Clinical trial NCT02325791: Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Syncytial Virus Infections
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-12-25
Enrollment: 1177
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Part A: Serum Concentration of Suptavumab Over Time
timeFrame: Day 1 through Day 150
measure: 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
timeFrame: From first study drug administration up to Day 150
Secondary outcomes:
measure: Part A: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Baseline through Day 150
measure: Part B: Serum Concentration of Suptavumab
timeFrame: Day 29, 57, 85, 113 and Day 150 Post-dose
measure: Part B: Number of Participants With At Least One Positive Anti-Drug Antibody (ADA) Assay
timeFrame: Day 1 through Day 150
measure: 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
timeFrame: From the first study drug administration up to Day 150
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Regeneron Investigational Site
state: Alabama
city: Mobile
country: United States
facility: Regeneron Study Site
state: Alabama
city: Little Rock
country: United States
facility: Regeneron Study Site
state: Arkansas
city: Anaheim
country: United States
facility: Regeneron Study Site
state: California
city: Bell Gardens
country: United States
facility: Regeneron Study Site
state: California
city: Dinuba
country: United States
facility: Regeneron Study Site
state: California
city: Downey
country: United States
facility: Regeneron Study Site
state: California
city: Huntington Beach
country: United States
facility: Regeneron Study Site
state: California
city: La Puente
country: United States
facility: Regeneron Study Site
state: California
city: Los Angeles
country: United States
facility: Regeneron Study Site
state: California
city: Madera
country: United States
facility: Regeneron Study Site
state: California
city: Palmdale
country: United States
facility: Regeneron Study Site
state: California
city: Ventura
country: United States
facility: Regeneron Study Site
state: California
city: West Covina
country: United States
facility: Regeneron Study Site
state: California
city: Aurora
country: United States
facility: Regeneron Study Site
state: Colorado
city: Thornton
country: United States
facility: Regeneron Study Site
state: Colorado
city: Hartford
country: United States
facility: Regeneron Study Site
state: Connecticut
city: Boynton Beach
country: United States
facility: Regeneron Study Site
state: Florida
city: Gainesville
country: United States
facility: Regeneron Study Site
state: Florida
city: Jacksonville
country: United States
facility: Regeneron Study Site
state: Florida
city: Miami
country: United States
facility: Regeneron Study Site
state: Florida
city: Orlando
country: United States
facility: Regeneron Study Site
state: Florida
city: Pensacola
country: United States
facility: Regeneron Study Site
state: Florida
city: Tampa
country: United States
facility: Regeneron Study Site
state: Florida
city: Winter Park
country: United States
facility: Regeneron Study Site
state: Florida
city: Atlanta
country: United States
facility: Regeneron Study Site
state: Georgia
city: Columbus
country: United States
facility: Regeneron Study Site
state: Georgia
city: Dalton
country: United States
facility: Regeneron Study Site
state: Georgia
city: Meridian
country: United States
facility: Regeneron Study Site
state: Idaho
city: Nampa
country: United States
facility: Regeneron Study Site
state: Idaho
city: Peoria
country: United States
facility: Regeneron Study Site
state: Illinois
city: South Bend
country: United States
facility: Regeneron Study Site
state: Indiana
city: Hutchinson
country: United States
facility: Regeneron Study Site
state: Kansas
city: Topeka
country: United States
facility: Regeneron Study Site
state: Kansas
city: Bardstown
country: United States
facility: Regeneron Study Site
state: Kentucky
city: Louisville
country: United States
facility: Regeneron Study Site
state: Kentucky
city: Metairie
country: United States
facility: Regeneron Study Site
state: Louisiana
city: New Orleans
country: United States
facility: Regeneron Study Site
state: Louisiana
city: Shreveport
country: United States
facility: Regeneron Study Site
state: Louisiana
city: Baltimore
country: United States
facility: Regeneron Study Site
state: Maryland
city: Silver Spring
country: United States
facility: Regeneron Study Site
state: Maryland
city: Fall River
country: United States
facility: Regeneron Study Site
state: Massachusetts
city: Woburn
country: United States
facility: Regeneron Study Site
state: Massachusetts
city: Stevensville
country: United States
facility: Regeneron Study Site
state: Michigan
city: Duluth
country: United States
facility: Regeneron Study Site
state: Minnesota
city: Minneapolis
country: United States
facility: Regeneron Study Site
state: Minnesota
city: Saint Paul
country: United States
facility: Regeneron Study Site
state: Minnesota
city: Jackson
country: United States
facility: Regeneron Study Site
state: Mississippi
city: Bridgeton
country: United States
facility: Regeneron Study Site
state: Missouri
city: Kansas City
country: United States
facility: Regeneron Study Site
state: Missouri
city: Lincoln
country: United States
facility: Regeneron Study Site
state: Nebraska
city: Norfolk
country: United States
facility: Regeneron Study Site
state: Nebraska
city: Omaha
country: United States
facility: Regeneron Study Site
state: Nebraska
city: Reno
country: United States
facility: Regeneron Study Site
state: Nevada
city: Lebanon
country: United States
facility: Regeneron Study Site
state: New Hampshire
city: Neptune
country: United States
facility: Regeneron Study Site
state: New Jersey
city: New Brunswick
country: United States
facility: Regeneron Study Site
state: New Jersey
city: Bronx
country: United States
facility: Regeneron Study Site
state: New York
city: Brooklyn
country: United States
facility: Regeneron Study Site
state: New York
city: Mineola
country: United States
facility: Regeneron Study Site
state: New York
city: New Hyde Park
country: United States
facility: Regeneron Study Site
state: New York
city: New York
country: United States
facility: Regeneron Study Site
state: New York
city: Rochester
country: United States
facility: Regeneron Study Site
state: New York
city: Syracuse
country: United States
facility: Regeneron Study Site
state: New York
city: Boone
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Chapel Hill
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Durham
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Raleigh
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Cincinnati
country: United States
facility: Regeneron Study Site
state: Ohio
city: Cleveland
country: United States
facility: Regeneron Study Site
state: Ohio
city: Columbus
country: United States
facility: Regeneron Study Site
state: Ohio
city: Dayton
country: United States
facility: Regeneron Study Site
state: Ohio
city: Fairfield
country: United States
facility: Regeneron Study Site
state: Ohio
city: Mayfield Heights
country: United States
facility: Regeneron Study Site
state: Ohio
city: Toledo
country: United States
facility: Regeneron Study Site
state: Ohio
city: Youngstown
country: United States
facility: Regeneron Study Site
state: Ohio
city: Oklahoma City
country: United States
facility: Regeneron Study Site
state: Oklahoma
city: Tulsa
country: United States
facility: Regeneron Study Site
state: Oklahoma
city: Gresham
country: United States
facility: Regeneron Study Site
state: Oregon
city: Allentown
country: United States
facility: Regeneron Study Site
state: Pennsylvania
city: Erie
country: United States
facility: Regeneron Study Site
state: Pennsylvania
city: Hermitage
country: United States
facility: Regeneron Study Site
state: Pennsylvania
city: Charleston
country: United States
facility: Regeneron Study Site
state: South Carolina
city: Cheraw
country: United States
facility: Regeneron Study Site
state: South Carolina
city: Greenville
country: United States
facility: Regeneron Study Site
state: South Carolina
city: North Charleston
country: United States
facility: Regeneron Study Site
state: South Carolina
city: Alcoa
country: United States
facility: Regeneron Study Site
state: Tennessee
city: Kingsport
country: United States
facility: Regeneron Study Site
state: Tennessee
city: Nashville
country: United States
facility: Regeneron Study Site
state: Tennessee
city: Austin
country: United States
facility: Regeneron Study Site
state: Texas
city: Fort Sam Houston
country: United States
facility: Regeneron Study Site
state: Texas
city: Houston
country: United States
facility: Regeneron Study Site
state: Texas
city: San Antonio
country: United States
facility: Regeneron Study Site
state: Texas
city: Layton
country: United States
facility: Regeneron Study Site
state: Utah
city: Roy
country: United States
facility: Regeneron Study Site
state: Utah
city: Saint George
country: United States
facility: Regeneron Study Site
state: Utah
city: Syracuse
country: United States
facility: Regeneron Study Site
state: Utah
city: Charlottesville
country: United States
facility: Regeneron Study Site
state: Virginia
city: Midlothian
country: United States
facility: Regeneron Study Site
state: Virginia
city: Richmond
country: United States
facility: Regeneron Study Site
state: Virginia
city: Vienna
country: United States
facility: Regeneron Study Site
state: Virginia
city: Huntington
country: United States
facility: Regeneron Study Site
state: West Virginia
city: Kingwood
country: United States
facility: Regeneron Study Site
state: West Virginia
city: Morgantown
country: United States
facility: Regeneron Study Site
state: West Virginia
city: Madison
country: United States
facility: Regeneron Study Site
state: Wisconsin
city: Marshfield
country: United States
facility: Regeneron Study Site
state: Wisconsin
city: Milwaukee
country: United States
facility: Regeneron Study Site
state: Wisconsin
city: Hobart
country: Australia
facility: Regeneron Study Site
state: Tasmania
city: Sofia
country: Bulgaria
facility: Regeneron Study Site
state: Sofia-Grad
city: Kazanlak
country: Bulgaria
facility: Regeneron Study Site
state: Stara Zagora
city: Blagoevgrad
country: Bulgaria
facility: Regeneron Study Site
city: Dobrich
country: Bulgaria
facility: Regeneron Study Site
city: Gabrovo
country: Bulgaria
facility: Regeneron Study Site
city: Lom
country: Bulgaria
facility: Regeneron Study Site
city: Montana
country: Bulgaria
facility: Regeneron Study Site
city: Pleven
country: Bulgaria
facility: Regeneron Study Site
city: Plovdiv
country: Bulgaria
facility: Regeneron Study Site
city: Ruse
country: Bulgaria
facility: Regeneron Study Site
city: Silistra
country: Bulgaria
facility: Regeneron Study Site
city: Sliven
country: Bulgaria
facility: Regeneron Study Site
city: Vidin
country: Bulgaria
facility: Regeneron Study Site
city: Calgary
country: Canada
facility: Regeneron Study Site
state: Alberta
city: Halifax
country: Canada
facility: Regeneron Study Site
state: Nova Scotia
city: Ottawa
country: Canada
facility: Regeneron Study Site
state: Ontario
city: La Florida
country: Chile
facility: Regeneron Study Site
state: Santiago
city: Providencia
country: Chile
facility: Regeneron Study Site
state: Santiago
city: Puente Alto
country: Chile
facility: Regeneron Study Site
state: Santiago
city: Recoleta
country: Chile
facility: Regeneron Study Site
state: Santiago
city: San Jose
country: Chile
facility: Regeneron Study Site
state: Santiago
city: San Ramon
country: Chile
facility: Regeneron Study Site
state: Santiago
city: Aalborg
country: Denmark
facility: Regeneron Study Site
city: Hjorring
country: Denmark
facility: Regeneron Study Site
city: Naestved
country: Denmark
facility: Regeneron Study Site
city: Viborg
country: Denmark
facility: Regeneron Study Site
city: Oulu
country: Finland
facility: Regeneron Study Site
state: Oulun Iaani
city: Tampere
country: Finland
facility: Regeneron Study Site
state: Oulun Iaani
city: Pori
country: Finland
facility: Regeneron Study Site
city: Turku
country: Finland
facility: Regeneron Study Site
city: Bochum
country: Germany
facility: Regeneron Study Site
city: Bramsche
country: Germany
facility: Regeneron Study Site
city: Bretten
country: Germany
facility: Regeneron Study Site
city: Frankenthal
country: Germany
facility: Regeneron Study Site
city: Freiburg
country: Germany
facility: Regeneron Study Site
city: Hamburg
country: Germany
facility: Regeneron Study Site
city: Herxheim
country: Germany
facility: Regeneron Study Site
city: Leipzig
country: Germany
facility: Regeneron Study Site
city: Mainz
country: Germany
facility: Regeneron Study Site
city: Mannheim
country: Germany
facility: Regeneron Study Site
city: Moenchengladbach
country: Germany
facility: Regeneron Study Site
city: Munich
country: Germany
facility: Regeneron Study Site
city: Sankt Augustin
country: Germany
facility: Regeneron Study Site
city: Wanzleben
country: Germany
facility: Regeneron Study Site
city: Szeged
country: Hungary
facility: Regeneron Study Site
state: Csongrad
city: Budapest
country: Hungary
facility: Regeneron Study Site
city: Gyula
country: Hungary
facility: Regeneron Study Site
city: Nyiregyhaza
country: Hungary
facility: Regeneron Study Site
city: Pecs
country: Hungary
facility: Regeneron Study Site
city: Veszprem
country: Hungary
facility: Regeneron Study Site
city: Utrecht
country: Netherlands
facility: Regeneron Study Site
city: Palmerston North
country: New Zealand
facility: Regeneron Study Site
state: Manawatu-Wanganui
city: Auckland
country: New Zealand
facility: Regeneron Study Site
state: North Island
city: Wellington
country: New Zealand
facility: Regeneron Study Site
city: Ciudad de Panama
country: Panama
facility: Regeneron Study Site
city: San Juan
country: Puerto Rico
facility: Regeneron Study Site
city: Johannesburg
country: South Africa
facility: Regeneron Study Site
state: Gauteng
city: Pretoria
country: South Africa
facility: Regeneron Study Site
state: Gauteng
city: Ga-Rankuwa
country: South Africa
facility: Regeneron Study Site
state: North - West
city: Esplugues de Llobregat
country: Spain
facility: Regeneron Study Site
state: Barcelona
city: Granada
country: Spain
facility: Regeneron Study Site
city: La Coruna
country: Spain
facility: Regeneron Study Site
city: Madrid
country: Spain
facility: Regeneron Study Site
city: Malaga
country: Spain
facility: Regeneron Study Site
city: Manises
country: Spain
facility: Regeneron Study Site
city: Santiago de Compostela
country: Spain
facility: Regeneron Study Site
city: Sevilla
country: Spain
facility: Regeneron Study Site
city: Goteborg
country: Sweden
facility: Regeneron Study Site
city: Uppsala
country: Sweden
facility: Regeneron Study Site
city: Ankara
country: Turkey
facility: Regeneron Study Site
city: Istanbul
country: Turkey
facility: Regeneron Study Site
city: Izmir
country: Turkey
facility: Regeneron Study Site
city: Kocaeli
country: Turkey
facility: Regeneron Study Site
city: Chernivtsi
country: Ukraine
facility: Regeneron Study Site
state: Chernivets'ka Oblast'
city: Dnipropetrovsk
country: Ukraine
facility: Regeneron Study Site
state: Dnipropetrovs'ka Oblast'
city: Odessa
country: Ukraine
facility: Regeneron Study Site
state: Odes'ka Oblast'
city: Vinnytsia
country: Ukraine
facility: Regeneron Study Site
state: Vinnyts'ka Oblast'
city: Kharkiv
country: Ukraine
facility: Regeneron Study Site
city: Kyiv
country: Ukraine
facility: Regeneron Study Site
city: Poltava
country: Ukraine
facility: Regeneron Study Site
city: Sumy
country: Ukraine
facility: Regeneron Study Site
city: Ternopil
country: Ukraine
facility: Regeneron Study Site
city: Zaporizhzhia
country: Ukraine
facility: Regeneron Study Site
city: Coventry
country: United Kingdom
facility: Regeneron Study Site
state: Birmingham
city: Southampton
country: United Kingdom
facility: Regeneron Study Site
state: Hampshire
city: Gillingham
country: United Kingdom
facility: Regeneron Study Site
state: Kent
city: London
country: United Kingdom
facility: Regeneron Study Site
state: London, City Of
city: Oldham
country: United Kingdom
facility: Regeneron Study Site
state: Manchester
city: Stockport
country: United Kingdom
facility: Regeneron Study Site
state: Manchester
city: Belfast
country: United Kingdom
facility: Regeneron Study Site
city: Birmingham
country: United Kingdom
facility: Regeneron Study Site
city: Glasgow
country: United Kingdom
facility: Regeneron Study Site
city: Manchester
country: United Kingdom
facility: Regeneron Study Site
city: Poole
country: United Kingdom
facility: Regeneron Study Site
city: Reading
country: United Kingdom
facility: Regeneron Study Site
city: Sheffield
country: United Kingdom
facility: Regeneron Study Site
city: Stockton on Tees
country: United Kingdom
facility: Regeneron Study Site
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
citation: 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.