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



Status:Completed
Conditions:Infectious Disease, Infectious Disease, Pulmonary
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:11/8/2018
Start Date:July 21, 2015
End Date:September 26, 2017

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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

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 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
We found this trial at
108
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Vienna, Virginia 22180
2268
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Alcoa, Tennessee
1922
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Allentown, Pennsylvania
2355
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Anaheim, California
17
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Atlanta, Georgia
1919
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Aurora, Colorado
825
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Aurora, CO
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1212
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Austin, TX
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Baltimore, Maryland
2301
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Bardstown, Kentucky
1829
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Bell Gardens, California
10
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Birmingham, Alabama
1785
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Boone, North Carolina
2046
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Boynton Beach, Florida
2307
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Bridgeton, Missouri
1562
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Bronx, New York
2439
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Brooklyn, New York
2436
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Brooklyn, NY
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Chapel Hill, North Carolina
1991
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Charleston, South Carolina
2185
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Charlottesville, Virginia
2208
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Cheraw, South Carolina
2161
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Cincinnati, Ohio
1882
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Cleveland, Ohio
2032
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Columbus, Georgia
1902
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Columbus, Ohio
1960
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Dalton, Georgia
1983
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Dayton, Ohio
1897
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Dinuba, California
187
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Downey, California
11
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Duluth, Minnesota
1609
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Durham, North Carolina
2201
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Erie, Pennsylvania
2117
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Fairfield, Ohio
1877
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Fall River, Massachusetts
2576
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Fort Sam Houston, Texas
1191
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Gainesville, Florida
2105
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Greenville, South Carolina
2019
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Gresham, Oregon
823
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Hartford, Connecticut
2497
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Hermitage, Pennsylvania
2096
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Hobart, Tasmania
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Houston, Texas
1357
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Huntington, West Virginia
1991
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Huntington Beach, California
28
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Hutchinson, Kansas
1152
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Jackson, Mississippi
1608
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Jacksonville, Florida
2130
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Kansas City, Missouri
1341
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Kingsport, Tennessee
1994
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Kingwood, West Virginia
2137
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La Puente, California
4
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Layton, Utah
584
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Lebanon, New Hampshire
2515
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Lincoln, Nebraska
1255
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Little Rock, Arkansas
1463
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Los Angeles, California
13
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Louisville, Kentucky
1812
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Madera, California
230
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1655
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Marshfield, Wisconsin
1646
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Mayfield Heights, Ohio
2044
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Meridian, Idaho
664
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1650
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Midlothian, Virginia 23113
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Milwaukee, Wisconsin
1729
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Mineola, New York
2451
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1510
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Mobile, Alabama
1757
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2122
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Nampa, Idaho
658
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1763
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2433
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2410
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2449
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1656
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2432
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1243
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2179
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1165
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Omaha, Nebraska
1301
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Orlando, Florida
2184
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Palmdale, California
35
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1810
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1618
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2218
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389
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2268
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2245
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588
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Roy, UT
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Saint George, Utah
325
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700 Raymond Avenue
Saint Paul, Minnesota 55114
1512
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1188
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1401
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2281
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1798
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Stevensville, Michigan 49127
1787
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2319
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583
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2136
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Thornton, Colorado
822
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Toledo, Ohio
1936
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