The Safety and Efficacy of NouvSoma001 in Neuromyelitis Optica Spectrum Disorders

Prior treatment

• Patients who have undergone hematopoietic stem cell transplantation or lymphatic irradiation before enrollment.
• Patients with active suicidal ideation within 6 months before screening or have a history of suicide attempts within 3 years before screening.
• Patients with positive for alcohol addiction or drug abuse.
• Patients who have experienced any of the following events within 12 weeks before enrollment: myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association Class IV heart failure.

Other illness

• Patients with a known history of allergies to human-derived biological products or those with an allergic predisposition.
• Patients with severe comorbidities, including immunodeficiency or coagulation disorders.
• Patients with severe psychiatric symptoms that prevent clinical cooperation.
• Patients with malignant tumors.
• Patients with persistent systemic infections and severe local infections.

Lab values

• Abnormal laboratory indicators of the subjects need to be excluded, including, but not limited to, the following indicators:
  • White blood cell count \< 3 × 10⁹/L Neutrophil count \< 1.5 × 10⁹/L Hemoglobin \< 85 g/L Platelet count \< 80 × 10⁹/L Serum creatinine \> 1.5 × ULN Total bilirubin \> 1.5 × ULN Aspartate aminotransferase (AST) \> 3 × ULN Alanine aminotransferase (ALT) \> 3 × ULN Alkaline phosphatase \> 2 × ULN (AST = Aspartate Aminotransferase; GOT = Glutamic-Oxaloacetic Transaminase; ALT = Alanine Aminotransferase; GPT = Glutamic-Pyruvic Transaminase)

Other

• Any contraindications to lumbar puncture.
• Pregnant or breastfeeding women, and patients with plans to conceive during the trial.
• Patients who have participated in any other clinical trial within the last 3 months.
• Patients unable to undergo magnetic resonance imaging during the trial.
• Patients deemed unsuitable for participation by the investigator.

• Patients must meet the 2015 International Consensus Diagnostic Criteria for Neuromyelitis Optica Spectrum Disorder (NMOSD) and test positive for AQP4 antibodies.
• Symptom onset occurred within 7 days prior to enrollment, with associated severe pain, lower limb motor dysfunction, or urinary/bowel impairment.
• Males or Females aged between 18 and 65 years.
• The Expanded Disability Status Scale (EDSS) score prior to the current disease episode is ≤ 4.
• Female participants of childbearing potential must present a negative pregnancy test at screening and agree to use effective contraception throughout the study period.
• Informed consent must be obtained from the patient or their legal representative, with a signed consent form must be provided.