An Open-Label Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
UCSD Altman Clinical and Translational Research Institute Building
RECRUITING
La Jolla
Loma Linda University Children's Hospital - PIN
RECRUITING
Loma Linda
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Other Locations
Argentina
Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. Garrahan
RECRUITING
Parque Patricios
Brazil
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
RECRUITING
Porto Alegre/rs
Hospital Santa Izabel-Rua Floriano Peixoto 300
RECRUITING
Salvador
CPQuali Pesquisa Clínica Sao Paulo
RECRUITING
São Paulo
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
RECRUITING
São Paulo
Canada
Hospital For Sick Children
RECRUITING
Toronto
France
Centre Hospitalier Universitaire de Bicêtre
RECRUITING
Le Kremlin-bicêtre
Netherlands
Erasmus MC Sophia Children's Hospital-Wytemaweg 80
RECRUITING
Rotterdam
Poland
Uniwersyteckie Centrum Kliniczne w Gdansku - Smoluchowskiego 17
RECRUITING
Gdansk
Serbia
Clinic for Neurology and Psychiatry for Children and Youth
RECRUITING
Belgrade
Spain
Hospital Sant Joan de Deu - PIN
RECRUITING
Espluges De Llobregat
Sweden
Karolinska Universitetssjukhuset Solna
RECRUITING
Stockholm
United Kingdom
Birmingham Women's and Children's NHS Foundation Trust
RECRUITING
Birmingham
Evelina London Children's Hospital
RECRUITING
London
Great Ormond Street Hospital - PPDS
RECRUITING
London
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date: 2023-07-03
Estimated Completion Date: 2027-04-13
Participants
Target number of participants: 15
Treatments
Experimental: Inebilizumab
Infusion of Inebilizumab
Related Therapeutic Areas
Sponsors
Leads: Amgen