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    Clinical Trial Results:
    An international, multicentre, efficacy and safety study of I10E in initial and maintenance treatment of patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy.

    Summary
    EudraCT number
    2013-005557-73
    Trial protocol
    GB   ES   IT   FR   DE  
    Global end of trial date
    29 Sep 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    15 Jan 2020
    First version publication date
    15 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    I10E-1302
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    LFB Biotechnologies
    Sponsor organisation address
    3 Avenue des Tropiques, COURTABOEUF, France, 91930
    Public contact
    Global Clinical Development Leader , LFB BIOTECHNOLOGIES, +33 1 69 82 70 10,
    Scientific contact
    Global Clinical Development Leader , LFB BIOTECHNOLOGIES, +33 1 69 82 70 10,
    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
    18 Dec 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Sep 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Sep 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to assess the efficacy of I10E in improving the disability of patients with CIDP.
    Protection of trial subjects
    This study was conducted in compliance with good clinical practice (GCP) as described in the International Conference on Harmonisation (ICH) document “Guidance for Industry-E6 Good Clinical Practice: Consolidated Guidance” dated April 1996. These practices were consistent with the principles stated in the Declaration of Helsinki (October 2013 revised version). All other applicable regulations were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    24 Feb 2015
    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
    Tunisia: 8
    Country: Number of subjects enrolled
    Turkey: 3
    Country: Number of subjects enrolled
    Poland: 8
    Country: Number of subjects enrolled
    Spain: 6
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Italy: 16
    Worldwide total number of subjects
    44
    EEA total number of subjects
    33
    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)
    32
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Between 24 Feb 2015 and 22 Mar 2017, 59 subjects from 23 sites signed an informed consent.

    Pre-assignment
    Screening details
    -

    Pre-assignment period milestones
    Number of subjects started
    59 [1]
    Number of subjects completed
    43

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Consent withdrawn by subject: 1
    Reason: Number of subjects
    Screening failure: 15
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 59 subjects signed an informed consent in the pre-assigment period. Among them, 18 subjects were considered as a screening failure including 3 subjects re-screened and finally enrolled. Of 44 enrolled subjects, one subject was discontinued (consent withdrawn by subject) from the study before the first administration of study drug.
    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    Single arm
    Arm description
    This study included patients never previously treated with IgG and patients already treated with IgG but in clinical relapse following IgG therapy discontinuation.
    Arm type
    Experimental

    Investigational medicinal product name
    IQYMUNE
    Investigational medicinal product code
    I10E
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    I10E (study drug) was administered at 2 g/kg over 2 to 5 days for the first course, then at 1 g/kg over 1 to 2 days for 7 additional courses at 3-week intervals. Study drug was administered intravenously, with an infusion pump (B-Braun Infusomat Space).

    Number of subjects in period 1 [2]
    Single arm
    Started
    43
    Completed
    37
    Not completed
    6
         Protocol deviation
    1
         Lack of efficacy
    2
         Adverse event, non-fatal
    2
         Consent withdrawn by subject
    1
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Of 44 enrolled subjects, one patient was discontinued (consent withdrawn by subject) from the study before the first administration of study drug.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment period
    Reporting group description
    -

    Reporting group values
    Treatment period Total
    Number of subjects
    43 43
    Age categorical
    Units: Subjects
        18 years and more
    43 43
    Age continuous
    Units: years
        median (full range (min-max))
    50.0 (21 to 79) -
    Gender categorical
    Units: Subjects
        Female
    19 19
        Male
    24 24
    Subject analysis sets

    Subject analysis set title
    Total Treated Set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All subjects who received at least one infusion of I10E

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All TTS patients having an available assessment of the primary efficacy criteria.

    Subject analysis sets values
    Total Treated Set Full Analysis Set
    Number of subjects
    43
    42
    Age categorical
    Units: Subjects
        18 years and more
    43
    42
    Age continuous
    Units: years
        median (full range (min-max))
    50.0 (21 to 79)
    50.0 (21 to 79)
    Gender categorical
    Units: Subjects
        Female
    19
    18
        Male
    24
    24

    End points

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    End points reporting groups
    Reporting group title
    Single arm
    Reporting group description
    This study included patients never previously treated with IgG and patients already treated with IgG but in clinical relapse following IgG therapy discontinuation.

    Subject analysis set title
    Total Treated Set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All subjects who received at least one infusion of I10E

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All TTS patients having an available assessment of the primary efficacy criteria.

    Primary: Responder Rate

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    End point title
    Responder Rate [1]
    End point description
    The primary efficacy endpoint was the responder rate at End of Study (EoS). Responders were defined as patients with a decrease ≥1 point in the adjusted INCAT disability score compared to baseline. If a patient was treated with a not-allowed treatment during the study period, then all adjusted INCAT disability score measured after the intake of these not-allowed treatments were censored. If the score at EoS visit was missing, then the Last Observation Carried Forward (LOCF) approach was applied to replace this missing value.
    End point type
    Primary
    End point timeframe
    During treatment period the adjusted INCAT disability score was evaluated at week 3, week 6, week 9, week 12, week 15, week 18, week 21, week 24 (End-of-Study).
    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: For this single-arm study, the response rate was tested against the historical response rate of 33.3% with a 1-sided Clopper-Pearson exact test at the nominal level of significance of 2.5% on the Full Analysis Set. The null and alternative hypotheses were as follows: H0: pI10E <= 33.3% H1: pI10E > 33.3% The estimate of the response rate was 76.2% (Exact 2-sided 95% Clopper-Pearson CI[60.5%;87.9%]). The p-value of the 1-sided Clopper-Pearson exact test was < 0.0001.
    End point values
    Full Analysis Set
    Number of subjects analysed
    42
    Units: Subjects
    32
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    throughout the study
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Total treated Set
    Reporting group description
    -

    Serious adverse events
    Total treated Set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 43 (16.28%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Synovial rupture
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Fibrin D dimer increased
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colorectal adenocarcinoma
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Pancreatitis acute
         subjects affected / exposed
    1 / 43 (2.33%)
         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
    Total treated Set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 43 (90.70%)
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    3 / 43 (6.98%)
         occurrences all number
    3
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 43 (6.98%)
         occurrences all number
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    20 / 43 (46.51%)
         occurrences all number
    79
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    3 / 43 (6.98%)
         occurrences all number
    5
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    8 / 43 (18.60%)
         occurrences all number
    11
    Asthenia
         subjects affected / exposed
    4 / 43 (9.30%)
         occurrences all number
    4
    Chills
         subjects affected / exposed
    3 / 43 (6.98%)
         occurrences all number
    10
    Malaise
         subjects affected / exposed
    3 / 43 (6.98%)
         occurrences all number
    5
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    5 / 43 (11.63%)
         occurrences all number
    6
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    3 / 43 (6.98%)
         occurrences all number
    4
    Rash
         subjects affected / exposed
    3 / 43 (6.98%)
         occurrences all number
    3
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    5 / 43 (11.63%)
         occurrences all number
    5
    Arthralgia
         subjects affected / exposed
    4 / 43 (9.30%)
         occurrences all number
    6
    Infections and infestations
    Influenza
         subjects affected / exposed
    8 / 43 (18.60%)
         occurrences all number
    10
    Urinary tract infection
         subjects affected / exposed
    5 / 43 (11.63%)
         occurrences all number
    5

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Mar 2016
    - Modification of some exclusion criteria - Removal of routine free bilirubin testing - Additional renal safety follow-up - Description of the patient population - Rules for follow-up of adverse events - Timing of safety monitoring (vital signs) - Update of IMP storage conditions This Amendment led to protocol version 5.0 dated 06 January 2016

    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
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