Evaluate the Safety and Tolerability, for Nirsevimab in Immunocompromised Children (MUSIC)

  • STATUS
    Not Recruiting
  • End date
    Feb 23, 2023
  • participants needed
    100
  • sponsor
    AstraZeneca
Updated on 5 April 2022
tacrolimus
immunodeficiency
methotrexate
HIV Infection
corticosteroid therapy
wiskott-aldrich syndrome

Summary

Study D5290C00008 is a Phase 2, open-label, uncontrolled, single-dose study to evaluate the safety and tolerability, PK, occurrence of ADA, and efficacy of nirsevimab in immunocompromised children who are ≤ 24 months of age at the time of dose administration. Approximately 100 subjects will be enrolled. Subjects will be followed for approximately 1 year after dose administration.

Description

Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infection (LRTI) among infants and young children, resulting in annual epidemics in Japan. Children with congenital or acquired immunodeficiencies, transplant recipients, and those receiving immunosuppressive therapy are at increased risk for severe RSV-associated LRTI with prolonged viral shedding and higher viral loads, resulting in prolonged hospitalizations, admissions to the intensive care unit (ICU), and the need for mechanical ventilation. Palivizumab (Synagis®) is the only approved agent for RSV prophylaxis, and its half-life (t1/2) is approximately 1 month, infants and young children need to receive monthly intramuscular doses of palivizumab throughout the RSV season to maintain protection. This constitutes a significant burden on healthcare providers as well as the infants/children and their families.

Nirsevimab may provide a cost-effective opportunity to protect all infants from RSV disease based on an improvement in potency and the extended t1/2 that is expected to support once-per-RSV-season dosing.

Details
Condition RSV Infection
Treatment Nirsevimab
Clinical Study IdentifierNCT04484935
SponsorAstraZeneca
Last Modified on5 April 2022

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