RecruitingPhase 3NCT05199688

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)

A Phase III, Multicenter, Open-Label, Uncontrolled Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric Patients With AQP4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)


Sponsor

Hoffmann-La Roche

Enrollment

8 participants

Start Date

May 6, 2026

Study Type

INTERVENTIONAL

Conditions

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 (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.


Eligibility

Min Age: 2 YearsMax Age: 11 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called satralizumab in children aged 2–11 with neuromyelitis optica spectrum disorder (NMOSD) — a rare disease where the immune system attacks the optic nerves and spinal cord, causing vision loss and paralysis. The study looks at how the drug behaves in children's bodies and whether it prevents attacks. You may be eligible if: - Your child is 2–11 years old and weighs at least 10 kg - Your child has been diagnosed with AQP4 antibody-positive NMOSD - Your child has had at least one documented attack in the past year - Your child has been neurologically stable for at least 30 days before the study You may NOT be eligible if: - Your child is pregnant or breastfeeding - Your child has another demyelinating disease that looks like NMOSD - Your child has an active or recurring serious infection - Your child has untreated tuberculosis - Your child received a live vaccine within 6 weeks before the study - Your child has a history of severe allergic reaction to a biologic drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSatralizumab

Participants will receive satralizumab treatment for a minimum of 48 weeks and then will have the opportunity to enter an optional satralizumab extension (OSE) period.


Locations(13)

Children's Hospital Colorado.

Denver, Colorado, United States

Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. Garrahan

Ciudad Autonoma Buenos Aires, Argentina

Clinica Universitaria Reina Fabiola

Córdoba, Argentina

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, China

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Centre Hospitalier Universitaire de Bicêtre

Le Kremlin-Bicêtre, France

IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN

Rome, Lazio, Italy

Fondazione Istituto Neurologico Mondino IRCCS

Pavia, Lombardy, Italy

Grupo Medico Camino

DF, Mexico CITY (federal District), Mexico

Uniwersyteckie Centrum Kliniczne

Gda?sk, Poland

Instytut "Pomnik - Centrum Zdrowia Dziecka"

Warsaw, Poland

Kocaeli University Research and Application Hospit

Kocaeli, Turkey (Türkiye)

Great Ormond Street Hospital for Children

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05199688


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