Respiratory Syncytial Virus InfectionsPhase 3NCT02325791
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 testing Suptavumab 30 mg/kg, Suptavumab 30 mg/kg- 1 Dose and Suptavumab 30 mg/kg - 2 Doses in people with Respiratory Syncytial Virus Infections, run by Regeneron Pharmaceuticals at 205 sites in 19 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- Suptavumab 30 mg/kg, Suptavumab 30 mg/kg- 1 Dose and Suptavumab 30 mg/kg - 2 Doses
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,177 participants
- Where
- 205 sitesin 19 countries
- Study dates
- 21 Jul 2015to 26 Sep 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
- Note: Other inclusion and exclusion criteria apply
Trial locations and contacts
205 sites in 19 countries.
205 sites in 19 countries
United States107 sites
Regeneron Study Site
Alcoa, Tennessee
Regeneron Study Site
Allentown, Pennsylvania
Regeneron Study Site
Anaheim, California
Regeneron Study Site
Atlanta, Georgia
Regeneron Study Site
Aurora, Colorado
Regeneron Study Site
Austin, Texas
Regeneron Study Site
Baltimore, Maryland
Regeneron Study Site
Bardstown, Kentucky
Regeneron Study Site
Bell Gardens, California
Regeneron Investigational Site
Birmingham, Alabama
Regeneron Study Site
Boone, North Carolina
Regeneron Study Site
Boynton Beach, Florida
Regeneron Study Site
Bridgeton, Missouri
Regeneron Study Site
Brooklyn, New York
Regeneron Study Site
Chapel Hill, North Carolina
Regeneron Study Site
Charleston, South Carolina
Regeneron Study Site
Charlottesville, Virginia
Regeneron Study Site
Cheraw, South Carolina
Regeneron Study Site
Cincinnati, Ohio
Regeneron Study Site
Cleveland, Ohio
Regeneron Study Site
Columbus, Georgia
Regeneron Study Site
Columbus, Ohio
Regeneron Study Site
Dalton, Georgia
Regeneron Study Site
Dayton, Ohio
Regeneron Study Site
Dinuba, California
Regeneron Study Site
Downey, California
Regeneron Study Site
Duluth, Minnesota
Regeneron Study Site
Durham, North Carolina
Regeneron Study Site
Erie, Pennsylvania
Regeneron Study Site
Fairfield, Ohio
Regeneron Study Site
Fall River, Massachusetts
Regeneron Study Site
Fort Sam Houston, Texas
Regeneron Study Site
Gainesville, Florida
Regeneron Study Site
Greenville, South Carolina
Regeneron Study Site
Gresham, Oregon
Regeneron Study Site
Hartford, Connecticut
Regeneron Study Site
Hermitage, Pennsylvania
Regeneron Study Site
Houston, Texas
Regeneron Study Site
Huntington, West Virginia
Regeneron Study Site
Huntington Beach, California
Regeneron Study Site
Hutchinson, Kansas
Regeneron Study Site
Jackson, Mississippi
Regeneron Study Site
Jacksonville, Florida
Regeneron Study Site
Kansas City, Missouri
Regeneron Study Site
Kingsport, Tennessee
Regeneron Study Site
Kingwood, West Virginia
Regeneron Study Site
La Puente, California
Regeneron Study Site
Layton, Utah
Regeneron Study Site
Lebanon, New Hampshire
Regeneron Study Site
Lincoln, Nebraska
Regeneron Study Site
Little Rock, Arkansas
Regeneron Study Site
Los Angeles, California
Regeneron Study Site
Louisville, Kentucky
Regeneron Study Site
Madera, California
Regeneron Study Site
Madison, Wisconsin
Regeneron Study Site
Marshfield, Wisconsin
Regeneron Study Site
Mayfield Heights, Ohio
Regeneron Study Site
Meridian, Idaho
Regeneron Study Site
Metairie, Louisiana
Regeneron Study Site
Miami, Florida
Regeneron Study Site
Midlothian, Virginia
Regeneron Study Site
Milwaukee, Wisconsin
Regeneron Study Site
Mineola, New York
Regeneron Study Site
Minneapolis, Minnesota
Regeneron Study Site
Mobile, Alabama
Regeneron Study Site
Morgantown, West Virginia
Regeneron Study Site
Nampa, Idaho
Regeneron Study Site
Nashville, Tennessee
Regeneron Study Site
Neptune City, New Jersey
Regeneron Study Site
New Brunswick, New Jersey
Regeneron Study Site
New Hyde Park, New York
Regeneron Study Site
New Orleans, Louisiana
Regeneron Study Site
New York, New York
Regeneron Study Site
Norfolk, Nebraska
Regeneron Study Site
North Charleston, South Carolina
Regeneron Study Site
Oklahoma City, Oklahoma
Regeneron Study Site
Omaha, Nebraska
Regeneron Study Site
Orlando, Florida
Regeneron Study Site
Palmdale, California
Regeneron Study Site
Pensacola, Florida
Regeneron Study Site
Peoria, Illinois
Regeneron Study Site
Raleigh, North Carolina
Regeneron Study Site
Reno, Nevada
Regeneron Study Site
Richmond, Virginia
Regeneron Study Site
Rochester, New York
Regeneron Study Site
Roy, Utah
Regeneron Study Site
Saint Paul, Minnesota
Regeneron Study Site
San Antonio, Texas
Regeneron Study Site
Shreveport, Louisiana
Regeneron Study Site
Silver Spring, Maryland
Regeneron Study Site
South Bend, Indiana
Regeneron Study Site
St. George, Utah
Regeneron Study Site
Stevensville, Michigan
Regeneron Study Site
Syracuse, New York
Regeneron Study Site
Syracuse, Utah
Regeneron Study Site
Tampa, Florida
Regeneron Study Site
The Bronx, New York
Regeneron Study Site
Thornton, Colorado
Regeneron Study Site
Toledo, Ohio
Regeneron Study Site
Topeka, Kansas
Regeneron Study Site
Tulsa, Oklahoma
Regeneron Study Site
Ventura, California
Regeneron Study Site
Vienna, Virginia
Regeneron Study Site
West Covina, California
Regeneron Study Site
Winter Park, Florida
Regeneron Study Site
Woburn, Massachusetts
Regeneron Study Site
Youngstown, Ohio
Germany14 sites
Regeneron Study Site
Bochum
Regeneron Study Site
Bramsche
Regeneron Study Site
Bretten
Regeneron Study Site
Frankenthal
Regeneron Study Site
Freiburg im Breisgau
Regeneron Study Site
Hamburg
Regeneron Study Site
Herxheim
Regeneron Study Site
Leipzig
Regeneron Study Site
Mainz
Regeneron Study Site
Mannheim
Regeneron Study Site
Mönchengladbach
Regeneron Study Site
Munich
Regeneron Study Site
Sankt Augustin
Regeneron Study Site
Wanzleben
United Kingdom14 sites
Regeneron Study Site
Belfast
Regeneron Study Site
Birmingham
Regeneron Study Site
Coventry, Birmingham
Regeneron Study Site
Gillingham, Kent
Regeneron Study Site
Glasgow
Regeneron Study Site
London, London, City of
Regeneron Study Site
Manchester
Regeneron Study Site
Oldham, Manchester
Regeneron Study Site
Poole
Regeneron Study Site
Reading
Regeneron Study Site
Sheffield
Regeneron Study Site
Southampton, Hampshire
Regeneron Study Site
Stockport, Manchester
Regeneron Study Site
Stockton-on-Tees
Bulgaria13 sites
Regeneron Study Site
Blagoevgrad
Regeneron Study Site
Dobrich
Regeneron Study Site
Gabrovo
Regeneron Study Site
Kazanlak, Stara Zagora
Regeneron Study Site
Lom
Regeneron Study Site
Montana
Regeneron Study Site
Pleven
Regeneron Study Site
Plovdiv
Regeneron Study Site
Rousse
Regeneron Study Site
Silistra
Regeneron Study Site
Sliven
Regeneron Study Site
Sofia, Sofia-Grad
Regeneron Study Site
Vidin
Ukraine10 sites
Regeneron Study Site
Chernivtsi, Chernivtsi Oblast
Regeneron Study Site
Dnipropetrovsk, Dnipropetrovsk Oblast
Regeneron Study Site
Kharkiv
Regeneron Study Site
Kyiv
Regeneron Study Site
Odesa, Odesa Oblast
Regeneron Study Site
Poltava
Regeneron Study Site
Sumy
Regeneron Study Site
Ternopil
Regeneron Study Site
Vinnytsia, Vinnytsia Oblast
Regeneron Study Site
Zaporizhzhya
Spain8 sites
Regeneron Study Site
A Coruña
Regeneron Study Site
Esplugues de Llobregat, Barcelona
Regeneron Study Site
Granada
Regeneron Study Site
Madrid
Regeneron Study Site
Málaga
Regeneron Study Site
Manises
Regeneron Study Site
Santiago de Compostela
Regeneron Study Site
Seville
Chile6 sites
Regeneron Study Site
La Florida, Santiago Metropolitan
Regeneron Study Site
Providencia, Santiago Metropolitan
Regeneron Study Site
Puente Alto, Santiago Metropolitan
Regeneron Study Site
Recoleta, Santiago Metropolitan
Regeneron Study Site
San José, Santiago Metropolitan
Regeneron Study Site
San Ramón, Santiago Metropolitan
Hungary6 sites
Regeneron Study Site
Budapest
Regeneron Study Site
Gyula
Regeneron Study Site
Nyíregyháza
Regeneron Study Site
Pécs
Regeneron Study Site
Szeged, Csongrád megye
Regeneron Study Site
Veszprém
Denmark4 sites
Regeneron Study Site
Aalborg
Regeneron Study Site
Hjørring
Regeneron Study Site
Næstved
Regeneron Study Site
Viborg
Finland4 sites
Regeneron Study Site
Oulu, Oulun Iaani
Regeneron Study Site
Pori
Regeneron Study Site
Tampere, Oulun Iaani
Regeneron Study Site
Turku
Turkey (Türkiye)4 sites
Regeneron Study Site
Ankara
Regeneron Study Site
Istanbul
Regeneron Study Site
Izmir
Regeneron Study Site
Kocaeli
Canada3 sites
Regeneron Study Site
Calgary, Alberta
Regeneron Study Site
Halifax, Nova Scotia
Regeneron Study Site
Ottawa, Ontario
New Zealand3 sites
Regeneron Study Site
Auckland, North Island
Regeneron Study Site
Palmerston North, Manawatu-Wanganui
Regeneron Study Site
Wellington
South Africa3 sites
Regeneron Study Site
Ga-Rankuwa, North West
Regeneron Study Site
Johannesburg, Gauteng
Regeneron Study Site
Pretoria, Gauteng
About this study
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
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.
Read the 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.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- Suptavumab 30 mg/kg, Placebo Matched to Suptavumab, Suptavumab 30 mg/kg- 1 Dose, Suptavumab 30 mg/kg - 2 Doses
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suptavumab 30 mg/kgDrug
Also called REGN2222
Participants received single dose of suptavumab 30 milligram per kilogram (mg/kg) intramuscularly (IM) on Day 1.
Placebo Matched to SuptavumabDrug
Participants received 2 IM doses of placebo matched to suptavumab: the first dose on Day 1 and the second dose on Day 57.
Suptavumab 30 mg/kg- 1 DoseDrug
Participants received single dose of suptavumab 30 mg/kg IM on Day 1 and single dose of placebo matched to suptavumab on Day 57.
Suptavumab 30 mg/kg - 2 DosesDrug
Participants received 2 doses of suptavumab 30 mg/kg IM: the first dose on Day 1 and the second dose on Day 57.
| Study group | Role | What they receive |
|---|---|---|
| Part A: Suptavumab 30 mg/kg | Experimental | Not described Receives: Drug: Suptavumab 30 mg/kg |
| Part B: Placebo Matched to Suptavumab | Experimental | Not described Receives: Drug: Placebo Matched to Suptavumab |
| Part B: Suptavumab 30 mg/kg- 1 Dose | Experimental | Not described Receives: Drug: Suptavumab 30 mg/kg- 1 Dose |
| Part B: Suptavumab 30 mg/kg - 2 Doses | Experimental | Not described Receives: Drug: Suptavumab 30 mg/kg - 2 Doses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From first study drug administration up to Day 150
Secondary outcomes (4)
Part A: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any untoward medical occurrence in participants, who received investigational medicinal product (IMP) was considered an adverse event (AE) without regard to possibility of causal relationship with this treatment. TEAEs: AEs that developed/worsened/became serious during on-treatment period (defined as time between the date of first study drug administration \& date of end of study/last visit).Serious AE: Any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious \& non-serious AEs. National Cancer Institute Common Terminology Criteria (NCI-CTCAE) version 4.03(Grade 3 [severe] \& Grade 4[life-threatening]) was used in this study to grade clinical AEs.
Measured: Baseline through Day 150
Part B: Serum Concentration of Suptavumab
Serum samples for drug concentration will be collected at pre-specified time points
Measured: 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
ADA category of each participant was classified as pre-existing immunoreactivity (a positive ADA response at baseline with a <4-fold increase in titer for all post baseline samples), treatment-boosted (a positive response at baseline with at least one post baseline titer at >=4-fold the baseline titer), or treatment-emergent (TE [any positive post baseline assay response when baseline results were negative or missing]). TE ADA responses were further classified as persistent (treatment-emergent positive ADA response detected in at least 2 consecutive post baseline samples separated by at least a 12-week post baseline period [based on nominal sampling time], with no ADA-negative samples in-between, regardless of any missing samples or a positive response at the last ADA sampling time point), indeterminate (a positive assay response at the last collection time point only, regardless of any missing samples), or transient (not persistent/indeterminate, regardless of any missing samples).
Measured: 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
A medically attended RSV infection was defined as an infant with a positive RSV test by RT-PCR with any of the following events: -Hospitalized (on the basis of the assessment of the admitting physician) for RSV infection - or Outpatient visit (ER, UC), or pediatric clinic visits [for either a sick or well visit]) with RSV 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 or difficulty breathing, and with 1 of the following signs of LRTI, as assessed by a healthcare provider: -Lower chest wall indrawing -Hypoxemia (peripheral capillary oxygen saturation <95% breathing room air) -Wheezing or crackles. The 150-day efficacy assessment period:first study drug intake through the Day 150 visit.
Measured: From the first study drug administration up to Day 150
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2014 (estimated)
- Study start21 Jul 2015
- Primary completion5 Jul 2017
- Study completion26 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325791
- Sponsor's protocol ID
- R2222-RSV-1332
- Status last verified
- Oct 2018
- First submitted
- 21 Dec 2014
- Last updated
- 6 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 32897368
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02325791
- Acronym / sponsor ID
- R2222-RSV-1332
- Conditions
- Respiratory Syncytial Virus Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,177 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2015
- Primary completion
- 5 Jul 2017 (actual)
- Study completion
- 26 Sep 2017 (actual)
- First posted
- 25 Dec 2014 (estimated)
- Results
- Posted 6 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suptavumab 30 mg/kgAlso: REGN2222Participants received single dose of suptavumab 30 milligram per kilogram (mg/kg) intramuscularly (IM) on Day 1. | Drug | Part A: Suptavumab 30 mg/kg |
| Placebo Matched to SuptavumabParticipants received 2 IM doses of placebo matched to suptavumab: the first dose on Day 1 and the second dose on Day 57. | Drug | Part B: Placebo Matched to Suptavumab |
| Suptavumab 30 mg/kg- 1 DoseParticipants received single dose of suptavumab 30 mg/kg IM on Day 1 and single dose of placebo matched to suptavumab on Day 57. | Drug | Part B: Suptavumab 30 mg/kg- 1 Dose |
| Suptavumab 30 mg/kg - 2 DosesParticipants received 2 doses of suptavumab 30 mg/kg IM: the first dose on Day 1 and the second dose on Day 57. | Drug | Part B: Suptavumab 30 mg/kg - 2 Doses |
Primary outcome
Part A: Serum Concentration of Suptavumab Over Time
Time frame: Day 1 through Day 150
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.
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
Time frame: From first study drug administration 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.
4 secondary outcomes
Part A: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Baseline through Day 150
Part B: Serum Concentration of Suptavumab
Time frame: 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
Time frame: 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
Time frame: From the first study drug administration up to Day 150
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32897368Simoes 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.
Related trials for Respiratory Syncytial Virus Infections
RecruitingPhase 3
Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
Respiratory Syncytial Virus (RSV)
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease
Respiratory Syncytial Virus Infections
Active, not recruitingPhase 1
A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV
Respiratory Syncytial Virus (RSV), Infectious Disease
RecruitingPhase 2
Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons
Respiratory Syncytial Virus (RSV)
RecruitingObservational study
TARSILA Real-World Evidence Study
Respiratory Syncytial Virus (RSV), Maternal Immunization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
205 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Suptavumab 30 mg/kg, Suptavumab 30 mg/kg- 1 Dose and Suptavumab 30 mg/kg - 2 Doses in people with Respiratory Syncytial Virus Infections, run by Regeneron Pharmaceuticals at 205 sites in 19 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 205 sites in United States, Germany, United Kingdom, Bulgaria, Ukraine and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Serum Concentration of Suptavumab Over Time (time frame: Day 1 through Day 150). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02325791, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2018.