臨床研究等提出・公開システム

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)

MEDLEY study

Uehara Motonori

IQVIA Services Japan G.K. (ICCC)

4-10-18 Takanawa, Minato-ku, Tokyo

motonori.uehara@iqvia.com

IQVIA Services Japan G.K. jRCT Inquiry Contact

IQVIA Services Japan G.K. (ICCC)

4-10-18 Takanawa, Minato-ku, Tokyo

+81-3-6859-9500

motonori.uehara@iqvia.com

completed

July. 30, 2019

Interventional

A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study

prevention purpose

2-3

- For the preterm cohort (excluding subjects with CLD, hemodynamically significant CHD, or Down syndrome): preterm infants in their first year of life and born < 35 weeks GA eligible to receive palivizumab in accordance with national or local guidelines or preterm infants who are 29 to 35 weeks GA and 6 to 12 months of age, including those with:
(a) Uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus, or
(b) Aortic stenosis, pulmonic stenosis, or coarctation of the aorta alone
- For the CLD/CHD/Down syndrome cohort:
(a) 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
(b) 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
(c) Subjects with Down syndrome - infants in their first year of life with a diagnosis of Down syndrome
- Infants who are entering their first RSV season at the time of screening

- Any fever (> 38.0 degree celsius, 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
- Receipt of palivizumab or other RSV mAb or any RSV vaccine, including maternal RSV vaccination

Both

Respiratory Syncytial Virus Infections

investigational material(s)
Generic name etc : MEDI8897
INN of investigational material : nirsevimab
Therapeutic category code : 625 Anti-virus agents
Dosage and Administration for Investigational material : Administered as a single IM dose of 50 mg to infants < 5 kg or 100 mg to infants > 5 kg in the first RSV season or a single 200-mg IM dose administered in the second RSV season.

control material(s)
Generic name etc : Palivizumab (Genetical Recombination)
INN of investigational material : Palivizumab
Therapeutic category code : 625 Anti-virus agents
Dosage and Administration for Investigational material : 5 once monthly IM doses of 15 mg/kg palivizumab.

safety
Safety and tolerability of MEDI8897 as assessed by the occurrence of all TEAEs, TESAEs, AESIs, and NOCDs

pharmacokinetics
- MEDI8897 and palivizumab serum concentrations
- MEDI8897 and palivizumab PK parameters: Summary of serum concentrations and estimated PK parameters (Cmax, AUC, apparent clearance, and t1/2, if data permit)
other
Incidence of ADA to MEDI8897 and palivizumab in serum
efficacy
- Incidence of medically attended LRTI (inpatient and outpatient) due to RT PCR-confirmed RSV through 150 days after Dose 1 for Season 1 and Season 2
- Incidence of hospitalizations due to RT PCR-confirmed RSV through 150 days after Dose 1 for Season 1 and Season 2

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June. 24, 2019