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Efficacy and Safety of Low-Dose IL-2 in Neuromyelitis Optica Spectrum Disorder
Sponsor: Peking University People's Hospital
Summary
Interleukin-2 (IL-2) is an essential cytokine for T-cell proliferation. Low-dose IL-2 has been shown to increase the proportion of regulatory T cells (Tregs), negatively regulate effector T cells such as Th17 and Tfh cells, and improve the peripheral Treg/Th17 balance, thus restoring immune homeostasis. Studies have demonstrated a positive correlation between the Th17/Treg ratio and the severity of various autoimmune diseases. Clinically, low-dose IL-2 has been successfully used in the treatment of diseases such as systemic lupus erythematosus and Sjögren's syndrome. However, the efficacy and safety of IL-2 in neuromyelitis optica spectrum disorder (NMOSD) remain unknown. This clinical trial aims to investigate the safety and biological efficacy of IL-2 in treating NMOSD.
Official title: Efficacy and Safety of Low-Dose IL-2 in Neuromyelitis Optica Spectrum Disorder: A Randomized, Double-Blind, Placebo-Controlled Phase II Trial
Key Details
Gender
All
Age Range
18 Years - 74 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-08-30
Completion Date
2028-12-30
Last Updated
2026-09-09
Healthy Volunteers
No
Interventions
Placebo
placebo s.c. injection every other day for the first 4 weeks and then twice a week for an additional 20 weeks. IL-2 (1 MIU) : placebo = 1:1
IL-2 (interleukin 2)
IL-2 (1 MIU) s.c. injection every other day for the first 4 weeks and then twice a week for an additional 20 weeks. IL-2 (1 MIU) : placebo = 1:1
Locations (1)
Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing, Beijing Municipality, China