A Study of the Efficacy of Genakumab in Prevention of Acute Flares in Gout Patients Initiating Urate-lowering TherapyUrate-lowering (GenSci048-202)
Phase 2
Completed
- Conditions
- GoutGout Initiating Urate-loweringUrate-lowering Therapy
- Interventions
- Drug: Genakumab for injection
- Registration Number
- NCT05936281
- Lead Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Brief Summary
To evaluate the safety and efficacy of Genakumab in prevention of acute flares in gout patients initiating urate-lowering therapyurate-lowering
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 165
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Genakumab group Genakumab for injection Genakumab 100mg single injection、Genakumab 200mg single injection Colchicine group Colchicine Oral colchicine 0.5mg once a day for 12 weeks
- Primary Outcome Measures
Name Time Method Mean Number of Gout Flares Per Participant Baseline to Week 12
- Secondary Outcome Measures
Name Time Method 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 Mean duration of flares Baseline to Week 12 5. Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) Baseline to Week 12
Trial Locations
- Locations (1)
Fudan University Affiliated Huashan Hospital
🇨🇳Shanghai, Shanghai, China