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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
165
150 mg/1ml/ vial
0.5 mg/table
Fudan University Affiliated Huashan Hospital
Shanghai, Shanghai Municipality, China
Mean Number of Gout Flares Per Participant
Time frame: Baseline to Week 12
Proportion of Participants With at Least 1 Gout Flare Within 12 Weeks After Randomization
Time frame: Baseline to Week 12
Time from Randomization to the First Flare
Time frame: Baseline to Week 12
Mean duration of flares
Time frame: Baseline to Week 12
5. Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Baseline to Week 12
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