Last updated 8 months 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 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.
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 resultsConcurrent/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 1Evidence 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 laboratoryReceipt of the following at any time prior to Day 1: 1. Alemtuzumab 2. Total lymphoid irradiation 3. Bone marrow transplant 4. T-cell vaccination therapyReceipt 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 LLNReceipt of intravenous immunoglobulin (IVIG) within one month prior to Day 1Receipt 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. EculizumabReceipt of natalizumab (Tysabri®) within 6 months prior to Day 1Severe 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
InCor - Instituto do Coração do HCFMUSP
Recruiting
INSCER - Instituto do Cérebro da PUC-RS
Recruiting
SponsorHorizon Therapeutics Ireland DAC
Study typeInterventional
Requirements
To 17 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05549258
