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NCT05199688 · ClinicalTrials.gov registry record · Phase 3
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 3 study of Neuromyelitis Optica Spectrum Disorder and NMOSD, sponsored by Hoffmann-La Roche.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 8
- Enrollment target
- 12
- Study locations
NCT05199688 is a Phase 3 study of Neuromyelitis Optica Spectrum Disorder and NMOSD that is actively recruiting participants, run by Hoffmann-La Roche. The registered enrollment target is 8 participants, below the 65-participant average among 6 other Neuromyelitis Optica Spectrum Disorder trials with a reported enrollment target (88% lower). The trial reports 12 study locations across 6 states.
The verdict
NCT05199688, a Phase 3 study of Neuromyelitis Optica Spectrum Disorder and NMOSD, is actively recruiting participants, sponsored by Hoffmann-La Roche.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 8 participants
- Enrollment target
- 12
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Satralizumab
Study Locations (12)
Other
- Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. Garrahan - Ciudad Autonoma Buenos Aires
- Clinica Universitaria Reina Fabiola - Córdoba
- Centre Hospitalier Universitaire de Bicêtre - Le Kremlin-Bicêtre
- Uniwersyteckie Centrum Kliniczne - Gdansk
- Instytut "Pomnik - Centrum Zdrowia Dziecka" - Warsaw
- Kocaeli University Research and Application Hospit - Kocaeli
- Great Ormond Street Hospital for Children - London
Colorado
- Children's Hospital Colorado. - Denver
Shanghai Municipality
- Children's Hospital of Fudan University - Shanghai
Lazio
- IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN - Rome
Lombardy
- Fondazione Istituto Neurologico Mondino IRCCS - Pavia
Mexico CITY (federal District)
- Grupo Medico Camino - DF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2026-03-31 |
| Est. Completion | 2029-09-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05199688
The ClinicalTrials.gov registry entry for NCT05199688 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 65-participant average among 6 other Neuromyelitis Optica Spectrum Disorder trials with a reported enrollment target (88% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Neuromyelitis Optica Spectrum Disorder appearing as the primary indexed condition, and to 1 intervention - of which Satralizumab is the first listed.
NCT05199688 reports 12 study locations spanning 6 distinct geographic areas - top geographies include Other, Colorado, Shanghai Municipality.
Frequently Asked Questions
What is clinical trial NCT05199688 about?
NCT05199688 is a clinical study titled "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)". 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 man...
What is the current status of trial NCT05199688?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 8 participants. The study started on 2026-03-31. Estimated completion is 2029-09-12.
What conditions does trial NCT05199688 study?
This clinical trial studies the following conditions: Neuromyelitis Optica Spectrum Disorder, NMOSD.
What interventions are being tested in trial NCT05199688?
The interventions under investigation include: Satralizumab (DRUG).
Who is sponsoring clinical trial NCT05199688?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05199688 being conducted?
This trial has 12 study locations across Colorado, Shanghai Municipality, Lazio, Lombardy, Mexico CITY (federal District). Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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