Safety and Efficacy of Genakumab for Injection in Patients With Gout Flare
- Conditions
- Acute GoutGout Flare
- Interventions
- Drug: Genakumab for injection
- Registration Number
- NCT05936268
- Lead Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Brief Summary
To evaluate the safety and efficacy of Genakumab for Injection in patients with gout flare as a first line therapy
- Detailed Description
Phase 2， randomized, open lable, multi-center, active controlled study. Patients are randomized to Genakumab 200mg single injection group or Etoricorxib 120mg qd po.(until remission or intorlerance, no longer than 8 days) group.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Genacumab group Genakumab for injection Genakumab 200mg single injection cholchicine group Colchicine Colchicine 0.5mg qd po.for 12 weeks
- Primary Outcome Measures
Name Time Method 72hours target joint VAS change from baseline 72h±2h 72hours target joint VAS change from baseline
- Secondary Outcome Measures
Name Time Method Recurrence of flare 12 weeks after the last dose Proportion of patients who have at least 1 flare Time to first flare
Pain intensity 6hours, 24hours, 48hours, 72hours, Day 8, target joint VAS Target joint VAS change from baseline Time to first VAS\<=50% baseline VAS Time to first VAS\<=30mm Time to first VAS\<=10mm
Safety outcome 12weeks AE, laboratory examination, ECG, vital signs and physical examination
immunogenic outcome 12 weeks after the last dose The incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibody
Trial Locations
- Locations (1)
Fudan University Affiliated Huashan Hospital
🇨🇳Shanghai, Shanghai, China