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    Clinical Trial Results:
    A Phase II, randomized, double-blind, placebo-controlled, multiple-dose study to evaluate the safety, tolerability, and efficacy of CIM331 in atopic dermatitis patients who are inadequately controlled by or intolerant to topical therapy.

    Summary
    EudraCT number
    2013-002470-46
    Trial protocol
    GB   DE  
    Global end of trial date
    06 Jun 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    30 Jun 2017
    First version publication date
    30 Jun 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CIM003JG
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01986933
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Chugai Pharma Europe Ltd.
    Sponsor organisation address
    Mulliner House, Flanders Road, London, United Kingdom, W4 1NN
    Public contact
    Clinical trials information, Chugai Pharmaceutical Co., Ltd., +81 332730934, clinical-trials@chugai-pharm.co.jp
    Scientific contact
    Clinical trials information, Chugai Pharmaceutical Co., Ltd., +81 332730934, clinical-trials@chugai-pharm.co.jp
    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
    09 Sep 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Apr 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the dose response profile of CIM331 in the treatment of pruritus as defined by the percent improvement in pruritus from baseline to Week 12, assessed by patients using the pruritus VAS (Part A).
    Protection of trial subjects
    This study was conducted in full conformance with the ICH E6 guideline for GCP and the principles of the Declaration of Helsinki, or the laws and regulations of the country in which the research is conducted, whichever affords the greater protection to the individual.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    17 Dec 2013
    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
    United Kingdom: 7
    Country: Number of subjects enrolled
    United States: 59
    Country: Number of subjects enrolled
    Germany: 53
    Country: Number of subjects enrolled
    Japan: 79
    Country: Number of subjects enrolled
    Poland: 66
    Worldwide total number of subjects
    264
    EEA total number of subjects
    126
    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)
    264
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at 57 study sites in 5 countries. A total of 397 subjects were screened between 25 Nov 2013 and 30 Dec 2014. 264 subjects were randomized and treated. 114 subjects were screen failures and 19 subjects were run-in failures due to exclusion and inclusion criteria not met.

    Pre-assignment
    Screening details
    Randomization was stratified by region (US, Europe and Japan). Assignment to arms was done centrally in 1:1:1:1:1 ratio for Nemolizumab (0.1mg/kg Q4W, 0.5mg/kg Q4W, 2.0mg/kg Q4W, 2.0mg/kg Q8W) and Placebo.

    Period 1
    Period 1 title
    12-week placebo-controlled period (Pt A)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    In order to maintain the blind, Nemolizumab and the placebo formulation were of identical volume and provided in identical containers.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Placebo: subcutaneous injections every 4 weeks on Day 1, Week 4 and Week 8
    Arm type
    Placebo

    Investigational medicinal product name
    Nemolizumab
    Investigational medicinal product code
    CIM331
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    subcutaneous injection in non-lesional abdomen at 20 μL/kg.

    Arm title
    Nemolizumab (0.1 mg/kg) q4w
    Arm description
    Nemolizumab (0.1 mg/kg) q4w: subcutaneous injections every 4 weeks for 12 weeks
    Arm type
    Experimental

    Investigational medicinal product name
    Nemolizumab
    Investigational medicinal product code
    CIM331
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    subcutaneous injection in non-lesional abdomen at 20 μL/kg.

    Arm title
    Nemolizumab (0.5 mg/kg) q4w
    Arm description
    Nemolizumab (0.5 mg/kg) q4w: subcutaneous injections every 4 weeks for 12 weeks
    Arm type
    Experimental

    Investigational medicinal product name
    Nemolizumab
    Investigational medicinal product code
    CIM331
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    subcutaneous injection in non-lesional abdomen at 20 μL/kg.

    Arm title
    Nemolizumab (2.0 mg/kg) q4w
    Arm description
    Nemolizumab (2.0 mg/kg) q4w: subcutaneous injections every 4 weeks for 12 weeks
    Arm type
    Experimental

    Investigational medicinal product name
    Nemolizumab
    Investigational medicinal product code
    CIM331
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    subcutaneous injection in non-lesional abdomen at 20 μL/kg.

    Arm title
    Nemolizumab (2.0 mg/kg) q8w
    Arm description
    Nemolizumab (2.0 mg/kg) q8w: subcutaneous injections Dose on Day 1 and at Week 8, placebo at Week 4.
    Arm type
    Experimental

    Investigational medicinal product name
    Nemolizumab
    Investigational medicinal product code
    CIM331
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    subcutaneous injection in non-lesional abdomen at 20 μL/kg.

    Number of subjects in period 1
    Placebo Nemolizumab (0.1 mg/kg) q4w Nemolizumab (0.5 mg/kg) q4w Nemolizumab (2.0 mg/kg) q4w Nemolizumab (2.0 mg/kg) q8w
    Started
    53
    53
    54
    52
    52
    Completed
    44
    44
    45
    45
    38
    Not completed
    9
    9
    9
    7
    14
         Lack of efficacy
    3
    1
    1
    2
    1
         Adverse event, non-fatal
    1
    5
    2
    2
    4
         Consent withdrawn by subject
    5
    2
    6
    2
    7
         Withdrawal by subject due to lack of efficacy
    -
    -
    -
    -
    2
         Lost to follow-up
    -
    1
    -
    1
    -
    Period 2
    Period 2 title
    64wks Active(PtA)+Active Treatment(PtB)
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Carer, Assessor
    Blinding implementation details
    In order to maintain the blind, Nemolizumab and the placebo formulation were of identical volume and provided in identical containers.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Nemolizumab (0.1 mg/kg) q4w
    Arm description
    CIM331 (0.1 mg/kg) was given subcutaneously every 4 weeks for 64 weeks
    Arm type
    Experimental

    Investigational medicinal product name
    Nemolizumab
    Investigational medicinal product code
    CIM331
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    subcutaneous injection in non-lesional abdomen at 20 μL/kg.

    Arm title
    Nemolizumab (0.5 mg/kg) q4w
    Arm description
    CIM331 (0.5 mg/kg) given subcutaneously every 4 weeks for 64 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Nemolizumab
    Investigational medicinal product code
    CIM331
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    subcutaneous injection in non-lesional abdomen at 20 μL/kg.

    Arm title
    Nemolizumab (2.0 mg/kg) q4w
    Arm description
    CIM331 (2.0 mg/kg) given subcutaneously every 4 weeks for 64 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Nemolizumab
    Investigational medicinal product code
    CIM331
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    subcutaneous injection in non-lesional abdomen at 20 μL/kg.

    Arm title
    Nemolizumab (2.0 mg/kg) q8w
    Arm description
    Nemolizumab (2.0 mg/kg) q8w: subcutaneous injections every 4 weeks for 12 weeks. Patients in this dosing group received placebo at Week 12, Nemolizumab at Week 16, and then alternating doses of placebo and Nemolizumab.
    Arm type
    Experimental

    Investigational medicinal product name
    Nemolizumab
    Investigational medicinal product code
    CIM331
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    subcutaneous injection in non-lesional abdomen at 20 μL/kg.

    Number of subjects in period 2 [1]
    Nemolizumab (0.1 mg/kg) q4w Nemolizumab (0.5 mg/kg) q4w Nemolizumab (2.0 mg/kg) q4w Nemolizumab (2.0 mg/kg) q8w
    Started
    41
    38
    39
    35
    Completed
    31
    28
    30
    19
    Not completed
    10
    10
    9
    16
         Patient return PIC due to skin worsening
    -
    -
    1
    -
         Physician decision
    -
    1
    1
    -
         Lack of efficacy
    3
    2
    -
    4
         Pregnancy
    -
    -
    -
    1
         Adverse event, non-fatal
    2
    -
    1
    3
         Met Withdrawal Criteria
    1
    -
    -
    -
         Consent withdrawn by subject
    4
    7
    6
    6
         Withdrawal by subject due to lack of efficacy
    -
    -
    -
    1
         Lost to follow-up
    -
    -
    -
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: It was optional for patients to participate in the part B of the study, therefore some patients decided to decline and not participate in part B.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo: subcutaneous injections every 4 weeks on Day 1, Week 4 and Week 8

    Reporting group title
    Nemolizumab (0.1 mg/kg) q4w
    Reporting group description
    Nemolizumab (0.1 mg/kg) q4w: subcutaneous injections every 4 weeks for 12 weeks

    Reporting group title
    Nemolizumab (0.5 mg/kg) q4w
    Reporting group description
    Nemolizumab (0.5 mg/kg) q4w: subcutaneous injections every 4 weeks for 12 weeks

    Reporting group title
    Nemolizumab (2.0 mg/kg) q4w
    Reporting group description
    Nemolizumab (2.0 mg/kg) q4w: subcutaneous injections every 4 weeks for 12 weeks

    Reporting group title
    Nemolizumab (2.0 mg/kg) q8w
    Reporting group description
    Nemolizumab (2.0 mg/kg) q8w: subcutaneous injections Dose on Day 1 and at Week 8, placebo at Week 4.

    Reporting group values
    Placebo Nemolizumab (0.1 mg/kg) q4w Nemolizumab (0.5 mg/kg) q4w Nemolizumab (2.0 mg/kg) q4w Nemolizumab (2.0 mg/kg) q8w Total
    Number of subjects
    53 53 54 52 52 264
    Age categorical
    Data is reported for the 264 treatred subjects included in the analyses.
    Units: Subjects
        Adults (18-64 years)
    53 53 54 52 52 264
    Age continuous
    Data is reported for the 264 treatred subjects included in the analyses.
    Units: years
        arithmetic mean (standard deviation)
    37 ± 13.1 33.5 ± 10.3 33.7 ± 11.7 34.4 ± 11.9 35.8 ± 13.6 -
    Gender categorical
    Data is reported for the 264 treated subjects included in the analyses.
    Units: Subjects
        Female
    28 25 32 21 23 129
        Male
    25 28 22 31 29 135
    Subject analysis sets

    Subject analysis set title
    Intent to treat
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    ITT population will include all patients who receive at least one dose of double-blind study drug. Patients who receive study drug different from that to which they are randomized will be included in the group to which they are randomized.

    Subject analysis sets values
    Intent to treat
    Number of subjects
    264
    Age categorical
    Data is reported for the 264 treatred subjects included in the analyses.
    Units: Subjects
        Adults (18-64 years)
    264
    Age continuous
    Data is reported for the 264 treatred subjects included in the analyses.
    Units: years
        arithmetic mean (standard deviation)
    34.9 ± 12.1
    Gender categorical
    Data is reported for the 264 treated subjects included in the analyses.
    Units: Subjects
        Female
    129
        Male
    135

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo: subcutaneous injections every 4 weeks on Day 1, Week 4 and Week 8

    Reporting group title
    Nemolizumab (0.1 mg/kg) q4w
    Reporting group description
    Nemolizumab (0.1 mg/kg) q4w: subcutaneous injections every 4 weeks for 12 weeks

    Reporting group title
    Nemolizumab (0.5 mg/kg) q4w
    Reporting group description
    Nemolizumab (0.5 mg/kg) q4w: subcutaneous injections every 4 weeks for 12 weeks

    Reporting group title
    Nemolizumab (2.0 mg/kg) q4w
    Reporting group description
    Nemolizumab (2.0 mg/kg) q4w: subcutaneous injections every 4 weeks for 12 weeks

    Reporting group title
    Nemolizumab (2.0 mg/kg) q8w
    Reporting group description
    Nemolizumab (2.0 mg/kg) q8w: subcutaneous injections Dose on Day 1 and at Week 8, placebo at Week 4.
    Reporting group title
    Nemolizumab (0.1 mg/kg) q4w
    Reporting group description
    CIM331 (0.1 mg/kg) was given subcutaneously every 4 weeks for 64 weeks

    Reporting group title
    Nemolizumab (0.5 mg/kg) q4w
    Reporting group description
    CIM331 (0.5 mg/kg) given subcutaneously every 4 weeks for 64 weeks.

    Reporting group title
    Nemolizumab (2.0 mg/kg) q4w
    Reporting group description
    CIM331 (2.0 mg/kg) given subcutaneously every 4 weeks for 64 weeks.

    Reporting group title
    Nemolizumab (2.0 mg/kg) q8w
    Reporting group description
    Nemolizumab (2.0 mg/kg) q8w: subcutaneous injections every 4 weeks for 12 weeks. Patients in this dosing group received placebo at Week 12, Nemolizumab at Week 16, and then alternating doses of placebo and Nemolizumab.

    Subject analysis set title
    Intent to treat
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    ITT population will include all patients who receive at least one dose of double-blind study drug. Patients who receive study drug different from that to which they are randomized will be included in the group to which they are randomized.

    Primary: The percent improvement in pruritus from baseline to Week 12, assessed by patients using the pruritus visual analogue scale (VAS)

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    End point title
    The percent improvement in pruritus from baseline to Week 12, assessed by patients using the pruritus visual analogue scale (VAS) [1]
    End point description
    Pruritus intensity in the last 24 hours, from 0 (no itch) to 10 (worst imaginable itch).
    End point type
    Primary
    End point timeframe
    Baseline and week 12
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not performed on the other arm that were not reported.
    End point values
    Placebo Nemolizumab (0.1 mg/kg) q4w Nemolizumab (0.5 mg/kg) q4w Nemolizumab (2.0 mg/kg) q4w
    Number of subjects analysed
    46
    46
    45
    47
    Units: percent
        least squares mean (confidence interval 95%)
    -20.07 (-29.94 to -10.21)
    -41.46 (-51.21 to -31.71)
    -61.24 (-71.13 to -51.35)
    -60.46 (-69.98 to -50.95)
    Statistical analysis title
    Difference in % change
    Statistical analysis description
    The primary analysis of the percent improvement VAS from baseline in pruritus VAS to Week 12 will be the pairwise comparison of each CIM331 Q4W dose against placebo.
    Comparison groups
    Placebo v Nemolizumab (0.1 mg/kg) q4w
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0027
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -21.39
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -35.25
         upper limit
    -7.53
    Statistical analysis title
    Difference in % change
    Statistical analysis description
    The primary analysis of the percent improvement VAS from baseline in pruritus VAS to Week 12 will be the pairwise comparison of each CIM331 Q4W dose against placebo.
    Comparison groups
    Placebo v Nemolizumab (0.5 mg/kg) q4w
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [2]
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -41.16
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -55.17
         upper limit
    -27.15
    Notes
    [2] - Since a hierarchical decision procedure can be regarded as a closed testing procedure, no inflation of the alpha level due to multiple comparisons exists, and the global 1-sided significance alpha level of 0.025 is maintained.
    Statistical analysis title
    Difference in % change
    Statistical analysis description
    The primary analysis of the percent improvement VAS from baseline in pruritus VAS to Week 12 will be the pairwise comparison of each CIM331 Q4W dose against placebo.
    Comparison groups
    Placebo v Nemolizumab (2.0 mg/kg) q4w
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [3]
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -40.39
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -54.11
         upper limit
    -26.67
    Notes
    [3] - Since a hierarchical decision procedure can be regarded as a closed testing procedure, no inflation of the alpha level due to multiple comparisons exists, and the global 1-sided significance alpha level of 0.025 is maintained.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Period 1 : 12-week placebo-controlled period (Part A) Period 2 : 64wks Active (Part A) + Active Treatment (Part B) (Part A+B)
    Adverse event reporting additional description
    The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Placebo (Part A)
    Reporting group description
    Placebo: subcutaneous injections every 4 weeks on Day 1, Week 4 and Week 8

    Reporting group title
    Nemolizumab (0.1 mg/kg) q4w (Part A)
    Reporting group description
    Nemolizumab (0.1 mg/kg) q4w: subcutaneous injections every 4 weeks for 12 weeks

    Reporting group title
    Nemolizumab (0.5 mg/kg) q4w (Part A)
    Reporting group description
    Nemolizumab (0.5 mg/kg) q4w: subcutaneous injections every 4 weeks for 12 weeks

    Reporting group title
    Nemolizumab (2.0 mg/kg) q4w (Part A)
    Reporting group description
    Nemolizumab (2.0 mg/kg) q4w: subcutaneous injections every 4 weeks for 12 weeks

    Reporting group title
    Nemolizumab (2.0 mg/kg) q8w (Part A)
    Reporting group description
    Nemolizumab (2.0 mg/kg) q8w: subcutaneous injections Dose on Day 1 and at Week 8, placebo at Week 4.

    Reporting group title
    Nemolizumab (0.1 mg/kg) q4w (Part A + B)
    Reporting group description
    CIM331 (0.1 mg/kg) was given subcutaneously every 4 weeks for 64 weeks

    Reporting group title
    Nemolizumab (0.5 mg/kg) q4w (Part A + B)
    Reporting group description
    CIM331 (0.5 mg/kg) given subcutaneously every 4 weeks for 64 weeks.

    Reporting group title
    Nemolizumab (2.0 mg/kg) q4w (Part A + B)
    Reporting group description
    CIM331 (2.0 mg/kg) given subcutaneously every 4 weeks for 64 weeks.

    Reporting group title
    Nemolizumab (2.0 mg/kg) q8w (Part A + B)
    Reporting group description
    Nemolizumab (2.0 mg/kg) q8w: subcutaneous injections every 4 weeks for 12 weeks. Patients in this dosing group received placebo at Week 12, Nemolizumab at Week 16, and then alternating doses of placebo and Nemolizumab."

    Serious adverse events
    Placebo (Part A) Nemolizumab (0.1 mg/kg) q4w (Part A) Nemolizumab (0.5 mg/kg) q4w (Part A) Nemolizumab (2.0 mg/kg) q4w (Part A) Nemolizumab (2.0 mg/kg) q8w (Part A) Nemolizumab (0.1 mg/kg) q4w (Part A + B) Nemolizumab (0.5 mg/kg) q4w (Part A + B) Nemolizumab (2.0 mg/kg) q4w (Part A + B) Nemolizumab (2.0 mg/kg) q8w (Part A + B)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 53 (1.89%)
    0 / 54 (0.00%)
    3 / 52 (5.77%)
    5 / 52 (9.62%)
    3 / 53 (5.66%)
    3 / 54 (5.56%)
    4 / 52 (7.69%)
    9 / 52 (17.31%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Upper limb fracture
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    1 / 53 (1.89%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Parkinson's disease
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Grand mal convulsion
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Retinal detachment
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Non-alcoholic steatohepatitis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    1 / 53 (1.89%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    2 / 52 (3.85%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
    1 / 54 (1.85%)
    2 / 52 (3.85%)
    2 / 52 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 2
    0 / 1
    0 / 0
    0 / 1
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    1 / 54 (1.85%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    1 / 54 (1.85%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pyoderma
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 53 (1.89%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    1 / 53 (1.89%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dermatitis exfoliative
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes simplex
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    2 / 52 (3.85%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    2 / 52 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo (Part A) Nemolizumab (0.1 mg/kg) q4w (Part A) Nemolizumab (0.5 mg/kg) q4w (Part A) Nemolizumab (2.0 mg/kg) q4w (Part A) Nemolizumab (2.0 mg/kg) q8w (Part A) Nemolizumab (0.1 mg/kg) q4w (Part A + B) Nemolizumab (0.5 mg/kg) q4w (Part A + B) Nemolizumab (2.0 mg/kg) q4w (Part A + B) Nemolizumab (2.0 mg/kg) q8w (Part A + B)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    36 / 53 (67.92%)
    38 / 53 (71.70%)
    36 / 54 (66.67%)
    40 / 52 (76.92%)
    37 / 52 (71.15%)
    47 / 53 (88.68%)
    46 / 54 (85.19%)
    52 / 52 (100.00%)
    43 / 52 (82.69%)
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    3 / 53 (5.66%)
    2 / 53 (3.77%)
    2 / 54 (3.70%)
    4 / 52 (7.69%)
    3 / 52 (5.77%)
    5 / 53 (9.43%)
    3 / 54 (5.56%)
    9 / 52 (17.31%)
    6 / 52 (11.54%)
         occurrences all number
    3
    2
    2
    4
    3
    6
    7
    14
    6
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    2 / 53 (3.77%)
    3 / 54 (5.56%)
    1 / 52 (1.92%)
    1 / 52 (1.92%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    3
    2
    1
    Asthma
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    3 / 53 (5.66%)
    0 / 54 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    3
    0
    1
    0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    3 / 53 (5.66%)
    2 / 53 (3.77%)
    1 / 54 (1.85%)
    1 / 52 (1.92%)
    1 / 52 (1.92%)
    3 / 53 (5.66%)
    1 / 54 (1.85%)
    1 / 52 (1.92%)
    2 / 52 (3.85%)
         occurrences all number
    3
    2
    1
    1
    1
    3
    1
    1
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 53 (0.00%)
    3 / 53 (5.66%)
    2 / 54 (3.70%)
    3 / 52 (5.77%)
    1 / 52 (1.92%)
    3 / 53 (5.66%)
    6 / 54 (11.11%)
    5 / 52 (9.62%)
    2 / 52 (3.85%)
         occurrences all number
    0
    5
    3
    3
    4
    6
    10
    5
    3
    Dizziness
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    3 / 53 (5.66%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    2 / 52 (3.85%)
         occurrences all number
    0
    0
    0
    0
    0
    3
    0
    0
    2
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 53 (3.77%)
    3 / 54 (5.56%)
    5 / 52 (9.62%)
    2 / 52 (3.85%)
    2 / 53 (3.77%)
    3 / 54 (5.56%)
    6 / 52 (11.54%)
    2 / 52 (3.85%)
         occurrences all number
    0
    3
    3
    6
    3
    3
    3
    8
    3
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    7 / 53 (13.21%)
    11 / 53 (20.75%)
    10 / 54 (18.52%)
    9 / 52 (17.31%)
    9 / 52 (17.31%)
    15 / 53 (28.30%)
    12 / 54 (22.22%)
    12 / 52 (23.08%)
    9 / 52 (17.31%)
         occurrences all number
    8
    12
    11
    11
    10
    20
    15
    14
    11
    Urticaria
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    1 / 53 (1.89%)
    3 / 54 (5.56%)
    1 / 52 (1.92%)
    1 / 52 (1.92%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    5
    3
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    1 / 53 (1.89%)
    2 / 54 (3.70%)
    3 / 52 (5.77%)
    2 / 52 (3.85%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    2
    5
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    8 / 53 (15.09%)
    9 / 53 (16.98%)
    6 / 54 (11.11%)
    5 / 52 (9.62%)
    7 / 52 (13.46%)
    15 / 53 (28.30%)
    14 / 54 (25.93%)
    15 / 52 (28.85%)
    12 / 52 (23.08%)
         occurrences all number
    8
    12
    8
    7
    11
    33
    31
    25
    21
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 53 (11.32%)
    4 / 53 (7.55%)
    1 / 54 (1.85%)
    4 / 52 (7.69%)
    5 / 52 (9.62%)
    6 / 53 (11.32%)
    3 / 54 (5.56%)
    5 / 52 (9.62%)
    5 / 52 (9.62%)
         occurrences all number
    7
    5
    1
    4
    5
    8
    8
    9
    6
    Folliculitis
         subjects affected / exposed
    3 / 53 (5.66%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    1 / 53 (1.89%)
    0 / 54 (0.00%)
    1 / 52 (1.92%)
    3 / 52 (5.77%)
         occurrences all number
    3
    0
    0
    0
    1
    1
    0
    1
    3
    Impetigo
         subjects affected / exposed
    0 / 53 (0.00%)
    4 / 53 (7.55%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    6 / 53 (11.32%)
    3 / 54 (5.56%)
    0 / 52 (0.00%)
    3 / 52 (5.77%)
         occurrences all number
    0
    4
    0
    0
    0
    7
    3
    0
    3
    Influenza
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    5 / 53 (9.43%)
    1 / 54 (1.85%)
    2 / 52 (3.85%)
    0 / 52 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    5
    1
    2
    0
    Pharyngitis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    1 / 53 (1.89%)
    3 / 54 (5.56%)
    3 / 52 (5.77%)
    1 / 52 (1.92%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    3
    3
    1
    Bronchitis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    3 / 53 (5.66%)
    2 / 54 (3.70%)
    2 / 52 (3.85%)
    0 / 52 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    3
    2
    2
    0
    Cystitis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    1 / 53 (1.89%)
    3 / 54 (5.56%)
    1 / 52 (1.92%)
    1 / 52 (1.92%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    3
    1
    1
    Sinusitis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    1 / 53 (1.89%)
    3 / 54 (5.56%)
    1 / 52 (1.92%)
    1 / 52 (1.92%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    3
    1
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    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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