Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder
Start Date
7/3/2023
Completion Date
4/13/2027
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.
Eligibility Criteria
Age Range: 2 years to 17 years
Interventions
Inebilizumab
Conditions
Locations
UCSD Altman Clinical and Translational Research Institute Building
La Jolla, California 92037-1337
United States
Loma Linda University Children's Hospital - PIN
Loma Linda, California 92354
United States
Massachusetts General Hospital
Boston, Massachusetts 02115
United States
University of Texas Southwestern Medical Center
Dallas, Texas 78701
United States
Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. Garrahan
Parque Patricios, Ciudad Autónoma de BuenosAires C1245AAM
Argentina
Hospital Santa Izabel-Rua Floriano Peixoto 300
Salvador, Estado de Bahia 40050-410
Brazil
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
Porto Alegre/RS, 90610-000
Brazil
CPQuali Pesquisa Clínica Sao Paulo
São Paulo, 01228-000
Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, 05403-000
Brazil
Hospital For Sick Children
Toronto, Ontario M5G 1X8
Canada
Centre Hospitalier Universitaire de Bicêtre
Le Kremlin-Bicêtre, Val-de-Marne 94275
France
Erasmus MC Sophia Children's Hospital-Wytemaweg 80
Rotterdam, South Holland 3015 GD
Netherlands
Uniwersyteckie Centrum Kliniczne w Gdansku - Smoluchowskiego 17
Gdansk, 80-952
Poland
Clinic for Neurology and Psychiatry for Children and Youth
Belgrade, Belgrade 11000
Serbia
Hospital Sant Joan de Deu - PIN
Espluges de Llobregat, Barcelona 08950
Spain
Karolinska Universitetssjukhuset Solna
Stockholm, Stockholm County 17176
Sweden
Evelina London Children's Hospital
London, London, City of SE1 7EH
United Kingdom
Great Ormond Street Hospital - PPDS
London, London, City of WC1N 3JH
United Kingdom
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, West Midlands B4 6NH
United Kingdom