Safety & Efffficacy of Genakumab in Patients With Frequent Flares

Phase 3 Completed 313 enrolled Changchun GeneScience Pharmaceutical Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of Genakumab Injection in patients with Gouty Arthritis (GA).

Timeline

Start: 2023-01-11
Primary completion: 2024-04-03
Completion: 2024-04-03

Outcome

Met primary endpoint

release “Phase III results demonstrating its best-in-class potential: compared to dexamethasone, Genakumab achieved a 90% reduction in recurrence risk at 12 weeks” genscigroup.com ↗

Publications

Zhu Z, Xue Y, Chu T, Hu J, Gou W, Zhang N, Li J, Yu J, Li R, Li R, Qian L, Duan X, Duan L, Xu Q, Gu F, Lian Y, Zhang X, Zou H. Efficacy and Safety of Firsekibart in Patients with Acute Gout Unsuitable for Standard Therapy: 48-Week Results from an Open-Label Extension of a Randomized Phase 3 Trial. Adv Ther. 2026 May 19. doi: 10.1007/s12325-026-03611-6. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Genakumab	Monoclonal antibody	200 mg	Subcutaneous
Comparator	betamethasone dipropionate	Small molecule	7 mg	Intramuscular