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New hope for kids with rare nerve disease: satralizumab trial begins

NCT ID NCT05199688

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 4 times

Summary

This study tests a drug called satralizumab in children aged 2 to 11 who have a rare autoimmune disease called NMOSD. The main goal is to see how the drug moves through the body and if it can safely reduce relapses. Only 8 children will take part, and the results will help doctors understand if this treatment works for younger patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 8 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 11 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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

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Conditions

The condition(s) this trial relates to.

neuromyelitis optica neuromyelitis optica spectrum disorder with anti-AQP4 antibodies

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neuromyelitis optica spectrum disorder NMOSD

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites in 9 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre Hospitalier Universitaire de Bicêtre

    RECRUITING

    Le Kremlin-Bicêtre, Val-de-Marne, 94275, France

  • Children's Hospital Colorado.

    RECRUITING

    Denver, Colorado, 80218-1007, United States

  • Children's Hospital of Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 201102, China

  • Clinica Universitaria Reina Fabiola

    RECRUITING

    Córdoba, X5004FHP, Argentina

  • Fondazione Istituto Neurologico Mondino IRCCS

    RECRUITING

    Pavia, Lombardy, 27100, Italy

  • Great Ormond Street Hospital for Children

    RECRUITING

    London, WC1N 3JH, United Kingdom

  • Grupo Medico Camino

    RECRUITING

    DF, Mexico CITY (federal District), DUMMY_VALUE, Mexico

  • Guangzhou Women and Children's Medical Center

    RECRUITING

    Guangzhou, Guangdong, 510120, China

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

    RECRUITING

    Ciudad Autonoma Buenos Aires, C1249ABN, Argentina

  • IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN

    RECRUITING

    Rome, Lazio, 00165, Italy

  • Instytut "Pomnik - Centrum Zdrowia Dziecka"

    RECRUITING

    Warsaw, 04-730, Poland

  • Kocaeli University Research and Application Hospit

    RECRUITING

    Kocaeli, 6810, Turkey (Türkiye)

  • Uniwersyteckie Centrum Kliniczne

    ACTIVE_NOT_RECRUITING

    Gda?sk, 80-214, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.