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. 2026 Jan 7.
doi: 10.1038/s41467-025-68100-w. Online ahead of print.

Efficacy and safety of low-dose interleukin 2 for Behçet's syndrome: a randomized, placebo-controlled, double-blind, phase 2 clinical trial

Tian Liu #  1   2 , Wenyan Zhou #  1 , Yan Zhu #  1 , Weiyi Xia #  1 , Jiali Chen  3 , Xian Xiao  1 , Bo Huang  1 , Ruiling Feng  1 , Hua Ye  1 , Shi Chen  1 , Xiaoying Zhang  1 , Miao Shao  1 , Chun Li  1 , Yuan Jia  1 , Miao Miao  1 , Yuebo Jin  1 , Xue Li  1 , Xia Zhang  1 , Yunshan Zhou  1 , Ru Li  1 , Xuewu Zhang  1 , Yin Su  1 , Huixin Liu  4 , Jing Li  1 , Fanlei Hu  1 , Jianping Guo  1 , Xiaolin Sun  1 , Jing He  5 , Zhanguo Li  6   7
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Free article

Efficacy and safety of low-dose interleukin 2 for Behçet's syndrome: a randomized, placebo-controlled, double-blind, phase 2 clinical trial

Tian Liu et al. Nat Commun. .
Free article

Abstract

Behçet's syndrome (BS), a chronic vasculitis, leads to recurrent oral ulcers, severely impacting quality of life. Here we report the results of a randomized, double-blind, placebo-controlled trial (NCT04065672) to evaluate the efficacy and safety of low-dose interleukin-2 (LD-IL-2) in BS patients. 60 participants with active oral ulcers are randomly assigned to receive LD-IL-2 or placebo. The primary endpoint is the oral ulcer count at week 12. The LD-IL-2 group has significantly fewer oral ulcers than the placebo group (0.69 ± 1.05 vs. 1.57 ± 0.90, P = 0.001) with greater improvements in ulcer pain, disease activity, and quality of life. No infections or severe adverse events are observed in either group. LD-IL-2 expands regulatory T (Treg) cells and decreased the ratio of effector T cell to Treg cells. Thus, LD-IL-2 therapy might be an effective and safe treatment in BS patients and is associated with the modulation of CD4 + T cell populations.

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Conflict of interest statement

Competing interests: The authors declare no competing interests.

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