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A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric Patients With Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)


About the study

This study will primarily evaluate the pharmacokinetics of satralizumab in pediatric patients aged 2-11 years with anti-aquaporin-4 (AQP4) antibody seropositive neuromyelitis optica spectrum disorder (NMOSD). Efficacy, safety, tolerability, and pharmacodynamics will be evaluated in a descriptive manner, given the small number of patients who will be enrolled in this study.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Inclusion Criteria:

  1. Age at screening 2-11 years, inclusive
  2. Body weight at screening >=10 kg
  3. For female patients of childbearing potential (postmenarchal): agreement to either remain completely abstinent (refrain from heterosexual intercourse) or to use a reliable means of contraception
  4. Diagnosed as having NMOSD with AQP4 antibody seropositive status as defined by the Wingerchuk 2015 criteria Clinical evidence of at least one documented attack (including first attack) in the last year prior to screening
  5. Neurological stability for >=30 days prior to both screening and baseline
  6. Expanded Disability Status Scale (EDSS) 0 to 6.5
  7. For patients receiving a baseline immunosuppressant treatment and planning to continue on these therapies, treatment must be at stable dose for 4 weeks prior to baseline


Exclusion Criteria:

  1. Pregnancy or lactation
  2. Evidence of other demyelinating disease mimicking NMOSD
  3. Active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection at baseline
  4. Evidence of chronic active hepatitis B or C
  5. Evidence of untreated latent or active tuberculosis (TB)
  6. Receipt of a live or live-attenuated vaccine within 6 weeks prior to baseline
  7. History of severe allergic reaction to a biologic agent
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Study Locations

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How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Neuromyelitis Optica Spectrum Disorder,NMOSD

Age (in years)

2 - 11


Phase 3

Participants needed


Est. Completion Date

Feb 28, 2027

Treatment type



Hoffmann-La Roche identifier


Study number


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