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Clinical Trial Results:
A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY)

Summary
EudraCT number	2019-000201-69
Trial protocol	BE LV GB SE DE BG CZ EE HU LT PL FI AT FR ES IT
Global end of trial date	23 Jun 2023

Results information
Results version number	v1(current)
This version publication date	04 Aug 2023
First version publication date	04 Aug 2023
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
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Trial information

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Sponsor protocol code

D5290C00005

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

AstraZeneca

Sponsor organisation address

One MedImmune Way, Gaithersburg, United States, 20878

Public contact

Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com

Scientific contact

Global Clinical Lead, AstraZeneca, +1 8772409479, information.center@astrazeneca.com

Is trial part of an agreed paediatric investigation plan (PIP)

Yes

EMA paediatric investigation plan number(s)

EMEA-001784-PIP01-15

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

06 Jun 2023

Is this the analysis of the primary completion data?

Yes

Primary completion date

06 Jun 2023

Global end of trial reached?

Yes

Global end of trial date

23 Jun 2023

Was the trial ended prematurely?

Main objective of the trial

Study D5290C00005 (MEDLEY) is a pivotal Phase 2/3 randomized, double-blind, palivizumab-controlled study to evaluate the safety, PK, 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).

Protection of trial subjects

Each subject was assigned a SID to ensure that personally identifiable information was kept separate from the study data. Subject data that were relevant to the trial, eg, demographic information, physical or mental health condition, diagnosis, comorbidities, laboratory test results, etc. were collected with the subject’s informed consent. The IRB/IEC responsible for each site must review and approve the final study protocol, including the final version of the Informed Consent Form and any other written information and/or materials to be provided to the subjects. The IRB/IEC must also approve all advertising used to recruit subjects for the study. Before the study was initiated, AstraZeneca/MedImmune ensured that the national regulatory authority in each country had been notified and their approval had been obtained, as required. AstraZeneca/MedImmune provided safety updates/reports according to local requirements, including suspected unexpected serious adverse reactions where relevant, to regulatory authorities, IRB/IEC, and principal investigators.

Background therapy

MEDI8897 is a recombinant human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody (mAb) directed against the prefusion conformation of the RSV fusion (F) protein. The antibody has been engineered with a triple amino acid substitution (YTE; M257Y/S259T/T261E [M252Y/S254T/T256E, according to the European Union (EU) numbering system]) in the fragment crystallizable (Fc) region to prolong the t1/2, which is expected to provide protection from serious RSV disease for the duration of the RSV season. MEDI8897 neutralizes RSV by binding the prefusion conformation of the RSV F protein at a site distinct from that bound by palivizumab. In preclinical studies, MEDI8897 was > 150 fold more potent than palivizumab in vitro and approximately 9-fold more potent than palivizumab in vivo in the cotton rat model. MEDI8897 is currently under development by MedImmune for the passive immunization of all infants entering their first RSV season and children with CLD or CHD entering their first and second RSV season for the prevention of LRTI caused by RSV. MEDI8897 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.

Evidence for comparator

Palivizumab is an approved RSV prophylaxis, requires 5 once-monthly injections for protection and due to cost is restricted for use only in infants at the greatest risk for morbidity and mortality from RSV.

Actual start date of recruitment

30 Jul 2019

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country