NCT05199688RecruitingPhase 3
A Study to Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, and Pharmacodynamics of Satralizumab in Pediatric Patients with Aquaporin-4 (AQP4) Antibody Positive Neuromyelitis Optica Spectrum Disorder
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)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 5 Aug 2026
Brief summary (registry, in English)
1. To investigate the pharmacokinetics (PK) of satralizumab by evaluating serum exposure over 24 weeks in participants aged 2-11 years, inclusive
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 7 (estimated)
- First submitted
- 5 Jun 2024
- Start date
- 21 Apr 2022
- Lead sponsor
- F. Hoffmann-La Roche AG
- Diseases
- Neuromyelitis optica (NMOSD)
- EU CT number
- 2023-507817-85-00
- EudraCT number
- 2019-004092-39
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 7
- 4 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receipt of a live or live-attenuated vaccine within 6 weeks prior to baseline
Other illness
- Evidence of other demyelinating disease mimicking NMOSD including but not limited to MS, myelin oligodendrocyte glycoprotein-IgG associated disease, or progressive multifocal leukoencephalopathy
- Active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection (excluding fungal infection of nail beds or dental caries) at baseline
- Evidence of chronic active hepatitis B or C
- Evidence of untreated latent or active tuberculosis (TB)
Other
- Pregnancy or lactation
Who the study is looking for
- Age at screening 2-11 years, inclusive
- Body weight at screening ≥10 kg
- For female participants 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
- Neurological stability for ≥30 days prior to both screening and baseline
- Normal or abnormal neurologic status as described by EDSS (0 to 6.5)
Age in the registry: - to 17 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Le Kremlin-Bicetre | France | Recruiting |
| Fondazione Istituto Neurologico Nazionale Casimiro Mondino Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| Ospedale Pediatrico Bambino Gesù Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Instytut Pomnik Centrum Zdrowia Dziecka Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.