Status:
RECRUITING
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)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Neuromyelitis Optica Spectrum Disorder
NMOSD
Eligibility:
All Genders
2-11 years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Age at screening 2-11 years, inclusive
- Body weight at screening \>=10 kg
- 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
- 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
- Neurological stability for \>=30 days prior to both screening and baseline
- Expanded Disability Status Scale (EDSS) 0 to 6.5
- 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
- Pregnancy or lactation
- Evidence of other demyelinating disease mimicking NMOSD
- Active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection at baseline
- Evidence of chronic active hepatitis B or C
- Evidence of untreated latent or active tuberculosis (TB)
- Receipt of a live or live-attenuated vaccine within 6 weeks prior to baseline
- History of severe allergic reaction to a biologic agent
Key Trial Info
Start Date :
December 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 12 2029
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT05199688
Start Date
December 31 2025
End Date
September 12 2029
Last Update
December 22 2025
Active Locations (10)
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1
Children's Hospital Colorado.
Denver, Colorado, United States, 80218-1007
2
Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. Garrahan
Ciudad Autonoma Buenos Aires, Argentina, C1249ABN
3
Clinica Universitaria Reina Fabiola
Córdoba, Argentina, X5004FHP
4
Centre Hospitalier Universitaire de Bicêtre
Le Kremlin-Bicêtre, France, 94275