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RECRUITING 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)

NCT05199688 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 8 participants
Start Date 2026-03-31
Est. Completion 2029-09-12
Phase Phase 3

Sponsor

Hoffmann-La Roche

758 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05199688 reports 12 study locations spanning 6 distinct geographic areas — top geographies include Other, Colorado, Shanghai Municipality. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05199688?

The interventions under investigation include: Satralizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05199688?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial