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

Sponsor
AstraZeneca (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04484935
Collaborator
Iqvia Pty Ltd (Industry)
100
Enrollment
28
Locations
1
Arm
30.2
Anticipated Duration (Months)
3.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Masking Description:
Open: no masking is used. All involved know the identity of the intervention assignment.
Primary Purpose:
Prevention
Official Title:
A Phase 2, Open-label, Uncontrolled, Single-dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Occurrence of Antidrug Antibody for Nirsevimab in Immunocompromised Children ≤ 24 Months of Age
Actual Study Start Date :
Aug 19, 2020
Anticipated Primary Completion Date :
Feb 23, 2023
Anticipated Study Completion Date :
Feb 23, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Nirsevimab

1st RSV season: 50mg nirsevimab st RSV season: 100mg nirsevimab nd RSV season: 200mg nirsevimab

Drug: Nirsevimab
Single fixed IM dose of nirsevimab 50 mg if body weight < 5 kg or 100 mg if body weight ≥ 5 kg, and subjects entering their second RSV season will receive a single fixed IM dose of nirsevimab 200 mg
Other Names:
  • MEDI8897

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety and tolerability of nirsevimab when administered to immunocompromised children ≤ 24 months of age [Through 360 days post dose.]

      All TEAEs, TESAEs, AESIs, NOCDs

    Secondary Outcome Measures

    1. To evaluate the PK of nirsevimab [Through 360 days post dose.]

      Summary of nirsevimab serum concentrations

    2. To evaluate ADA responses to nirsevimab in serum [Through 360 days post dose.]

      Incidence of ADA to nirsevimab in serum

    3. To assess the efficacy of nirsevimab when administered as a single intramuscular (IM) dose to infants ≤ 24 months of age [Through 360 days post dose]

      Incidence of medically attended lower respiratory tract infection (LRTI; inpatient and outpatient) and hospitalizations due to reverse transcriptase-polymerase chain reaction (RT-PCR)-confirmed respiratory syncytial virus (RSV) through 150 days after administration of nirsevimab

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Years to 2 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Neonate, infant, or young child ≤ 24 months of age at the time of dose administration who, per investigator judgement, are:

    1. In their first year of life AND entering their first RSV season at the time of dose administration OR

    2. In their second year of life AND entering their second RSV season at the time of dose administration

    • The subject must meet at least 1 of the following conditions at the time of informed consent.

    1. Diagnosed with combined immunodeficiency (severe combined immunodeficiency, X-linked hyper-immunoglobulin M [IgM] syndrome, etc); antibody deficiency (X linked agammaglobulinemia, common variable immunodeficiency, non-X-linked hyper-IgM syndromes, etc); or other immunodeficiency (Wiskott-Aldrich syndrome, DiGeorge syndrome, etc), or

    2. Diagnosed with human immunodeficiency virus infection, or

    3. History of organ or bone marrow transplantation, or

    4. Subject is receiving immunosuppressive chemotherapy, or

    5. Subject is receiving systemic high-dose corticosteroid therapy (prednisone equivalents ≥ 0.5 mg/kg every other day, other than inhaler or topical use), or

    6. Subject is receiving other immunosuppressive therapy (eg, azathioprine, methotrexate, mizoribine, mycophenolate mofetil, cyclophosphamide, cyclosporine, tacrolimus, cytokine inhibitors, etc)

    • Written informed consent and any locally required authorization obtained from the subject's parent(s)/legal representative(s) prior to performing any protocol-related procedures, including screening evaluations.

    • Subject's parent(s)/legal representative(s) able to understand and comply with the requirements of the protocol including follow-up visits as judged by the investigator.

    • Subject is available to complete the follow-up period, which will be approximately 1 year after receipt of nirsevimab

    Exclusion Criteria:
    • Subject who meets any of the palivizumab indications approved in Japan other than immunocompromised condition.

    1. Subject born at ≤ 28 weeks gestation and is ≤ 12 months of age

    2. Subject born at 29 to 35 weeks gestation and is ≤ 6 months of age

    3. Age ≤ 24 months with a history of bronchopulmonary dysplasia requiring medical management within the past 6 months

    4. Age ≤ 24 months with current hemodynamically significant CHD

    5. Age ≤ 24 months with Down syndrome

    • Requirement for oxygen supplementation, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure, or other mechanical respiratory or cardiac support at screening

    • A current, active infection, including RSV infection, at the time of screening or at the time of investigational product administration.

    • Any fever (≥ 100.4°F [≥ 38.0°C], regardless of route) or acute illness within 7 days prior to investigational product administration.

    • Any serious concurrent medical condition (renal failure, hepatic dysfunction, suspected active or chronic hepatitis infection, seizure disorder, unstable neurologic disorder, etc), except those resulting in an immune deficiency condition.

    • Clinically significant congenital anomaly of the respiratory tract.

    • Receipt of palivizumab.

    • Any known allergy or history of allergic reaction to any component of nirsevimab.

    • Any known allergy or history of allergic reaction to immunoglobulin products, blood products, or other foreign proteins.

    • Concurrent enrollment in another interventional study, or prior receipt of any investigational agent.

    • Anticipated survival of less than 1 year at the time of informed consent.

    • Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of study results.

    • Children of employees of the sponsor, clinical study site, or any other individuals involved with the conduct of the study, or immediate family members of such individuals.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Los Angeles California United States 90027
    2 Research Site Tampa Florida United States 33606
    3 Research Site Syracuse New York United States 13210
    4 Research Site North Charleston South Carolina United States 29406
    5 Research Site Memphis Tennessee United States 38105
    6 Research Site Fort Worth Texas United States 76104
    7 Research Site Tacoma Washington United States 98405
    8 Research Site Bruxelles Belgium 1200
    9 Research Site Liège Belgium 4000
    10 Research Site Bunkyo-ku Japan 113-8519
    11 Research Site Fuchu-shi Japan 183-8561
    12 Research Site Kawasaki-shi Japan 216-8511
    13 Research Site Kurume-shi Japan 830-0011
    14 Research Site Kyoto-shi Japan 606-8507
    15 Research Site Nagasaki-shi Japan 852-8501
    16 Research Site Setagaya-ku Japan 157-8535
    17 Research Site Tsukuba-shi Japan 305-8576
    18 Research Site Yokohama-shi Japan 232 8555
    19 Research Site Bydgoszcz Poland 85-048
    20 Research Site Parktown South Africa 2193
    21 Research Site Soweto South Africa 2013
    22 Research Site Barcelona Spain 8035
    23 Research Site Granada Spain 18014
    24 Research Site Madrid Spain 28041
    25 Research Site Madrid Spain 28046
    26 Research Site Dnipro Ukraine 49006
    27 Research Site Kharkiv Ukraine 61075
    28 Research Site Nottingham United Kingdom NG7 2UH

    Sponsors and Collaborators

    • AstraZeneca
    • Iqvia Pty Ltd

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT04484935
    Other Study ID Numbers:
    • D5290C00008
    First Posted:
    Jul 24, 2020
    Last Update Posted:
    Mar 21, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by AstraZeneca
    LRTI by RSV infection
    Additional relevant MeSH terms:
    Respiratory Syncytial Virus Infections

    Study Results

    No Results Posted as of Mar 21, 2022