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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Subjects with Prurigo Nodularis

    Summary
    EudraCT number
    		 2019-004789-17
    Trial protocol
    		 FR   BE   NL   PL  
    Global end of trial date
    30 Mar 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Jul 2024
    First version publication date
    10 Jul 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RD.06.SPR.203065
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND number: 117122
    Sponsors
    Sponsor organisation name
    Galderma S.A.
    Sponsor organisation address
    Zahlerweg 10, , ZUG, Switzerland, 6300
    Public contact
    Clinical Trial Information Desk, Galderma S.A., CTA.coordinator@galderma.com
    Scientific contact
    Clinical Trial Information Desk, Galderma S.A., CTA.coordinator@galderma.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
    30 Mar 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Mar 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to assess the efficacy and safety of nemolizumab (CD14152) compared to placebo in subjects ≥ 18 years of age with PN after a 16 week treatment period.
    Protection of trial subjects
    Subject protection was ensured by following high medical and ethical standards in accordance with the principles laid down in the Declaration of Helsinki, and that are consistent with Good Clinical Practice and applicable regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Jul 2020
    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
    Netherlands: 16
    Country: Number of subjects enrolled
    Poland: 88
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    Belgium: 22
    Country: Number of subjects enrolled
    France: 43
    Country: Number of subjects enrolled
    Korea, Republic of: 22
    Country: Number of subjects enrolled
    Switzerland: 11
    Country: Number of subjects enrolled
    United States: 32
    Country: Number of subjects enrolled
    Canada: 37
    Worldwide total number of subjects
    274
    EEA total number of subjects
    172
    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)
    214
    From 65 to 84 years
    60
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 55 sites in 9 countries.

    Pre-assignment
    Screening details
    		 A total of 274 subjects were randomized and treated (183 subjects in Nemolizumab and 91 subjects in Placebo group) received treatment in this study.

    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
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nemolizumab
    Arm description
    		 Subjects weighing less than (<) 90 kilogram (kg) received two subcutaneous (SC) injections of 30 milligrams (mg) nemolizumab (60 mg loading dose) at baseline then one SC injection once for every 4 weeks (Q4W). Subjects weighing greater than or equal to (>=) 90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Subjects received either 30 mg or 60 mg dose of nemolizumab as SC injection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nemolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects weighing less than (<) 90 kilogram (kg) received two subcutaneous (SC) injections of 30 milligrams (mg) nemolizumab (60 mg loading dose) at baseline then one SC injection once for every 4 weeks (Q4W). Subjects weighing greater than or equal to (>=) 90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Subjects weighing <90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Subjects weighing >=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Subjects received matching placebo as SC injection.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects weighing < 90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Subjects weighing >= 90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks.

    Number of subjects in period 1
    		Nemolizumab Placebo
    Started
    183
    91
    Treated
    183
    91
    Completed
    174
    88
    Not completed
    9
    3
         Consent withdrawn by subject
    2
    -
         Physician decision
    1
    -
         Adverse event, non-fatal
    4
    2
         Pregnancy
    -
    1
         Lost to follow-up
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nemolizumab
    Reporting group description
    		 Subjects weighing less than (<) 90 kilogram (kg) received two subcutaneous (SC) injections of 30 milligrams (mg) nemolizumab (60 mg loading dose) at baseline then one SC injection once for every 4 weeks (Q4W). Subjects weighing greater than or equal to (>=) 90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Subjects received either 30 mg or 60 mg dose of nemolizumab as SC injection.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects weighing <90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Subjects weighing >=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Subjects received matching placebo as SC injection.

    Reporting group values
    		 Nemolizumab Placebo Total
    Number of subjects
    		 183 91 274
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 53.7 ( 14.41 ) 50.8 ( 15.00 ) -
    Gender categorical
    Units: Subjects
        Female
    		 113 55 168
        Male
    		 70 36 106
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 5 7 12
        Not Hispanic or Latino
    		 173 79 252
        Unknown or Not Reported
    		 5 5 10
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 23 14 37
        Native Hawaiian or Other Pacific Islander
    		 2 0 2
        Black or African American
    		 5 7 12
        White
    		 147 68 215
        Unknown or Not Reported
    		 1 0 1
        Others
    		 5 2 7
    Region of Enrollment
    Units: Subjects
        Europe
    		 122 61 183
        North America
    		 47 22 69
        Asia Pacific
    		 14 8 22

    End points

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    End points reporting groups
    Reporting group title
    Nemolizumab
    Reporting group description
    		 Subjects weighing less than (<) 90 kilogram (kg) received two subcutaneous (SC) injections of 30 milligrams (mg) nemolizumab (60 mg loading dose) at baseline then one SC injection once for every 4 weeks (Q4W). Subjects weighing greater than or equal to (>=) 90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Subjects received either 30 mg or 60 mg dose of nemolizumab as SC injection.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects weighing <90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Subjects weighing >=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Subjects received matching placebo as SC injection.

    Primary: Number of Subjects With Improvement of Greater Than or Equal to (>=) 4 From Baseline in Weekly Average PP NRS at Week 16

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    End point title
    		 Number of Subjects With Improvement of Greater Than or Equal to (>=) 4 From Baseline in Weekly Average PP NRS at Week 16
    End point description
    Peak Pruritus NRS (PP NRS) is a scale that was used by the subjects to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. ITT population included all randomized subjects.
    End point type
    Primary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Nemolizumab Placebo
    Number of subjects analysed
    183
    91
    Units: subjects
    103
    19
    Statistical analysis title
    		 Nemolizumab versus Placebo
    Comparison groups
    Nemolizumab v Placebo
    Number of subjects included in analysis
    274
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.0001 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata adjusted percentage difference
    Point estimate
    35.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 24.4
         upper limit
    		 46.4
    Notes
    [1] - A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.
    [2] - CMH test using the randomized stratification variables (analysis center and body weight at randomization [< 90 kg,>= 90 kg]).

    Primary: Number of Subjects With an Investigator Global Assessment (IGA) Success at Week 16

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    End point title
    		 Number of Subjects With an Investigator Global Assessment (IGA) Success at Week 16
    End point description
    IGA success is defined as clear (0) or almost clear (1), and a reduction from baseline of >=2 points at week 16. Full scale is scored from 0-4, higher score indicates more severe symptoms. ITT population included all randomized subjects.
    End point type
    Primary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Nemolizumab Placebo
    Number of subjects analysed
    183
    91
    Units: subjects
    69
    10
    Statistical analysis title
    		 Nemolizumab versus Placebo
    Comparison groups
    Nemolizumab v Placebo
    Number of subjects included in analysis
    274
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 < 0.0001 [4]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata adjusted percentage difference
    Point estimate
    26.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 17.2
         upper limit
    		 36.2
    Notes
    [3] - A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.
    [4] - CMH test using the randomized stratification variables (analysis center and body weight at randomization [< 90 kg,>= 90 kg]).

    Secondary: Number of Subjects With Adverse Events, Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs)

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    End point title
    		 Number of Subjects With Adverse Events, Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs)
    End point description
    An AE was any untoward medical occurrence, new or worsening of any pre-existing condition, in a clinical study subject administered a medicinal product and which did not necessarily had to have a causal relationship with the treatment. TEAEs: AES with an onset date on or after the start date of the IMP administration. AESIs: skin-related events (SRE) (except exacerbation and infective exacerbation of PN) or injection site reactions (ISRs) as per common terminology criteria for AEs (Grade 3: ulceration or necrosis; severe tissue damage; operative intervention indicated, Grade 4: life-threatening consequences; urgent intervention indicated, Grade 5: death ). An SAE: AE that resulted in any of the following outcomes: death; life threatening; results in persistent disability; requires in-patient hospitalization congenital anomaly; is medically significant. Safety population included all randomized subjects who received at least 1 administration of study drug.
    End point type
    Secondary
    End point timeframe
    From baseline up to end of treatment period (16 weeks)
    End point values
    		 Nemolizumab Placebo
    Number of subjects analysed
    183
    91
    Units: subjects
        Adverse Events
    112
    49
        Treatment Emergent Adverse Events (TEAEs)
    112
    49
        Adverse Events of Special Interest (AESIs)
    21
    9
        Serious Adverse Events (SAEs)
    4
    6
    No statistical analyses for this end point

    Secondary: Number of Subjects With an Improvement of >= 4 From Baseline in Weekly Average PP NRS at Week 4

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    End point title
    		 Number of Subjects With an Improvement of >= 4 From Baseline in Weekly Average PP NRS at Week 4
    End point description
    PP NRS is a scale that was used by the subjects to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. ITT population included all randomized subjects.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4
    End point values
    		 Nemolizumab Placebo
    Number of subjects analysed
    183
    91
    Units: subjects
    75
    7
    Statistical analysis title
    		 Nemolizumab versus Placebo
    Comparison groups
    Nemolizumab v Placebo
    Number of subjects included in analysis
    274
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 < 0.0001 [6]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata adjusted percentage difference
    Point estimate
    33.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 24.3
         upper limit
    		 42.4
    Notes
    [5] - A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.
    [6] - CMH test using the randomized stratification variables (analysis center and body weight at randomization [<90 kg,>=90 kg]).

    Secondary: Number of Subjects With PP NRS < 2 at Week 16

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    End point title
    		 Number of Subjects With PP NRS < 2 at Week 16
    End point description
    Pruritus NRS is a scale that was used by the subjects to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. ITT population included all randomized subjects.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Nemolizumab Placebo
    Number of subjects analysed
    183
    91
    Units: subjects
    64
    7
    Statistical analysis title
    		 Nemolizumab versus Placebo
    Comparison groups
    Nemolizumab v Placebo
    Number of subjects included in analysis
    274
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    P-value
    		 < 0.0001 [8]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata adjusted percentage difference
    Point estimate
    30
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 21.3
         upper limit
    		 38.6
    Notes
    [7] - A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.
    [8] - CMH test using the randomized stratification variables (analysis center and body weight at randomization [<90 kg,>=90 kg].

    Secondary: Number of Subjects With an Improvement of >=4 From Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Week 16

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    End point title
    		 Number of Subjects With an Improvement of >=4 From Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Week 16
    End point description
    The SD NRS is a scale to be used by the subjects to report the degree of their sleep loss related to PN. The baseline SD NRS was determined based on the average of daily SD NRS (score ranging from 0 to 10) during the 7 days up to the treatment start (including until treatment start time) (rounding to nearest whole number is not permitted). A minimum of 4 daily scores out of the 7 days up to baseline study day is required for this calculation. On a scale of 0 to 10, with 0 being ‘no sleep loss related to the symptoms of my skin disease (prurigo nodularis)’ and 10 being ‘I did not sleep at all due to the symptoms of prurigo nodularis’. Higher scores indicate worse outcome. ITT population included all randomized subjects.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Nemolizumab Placebo
    Number of subjects analysed
    183
    91
    Units: subjects
    95
    19
    Statistical analysis title
    		 Nemolizumab versus Placebo
    Comparison groups
    Nemolizumab v Placebo
    Number of subjects included in analysis
    274
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [9]
    P-value
    		 < 0.0001 [10]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata adjusted percentage difference
    Point estimate
    31.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 20.7
         upper limit
    		 43.2
    Notes
    [9] - A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.
    [10] - CMH test using the randomized stratification variables (analysis center and body weight at randomization [<90 kg,>=90 kg].

    Secondary: Number of Subjects With an Improvement of >=4 From Baseline in SD NRS at Week 4

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    End point title
    		 Number of Subjects With an Improvement of >=4 From Baseline in SD NRS at Week 4
    End point description
    The SD NRS is a scale to be used by the subjects to report the degree of their sleep loss related to PN. The baseline SD NRS was determined based on the average of daily SD NRS (score ranging from 0 to 10) during the 7 days up to the treatment start (including until treatment start time) (rounding to nearest whole number is not permitted). A minimum of 4 daily scores out of the 7 days up to baseline study day is required for this calculation. On a scale of 0 to 10, with 0 being ‘no sleep loss related to the symptoms of my skin disease (prurigo nodularis)’ and 10 being ‘I did not sleep at all due to the symptoms of prurigo nodularis’. Higher scores indicate worse outcome. ITT population included all randomized subjects.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4
    End point values
    		 Nemolizumab Placebo
    Number of subjects analysed
    183
    91
    Units: subjects
    68
    9
    Statistical analysis title
    		 Nemolizumab versus Placebo
    Comparison groups
    Nemolizumab v Placebo
    Number of subjects included in analysis
    274
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [11]
    P-value
    		 < 0.0001 [12]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata adjusted percentage difference
    Point estimate
    27.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 18.4
         upper limit
    		 37.5
    Notes
    [11] - A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.
    [12] - CMH test using the randomized stratification variables (analysis center and body weight at randomization [<90 kg,>=90 kg].

    Secondary: Number of Subjects With Weekly Average PP NRS < 2 at Week 4

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    End point title
    		 Number of Subjects With Weekly Average PP NRS < 2 at Week 4
    End point description
    Pruritus NRS is a scale that was used by the subjects to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. ITT population included all randomized subjects.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Nemolizumab Placebo
    Number of subjects analysed
    183
    91
    Units: subjects
    36
    2
    Statistical analysis title
    		 Nemolizumab versus Placebo
    Comparison groups
    Nemolizumab v Placebo
    Number of subjects included in analysis
    274
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [13]
    P-value
    		 < 0.0001 [14]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Strata adjusted percentage difference
    Point estimate
    18.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12
         upper limit
    		 25.7
    Notes
    [13] - A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.
    [14] - CMH test using the randomized stratification variables (analysis center and body weight at randomization [<90 kg,>=90 kg].

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline up to end of treatment period (16 weeks)
    Adverse event reporting additional description
    Safety population included all randomized subjects who received at least 1 administration of study drug. TEAEs during treatment period are defined as adverse events with onset date on or after the first dose date till 4 weeks after the last treatment or early discontinuation date whichever is earlier.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Nemolizumab
    Reporting group description
    		 Subjects weighing less than (<) 90 kilogram (kg) received two subcutaneous (SC) injections of 30 milligrams (mg) nemolizumab (60 mg loading dose) at baseline then one SC injection once for every 4 weeks (Q4W). Subjects weighing greater than or equal to (>=) 90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Subjects received either 30 mg or 60 mg dose of nemolizumab as SC injection.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects weighing < 90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Subjects weighing >= 90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Subjects received matching placebo as SC injection.

    Serious adverse events
    		 Nemolizumab Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 183 (2.19%)
    5 / 91 (5.49%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Atrial flutter
    alternative dictionary used: MedDRA 25.0
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 91 (1.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 91 (1.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 91 (1.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 91 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 91 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis exfoliative generalised
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 91 (1.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pemphigoid
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 91 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 91 (1.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 91 (1.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumococcal sepsis
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 91 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 91 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 91 (1.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Nemolizumab Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 183 (15.85%)
    13 / 91 (14.29%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    12 / 183 (6.56%)
    4 / 91 (4.40%)
         occurrences all number
    17
    4
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    10 / 183 (5.46%)
    0 / 91 (0.00%)
         occurrences all number
    15
    0
    Neurodermatitis
         subjects affected / exposed
    7 / 183 (3.83%)
    10 / 91 (10.99%)
         occurrences all number
    7
    10

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Dec 2020
    This amendment was required as there was update in number of sites, inclusion criteria including clarification of contraception methods, females of non-childbearing potential must have a confirmed follicle-stimulating hormone level in the postmenopausal range, exclusion criteria including addition of positive confirmatory test for HCV, clarifying excluded prior treatments, current and history of untreated or inadequately treated active or latent TB, investigational drug exclusion period was 8 weeks, rescued with oral psoralen required discontinuation of study drug and rationale for placebo-controlled design.
    19 Nov 2021
    This amendment included addition of secondary efficacy endpoint of the proportion of subjects with PP NRS improvement ≥4, along with an update in restricted prior treatments, prohibited therapy, and ADA assay information to be harmonized with other protocols in the nemolizumab program and specified that ADA was to be determined using validated ECLIA (not ESLIA).

    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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    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
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