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
Sex
ALL
Min age
18 Years
Max age
74 Years
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* Any prior history of receiving whole-body irradiation or bone marrow transplantation.
* Any treatment with investigational drugs within 3 months prior to baseline.
* Pregnancy or breastfeeding.
* Any surgical procedure within 4 weeks prior to baseline (except minor surgeries).
* Evidence of other demyelinating diseases or progressive multifocal leukoencephalopathy (PML).
* Evidence of severe uncontrolled comorbidities that may hinder participation.
* Other neurological disorders, hematological / hematopoietic disorders, congenital/acquired severe immunodeficiencies.
* Heart failure (≥NYHA Class III), renal insufficiency, liver insufficiency, or respiratory failure.
* White blood cell count \<3000/ml, lymphocyte count \<1000/ml, platelet count \<150,000/ml.
* Evidence of chronic active hepatitis B or C.
* Substance abuse or alcoholism history within 1 year prior to baseline.
* 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).
* Active suicidal ideation within the past 6 months before screening, or a history of suicide attempts within the past 3 years.
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.
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