NCT05549258

Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder

An Open-Label Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Approximately 15 participants to be enrolled and receive Inebilizumab administered intravenously over 28 weeks. The maximum trial duration per participant is approximately 80 weeks, including up to 4 week screening period, 9 visits during a 28 week open-label treatment period, and approximately 4 visits during a 52 week follow-up period. Safety evaluations will be performed regularly throughout the course of the study. Acquired from Horizon in 2023.

Conditions

• Neuromyelitis Optica Spectrum Disorder

Interventions

Type	Name	Description
DRUG	Inebilizumab	Inebilizumab administered intravenously (IV) over a total of 28 weeks.

Timeline

• Start date: 2023-07-03
• Primary completion: 2027-04-13
• Completion: 2027-04-13
• First posted: 2022-09-22
• Last updated: 2025-12-05

Locations

19 sites across 11 countries: United States, Argentina, Brazil, Canada, France, Netherlands, Poland, Serbia, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study