Efficacy and Safety of Low-Dose IL-2 in Neuromyelitis Optica Spectrum Disorder
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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.
Eligibility
Primary outcome measure(s)
- Change in the percentage of Tregs at week 4 compared to baseline (week 0) — Week 4
expressed as a percentage of the total CD4+ cells
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Department of Rheumatology and Immunology, Peking University People's Hospital | Beijing | Beijing Municipality |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07809724 on ClinicalTrials.gov ↗ ← All trials in China