Actively Recruiting
Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder
Led by Amgen · Updated on 2025-12-05
15
Participants Needed
19
Research Sites
197 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 2 to under 18 years with a minimum body weight of 15 kg
- Positive serum anti-AQP4-IgG test at screening
- Diagnosed with neuromyelitis optica spectrum disorder according to Wingerchuk et al, 2015 criteria
- Documented history of one or more NMOSD acute relapses within the last year, or two or more acute relapses within two years prior to screening
You will not qualify if you...
- Any condition that may interfere with treatment evaluation or participant safety, as judged by the Investigator
- Participation in another clinical study with investigational treatment within 4 weeks or 5 half-lives of that treatment before Day 1
- Significant liver, kidney, metabolic, or blood abnormalities confirmed by testing
- B-cell counts less than half the lower limit of normal for age
- Prior receipt of alemtuzumab, total lymphoid irradiation, bone marrow transplant, or T-cell vaccination therapy at any time before Day 1
- Use of rituximab or experimental B-cell depleting agents within 6 months before screening unless B-cell counts recovered
- Receipt of intravenous immunoglobulin within 1 month prior to Day 1
- Use of cyclosporine, methotrexate, mitoxantrone, cyclophosphamide, tocilizumab, satralizumab, or eculizumab within 2 months before Day 1
- Use of natalizumab within 6 months before Day 1
- Severe allergies or anaphylaxis to two or more foods or medicines, including sensitivities to acetaminophen, diphenhydramine, or methylprednisolone
- Uncontrolled autoimmune disease unless approved by medical monitor
- Recent live or attenuated vaccine within 4 weeks before Day 1, blood transfusion within 4 weeks before or during screening
- Serious active or chronic infections requiring treatment or hospitalization within 2 months before Day 1
- History of congenital or acquired immunodeficiency
- Positive tests for chronic hepatitis B or hepatitis C infection
- Negative test for varicella zoster virus IgG
- History of cancer other than certain skin cancers treated successfully over 3 months prior to Day 1
- History or positive test for tuberculosis unless treated according to guidelines
- Inability to undergo or tolerate MRI scans due to medical devices or hypersensitivity to contrast agents
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
UCSD Altman Clinical and Translational Research Institute Building
La Jolla, California, United States, 92037-1337
Actively Recruiting
2
Loma Linda University Children's Hospital - PIN
Loma Linda, California, United States, 92354
Actively Recruiting
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
4
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 78701
Actively Recruiting
5
Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. Garrahan
Parque Patricios, Ciudad Autónoma de BuenosAires, Argentina, C1245AAM
Actively Recruiting
6
Hospital Santa Izabel-Rua Floriano Peixoto 300
Salvador, Estado de Bahia, Brazil, 40050-410
Actively Recruiting
7
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
Porto Alegre/RS, Brazil, 90610-000
Actively Recruiting
8
CPQuali Pesquisa Clínica Sao Paulo
São Paulo, Brazil, 01228-000
Actively Recruiting
9
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazil, 05403-000
Actively Recruiting
10
Hospital For Sick Children
Toronto, Ontario, Canada, M5G 1X8
Actively Recruiting
11
Centre Hospitalier Universitaire de Bicêtre
Le Kremlin-Bicêtre, Val-de-Marne, France, 94275
Actively Recruiting
12
Erasmus MC Sophia Children's Hospital-Wytemaweg 80
Rotterdam, South Holland, Netherlands, 3015 GD
Actively Recruiting
13
Uniwersyteckie Centrum Kliniczne w Gdansku - Smoluchowskiego 17
Gdansk, Poland, 80-952
Actively Recruiting
14
Clinic for Neurology and Psychiatry for Children and Youth
Belgrade, Belgrade, Serbia, 11000
Actively Recruiting
15
Hospital Sant Joan de Deu - PIN
Espluges de Llobregat, Barcelona, Spain, 08950
Actively Recruiting
16
Karolinska Universitetssjukhuset Solna
Stockholm, Stockholm County, Sweden, 17176
Actively Recruiting
17
Evelina London Children's Hospital
London, London, City of, United Kingdom, SE1 7EH
Actively Recruiting
18
Great Ormond Street Hospital - PPDS
London, London, City of, United Kingdom, WC1N 3JH
Actively Recruiting
19
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, West Midlands, United Kingdom, B4 6NH
Actively Recruiting
Research Team
A
Amgen Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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