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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02325791
Registration number
NCT02325791
Ethics application status
Date submitted
21/12/2014
Date registered
25/12/2014
Date last updated
6/11/2018
Titles & IDs
Public title
Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants
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Scientific 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
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Secondary ID [1]
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R2222-RSV-1332
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Infection
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Sexually transmitted infections
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Respiratory
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Suptavumab 30 mg/kg
Treatment: Drugs - Placebo Matched to Suptavumab
Treatment: Drugs - Suptavumab 30 mg/kg- 1 Dose
Treatment: Drugs - Suptavumab 30 mg/kg - 2 Doses
Experimental: Part A: Suptavumab 30 mg/kg -
Experimental: Part B: Placebo Matched to Suptavumab -
Experimental: Part B: Suptavumab 30 mg/kg- 1 Dose -
Experimental: Part B: Suptavumab 30 mg/kg - 2 Doses -
Treatment: Drugs: Suptavumab 30 mg/kg
Participants received single dose of suptavumab 30 milligram per kilogram (mg/kg) intramuscularly (IM) on Day 1.
Treatment: Drugs: 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.
Treatment: Drugs: 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.
Treatment: Drugs: 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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part A: Serum Concentration of Suptavumab Over Time
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Assessment method [1]
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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.
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Timepoint [1]
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Day 1 through Day 150
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Primary outcome [2]
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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
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Assessment method [2]
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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.
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Timepoint [2]
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From first study drug administration up to Day 150
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Secondary outcome [1]
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Part A: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline through Day 150
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Secondary outcome [2]
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Part B: Serum Concentration of Suptavumab
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Assessment method [2]
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Serum samples for drug concentration will be collected at pre-specified time points
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Timepoint [2]
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Day 29, 57, 85, 113 and Day 150 Post-dose
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Secondary outcome [3]
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Part B: Number of Participants With At Least One Positive Anti-Drug Antibody (ADA) Assay
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Assessment method [3]
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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).
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Timepoint [3]
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Day 1 through Day 150
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Secondary outcome [4]
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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
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Assessment method [4]
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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.
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Timepoint [4]
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From the first study drug administration up to Day 150
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Eligibility
Key inclusion criteria
Key
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
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Minimum age
No limit
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Maximum age
6
Months
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/07/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
26/09/2017
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Sample size
Target
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Accrual to date
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Final
1177
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Recruitment in Australia
Recruitment state(s)
TAS
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Recruitment hospital [1]
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Regeneron Study Site - Hobart
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Recruitment postcode(s) [1]
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- Hobart
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Recruitment outside Australia
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Sumy
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Ukraine
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Ternopil
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Ukraine
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State/province [112]
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Zaporizhzhia
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Country [113]
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United Kingdom
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Birmingham
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Country [114]
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United Kingdom
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State/province [114]
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Hampshire
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Country [115]
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United Kingdom
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State/province [115]
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Kent
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United Kingdom
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State/province [116]
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London, City Of
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Country [117]
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United Kingdom
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State/province [117]
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Manchester
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Country [118]
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United Kingdom
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State/province [118]
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Belfast
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United Kingdom
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Glasgow
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Country [120]
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United Kingdom
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Poole
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United Kingdom
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Reading
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United Kingdom
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Sheffield
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United Kingdom
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Stockton on Tees
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Funding & Sponsors
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Commercial sector/Industry
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Name
Regeneron Pharmaceuticals
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02325791
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Public notes
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Contacts
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Clinical Trial Management
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Regeneron Pharmaceuticals
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02325791
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