Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder
NCT ID: NCT05549258
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
15 participants
INTERVENTIONAL
2023-07-03
2027-04-13
Brief Summary
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Detailed Description
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Acquired from Horizon in 2023.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Inebilizumab
Infusion of Inebilizumab
Inebilizumab
Inebilizumab administered intravenously (IV) over a total of 28 weeks.
Interventions
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Inebilizumab
Inebilizumab administered intravenously (IV) over a total of 28 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
Receipt of any of the following:
1. Any live or attenuated vaccine within 4 weeks prior to Day 1 (administration of killed vaccines and nucleoside-modified mRNA-based vaccines is acceptable; the Sponsor recommends that Investigators ensure all participants are up to date on required vaccinations prior to study entry).
2. Bacillus Calmette Guérin vaccine within one year of screening.
3. Blood transfusion within 4 weeks prior to screening or during screening.
* Clinically significant serious active or chronic viral, bacterial, or fungal infection that requires treatment with anti-infectives, hospitalization, or, in the Investigator's opinion, represents an additional risk to the participant, within 2 months prior to Day 1.
* Known history of congenital or acquired immunodeficiency (e.g., due to human immunodeficiency virus \[HIV\] infection, splenectomy, immunosuppression-related or idiopathic T-cell deficiencies) that predisposes the participant to infection.
* Positive test for chronic hepatitis B infection at screening, defined as either:
a. Positive hepatitis B surface antigen (HBsAg), or b. Positive hepatitis B core (HBc) antibody (anti-HBc) plus negative hepatitis B surface (HBs) antibody (anti-HBs).
* Positive test for hepatitis C virus antibody.
* Negative test for varicella zoster virus (VZV)-IgG.
* History of cancer, apart from squamous cell or basal cell carcinoma of the skin treated with documented success of curative therapy \> 3 months prior to Day 1.
* History of active or latent tuberculosis (TB), or a positive QuantiFERON®-TB Gold test at screening, unless treatment for TB was completed per local guidelines. Participants with latent TB or a positive QuantiFERON®-TB Gold test who are actively on anti-TB treatment can enroll if they have completed at least one month of anti-TB treatment and intend to complete the full course of anti-TB treatment. Participants with an indeterminate QuantiFERON®-TB Gold test result can enroll if a repeat QuantiFERON®-TB Gold test is negative or a tuberculin skin test is negative.
* For participants who may undergo MRI scans:
1. Unable to undergo an MRI scan (e.g., hypersensitivity to Gd-containing MRI contrast agents, implanted pacemakers, defibrillators, or other metallic objects on or inside the body that limit performing MRI scans), or
2. Unable to tolerate or comply with the MRI procedure.
2 Years
17 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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UCSD Altman Clinical and Translational Research Institute Building
La Jolla, California, United States
Loma Linda University Children's Hospital - PIN
Loma Linda, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. Garrahan
Parque Patricios, Ciudad Autónoma de BuenosAires, Argentina
Hospital Santa Izabel-Rua Floriano Peixoto 300
Salvador, Estado de Bahia, Brazil
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
Porto Alegre/RS, , Brazil
CPQuali Pesquisa Clínica Sao Paulo
São Paulo, , Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, , Brazil
Hospital For Sick Children
Toronto, Ontario, Canada
Centre Hospitalier Universitaire de Bicêtre
Le Kremlin-Bicêtre, Val-de-Marne, France
Erasmus MC Sophia Children's Hospital-Wytemaweg 80
Rotterdam, South Holland, Netherlands
Uniwersyteckie Centrum Kliniczne w Gdansku - Smoluchowskiego 17
Gdansk, , Poland
Clinic for Neurology and Psychiatry for Children and Youth
Belgrade, Belgrade, Serbia
Hospital Sant Joan de Deu - PIN
Espluges de Llobregat, Barcelona, Spain
Karolinska Universitetssjukhuset Solna
Stockholm, Stockholm County, Sweden
Evelina London Children's Hospital
London, London, City of, United Kingdom
Great Ormond Street Hospital - PPDS
London, London, City of, United Kingdom
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, West Midlands, United Kingdom
Countries
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Central Contacts
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2023-510007-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
VIB0551.P2.S2.NMO
Identifier Type: -
Identifier Source: org_study_id
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