Tests low-dose IL-2 in people with neuromyelitis optica spectrum disorder
Tests low-dose IL-2 against placebo in adults with neuromyelitis optica spectrum disorder.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Low-Dose IL-2 in Neuromyelitis Optica Spectrum Disorder
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 74 years old?
Source: NCT07809724, who can take part
Where in China
- Department of Rheumatology and Immunology, Peking University People's HospitalBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Peking University People's Hospital
- Trial code
- NCT07809724
- Record updated
- 9 September 2026
- Original description
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.Read full original descriptionShow less
Efficacy and Safety of Low-Dose IL-2 in Neuromyelitis Optica Spectrum Disorder: A Randomized, Double-Blind, Placebo-Controlled Phase II Trial
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.
Inclusion: Age: 18 to 74 years, inclusive at the time of informed consent; Diagnosed with NMOSD according to the 2015 international consensus diagnostic criteria for NMOSD; Expanded Disability Status Scale (EDSS) score between 0 and 6.5; For women of childbearing potential, contraception must be used for more than 2 weeks after meeting the inclusion criteria, and HCG must be negative at the time of enrollment; Able to provide written informed consent and demonstrate the ability and willingness to comply with the study protocol requirements.
Exclusion: Any prior history of receiving whole-body irradiation or bone marrow transplantation; Any treatment with investigational drugs within 3 months prior to baseline; Any surgical procedure within 4 weeks prior to baseline (except minor surgeries); Substance abuse or alcoholism history within 1 year prior to baseline; Active suicidal ideation within the past 6 months before screening, or a history of suicide attempts within the past 3 years; Evidence of other demyelinating diseases or progressive multifocal leukoencephalopathy (PML); Other neurological disorders, hematological / hematopoietic disorders, congenital/acquired severe immunodeficiencies; Heart failure (≥NYHA Class III), renal insufficiency, liver insufficiency, or respiratory failure; Evidence of chronic active hepatitis B or C; Evidence of active tuberculosis (excluding participants undergoing chemoprophylaxis for latent tuberculosis infection); Intolerance to IL-2: hypersensitivity reactions to the active substance or any of its excipients (e.g. shock, allergic reactions); White blood cell count <3000/ml, lymphocyte count <1000/ml, platelet count <150,000/ml; Pregnancy or breastfeeding; Evidence of severe uncontrolled comorbidities that may hinder participation.