drugset / Trial / NCT05549258

Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder

NCT05549258

Phase 2 Recruiting 15 enrolled Amgen
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2023-07-03
Primary completion
2027-04-13
Completion
2027-04-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Inebilizumab Monoclonal antibody Intravenous