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

Korábbi kezelés

• 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.

Más betegség

• 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).

Laborértékek

• White blood cell count <3000/ml, lymphocyte count <1000/ml, platelet count <150,000/ml.

Egyéb

• Pregnancy or breastfeeding.
• Evidence of severe uncontrolled comorbidities that may hinder participation.

• 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.