Last updated 57 days ago

Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder

15 patients around the world

Available in Argentina, United States, Brazil, Spain

Approximately 15 subjects 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 2024.

Horizon Therapeutics Ireland DAC

3Research sites

15Patients around the world

Requirements for the patient

To 17 Years

All Gender

Medical requirements

: Male or female subjects 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.

: Any condition that, in the opinion of the Investigator, would interfere with the evaluation or administration of the Investigational Product or interpretation of subject safety or study results
Concurrent/previous enrollment in another clinical study involving an investigational treatment within 4 weeks or 5 published half-lives of the investigational treatment, whichever is the longer, prior to Day 1
Evidence of significant hepatic, renal, or metabolic dysfunction or significant hematological abnormality (one repeat test may be conducted to confirm results within the same screening period):
B-cell counts < one-half of the lower limit of normal (LLN) for age according to the central laboratory
Receipt of the following at any time prior to Day 1: 1. Alemtuzumab 2. Total lymphoid irradiation 3. Bone marrow transplant 4. T-cell vaccination therapy
Receipt of rituximab or any experimental B-cell depleting agent within 6 months prior to screening unless B-cell counts have returned to ≥ one-half the LLN
Receipt of intravenous immunoglobulin (IVIG) within one month prior to Day 1
Receipt of any of the following within 2 months prior to Day 1: 1. Cyclosporine 2. Methotrexate 3. Mitoxantrone 4. Cyclophosphamide 5. Tocilizumab 6. Satralizumab 7. Eculizumab
Receipt of natalizumab (Tysabri®) within 6 months prior to Day 1
Severe drug allergic history or anaphylaxis to 2 or more food products or medicine (including known sensitivity to acetaminophen/paracetamol, diphenhydramine or equivalent antihistamine, and methylprednisolone or equivalent glucocorticoid)
Diagnosed with a concurrent autoimmune disease that is uncontrolled (unless approved by the medical monitor)
Recent receipt of live/attenuated vaccine or blood transfusion

Sites

Hospital de Pediatría Dr. Juan P. Garrahan

Recruiting

Combate de los Pozos 1881, CABA, Buenos Aires

INSCER - Instituto do Cérebro da PUC-RS

Recruiting

Av. Ipiranga, 6690, 4o Andar, Centro de Pesquisa Clínica do HSLPUCRS - Jardim Botânico – Porto Alegre/RS - 90610-000

Instituto do Coração do HCFMUSP

Recruiting

Av. Dr. Enéas Carvalho de Aguiar, 44 - 1° andar, sala 2 - Cerqueira César, São Paulo - SP, CEP: 05403-000

SponsorHorizon Therapeutics Ireland DAC

Study typeInterventional

Requirements

To 17 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT05549258