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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-001714-96
    Sponsor's Protocol Code Number:R2222-RSV-1332
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-09-10
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBulgarian Drug Agency
    A.2EudraCT number2015-001714-96
    A.3Full title of the trial
    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`
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Trial to Test Effect and Safety of REGN2222 in Preterm Infants
    A.3.2Name or abbreviated title of the trial where available
    NURSERY Pre-Term
    A.4.1Sponsor's protocol code numberR2222-RSV-1332
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02325791
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/037/2016
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRegeneron Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRegeneron Pharmaceutical, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegeneron Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trial Management
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown
    B.5.3.3Post code10591
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@regeneron.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameREGN2222
    D.3.2Product code REGN2222
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsuptavumab
    D.3.9.1CAS number 1629615-23-1
    D.3.9.2Current sponsor codeREGN2222
    D.3.9.3Other descriptive nameREGN2222
    D.3.9.4EV Substance CodeSUB176424
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboLyophilisate for solution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Medically attended respiratory syncytial virus infection
    E.1.1.1Medical condition in easily understood language
    RSV infection requiring medical care
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10038717
    E.1.2Term Respiratory syncytial viral infections
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part A:
    • To determine the PK of IM administration of REGN2222
    Part B: Study sites in the EU will only participate in Part B of the trial
    • To demonstrate the efficacy of REGN2222 in preventing medically
    attended respiratory syncytial virus (RSV) infections (subjects with
    either RSV-confirmed hospitalizations or outpatient lower respiratory
    tract infection [LRTI])
    E.2.2Secondary objectives of the trial
    Part A:
    • To evaluate safety, tolerability, and immunogenicity of REGN2222 following IM administration
    Part B:
    • To evaluate safety and tolerability of REGN2222
    • To demonstrate the efficacy of REGN2222 in reducing RSV confirmed hospitalizations, emergency room (ER), urgent care (UC), or paediatric clinic visits
    • To assess monthly serum levels of different dosing regimens of REGN2222
    • To assess immunogenicity of REGN2222
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    An optional substudy is to collect a cheek swab from subjects for DNA for future use for the purpose of discovery of predictive biomarkers.
    The purpose of the genomic analyses is to identify genomic associations with disease prognosis/severity and long-term outcomes, or other clinical outcome measures. These data may be used or combined with data collected from other studies to identify genomic markers that may predict response and elucidate mechanisms of disease. Analyses may include sequence determination or single nucleotide polymorphism studies of candidate genes and surrounding genomic regions. Genome-wide studies, including (but not limited to) single nucleotide polymorphism analyses, genomic sequencing, and transcriptome sequencing may also be performed. If indicated, genomic analyses may also be performed to identify markers associated with toxicity.
    E.3Principal inclusion criteria
    A subject must meet the following criteria to be eligible for inclusion in the study:
    1. Preterm, otherwise healthy male or female infant who has a chronological age of ≤6 months of age at the time of the first dose (ie., infant must receive the first dose on or before the subject’s 6 month birthday)
    2. Gestational age at birth is no more than 35 weeks, 6 days
    3. Parent(s) or legal guardian(s) of the infant is able to understand the study requirements, willing to provide informed consent, and legally able to provide informed consent.
    E.4Principal exclusion criteria
    An infant who meets any of the following criteria will be excluded from
    the study:
    - Eligible and recommended to receive palivizumab per AAP or other
    local guidelines, standard practice, or by their healthcare provider
    - Diagnosis of CLD defined as requirement of supplemental oxygen for at
    least 28 days (cumulative) after birth.
    - Known hemodynamically significant congenital heart disease
    - Known immunodeficiency, neuromuscular disease, or congenital
    abnormalities of the airway
    - Previously received palivizumab, IV gamma globulin, or any other
    investigational RSV prophylaxis or vaccine product
    - Previous reaction to IV immunoglobulin, blood products or
    other foreign proteins, such as vaccines and monoclonal antibodies, or
    any of the components of the investigational product formulation
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints are the following:
    Part A:
    • Serum concentration of REGN2222 over time and other PK parameters
    Part B:
    • Proportion of subjects with a medically attended RSV infection (hospitalization or outpatient LRTI) during the study period. A medically attended RSV infection is 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
    - Outpatient visit (ER, UC, or paediatric clinic [for either a sick or well visit]) with RSV LRTI.
    An RSV LRTI in an infant is defined as an RSV-proven respiratory infection (ie, positive RSV RT-PCR test) with parent(s)/legal 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
    E.5.1.1Timepoint(s) of evaluation of this end point
    Collected between first dose to study Day 150
    E.5.2Secondary end point(s)
    The secondary endpoints are the following:
    Part A:
    • Incidence and severity of TEAEs
    • Presence and titer of anti-REGN2222 antibodies
    Part B:
    • Proportion of subjects who have RSV-confirmed hospitalization, ER,UC, or paediatric clinic visits (for upper or lower respiratory infection) during the study period
    • PK parameters using sparse sampling
    • Presence and titer of anti-REGN2222 antibodies

    E.5.2.1Timepoint(s) of evaluation of this end point
    Collected between first dose to study Day 150
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned18
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA76
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Bulgaria
    Canada
    Chile
    Denmark
    Finland
    Germany
    Hungary
    Netherlands
    New Zealand
    Panama
    South Africa
    Spain
    Sweden
    Turkey
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 1539
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 154
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 1385
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Preterm infants ≤ 6 months of age
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 368
    F.4.2.2In the whole clinical trial 1539
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-09-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-09-26
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