Phase 3
Completed N=1,172
Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants
Source: ClinicalTrials.gov NCT02325791 ↗Enrolled (actual)
1,172
Serious AEs
10.8%
Results posted
Nov 2018
Primary outcomePrimary: Part A: Serum Concentration of Suptavumab Over Time — 280; 177; 145; 128 mg/L
◆ Published Evidence
Highly cited
159citations · ~32 / year
Suptavumab for the Prevention of Medically Attended Respiratory Syncytial Virus Infection in Preterm Infants.
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.
Linked Publications
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Suptavumab for the Prevention of Medically Attended Respiratory Syncytial Virus Infection in Preterm Infants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A: Serum Concentration of Suptavumab Over Time |
280; 177; 145; 128; 110; 70.9 | — |
| PRIMARY Part B: Percentage of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Infection (Hospitalization or Outpatient Visit With Lower Respiratory Tract Infection [LRTI]) Up to Day 150 |
8.1; 7.7; 9.3 | 0.5773 |
| SECONDARY Part A: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) |
69.6; 4.3 | — |
| SECONDARY Part B: Serum Concentration of Suptavumab |
142; 145; 95.6; 93.5; 70.1; 238 | — |
| SECONDARY Part B: Number of Participants With At Least One Positive Anti-Drug Antibody (ADA) Assay |
351; 380; 336; 0; 0; 0 | — |
| SECONDARY Part B: Percentage of Participants Hospitalized With Medically Attended RSV Infection or Outpatient Visit Lower Respiratory Tract Infection (LRTI) or Upper Respiratory Tract Infection (URTI) Up to Day 150 |
12.5; 11.9; 14.5 | — |
Eligibility Criteria
Key Inclusion Criteria
- 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)
- Gestational age is ≤35 weeks, 6 days at birth
- 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
- Eligible, recommended and have access to receive palivizumab per AAP or other local guidelines, standard practice, or by their healthcare provider
- History of CLD defined as requirement of supplemental oxygen for 28 days after birth
- Known hemodynamically significant congenital heart disease
- Known immunodeficiency, neuromuscular disease, or congenital abnormalities of the airway
- Known renal or hepatic dysfunction
- Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
- Known or suspected impairment of immunological functions or autoimmune diseases
- History of anaphylaxis
- Previously received palivizumab or any other investigational RSV prophylaxis or vaccine product
- Previous reaction to IV immunoglobulin, blood products or other foreign proteins, including vaccines and monoclonal antibodies
Note: Other inclusion and exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT02325791) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.