An Open-Label Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder
Amgen
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).
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.
Eligibility
- Age range
- 2–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or female participants, minimum body weight of 15 kg, age 2 to \< 18 years at the time of screening. * Positive serum anti-AQP4-IgG result at screening and diagnosed with NMOSD according to the criteria of Wingerchuk et al, 2015. * Documented history of one or more NMOSD acute relapses within the last year, or 2 or more NMOSD acute relapses within 2 years prior to screening. Exclusion Criteria: * Any condition that, in the opinion of the Investigator, would interfere with the evaluation or administration of the Investigational Product or interpretation of particip…
Interventions
- DrugInebilizumab
Inebilizumab administered intravenously (IV) over a total of 28 weeks.
Locations (19)
- UCSD Altman Clinical and Translational Research Institute BuildingLa Jolla, California
- Loma Linda University Children's Hospital - PINLoma Linda, California
- Massachusetts General HospitalBoston, Massachusetts
- University of Texas Southwestern Medical CenterDallas, Texas
- Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. GarrahanParque Patricios, Ciudad Autónoma de BuenosAires
- Hospital Santa Izabel-Rua Floriano Peixoto 300Salvador, Estado de Bahia