Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 3 for:    Nirsevimab | RSV
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04484935
Recruitment Status : Active, not recruiting
First Posted : July 24, 2020
Last Update Posted : March 21, 2022
Sponsor:
Collaborator:
Iqvia Pty Ltd
Information provided by (Responsible Party):
AstraZeneca

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
RSV Infection Drug: Nirsevimab Phase 2

Expanded Access : AstraZeneca has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : August 19, 2020
Estimated Primary Completion Date : February 23, 2023
Estimated Study Completion Date : February 23, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nirsevimab

1st RSV season: 50mg nirsevimab

  1. st RSV season: 100mg nirsevimab
  2. 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 Name: MEDI8897




Primary Outcome Measures :
  1. Safety and tolerability of nirsevimab when administered to immunocompromised children ≤ 24 months of age [ Time Frame: Through 360 days post dose. ]
    All TEAEs, TESAEs, AESIs, NOCDs


Secondary Outcome Measures :
  1. To evaluate the PK of nirsevimab [ Time Frame: Through 360 days post dose. ]
    Summary of nirsevimab serum concentrations

  2. To evaluate ADA responses to nirsevimab in serum [ Time Frame: 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 [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04484935


Locations
Layout table for location information
United States, California
Research Site
Los Angeles, California, United States, 90027
United States, Florida
Research Site
Tampa, Florida, United States, 33606
United States, New York
Research Site
Syracuse, New York, United States, 13210
United States, South Carolina
Research Site
North Charleston, South Carolina, United States, 29406
United States, Tennessee
Research Site
Memphis, Tennessee, United States, 38105
United States, Texas
Research Site
Fort Worth, Texas, United States, 76104
United States, Washington
Research Site
Tacoma, Washington, United States, 98405
Belgium
Research Site
Bruxelles, Belgium, 1200
Research Site
Liège, Belgium, 4000
Japan
Research Site
Bunkyo-ku, Japan, 113-8519
Research Site
Fuchu-shi, Japan, 183-8561
Research Site
Kawasaki-shi, Japan, 216-8511
Research Site
Kurume-shi, Japan, 830-0011
Research Site
Kyoto-shi, Japan, 606-8507
Research Site
Nagasaki-shi, Japan, 852-8501
Research Site
Setagaya-ku, Japan, 157-8535
Research Site
Tsukuba-shi, Japan, 305-8576
Research Site
Yokohama-shi, Japan, 232 8555
Poland
Research Site
Bydgoszcz, Poland, 85-048
South Africa
Research Site
Parktown, South Africa, 2193
Research Site
Soweto, South Africa, 2013
Spain
Research Site
Barcelona, Spain, 8035
Research Site
Granada, Spain, 18014
Research Site
Madrid, Spain, 28041
Research Site
Madrid, Spain, 28046
Ukraine
Research Site
Dnipro, Ukraine, 49006
Research Site
Kharkiv, Ukraine, 61075
United Kingdom
Research Site
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
AstraZeneca
Iqvia Pty Ltd
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04484935    
Other Study ID Numbers: D5290C00008
First Posted: July 24, 2020    Key Record Dates
Last Update Posted: March 21, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

Layout table for additional information
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:
Layout table for MeSH terms
Respiratory Syncytial Virus Infections
Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases