RecruitingPhase 2NCT05549258

Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder

An Open-Label Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder

Sponsor

Amgen

Enrollment

15 participants

Start Date

Jul 3, 2023

Study Type

INTERVENTIONAL

Conditions

Neuromyelitis Optica Spectrum Disorder

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

Min Age: 2 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a medication called inebilizumab in children and teenagers who have a rare autoimmune condition called neuromyelitis optica spectrum disorder (NMOSD). NMOSD is a disease in which the immune system mistakenly attacks the optic nerves and spinal cord, causing vision loss, weakness, and other serious neurological problems. Inebilizumab works by depleting certain immune cells (B cells) that drive the disease. Researchers want to see if this treatment is safe and effective for younger patients. You may be eligible if: - Your child is between 2 and 17 years old and weighs at least 15 kg - Your child has been diagnosed with NMOSD and tests positive for anti-AQP4 antibodies - Your child has had at least one NMOSD relapse in the past year, or two or more relapses in the past two years You may NOT be eligible if: - Your child has previously received certain immune treatments like alemtuzumab, bone marrow transplant, or T-cell vaccination - Your child has recently received rituximab or other B-cell depleting therapies (within 6 months) unless B-cell counts have recovered - Your child has a chronic or active serious infection, including hepatitis B, hepatitis C, or HIV - Your child has a known immunodeficiency - Your child has a history of active or latent tuberculosis (unless fully treated) - Your child cannot undergo MRI scans - Your child has been vaccinated with a live vaccine within the past 4 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInebilizumab

Inebilizumab administered intravenously (IV) over a total of 28 weeks.

Locations(19)

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

View Full Details on ClinicalTrials.gov

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NCT05549258

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