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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

NCT ID: NCT02325791

Last Updated: 2018-11-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1177 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-21

Study Completion Date

2017-09-26

Brief Summary

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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.

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Detailed Description

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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

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Respiratory Syncytial Virus Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part A: Suptavumab 30 mg/kg

Group Type EXPERIMENTAL

Suptavumab 30 mg/kg

Intervention Type DRUG

Participants received single dose of suptavumab 30 milligram per kilogram (mg/kg) intramuscularly (IM) on Day 1.

Part B: Placebo Matched to Suptavumab

Group Type EXPERIMENTAL

Placebo Matched to Suptavumab

Intervention Type DRUG

Participants received 2 IM doses of placebo matched to suptavumab: the first dose on Day 1 and the second dose on Day 57.

Part B: Suptavumab 30 mg/kg- 1 Dose

Group Type EXPERIMENTAL

Suptavumab 30 mg/kg- 1 Dose

Intervention Type DRUG

Participants received single dose of suptavumab 30 mg/kg IM on Day 1 and single dose of placebo matched to suptavumab on Day 57.

Part B: Suptavumab 30 mg/kg - 2 Doses

Group Type EXPERIMENTAL

Suptavumab 30 mg/kg - 2 Doses

Intervention Type DRUG

Participants received 2 doses of suptavumab 30 mg/kg IM: the first dose on Day 1 and the second dose on Day 57.

Interventions

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Suptavumab 30 mg/kg

Participants received single dose of suptavumab 30 milligram per kilogram (mg/kg) intramuscularly (IM) on Day 1.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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REGN2222

Eligibility Criteria

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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

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
Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

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Regeneron Investigational Site

Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Little Rock, Arkansas, United States

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Anaheim, California, United States

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Bell Gardens, California, United States

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Dinuba, California, United States

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Downey, California, United States

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Huntington Beach, California, United States

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La Puente, California, United States

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Los Angeles, California, United States

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Madera, California, United States

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Palmdale, California, United States

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Ventura, California, United States

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West Covina, California, United States

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Aurora, Colorado, United States

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Thornton, Colorado, United States

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Hartford, Connecticut, United States

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Boynton Beach, Florida, United States

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Gainesville, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Pensacola, Florida, United States

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Tampa, Florida, United States

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Winter Park, Florida, United States

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Atlanta, Georgia, United States

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Columbus, Georgia, United States

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Dalton, Georgia, United States

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Meridian, Idaho, United States

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Nampa, Idaho, United States

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Peoria, Illinois, United States

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South Bend, Indiana, United States

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Hutchinson, Kansas, United States

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Topeka, Kansas, United States

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Bardstown, Kentucky, United States

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Louisville, Kentucky, United States

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Metairie, Louisiana, United States

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New Orleans, Louisiana, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Silver Spring, Maryland, United States

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Fall River, Massachusetts, United States

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Woburn, Massachusetts, United States

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Stevensville, Michigan, United States

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Duluth, Minnesota, United States

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Minneapolis, Minnesota, United States

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Saint Paul, Minnesota, United States

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Jackson, Mississippi, United States

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Bridgeton, Missouri, United States

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Kansas City, Missouri, United States

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Lincoln, Nebraska, United States

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Norfolk, Nebraska, United States

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Omaha, Nebraska, United States

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Reno, Nevada, United States

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Lebanon, New Hampshire, United States

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Neptune City, New Jersey, United States

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New Brunswick, New Jersey, United States

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Brooklyn, New York, United States

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Mineola, New York, United States

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New Hyde Park, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Syracuse, New York, United States

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The Bronx, New York, United States

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Boone, North Carolina, United States

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Chapel Hill, North Carolina, United States

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Durham, North Carolina, United States

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Raleigh, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Fairfield, Ohio, United States

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Mayfield Heights, Ohio, United States

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Toledo, Ohio, United States

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Youngstown, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Gresham, Oregon, United States

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Allentown, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Hermitage, Pennsylvania, United States

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Charleston, South Carolina, United States

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Cheraw, South Carolina, United States

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Greenville, South Carolina, United States

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North Charleston, South Carolina, United States

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Alcoa, Tennessee, United States

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Kingsport, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Fort Sam Houston, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Layton, Utah, United States

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Roy, Utah, United States

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St. George, Utah, United States

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Syracuse, Utah, United States

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Charlottesville, Virginia, United States

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Midlothian, Virginia, United States

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Richmond, Virginia, United States

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Vienna, Virginia, United States

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Huntington, West Virginia, United States

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Kingwood, West Virginia, United States

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Morgantown, West Virginia, United States

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Madison, Wisconsin, United States

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Marshfield, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Hobart, Tasmania, Australia

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Sofia, Sofia-Grad, Bulgaria

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Kazanlak, Stara Zagora, Bulgaria

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Blagoevgrad, , Bulgaria

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Dobrich, , Bulgaria

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Gabrovo, , Bulgaria

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Lom, , Bulgaria

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Montana, , Bulgaria

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Pleven, , Bulgaria

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Plovdiv, , Bulgaria

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Rousse, , Bulgaria

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Silistra, , Bulgaria

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Sliven, , Bulgaria

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Vidin, , Bulgaria

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Calgary, Alberta, Canada

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Halifax, Nova Scotia, Canada

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Ottawa, Ontario, Canada

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La Florida, Santiago Metropolitan, Chile

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Providencia, Santiago Metropolitan, Chile

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Puente Alto, Santiago Metropolitan, Chile

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Recoleta, Santiago Metropolitan, Chile

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San José, Santiago Metropolitan, Chile

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San Ramón, Santiago Metropolitan, Chile

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Aalborg, , Denmark

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Hjørring, , Denmark

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Næstved, , Denmark

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Viborg, , Denmark

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Oulu, Oulun Iaani, Finland

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Tampere, Oulun Iaani, Finland

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Pori, , Finland

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Turku, , Finland

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Bochum, , Germany

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Bramsche, , Germany

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Bretten, , Germany

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Frankenthal, , Germany

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Freiburg im Breisgau, , Germany

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Hamburg, , Germany

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Herxheim, , Germany

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Leipzig, , Germany

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Mainz, , Germany

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Mannheim, , Germany

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Mönchengladbach, , Germany

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Munich, , Germany

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Sankt Augustin, , Germany

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Wanzleben, , Germany

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Szeged, Csongrád megye, Hungary

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Budapest, , Hungary

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Gyula, , Hungary

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Nyíregyháza, , Hungary

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Pécs, , Hungary

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Veszprém, , Hungary

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Utrecht, , Netherlands

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Palmerston North, Manawatu-Wanganui, New Zealand

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Auckland, North Island, New Zealand

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Wellington, , New Zealand

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Panama City, , Panama

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San Juan, , Puerto Rico

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Johannesburg, Gauteng, South Africa

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Pretoria, Gauteng, South Africa

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Ga-Rankuwa, North West, South Africa

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Esplugues de Llobregat, Barcelona, Spain

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A Coruña, , Spain

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Granada, , Spain

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Madrid, , Spain

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Manises, , Spain

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Málaga, , Spain

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Santiago de Compostela, , Spain

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Seville, , Spain

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Gothenburg, , Sweden

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Uppsala, , Sweden

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Ankara, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Kocaeli, , Turkey (Türkiye)

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Chernivtsi, Chernivtsi Oblast, Ukraine

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Dnipropetrovsk, Dnipropetrovsk Oblast, Ukraine

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Odesa, Odesa Oblast, Ukraine

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Vinnytsia, Vinnytsia Oblast, Ukraine

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Kharkiv, , Ukraine

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Kyiv, , Ukraine

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Poltava, , Ukraine

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Sumy, , Ukraine

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Ternopil, , Ukraine

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Zaporizhzhia, , Ukraine

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Coventry, Birmingham, United Kingdom

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Southampton, Hampshire, United Kingdom

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Gillingham, Kent, United Kingdom

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London, London, City of, United Kingdom

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Oldham, Manchester, United Kingdom

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Stockport, Manchester, United Kingdom

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Belfast, , United Kingdom

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Birmingham, , United Kingdom

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Glasgow, , United Kingdom

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Manchester, , United Kingdom

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Poole, , United Kingdom

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Reading, , United Kingdom

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Sheffield, , United Kingdom

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Stockton-on-Tees, , United Kingdom

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Countries

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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

References

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Simoes EAF, Forleo-Neto E, Geba GP, Kamal M, Yang F, Cicirello H, Houghton MR, Rideman R, Zhao Q, Benvin SL, Hawes A, Fuller ED, Wloga E, Pizarro JMN, Munoz FM, Rush SA, McLellan JS, Lipsich L, Stahl N, Yancopoulos GD, Weinreich DM, Kyratsous CA, Sivapalasingam S. Suptavumab for the Prevention of Medically Attended Respiratory Syncytial Virus Infection in Preterm Infants. Clin Infect Dis. 2021 Dec 6;73(11):e4400-e4408. doi: 10.1093/cid/ciaa951.

Reference Type DERIVED
PMID: 32897368 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan: Part A

View Document

Document Type: Statistical Analysis Plan: Part B

View Document

Other Identifiers

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R2222-RSV-1332

Identifier Type: -

Identifier Source: org_study_id

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