A Study to Evaluate the Efficacy and Safety of Hemay005 in the Treatment of Behçet Disease

Summary

This is a phase 2, multi-center, randomized, placebo-controlled, double-blind, parallel-group study with an equal randomization among the Hemay005 high dose, lower dose and placebo treatment groups. After subject randomization, each subject will enter an core-treatment Phase for 12 weeks following an extended-treatment phase for another 12weeks and a follow up phase for 4weeks.

Timeline

Start

2020-11-30

Primary completion

2022-04-30

Completion

2022-04-30

Publications

• Liu T, Li C, Zheng W, Tang J, Chen D, Peng Y, Yin S, Zhou D, Zhang Z, Huang C, Dai L, Wei X, Lin J, Yu Y, Wu L, Zhang Z, Liu S, Li X, Jiang L, Wu J, Zhao Y, Chen L, Meng T, Wu L, Wang Y, Wan W, Kong N, Ke Y, Bi L, Li Y, Dang W, Zhang H, Jones R, Li Z. Efficacy and safety of mufemilast in patients with Behcet's syndrome: a phase 2 randomised clinical trial. Ann Rheum Dis. 2026 Jul;85(7):1425-1435. doi: 10.1016/j.ard.2026.01.014. Epub 2026 Feb 25.

Drugs

Indications