MedTrace Logo

Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder

NCT05549258 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-12-05

No results posted yet for this study

Summary

A Phase 2, open-label, multicenter study to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of inebilizumab in eligible pediatric participants 2 to \< 18 years of age with recently active neuromyelitis optica spectrum disorder (NMOSD) who are seropositive for autoantibodies against aquaporin-4 (AQP4-immunoglobulin \[Ig\]G).

Conditions

Interventions

DRUG

Inebilizumab

Inebilizumab administered intravenously (IV) over a total of 28 weeks.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-03
Primary Completion
2027-04-13
Completion
2027-04-13
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • France
  • Netherlands
  • Poland
  • Serbia
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05549258 on ClinicalTrials.gov