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    Clinical Trial Results:
    A Phase IIa, Randomised, Double Blind, Placebo Controlled, Parallel Group, Multicentre Study of an Anti OX40L Monoclonal Antibody (KY1005) in Moderate to Severe Atopic Dermatitis

    Summary
    EudraCT number
    2018-002299-41
    Trial protocol
    GB   DE   ES  
    Global end of trial date
    08 Oct 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    08 Oct 2021
    First version publication date
    08 Oct 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    KY1005-CT02
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Kymab Limited
    Sponsor organisation address
    The Bennet Building (B930), Babraham Research Campus, Cambridge, United Kingdom, CB22 3AT
    Public contact
    Development Clinical Trial Desk, Kymab Limited, Clinicaltrial@kymab.com
    Scientific contact
    Development Clinical Trial Desk, Kymab Limited, Clinicaltrial@kymab.com
    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
    15 Dec 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Oct 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Oct 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To explore the efficacy and safety of KY1005 on the signs of atopic dermatitis (AD) using the Eczema Area and Severity Index (EASI) and the incidence of treatment-emergent adverse events (TEAEs).
    Protection of trial subjects
    This study was conducted in accordance with the protocol, all applicable regulatory requirements, the International Council for Harmonisation (ICH) E6 guideline for Good Clinical Practice (GCP) and the general principles of the Declaration of Helsinki. Written informed consent for the study was obtained from each patient by the Investigator or suitably qualified designee before any protocol-specific procedures were carried out. Written information (including patient information sheets, ICFs, adverts, general practitioner letters) was only discussed with or given to patients once the IEC approved the document in writing. Patients provided written informed consent on an IEC-approved ICF. Patients were re-consented and ICFs were re-signed before implementation of each protocol amendment, where applicable. Each patient’s ICF was also signed and dated by the person who conducted the informed consent discussion. Informed consent was documented in the patient’s medical records. The patient was given a copy of the information sheet and their signed and dated consent form, and the original ICF was filed in the Investigator site file (ISF).
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    13 Dec 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 72
    Country: Number of subjects enrolled
    Spain: 9
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    Germany: 5
    Worldwide total number of subjects
    89
    EEA total number of subjects
    86
    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)
    88
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Subjects were screened within 29 to 8 days prior to baseline.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Monitor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Low dose KY1005
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    KY1005
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Patients received a low loading dose of KY1005 on Day 1, followed by three maintenance doses at 50% of the loading dose at 28-day intervals on Days 29, 57 and 85.

    Arm title
    High dose KY1005
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    KY1005
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Patients received a high loading dose of KY1005 on Day 1, followed by three maintenance doses at 50% of the loading dose at 28-day intervals on Days 29, 57 and 85.

    Arm title
    Placebo
    Arm description
    -
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Patients received placebo on Day 1, followed by three further doses at 28-day intervals on Days 29, 57 and 85.

    Number of subjects in period 1
    Low dose KY1005 High dose KY1005 Placebo
    Started
    29
    30
    30
    Completed
    20
    22
    17
    Not completed
    9
    8
    13
         Protocol deviation
    -
    -
    2
         Other
    2
    3
    5
         Failure to meet randomisation criteria
    1
    -
    -
         Adverse event, non-fatal
    -
    -
    3
         Consent withdrawn by subject
    6
    5
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Low dose KY1005
    Reporting group description
    -

    Reporting group title
    High dose KY1005
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Reporting group values
    Low dose KY1005 High dose KY1005 Placebo Total
    Number of subjects
    29 30 30 89
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0
        Newborns (0-27 days)
    0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0
        Children (2-11 years)
    0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0
        Adults (18-64 years)
    28 30 30 88
        From 65-84 years
    1 0 0 1
        85 years and over
    0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    13 14 11 38
        Male
    16 16 19 51

    End points

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    End points reporting groups
    Reporting group title
    Low dose KY1005
    Reporting group description
    -

    Reporting group title
    High dose KY1005
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Primary: Percentage change in EASI from Baseline to Day 113 (FAS)

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    End point title
    Percentage change in EASI from Baseline to Day 113 (FAS)
    End point description
    Full analysis set
    End point type
    Primary
    End point timeframe
    From Baseline to Day 113
    End point values
    Low dose KY1005 High dose KY1005 Placebo
    Number of subjects analysed
    27
    27
    24
    Units: Percentage
        least squares mean (confidence interval 95%)
    -80.12 (-95.55 to -64.68)
    -69.97 (-85.04 to -54.90)
    -49.37 (-66.02 to -32.72)
    Statistical analysis title
    Difference in LSM estimate
    Comparison groups
    Low dose KY1005 v Placebo
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.009
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -30.75
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -53.43
         upper limit
    -8.06
    Variability estimate
    Standard error of the mean
    Dispersion value
    11.38
    Statistical analysis title
    Difference in LSM estimate
    Comparison groups
    Placebo v High dose KY1005
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.072
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -20.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -43.08
         upper limit
    1.88
    Variability estimate
    Standard error of the mean
    Dispersion value
    11.27

    Primary: Summary of TEAEs to Day 113

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    End point title
    Summary of TEAEs to Day 113 [1]
    End point description
    End point type
    Primary
    End point timeframe
    To Day 113
    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: Per protocol no statistical analyses were conducted on this end point.
    End point values
    Low dose KY1005 High dose KY1005 Placebo
    Number of subjects analysed
    29
    30
    29
    Units: Number of patients
        At least one TEAE
    18
    14
    20
        At least one related TEAE
    10
    6
    9
        At least one serious TEAE
    1
    0
    0
        A least one related serious TEAE
    1
    0
    0
        At least one treatment-emergent AESI
    0
    1
    0
        At least one related TEAE of special interest
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose to Day 113
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Low dose KY1005
    Reporting group description
    -

    Reporting group title
    High dose KY1005
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Serious adverse events
    Low dose KY1005 High dose KY1005 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Infections and infestations
    Infected dermal cyst
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Low dose KY1005 High dose KY1005 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 29 (62.07%)
    14 / 30 (46.67%)
    20 / 29 (68.97%)
    Vascular disorders
    Orthostatic hypotension
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Hypertension
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    1
    1
    0
    Immune system disorders
    Food allergy
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 30 (6.67%)
    1 / 29 (3.45%)
         occurrences all number
    0
    3
    1
    Pyrexia
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    0
    Asthenia
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Drug ineffective
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Malaise
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    Depressed mood
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Insomnia
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    2
    0
    Mood altered
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Reproductive system and breast disorders
    Menometrorrhagia
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Menorrhagia
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Wound
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 30 (6.67%)
    1 / 29 (3.45%)
         occurrences all number
    1
    2
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 30 (6.67%)
    0 / 29 (0.00%)
         occurrences all number
    0
    2
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    1
    0
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Blood potassium increased
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Blood urine present
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Haematocrit increased
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Red blood cells urine positive
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Urine analysis abnormal
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Weight decreased
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Cough
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 29 (0.00%)
    3 / 30 (10.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    12
    2
    Formication
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Somnolence
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Eye disorders
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Eyelid cyst
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Ulcerative keratitis
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    0
    2
    Ear pain
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Abdominal pain lower
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Abdominal pain upper
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    3 / 29 (10.34%)
    4 / 30 (13.33%)
    9 / 29 (31.03%)
         occurrences all number
    3
    5
    16
    Hyperhidrosis
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 30 (6.67%)
    0 / 29 (0.00%)
         occurrences all number
    0
    2
    0
    Eczema
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    3
    Erythema
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Pain of skin
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Pruritus allergic
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Rash
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Skin erosion
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Swelling face
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    0
    2
    Musculoskeletal pain
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Neck pain
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Spinal pain
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Endocrine disorders
    Hyperprolactinaemia
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 29 (6.90%)
    3 / 30 (10.00%)
    6 / 29 (20.69%)
         occurrences all number
    2
    3
    9
    Folliculitis
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 30 (6.67%)
    1 / 29 (3.45%)
         occurrences all number
    1
    5
    1
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 29 (10.34%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    3
    0
    1
    Skin infection
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    1
    1
    0
    Tonsillitis
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    1
    0
    1
    Bacterial infection
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Bronchitis
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Conjunctivitis
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Furuncle
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Herpes simplex
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Infected dermal cyst
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Periodontitis
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Pharyngitis
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Rash pustular
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Skin bacterial infection
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Tooth infection
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    Vulvovaginal candidiasis
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences all number
    0
    2
    0

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Sep 2018
    Amendment of exclusion criterion related to recommended washout of systemic immunosuppressive or immunomodulatory drugs Addition of lower weight limit Amendment of exclusion criterion related to anaemia Revision of guidance regarding the adequacy of double barrier contraceptive methods Revision of liver function test criteria in relation to the permanent discontinuation of IMP Establishment of consistent safety follow up for all study participants that covers 4 to 5 half-lives of IMP. Revision of code break process in the event of a medical emergency
    19 Jun 2019
    Corrected previous omission in synopsis Clarification that change in immunohistochemistry of K16 would be measured by a qualified pathologist Clarification that Cmax would be determined after all infusions. Reduction of Follow-up Period to Day 253 for all patients Clarification of the personnel who would be blinded Reduction of washout period for systemic Cyclosporin A to within 3 weeks of Baseline Clarification of Total bilirubin >ULN (except in circumstances where Gilbert’s Syndrome can be confirmed) Clarification of the duration of birth control measures Clarification of the rules for replacement of patients and dosing Clarification of rules around dosing if a dose needs to be temporarily discontinued Investigator Assessments to be performed by the same Assessor One repeat of safety laboratory tests and vital signs and more flexibility for rescreening Clarification of timing of baseline biopsy Clarification of the type of assay to be used for Inflammatory Proteomic Analysis Reduction in blood volume required during study extension Further clarification of the FAS population Further clarification and detail provided on PK analysis Where previously used incorrectly the term Monitor or Medical Monitor was replaced by Study Monitor Replacement of Amendment 1 by Summary of Protocol Amendments

    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.
    The study was not prospectively powered. Any P values presented are nominal.
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