NCT02325791

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

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 RSV Infection in Preterm Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,177 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study was to evaluate the efficacy, safety, pharmacokinetics (PK), and immunogenicity of suptavumab (REGN2222) in infants born no more than 35 weeks, 6 days gestational age who are no more than 6 months of age at the time of enrollment in their respective geographic location. In order to optimize the potential benefit in this vulnerable population, we conducted this study during the RSV season using dosing regimens that are expected to be effective.

Detailed description

This study occurred in two parts: Part A and Part B. Part A of the study was an open-label, PK evaluation of intramuscular (IM) administered suptavumab in preterm infants for whom palivizumab was not recommended to enable the selection of dosing regimens for Part B. Part B of the study was randomized, double-blind, and placebo-controlled, designed to evaluate efficacy, safety, serum concentration and immunogenicity of IM administration of suptavumab in preterm infants for whom palivizumab was not recommended. The total duration of Part B was up to 265 days (includes a 28-day screening period, 57-day treatment period and 180-day follow-up period). Up to 1515 subjects were planned to be included in Part B of the study. Participants were randomly assigned to 1 of 3 different groups, each with 505 infants; one group received one dose of suptavumab and one dose of placebo, the second group received two doses of suptavumab, and the third group received two doses of placebo. There was a separate genetic testing sub study.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
DRUG	Suptavumab 30 mg/kg	Participants received single dose of suptavumab 30 milligram per kilogram (mg/kg) intramuscularly (IM) on Day 1.
DRUG	Placebo Matched to Suptavumab	Participants received 2 IM doses of placebo matched to suptavumab: the first dose on Day 1 and the second dose on Day 57.
DRUG	Suptavumab 30 mg/kg- 1 Dose	Participants received single dose of suptavumab 30 mg/kg IM on Day 1 and single dose of placebo matched to suptavumab on Day 57.
DRUG	Suptavumab 30 mg/kg - 2 Doses	Participants received 2 doses of suptavumab 30 mg/kg IM: the first dose on Day 1 and the second dose on Day 57.

Timeline

• Start date: 2015-07-21
• Primary completion: 2017-07-05
• Completion: 2017-09-26
• First posted: 2014-12-25
• Last updated: 2018-11-06
• Results posted: 2018-11-06

Locations

205 sites across 19 countries: United States, Australia, Bulgaria, Canada, Chile, Denmark, Finland, Germany, Hungary, Netherlands, New Zealand, Panama, Puerto Rico, South Africa, Spain, Sweden, Turkey (Türkiye), Ukraine, United Kingdom