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Contact Information:

Study Location:

Regeneron Study Site
Coventry
Birmingham


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

Medical Conditions

Respiratory Syncytial Virus Infections


Study 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.

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.


Key dates

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Jul 2015

Jul 2017

Study type

Interventional

Intervention Type : Drug
Intervention Name : Suptavumab 30 mg/kg
Intervention Description : Participants received single dose of suptavumab 30 milligram per kilogram (mg/kg) intramuscularly (IM) on Day 1.

Intervention Arm Group : Part A: Suptavumab 30 mg/kg

Intervention Type : Drug
Intervention Name : Placebo Matched to Suptavumab
Intervention Description : Participants received 2 IM doses of placebo matched to suptavumab: the first dose on Day 1 and the second dose on Day 57.

Intervention Arm Group : Part B: Placebo Matched to Suptavumab

Intervention Type : Drug
Intervention Name : Suptavumab 30 mg/kg- 1 Dose
Intervention Description : Participants received single dose of suptavumab 30 mg/kg IM on Day 1 and single dose of placebo matched to suptavumab on Day 57.

Intervention Arm Group : Part B: Suptavumab 30 mg/kg- 1 Dose

Intervention Type : Drug
Intervention Name : Suptavumab 30 mg/kg - 2 Doses
Intervention Description : Participants received 2 doses of suptavumab 30 mg/kg IM: the first dose on Day 1 and the second dose on Day 57.

Intervention Arm Group : Part B: Suptavumab 30 mg/kg - 2 Doses

Who can take part?

You can take part if:


Key Inclusion Criteria:

1. Preterm, otherwise healthy male or female infant who is ≤6 months of age at the time of the first dose (i.e., infant must be treated on or before their 6 month birthday)

2. Gestational age is ≤35 weeks, 6 days at birth

3. Parent(s) or legal guardian(s) of the infant is able to understand the study requirements and willing to provide informed consent

Key Exclusion Criteria:

1. Eligible, recommended and have access to receive palivizumab per AAP or other local guidelines, standard practice, or by their healthcare provider

2. History of CLD defined as requirement of supplemental oxygen for 28 days after birth

3. Known hemodynamically significant congenital heart disease

4. Known immunodeficiency, neuromuscular disease, or congenital abnormalities of the airway

5. Known renal or hepatic dysfunction

6. Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders

7. Known or suspected impairment of immunological functions or autoimmune diseases

8. History of anaphylaxis

9. Previously received palivizumab or any other investigational RSV prophylaxis or vaccine product

10. Previous reaction to IV immunoglobulin, blood products or other foreign proteins, including vaccines and monoclonal antibodies

Note: Other inclusion and exclusion criteria apply




You may not be able to take part if:

This is in the inclusion criteria above


Where can I take part?

Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Regeneron Study Site
    Coventry
    Birmingham
  • Regeneron Study Site
    Southampton
    Hampshire
  • Regeneron Study Site
    Gillingham
    Kent
  • Regeneron Study Site
    London
    London, City Of
  • Regeneron Study Site
    Oldham
    Manchester
  • Regeneron Study Site
    Stockport
    Manchester
  • Regeneron Study Site
    Belfast
  • Regeneron Study Site
    Birmingham
  • Regeneron Study Site
    Glasgow
  • Regeneron Study Site
    Manchester
  • Regeneron Study Site
    Poole
  • Regeneron Study Site
    Reading
  • Regeneron Study Site
    Sheffield
  • Regeneron Study Site
    Stockton on Tees

Funders/Sponsors


The study is sponsored by Regeneron Pharmaceuticals .



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for Trial ID: NCT02325791

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