A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus(RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children

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AstraZeneca

Status and phase

Completed
Phase 3
Phase 2

Conditions

Respiratory Syncytial Virus Infections

Treatments

Drug: Palivizumab
Drug: MEDI8897

Study type

Interventional

Funder types

Industry

Identifiers

NCT03959488
2019-000201-69 (EudraCT Number)
D5290C00005

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and tolerability of MEDI8897 compared to palivizumab when administered to preterm infants entering their first RSV season and children with chronic lung disease (CLD) and congenital heart disease (CHD) entering their first and second RSV season.

Full description

This study is a pivotal Phase 2/3 randomized, double-blind, palivizumab-controlled study to evaluate the safety, pharmacokinetics (PK), anti-drug antibody (ADA) response, and descriptive efficacy for MEDI8897 in high-risk infants eligible to receive palivizumab when entering their first or second RSV season (Season 1 or Season 2, respectively). Approximately 900 palivizumab-eligible infants entering their first RSV season will be enrolled into one of 2 cohorts: (1) preterm cohort, including approximately 600 preterm infants (≤ 35 weeks gestational age [GA]) without CLD/CHD, or (2) CLD/CHD cohort, including approximately 300 infants with CLD of prematurity or hemodynamically significant CHD. A minimum of 100 infants with hemodynamically significant CHD will be enrolled. Within each cohort, randomization will be stratified by hemisphere (northern, southern) and subject age at the time of Season 1 randomization (≤ 3 months, > 3 to ≤ 6 months, > 6 months).

Enrollment

925 patients

Sex

All

Ages

Under 1 year old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

For the preterm cohort (excluding subjects with CLD or hemodynamically significant CHD): preterm infants in their first year of life and born ≤ 35 weeks 0 days GA eligible to receive palivizumab in accordance with national or local guidelines, including those with:

  • Uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus, or
  • Aortic stenosis, pulmonic stenosis, or coarctation of the aorta alone

For the CLD/CHD cohort:

  • Subjects with CLD - infants in their first year of life and a diagnosis of CLD of prematurity requiring medical intervention/management (ie, supplemental oxygen, bronchodilators, or diuretics) within the 6 months prior to randomization
  • Subjects with CHD - infants in their first year of life and documented, hemodynamically significant CHD (must be unoperated or partially corrected CHD) Note: Infants with hemodynamically significant acyanotic cardiac lesions must have pulmonary hypertension (≥ 40 mmHg measured pressure in the pulmonary artery) or the need for daily medication to manage CHD
  • Infants who are entering their first RSV season at the time of screening
  • Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the USA, EU Data Privacy Directive in the EU) 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 and illness visits as judged by the investigator
  • Subject is available to complete the follow-up period, which will be 1 year after Season 1/ Dose 1 for subjects without CLD/CHD, or 1 year after Season 2/Dose 1 (or last replacement dose as applicable for CHD) for subjects with CLD/CHD

Exclusion criteria

  • Any fever (≥ 100.4°F [≥ 38.0°C], regardless of route) or acute illness within 7 days prior to randomization
  • Any history of LRTI or active LRTI prior to, or at the time of, randomization
  • Known history of RSV infection or active RSV infection prior to, or at the time of, randomization
  • Hospitalization at the time of randomization, unless discharge is expected within the 7 days after randomization
  • Requirement for mechanical ventilation, extracorporeal membrane oxygenation, CPAP, or other mechanical respiratory or cardiac support at the time of randomization
  • Anticipated cardiac surgery within 2 weeks after randomization
  • Anticipated survival of < 6 months after randomization
  • Receipt of any investigational drug
  • Known renal impairment
  • Known hepatic dysfunction including known or suspected active or chronic hepatitis infection
  • Clinically significant congenital anomaly of the respiratory tract
  • Chronic seizure, or evolving or unstable neurologic disorder
  • Prior history of a suspected or actual acute life-threatening event
  • Known immunodeficiency, including human immunodeficiency virus (HIV)
  • Mother with HIV infection (unless the child has been proven to be not infected)
  • Any known allergy, including to immunoglobulin products, or history of allergic reaction
  • Receipt of palivizumab or other RSV mAb or any RSV vaccine, including maternal RSV vaccination
  • Receipt of any monoclonal or polyclonal antibody (for example, hepatitis B immune globulin, intravenous immunoglobulin) or anticipated use during the study
  • Any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of subject safety or study results
  • Concurrent enrollment in another interventional study
  • 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

Trial design

925 participants in 2 patient groups

MEDI8897
Experimental group
Description:
anti-RSV monoclonal antibody with an extended half-life
Treatment:
Drug: MEDI8897
Palivizumab
Active Comparator group
Description:
anti-RSV monoclonal antibody
Treatment:
Drug: Palivizumab

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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