Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07809724
PHASE2

Efficacy and Safety of Low-Dose IL-2 in Neuromyelitis Optica Spectrum Disorder

Sponsor: Peking University People's Hospital

View on ClinicalTrials.gov

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

DRUG

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

DRUG

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