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NCT02325791 · ClinicalTrials.gov registry record · Phase 3
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 study of Respiratory Syncytial Virus Infections, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,177
- Enrollment target
- 20
- Study locations
NCT02325791: Completed Phase 3 study of Respiratory Syncytial Virus Infections, sponsored by Regeneron Pharmaceuticals.
NCT02325791 is a Phase 3 study of Respiratory Syncytial Virus Infections that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 1,177 participants, above the 1,035-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (14% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02325791, a Phase 3 study of Respiratory Syncytial Virus Infections, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,177 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Part A was primarily designed to determine the pharmacokinetics (PK) of suptavumab in infants to inform the dose regimen used in Part B of the study. The study protocol specified the process and criteria for assessment of the dose. The dose used in Part B was to remain the same as Part A if the PK data up to Day 57 demonstrated that the individual PK observations were consistent with model-predicted concentrations, following age and body weight corrections.
Conditions Studied
Interventions
- DRUG Suptavumab 30 mg/kg
- DRUG Placebo Matched to Suptavumab
- DRUG Suptavumab 30 mg/kg- 1 Dose
- DRUG Suptavumab 30 mg/kg - 2 Doses
Study Locations (20)
California
- Regeneron Study Site - Anaheim
- Regeneron Study Site - Bell Gardens
- Regeneron Study Site - Dinuba
- Regeneron Study Site - Downey
- Regeneron Study Site - Huntington Beach
- Regeneron Study Site - La Puente
- Regeneron Study Site - Los Angeles
- Regeneron Study Site - Madera
- Regeneron Study Site - Palmdale
- Regeneron Study Site - Ventura
- Regeneron Study Site - West Covina
Florida
- Regeneron Study Site - Boynton Beach
- Regeneron Study Site - Gainesville
- Regeneron Study Site - Jacksonville
Alabama
- Regeneron Investigational Site - Birmingham
- Regeneron Study Site - Mobile
Colorado
- Regeneron Study Site - Aurora
- Regeneron Study Site - Thornton
Arkansas
- Regeneron Study Site - Little Rock
Connecticut
- Regeneron Study Site - Hartford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,177 participants |
| Start Date | 2015-07-21 |
| Est. Completion | 2017-09-26 |
| Phase | Phase 3 |
What the finished NCT02325791 record still lists
NCT02325791 is an interventional study that assigns participants to a tested intervention. Its 1,177 participants enrollment target places it among the larger protocols in the corpus, above the 1,035-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (14% higher).
The record links to 1 condition, with Respiratory Syncytial Virus Infections appearing as the primary indexed condition, and to 4 interventions - of which Suptavumab 30 mg/kg is the first listed.
NCT02325791 names 20 study sites across 6 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT02325791 about?
NCT02325791 is a clinical study titled "Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants". 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 ...
What is the current status of trial NCT02325791?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,177 participants. The study started on 2015-07-21. Estimated completion is 2017-09-26.
What conditions does trial NCT02325791 study?
This clinical trial studies the following conditions: Respiratory Syncytial Virus Infections.
What interventions are being tested in trial NCT02325791?
The interventions under investigation include: Suptavumab 30 mg/kg (DRUG), Placebo Matched to Suptavumab (DRUG), Suptavumab 30 mg/kg- 1 Dose (DRUG), Suptavumab 30 mg/kg - 2 Doses (DRUG).
Who is sponsoring clinical trial NCT02325791?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02325791 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02325791's enrollment target sits among peer trials
1,177 5th of 21 higher than 17 of 21 other Respiratory Syncytial Virus Infections trials
participants (enrollment target), bucketed by value
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