Clinical Trial: Study to Evaluate the Efficacy and Safety of REGN2222, for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of a Human Monoclonal Antibody, REGN2222, for the Prevention of Medically Attended This study occurs in two parts: Part A and Part B. The status of Part A is 'Complete'. The status of Part B is 'Active, not recruiting.'

Part A of the study is an open-label, PK evaluation of intramuscular (IM) administered REGN2222 in preterm infants for whom palivizumab is not recommended to enable the selection of dosing regimens for Part B.

Part B of the study is randomized, double-blind, and placebo-controlled, designed to evaluate efficacy, safety, serum concentration and immunogenicity of IM administration of REGN2222 in preterm infants for whom palivizumab is not recommended. The total duration of Part B will be up to 265 days (includes a 28-day screening period, 57-day treatment period and 180-day follow-up period).

Up to 1515 subjects are planned to be included in Part B of the study. Participants will be randomly assigned to 1 of 3 different groups, each with 505 infants; 1 group will get 1 dose of REGN2222 and 1 dose of placebo, the second group will receive 2 doses of REGN2222, and the third group will receive 2 doses of placebo.

There is a separate genetic testing sub study.


Sponsor: Regeneron Pharmaceuticals

Current Primary Outcome:

  • Part A: Serum concentration of REGN2222 over time [ Time Frame: day 1 through day 150 ]
    Serum samples for drug concentration will be collected at pre-specified time points
  • Part B: Proportion of participants with a medically attended RSV infection [(hospitalization or outpatient lower respiratory tract infection (LRTI)] [ Time Frame: day 1 through day 150 ]

    A medically attended RSV infection is defined as an infant with a positive RSV test by reverse-transcriptase polymerase chain reaction (RT-PCR) with any of the following events:

    • Hospitalized (on the basis of the assessment of the admitting physician) for RSV infection
    • Outpatient visit [(ER, Urgent Care (UC), or pediatric clinic (for either a sick or well visit)] with RSV LRTI


Original Primary Outcome: Serum concentration of REGN2222 over time [ Time Frame: day 1 through day 150 ]

Serum samples for drug concentration will be collected at pre-specified time points


Current Secondary Outcome:

  • Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: day 1 through day 237 ]
  • Presence and titer of anti-REGN2222 antibodies [ Time Frame: day 1 through day 150 ]
  • Part B: Proportion of subjects who have RSV-confirmed hospitalization, ER,UC, or pediatric clinic visits (for upper or lower respiratory infection) [ Time Frame: day 1 through day 150 ]


Original Secondary Outcome:

  • Incidence and severity of treatment-emergent adverse events (TEAEs) [ Time Frame: day 1 through day 150 ]
  • Presence and titer of anti-REGN2222 antibodies [ Time Frame: day 1 through day 150 ]


Information By: Regeneron Pharmaceuticals

Dates:
Date Received: December 21, 2014
Date Started: June 2015
Date Completion: September 2017
Last Updated: March 9, 2017
Last Verified: March 2017