Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    An Open-Label Safety Study of Patients with Severe Eosinophilic Asthma Who Were Previously Enrolled in the Reslizumab Open Label Extension Study C38072/3085

    Summary
    EudraCT number
    2014-002659-25
    Trial protocol
    FR  
    Global end of trial date
    06 Mar 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    21 Oct 2018
    First version publication date
    21 Oct 2018
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    C38072-AS-30024
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Teva Branded Pharmaceutical Products, R&D Inc.
    Sponsor organisation address
    41 Moores Road, Frazer, Pennsylvania, United States, 19355
    Public contact
    Director, Clinical Research, Teva Branded Pharmaceutical Products R&D, Inc., 1 888-483-8279, info.era-clinical@teva.de
    Scientific contact
    Director, Clinical Research, Teva Branded Pharmaceutical Products R&D, Inc., 1 888-483-8279, info.era-clinical@teva.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 Mar 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Mar 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this open-label study is to obtain additional long-term safety data for reslizumab in patients with eosinophilic asthma who enrolled in open-label extension study C38072/3085. These data include adverse events, vital signs, and concomitant medications.
    Protection of trial subjects
    This study was conducted in full accordance with the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Consolidated Guideline (E6) and any applicable national and local laws and regulations (eg, EU Directive 2001/20/EC on the approximation of the laws, regulations, and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use).
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    26 Nov 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 7
    Worldwide total number of subjects
    7
    EEA total number of subjects
    7
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    4
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Eligible patients must have completed the Study C38072/3085 end-of-treatment visit or early termination visit. In all cases, the screening/baseline visit must have been scheduled at least 21 days after the subject’s last dose of reslizumab in the previous study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Reslizumab
    Arm description
    Reslizumab (3.0 mg/kg), administered by intravenous (IV) infusion every 4 weeks (28 days±7 days) for up to 104 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    reslizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The reslizumab dose was calculated based on baseline body weight.

    Number of subjects in period 1
    Reslizumab
    Started
    7
    Completed
    7

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    -

    Reporting group values
    Overall Study Total
    Number of subjects
    7 7
    Age categorical
    Units: Subjects
        <65 years
    4 4
        >=65 years
    3 3
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    59.1 ± 13.78 -
    Gender categorical
    Units: Subjects
        Female
    5 5
        Male
    2 2
    Race
    Units: Subjects
        White
    7 7
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    6 6
        Hispanic or Latino
    1 1

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Reslizumab
    Reporting group description
    Reslizumab (3.0 mg/kg), administered by intravenous (IV) infusion every 4 weeks (28 days±7 days) for up to 104 weeks.

    Primary: Number of Subjects wth Treatment Emergents Adverse Events (AEs) and Serious AEs (SAEs)

    Close Top of page
    End point title
    Number of Subjects wth Treatment Emergents Adverse Events (AEs) and Serious AEs (SAEs) [1]
    End point description
    An AE was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, regardless of whether it had a causal relationship with this treatment. An SAE was defined as an AE occurring at any dose that resulted in any of the following outcomes or actions: death; a life-threatening AE; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; a congenital anomaly or birth defect; an important medical event that may have resulted in death, was not life-threatening, or did not require hospitalization, but may have jeopardized the patient and required medical intervention to prevent 1 of the outcomes listed in this definition. AEs summarized are those that began or worsened after treatment with reslizumab.
    End point type
    Primary
    End point timeframe
    Day 1 up to Day 757.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There is no analysis because the study has a single arm
    End point values
    Reslizumab
    Number of subjects analysed
    7
    Units: subjects
        Any AEs
    7
        Severe AEs
    2
        Treatment-related AEs
    1
        Deaths
    0
        Other SAEs
    2
        Discontinuations from treatment due to AEs
    0
    No statistical analyses for this end point

    Secondary: Annualized Rate of Clinical Asthma Exacerbations (CAEs)

    Close Top of page
    End point title
    Annualized Rate of Clinical Asthma Exacerbations (CAEs)
    End point description
    Rate of yearly asthma exacerbation is defined as number of exacerbations/(duration of treatment phase (days)/365.25). CAEs were recorded on the electronic case report form. A worsening of asthma was recorded in the adverse event electronic case report form (eCRF) as a clinical asthma exacerbation if it met 1 or more of the following criteria: 1. use of systemic corticosteroids (or at least a doubling of the maintenance dose of systemic corticosteroids) for 3 days or more, 2. an emergency department visit because of asthma that required systemic corticosteroids for 3 days or more, or 3. hospitalization because of asthma. Additional adverse events other than “clinical asthma exacerbations” that were reported by the investigator as associated to asthma and had a concomitant requirement for a systemic corticosteroid or resulted in hospitalization were adjudicated as asthma exacerbation and were also counted, if applicable.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Day 757.
    End point values
    Reslizumab
    Number of subjects analysed
    7
    Units: CAEs/year/subject
        arithmetic mean (standard deviation)
    1.350 ± 0.6799
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Day 1 up to Day 757.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Reslizumab
    Reporting group description
    Reslizumab (3.0 mg/kg), administered by intravenous (IV) infusion every 4 weeks (28 days±7 days) for up to 104 weeks.

    Serious adverse events
    Reslizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 7 (28.57%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Reslizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 7 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Angiolipoma
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Congenital, familial and genetic disorders
    Atrial septal defect
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Dolichocolon
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Vascular disorders
    Thrombophlebitis
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Cardiac disorders
    Supraventricular extrasystoles
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    7 / 7 (100.00%)
         occurrences all number
    20
    Oropharyngeal pain
         subjects affected / exposed
    2 / 7 (28.57%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    2 / 7 (28.57%)
         occurrences all number
    2
    Arthralgia
         subjects affected / exposed
    2 / 7 (28.57%)
         occurrences all number
    3
    Polymyalgia rheumatica
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Muscle spasms
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Limb discomfort
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    4 / 7 (57.14%)
         occurrences all number
    11
    Acute sinusitis
         subjects affected / exposed
    3 / 7 (42.86%)
         occurrences all number
    5
    Urinary tract infection
         subjects affected / exposed
    2 / 7 (28.57%)
         occurrences all number
    8
    Conjunctivitis
         subjects affected / exposed
    2 / 7 (28.57%)
         occurrences all number
    2
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Tooth abscess
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    2
    Bacterial disease carrier
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Urinary tract infection staphylococcal
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    3
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Dehydration
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Hyponatraemia
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Jul 2014
    The following major procedural changes were made to the protocol: - change to the planned study period in response to a request from the investigator - changes to the stopping rules and discontinuation in response to a request from the investigator
    05 Sep 2016
    The following major procedural changes were made to the protocol: - update in information on reslizumab safety, including relevant clinical results and risk/benefit assessment included in the updated Investigator’s Brochure - extension of the observation period after reslizumab injection from at least 30 minutes to at least 60 minutes after the final saline flush - clarification that birth control should be used for 5 months after the last dose of reslizumab - newly identified protocol-defined adverse events for expedited reporting for reslizumab - new section to describe the capturing of specific adverse events on the eCRF

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA