacy and safety of Genakumab Injection in patients with Gouty Arthritis (GA).
A multicenter, randomized, double-blind, double-dummy, active-controlled study was to demonstrate the efficacy of Genakumab versus compound betamethasone injection in adult patients with frequent gouty arthritis attacks in whom non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine are contraindicated, are not tolerated, or do not provide an adequate response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genakumab | Experimental | Genakumab 200mg s.c |
|
| Diprospan | Active Comparator | Diprospan 7mg im |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| genakumab | Drug | 200mg s.c. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The change in the gout pain intensity in the target joint measured by VAS | The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. In this study patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0mm) to unbearable pain (100mm), at 72 hours post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. | 72 hours post-dose |
| Time to first new flare | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patients assessment of gout pain intensity in the target joints measured by VAS(0-100mm) | At 6, 24, 48, and 72 hours and 7 days post-dose | |
| The change in the gout pain intensity in the target joint measured by VAS. | At 6, 24, 48, and 72 hours and 7 days post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| High Sensitivity C-reactive Protein (hsCRP) | 72 hours, 7 days and 4 weeks post-dose | |
| SF-36 | The SF-36 measures the impact of disease on overall quality of life (QoL). This 36-item survey has 8 subscales that can be aggregated into physical- and mental-component summary scores. Scores are standardized with the use of norm-based methods based on an assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL. A negative change score indicates improvement. An ANCOVA model was used with treatment group and baseline SF-36 physical function subscore as covariates. |
Inclusion Criteria:
Exclusion Criteria:
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Affiliated Huashan Hospital | Shanghai | Shanghai Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42154367 | Derived | Zhu Z, Xue Y, Chu T, Hu J, Gou W, Zhang N, Li J, Yu J, Li R, Li R, Qian L, Duan X, Duan L, Xu Q, Gu F, Lian Y, Zhang X, Zou H. Efficacy and Safety of Firsekibart in Patients with Acute Gout Unsuitable for Standard Therapy: 48-Week Results from an Open-Label Extension of a Randomized Phase 3 Trial. Adv Ther. 2026 May 19. doi: 10.1007/s12325-026-03611-6. Online ahead of print. |
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| ID | Term |
|---|---|
| C032812 | betamethasone dipropionate, betamethasone sodium phosphate drug combination |
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| placebo for Diprospan |
| Drug |
i.m. |
|
| placebo for genakumab | Drug | s.c. |
|
| Diprospan | Drug | 7mg i.m. |
|
| The number of patients with at least 1 new gout flare | 12 weeks, 24 weeks, 48 weeks |
| Time to at Least a 50% Reduction in Baseline Pain Intensity | 7 days |
| Percent Patients Who Took Rescue Medication | 24 weeks,48 weeks |
| Time to first flare | 24 weeks, 48 weeks |
| Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | 24weeks, 48weeks |
| Immunogenicity The incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibody | 24 weeks, 48 weeks |
| Genakumab Pharmacokinetics (PK) Serum Concentration During the Treatment Period | Blood was collected for Ganakumab levels at2 hours pre-dose, Days 4，8，29，57，85，169，253 days post-dose. | 2 hours pre-dose, Days 4，8，29，57，85，169，253 days post-dose |
| 8 weeks, 24 weeks and 48 weeks |