drugset

drugset / Trial / NCT05936268

Safety and Efficacy of Genakumab for Injection in Patients With Gout Flare

NCT05936268 ↗

Phase 2 Completed 106 enrolled Changchun GeneScience Pharmaceutical Co., Ltd. Huashan Hospital · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

To evaluate the safety and efficacy of Genakumab for Injection in patients with gout flare as a first line therapy

Timeline

Start: 2023-07-21
Primary completion: 2024-02-28
Completion: 2024-02-28

Publications

Kong N, Xue Y, Mao L, Qian L, Guo H, Hu J, Yuan F, Li R, Duan X, Yu J, Gou W, Yang L, Wei H, Li R, Xu Q, Luo T, Zhang X, Zou H. Efficacy and Safety of Firsekibart Compared to Etoricoxib for Gout Flares: A Phase 2, Multicenter, Open-label, Active-controlled, Randomized Non-inferiority Trial. Rheumatol Ther. 2025 Oct;12(5):975-990. doi: 10.1007/s40744-025-00790-6. Epub 2025 Aug 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Colchicine	Small molecule	0.5 mg	Oral
Subject	Genakumab	Monoclonal antibody	200 mg	Subcutaneous

Indications