Assessment on Efficacy and Safety of BAT2306 and Cosentyx® in Plaque Psoriasis Patients

Summary

This study is a multicenter, randomized, double-blind, parallel-arm, Phase 3 study designed to compare efficacy, safety, immunogenicity, and PK of BAT2306 with Cosentyx in patients with moderate to severe plaque psoriasis. The study is composed of a ≤ 28-day screening period, a 24-week initial treatment period (Treatment Period 1 \[TP1\]), and a 28-week secondary treatment period (Treatment Period 2 \[TP2\]). The study will be a maximum of 56 weeks.

Timeline

Start

2022-10-26

Primary completion

2024-05-24

Completion

2024-12-10

Publications

• Chen JQ, Chen R, Wu L, Ding Y, Kaszuba A, Tanizaki H, Yang X, Jin L, Dong Q, Zheng M, Man XY. Secukinumab biosimilar BAT2306 versus reference secukinumab in patients with moderate-to-severe plaque psoriasis: a multicentre, double-blind, randomised, active-controlled, phase 3 trial. Lancet Rheumatol. 2026 Jun 29:S2665-9913(26)00118-9. doi: 10.1016/S2665-9913(26)00118-9. Online ahead of print.

Drugs

Indications