Actively 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)
Led by Hoffmann-La Roche · Updated on 2026-05-08
8
Participants Needed
13
Research Sites
175 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age at screening 2-11 years, inclusive
- Body weight at screening �3D10 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 �3E=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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Children's Hospital Colorado.
Denver, Colorado, United States, 80218-1007
Actively Recruiting
2
Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. Garrahan
Ciudad Autonoma Buenos Aires, Argentina, C1249ABN
Actively Recruiting
3
Clinica Universitaria Reina Fabiola
Córdoba, Argentina, X5004FHP
Actively Recruiting
4
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China, 510120
Actively Recruiting
5
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 201102
Actively Recruiting
6
Centre Hospitalier Universitaire de Bicêtre
Le Kremlin-Bicêtre, France, 94275
Actively Recruiting
7
IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
Rome, Lazio, Italy, 00165
Actively Recruiting
8
Fondazione Istituto Neurologico Mondino IRCCS
Pavia, Lombardy, Italy, 27100
Actively Recruiting
9
Grupo Medico Camino
DF, Mexico CITY (federal District), Mexico, DUMMY_VALUE
Actively Recruiting
10
Uniwersyteckie Centrum Kliniczne
Gda?sk, Poland, 80-214
Active, Not Recruiting
11
Instytut "Pomnik - Centrum Zdrowia Dziecka"
Warsaw, Poland, 04-730
Actively Recruiting
12
Kocaeli University Research and Application Hospit
Kocaeli, Turkey (Türkiye), 6810
Actively Recruiting
13
Great Ormond Street Hospital for Children
London, United Kingdom, WC1N 3JH
Actively Recruiting
Research Team
R
Reference Study ID Number: WN41733 https://forpatients.roche.com/
CONTACT
G
Global Medical Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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