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

Outcome

Met primary endpoint

Stopped: “The study purpose has been achieved”

paper AUC0-12 for oral ulcers between the 45 mg and 60 mg groups and the placebo was -104.8 (95% CI, -156.3 to -53.2; P < .001) PMID 41748391 ↗

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

Evaluation	Drug	Modality	Dose	Route
Subject	MUFEMILAST	Small molecule	45 mg	Oral
Subject	MUFEMILAST	Small molecule	60 mg	Oral

Indications