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

NCT02325791 | Completed Phase 3 Results DMC

• 1 other identifier: R2222-RSV-1332
• Study Type: interventional
• Target: 1,177
• Locations: 19 countries
• Sites: 205

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.

Conditions

Respiratory Syncytial Virus Infections

Outcome Measures

Primary Outcomes (2)

• Part A: Serum Concentration of Suptavumab Over Time

  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.

  Day 1 through Day 150

• 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

  A medically attended RSV infection defined as an infant with positive RSV test by Reverse-transcriptase polymerase chain reaction (RT-PCR) with any of following events: Hospitalized (on basis of assessment of admitting physician) for RSV infection or outpatient visit (emergency room \[ER\], urgent care \[UC\], or pediatric clinic visits \[for either a sick or well visit\]) with RSV lower respiratory tract infection (LRTI). An RSV LRTI in an infant: RSV proven respiratory infection (i.e positive RSV RT-PCR test) with parent(s)/guardian(s) report of cough/difficulty breathing, \& with 1 of following signs of LRTI, as assessed by healthcare provider: - lower chest wall in drawing -hypoxemia (peripheral capillary oxygen saturation \<95% breathing room air) - Wheezing/crackles. The 150-day efficacy assessment period: first study drug intake through the Day 150 visit.

  From first study drug administration up to Day 150

Secondary Outcomes (4)

• Part A: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

  Baseline through Day 150

• Part B: Serum Concentration of Suptavumab

  Day 29, 57, 85, 113 and Day 150 Post-dose

• Part B: Number of Participants With At Least One Positive Anti-Drug Antibody (ADA) Assay

  Day 1 through Day 150

• 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

  From the first study drug administration up to Day 150

Study Arms (4)

Part A: Suptavumab 30 mg/kg

EXPERIMENTAL

Drug: Suptavumab 30 mg/kg

Part B: Placebo Matched to Suptavumab

EXPERIMENTAL

Drug: Placebo Matched to Suptavumab

Part B: Suptavumab 30 mg/kg- 1 Dose

EXPERIMENTAL

Drug: Suptavumab 30 mg/kg- 1 Dose

Part B: Suptavumab 30 mg/kg - 2 Doses

EXPERIMENTAL

Drug: Suptavumab 30 mg/kg - 2 Doses

Interventions

Suptavumab 30 mg/kg DRUG

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

Also known as: REGN2222

Part A: Suptavumab 30 mg/kg

Placebo Matched to Suptavumab 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: Placebo Matched to Suptavumab

Suptavumab 30 mg/kg- 1 Dose 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- 1 Dose

Suptavumab 30 mg/kg - 2 Doses DRUG

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

Part B: Suptavumab 30 mg/kg - 2 Doses

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (205)

Regeneron Investigational Site

Birmingham, Alabama, United States

Location

Regeneron Study Site

Mobile, Alabama, United States

Location

Regeneron Study Site

Little Rock, Arkansas, United States

Location

Regeneron Study Site

Anaheim, California, United States

Location

Regeneron Study Site

Bell Gardens, California, United States

Location

Regeneron Study Site

Dinuba, California, United States

Location

Regeneron Study Site

Downey, California, United States

Location

Regeneron Study Site

Huntington Beach, California, United States

Location

Regeneron Study Site

La Puente, California, United States

Location

Regeneron Study Site

Los Angeles, California, United States

Location

Regeneron Study Site

Madera, California, United States

Location

Regeneron Study Site

Palmdale, California, United States

Location

Regeneron Study Site

Ventura, California, United States

Location

Regeneron Study Site

West Covina, California, United States

Location

Regeneron Study Site

Aurora, Colorado, United States

Location

Regeneron Study Site

Thornton, Colorado, United States

Location

Regeneron Study Site

Hartford, Connecticut, United States

Location

Regeneron Study Site

Boynton Beach, Florida, United States

Location

Regeneron Study Site

Gainesville, Florida, United States

Location

Regeneron Study Site

Jacksonville, Florida, United States

Location

Regeneron Study Site

Miami, Florida, United States

Location

Regeneron Study Site

Orlando, Florida, United States

Location

Regeneron Study Site

Pensacola, Florida, United States

Location

Regeneron Study Site

Tampa, Florida, United States

Location

Regeneron Study Site

Winter Park, Florida, United States

Location

Regeneron Study Site

Atlanta, Georgia, United States

Location

Regeneron Study Site

Columbus, Georgia, United States

Location

Regeneron Study Site

Dalton, Georgia, United States

Location

Regeneron Study Site

Meridian, Idaho, United States

Location

Regeneron Study Site

Nampa, Idaho, United States

Location

Regeneron Study Site

Peoria, Illinois, United States

Location

Regeneron Study Site

South Bend, Indiana, United States

Location

Regeneron Study Site

Hutchinson, Kansas, United States

Location

Regeneron Study Site

Topeka, Kansas, United States

Location

Regeneron Study Site

Bardstown, Kentucky, United States

Location

Regeneron Study Site

Louisville, Kentucky, United States

Location

Regeneron Study Site

Metairie, Louisiana, United States

Location

Regeneron Study Site

New Orleans, Louisiana, United States

Location

Regeneron Study Site

Shreveport, Louisiana, United States

Location

Regeneron Study Site

Baltimore, Maryland, United States

Location

Regeneron Study Site

Silver Spring, Maryland, United States

Location

Regeneron Study Site

Fall River, Massachusetts, United States

Location

Regeneron Study Site

Woburn, Massachusetts, United States

Location

Regeneron Study Site

Stevensville, Michigan, United States

Location

Regeneron Study Site

Duluth, Minnesota, United States

Location

Regeneron Study Site

Minneapolis, Minnesota, United States

Location

Regeneron Study Site

Saint Paul, Minnesota, United States

Location

Regeneron Study Site

Jackson, Mississippi, United States

Location

Regeneron Study Site

Bridgeton, Missouri, United States

Location

Regeneron Study Site

Kansas City, Missouri, United States

Location

Regeneron Study Site

Lincoln, Nebraska, United States

Location

Regeneron Study Site

Norfolk, Nebraska, United States

Location

Regeneron Study Site

Omaha, Nebraska, United States

Location

Regeneron Study Site

Reno, Nevada, United States

Location

Regeneron Study Site

Lebanon, New Hampshire, United States

Location

Regeneron Study Site

Neptune City, New Jersey, United States

Location

Regeneron Study Site

New Brunswick, New Jersey, United States

Location

Regeneron Study Site

Brooklyn, New York, United States

Location

Regeneron Study Site

Mineola, New York, United States

Location

Regeneron Study Site

New Hyde Park, New York, United States

Location

Regeneron Study Site

New York, New York, United States

Location

Regeneron Study Site

Rochester, New York, United States

Location

Regeneron Study Site

Syracuse, New York, United States

Location

Regeneron Study Site

The Bronx, New York, United States

Location

Regeneron Study Site

Boone, North Carolina, United States

Location

Regeneron Study Site

Chapel Hill, North Carolina, United States

Location

Regeneron Study Site

Durham, North Carolina, United States

Location

Regeneron Study Site

Raleigh, North Carolina, United States

Location

Regeneron Study Site

Cincinnati, Ohio, United States

Location

Regeneron Study Site

Cleveland, Ohio, United States

Location

Regeneron Study Site

Columbus, Ohio, United States

Location

Regeneron Study Site

Dayton, Ohio, United States

Location

Regeneron Study Site

Fairfield, Ohio, United States

Location

Regeneron Study Site

Mayfield Heights, Ohio, United States

Location

Regeneron Study Site

Toledo, Ohio, United States

Location

Regeneron Study Site

Youngstown, Ohio, United States

Location

Regeneron Study Site

Oklahoma City, Oklahoma, United States

Location

Regeneron Study Site

Tulsa, Oklahoma, United States

Location

Regeneron Study Site

Gresham, Oregon, United States

Location

Regeneron Study Site

Allentown, Pennsylvania, United States

Location

Regeneron Study Site

Erie, Pennsylvania, United States

Location

Regeneron Study Site

Hermitage, Pennsylvania, United States

Location

Regeneron Study Site

Charleston, South Carolina, United States

Location

Regeneron Study Site

Cheraw, South Carolina, United States

Location

Regeneron Study Site

Greenville, South Carolina, United States

Location

Regeneron Study Site

North Charleston, South Carolina, United States

Location

Regeneron Study Site

Alcoa, Tennessee, United States

Location

Regeneron Study Site

Kingsport, Tennessee, United States

Location

Regeneron Study Site

Nashville, Tennessee, United States

Location

Regeneron Study Site

Austin, Texas, United States

Location

Regeneron Study Site

Fort Sam Houston, Texas, United States

Location

Regeneron Study Site

Houston, Texas, United States

Location

Regeneron Study Site

San Antonio, Texas, United States

Location

Regeneron Study Site

Layton, Utah, United States

Location

Regeneron Study Site

Roy, Utah, United States

Location

Regeneron Study Site

St. George, Utah, United States

Location

Regeneron Study Site

Syracuse, Utah, United States

Location

Regeneron Study Site

Charlottesville, Virginia, United States

Location

Regeneron Study Site

Midlothian, Virginia, United States

Location

Regeneron Study Site

Richmond, Virginia, United States

Location

Regeneron Study Site

Vienna, Virginia, United States

Location

Regeneron Study Site

Huntington, West Virginia, United States

Location

Regeneron Study Site

Kingwood, West Virginia, United States

Location

Regeneron Study Site

Morgantown, West Virginia, United States

Location

Regeneron Study Site

Madison, Wisconsin, United States

Location

Regeneron Study Site

Marshfield, Wisconsin, United States

Location

Regeneron Study Site

Milwaukee, Wisconsin, United States

Location

Regeneron Study Site

Hobart, Tasmania, Australia

Location

Regeneron Study Site

Sofia, Sofia-Grad, Bulgaria

Location

Regeneron Study Site

Kazanlak, Stara Zagora, Bulgaria

Location

Regeneron Study Site

Blagoevgrad, Bulgaria

Location

Regeneron Study Site

Dobrich, Bulgaria

Location

Regeneron Study Site

Gabrovo, Bulgaria

Location

Regeneron Study Site

Lom, Bulgaria

Location

Regeneron Study Site

Montana, Bulgaria

Location

Regeneron Study Site

Pleven, Bulgaria

Location

Regeneron Study Site

Plovdiv, Bulgaria

Location

Regeneron Study Site

Rousse, Bulgaria

Location

Regeneron Study Site

Silistra, Bulgaria

Location

Regeneron Study Site

Sliven, Bulgaria

Location

Regeneron Study Site

Vidin, Bulgaria

Location

Regeneron Study Site

Calgary, Alberta, Canada

Location

Regeneron Study Site

Halifax, Nova Scotia, Canada

Location

Regeneron Study Site

Ottawa, Ontario, Canada

Location

Regeneron Study Site

La Florida, Santiago Metropolitan, Chile

Location

Regeneron Study Site

Providencia, Santiago Metropolitan, Chile

Location

Regeneron Study Site

Puente Alto, Santiago Metropolitan, Chile

Location

Regeneron Study Site

Recoleta, Santiago Metropolitan, Chile

Location

Regeneron Study Site

San José, Santiago Metropolitan, Chile

Location

Regeneron Study Site

San Ramón, Santiago Metropolitan, Chile

Location

Regeneron Study Site

Aalborg, Denmark

Location

Regeneron Study Site

Hjørring, Denmark

Location

Regeneron Study Site

Næstved, Denmark

Location

Regeneron Study Site

Viborg, Denmark

Location

Regeneron Study Site

Oulu, Oulun Iaani, Finland

Location

Regeneron Study Site

Tampere, Oulun Iaani, Finland

Location

Regeneron Study Site

Pori, Finland

Location

Regeneron Study Site

Turku, Finland

Location

Regeneron Study Site

Bochum, Germany

Location

Regeneron Study Site

Bramsche, Germany

Location

Regeneron Study Site

Bretten, Germany

Location

Regeneron Study Site

Frankenthal, Germany

Location

Regeneron Study Site

Freiburg im Breisgau, Germany

Location

Regeneron Study Site

Hamburg, Germany

Location

Regeneron Study Site

Herxheim, Germany

Location

Regeneron Study Site

Leipzig, Germany

Location

Regeneron Study Site

Mainz, Germany

Location

Regeneron Study Site

Mannheim, Germany

Location

Regeneron Study Site

Mönchengladbach, Germany

Location

Regeneron Study Site

Munich, Germany

Location

Regeneron Study Site

Sankt Augustin, Germany

Location

Regeneron Study Site

Wanzleben, Germany

Location

Regeneron Study Site

Szeged, Csongrád megye, Hungary

Location

Regeneron Study Site

Budapest, Hungary

Location

Regeneron Study Site

Gyula, Hungary

Location

Regeneron Study Site

Nyíregyháza, Hungary

Location

Regeneron Study Site

Pécs, Hungary

Location

Regeneron Study Site

Veszprém, Hungary

Location

Regeneron Study Site

Utrecht, Netherlands

Location

Regeneron Study Site

Palmerston North, Manawatu-Wanganui, New Zealand

Location

Regeneron Study Site

Auckland, North Island, New Zealand

Location

Regeneron Study Site

Wellington, New Zealand

Location

Regeneron Study Site

Panama City, Panama

Location

Regeneron Study Site

San Juan, Puerto Rico

Location

Regeneron Study Site

Johannesburg, Gauteng, South Africa

Location

Regeneron Study Site

Pretoria, Gauteng, South Africa

Location

Regeneron Study Site

Ga-Rankuwa, North West, South Africa

Location

Regeneron Study Site

Esplugues de Llobregat, Barcelona, Spain

Location

Regeneron Study Site

A Coruña, Spain

Location

Regeneron Study Site

Granada, Spain

Location

Regeneron Study Site

Madrid, Spain

Location

Regeneron Study Site

Manises, Spain

Location

Regeneron Study Site

Málaga, Spain

Location

Regeneron Study Site

Santiago de Compostela, Spain

Location

Regeneron Study Site

Seville, Spain

Location

Regeneron Study Site

Gothenburg, Sweden

Location

Regeneron Study Site

Uppsala, Sweden

Location

Regeneron Study Site

Ankara, Turkey (Türkiye)

Location

Regeneron Study Site

Istanbul, Turkey (Türkiye)

Location

Regeneron Study Site

Izmir, Turkey (Türkiye)

Location

Regeneron Study Site

Kocaeli, Turkey (Türkiye)

Location

Regeneron Study Site

Chernivtsi, Chernivtsi Oblast, Ukraine

Location

Regeneron Study Site

Dnipropetrovsk, Dnipropetrovsk Oblast, Ukraine

Location

Regeneron Study Site

Odesa, Odesa Oblast, Ukraine

Location

Regeneron Study Site

Vinnytsia, Vinnytsia Oblast, Ukraine

Location

Regeneron Study Site

Kharkiv, Ukraine

Location

Regeneron Study Site

Kyiv, Ukraine

Location

Regeneron Study Site

Poltava, Ukraine

Location

Regeneron Study Site

Sumy, Ukraine

Location

Regeneron Study Site

Ternopil, Ukraine

Location

Regeneron Study Site

Zaporizhzhia, Ukraine

Location

Regeneron Study Site

Coventry, Birmingham, United Kingdom

Location

Regeneron Study Site

Southampton, Hampshire, United Kingdom

Location

Regeneron Study Site

Gillingham, Kent, United Kingdom

Location

Regeneron Study Site

London, London, City of, United Kingdom

Location

Regeneron Study Site

Oldham, Manchester, United Kingdom

Location

Regeneron Study Site

Stockport, Manchester, United Kingdom

Location

Regeneron Study Site

Belfast, United Kingdom

Location

Regeneron Study Site

Birmingham, United Kingdom

Location

Regeneron Study Site

Glasgow, United Kingdom

Location

Regeneron Study Site

Manchester, United Kingdom

Location

Regeneron Study Site

Poole, United Kingdom

Location

Regeneron Study Site

Reading, United Kingdom

Location

Regeneron Study Site

Sheffield, United Kingdom

Location

Regeneron Study Site

Stockton-on-Tees, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 32897368 DERIVED

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Clinical Trial Management
• Organization: Regeneron Pharmaceuticals, Inc.

clinicaltrials@regeneron.com

844-734-6643

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2014
• First Posted: December 25, 2014
• Study Start: July 21, 2015
• Primary Completion: July 5, 2017
• Study Completion: September 26, 2017
• Last Updated: November 6, 2018
• Results First Posted: November 6, 2018

Record last verified: 2018-10

Locations

HU (6); AU (1); BU (13); DK (4); US (107); NZ (3); TU (4); DE (14); ZA (3); UA (10); PA (1); GB (14); ES (8); PR (1); SE (2); FI (4); NL (1); CL (6); CA (3)