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

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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Publication Details

Journal
Nature Communications
Published
2026-01-07
DOI
https://doi.org/10.1038/s41467-025-68100-w
Citations
1
Primary Topic
Ocular Diseases and Behçet’s Syndrome
Type
article
Field-Weighted Citation Impact
22.55

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article

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

X Y Zhang, Jun He, Yuan Jia, X W Li et al.
1 citations
Nature Communications
Ocular Diseases and Behçet’s Syndrome
22.55
article

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

X Y Zhang, Jun He, Yuan Jia, X W Li, Z. Li, Yuebo Jin, Xian Xiao, J. LI, Yu Zhou, Yan Zhu, Xiaoying Zhang, Miao Miao, Ru Li, Weiyi Xia, Hua Ye, Bo Huang, Jianping Guo, Y G Su, M. Shao, Huixin Liu, Fanlei Hu, Jiali Chen, Tian Liu, W Zhou, Chun Li, Xiaolin Sun, Shi Chen, Ruiling Feng
article en
1 citations

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.

Nature CommunicationsVol. 17(1)
Central South University (CN), China Pharmaceutical University (CN), Peking University (CN), First Hospital of Shijiazhuang (CN), Peking University People's Hospital (CN), Second Xiangya Hospital of Central South University (CN)
National Natural Science Foundation of China, Beijing Nova Program
Good health and well-being
Openalex Percentile: Top 2%
Ocular Diseases and Behçet’s Syndrome
22.55
DOIOpen Access PDFOpenAlex
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