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| Name | Class |
|---|---|
| Huashan Hospital | OTHER |
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To evaluate the safety and efficacy of Genakumab in prevention of acute flares in gout patients initiating urate-lowering therapyurate-lowering
A randomized, open-lable, multi-center, active-controlled Phase 2 study. Patients are randomized to Genakumab 100mg single injection group, Genakumab 200mg single injection group or oral colchicine 0.5mg once a day.for 12 weeks group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genakumab group | Experimental | Genakumab 100mg single injection、Genakumab 200mg single injection |
|
| Colchicine group | Active Comparator | Oral colchicine 0.5mg once a day for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genakumab for injection | Drug | 150 mg/1ml/ vial |
| |
| Colchicine |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Gout Flares Per Participant | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With at Least 1 Gout Flare Within 12 Weeks After Randomization | Baseline to Week 12 | |
| Time from Randomization to the First Flare | Baseline to Week 12 | |
| Measure | Description | Time Frame |
|---|---|---|
| 6. Immunogenic Outcome The incidence of anti-drug antibodies and the incidence of neutralizing antibody | Baseline to Week 12 |
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| Name | Affiliation | Role |
|---|---|---|
| Hejian Zou | Fudan University Affiliated Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Affiliated Huashan Hospital | Shanghai | Shanghai Municipality | 200030 | China |
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Gout patients initiating urate-lowering therapy Group A: Genakumab 100mg single injection; Group B: Genakumab 200mg single injection;Group C: Oral colchicine 0.5mg once a day for 12 weeks
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| Drug |
0.5 mg/table |
|
| Mean duration of flares |
| Baseline to Week 12 |
| 5. Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | Baseline to Week 12 |
| ID | Term |
|---|---|
| D006073 | Gout |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007267 | Injections |
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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