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    Clinical Trial Results:
    A randomized, double-blind, placebo controlled, multiple dose study to evaluate the clinical efficacy, safety, tolerability, dose relation, pharmacokinetics and pharmacodynamics of CJM112 in moderate to severe chronic hidradenitis suppurativa patients.

    Summary
    EudraCT number
    		 2014-004731-39
    Trial protocol
    		 DE   DK   NL  
    Global end of trial date
    23 Nov 2016

    Results information
    Results version number
    		 v2(current)
    This version publication date
    03 Jul 2022
    First version publication date
    07 Dec 2017
    Other versions
    		 v1
    Version creation reason
    • New data added to full data set
    Actual doses added

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CCJM112X2202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02421172
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    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
    23 Nov 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Nov 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the efficacy of CJM112 High Dose in chronic hidradenitis suppurativa (HS) patients, by clinical responder rate at Week 16.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Apr 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 3
    Country: Number of subjects enrolled
    United States: 29
    Country: Number of subjects enrolled
    Germany: 9
    Country: Number of subjects enrolled
    Switzerland: 10
    Country: Number of subjects enrolled
    Netherlands: 15
    Worldwide total number of subjects
    66
    EEA total number of subjects
    27
    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)
    65
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study with 4 wks screening,two sequential treatment periods 16 wks (Period 1 & Extension Period 2)& 12 wks Follow-up. Randomization 2:1:1 to three sequences:Seq. 1: Period 1: CJM112 High Dose sc then Period 2: placebo sc; Seq. 2: Period 1: Placebo sc then Period 2: CJM112 Low Dose sc; Seq, 3: Period 1: Placebo sc then Period 2: CJM112 High Dose sc.

    Pre-assignment
    Screening details
    		 A total of 66 patients were enrolled, randomized and entered into two sequential periods (Period 1 and Extension Period 2) of which 60 patients completed Week 16 in Period 1 and entered Extension Period 2.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Period 1: CJM112 High Dose (300mg)
    Arm description
    		 Period 1: CJM112 High Dose (300mg) subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses
    Arm type
    		 Experimental

    Investigational medicinal product name
    CJM112
    Investigational medicinal product code
    CJM112
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses

    Arm title
    		 Period 1: Placebo
    Arm description
    		 Period 1: Placebo subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    CJM112
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses

    Number of subjects in period 1
    		Period 1: CJM112 High Dose (300mg) Period 1: Placebo
    Started
    33
    33
    PD Analysis Set Period 1
    31
    33
    Completed
    29
    31
    Not completed
    4
    2
         Adverse event, non-fatal
    1
    -
         Patient/guardian decision
    -
    1
         Lost to follow-up
    3
    1
    Period 2
    Period 2 title
    Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Extension Period 2: CJM112 High Dose (300mg) /Placebo
    Arm description
    		 Extension Period 2: Placebo subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on CJM112 High Dose (300mg) in Period 1
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    CJM112
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses

    Arm title
    		 Extension Period 2: Placebo/CJM112 Low Dose (50mg)
    Arm description
    		 Extension Period 2: CJM112 Low Dose (50mg) subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on Placebo in Period 1
    Arm type
    		 Experimental

    Investigational medicinal product name
    CJM112
    Investigational medicinal product code
    CJM112
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    CJM112 Low Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses

    Arm title
    		 Extension Period 2: Placebo/CJM112 High Dose (300mg)
    Arm description
    		 Extension Period 2: CJM112 High Dose (300mg) subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on Placebo in Period 1
    Arm type
    		 Experimental

    Investigational medicinal product name
    CJM112
    Investigational medicinal product code
    CJM112
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses

    Number of subjects in period 2
    		Extension Period 2: CJM112 High Dose (300mg) /Placebo Extension Period 2: Placebo/CJM112 Low Dose (50mg) Extension Period 2: Placebo/CJM112 High Dose (300mg)
    Started
    29
    16
    15
    Completed
    22
    13
    14
    Not completed
    7
    3
    1
         Adverse event, non-fatal
    4
    -
    -
         Patient/guardian decision
    3
    2
    1
         Lost to follow-up
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Period 1: CJM112 High Dose (300mg)
    Reporting group description
    		 Period 1: CJM112 High Dose (300mg) subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses

    Reporting group title
    Period 1: Placebo
    Reporting group description
    		 Period 1: Placebo subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses

    Reporting group values
    		 Period 1: CJM112 High Dose (300mg) Period 1: Placebo Total
    Number of subjects
    		 33 33 66
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 32 33 65
        From 65-84 years
    		 1 0 1
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 36 ± 9.8 39 ± 10.9 -
    Gender, Male/Female
    Units: Subjects
        Female
    		 22 22 44
        Male
    		 11 11 22

    End points

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    End points reporting groups
    Reporting group title
    Period 1: CJM112 High Dose (300mg)
    Reporting group description
    		 Period 1: CJM112 High Dose (300mg) subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses

    Reporting group title
    Period 1: Placebo
    Reporting group description
    		 Period 1: Placebo subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses
    Reporting group title
    Extension Period 2: CJM112 High Dose (300mg) /Placebo
    Reporting group description
    		 Extension Period 2: Placebo subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on CJM112 High Dose (300mg) in Period 1

    Reporting group title
    Extension Period 2: Placebo/CJM112 Low Dose (50mg)
    Reporting group description
    		 Extension Period 2: CJM112 Low Dose (50mg) subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on Placebo in Period 1

    Reporting group title
    Extension Period 2: Placebo/CJM112 High Dose (300mg)
    Reporting group description
    		 Extension Period 2: CJM112 High Dose (300mg) subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on Placebo in Period 1

    Primary: Clinical responder rate at Period 1: Week 16

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    End point title
    		 Clinical responder rate at Period 1: Week 16
    End point description
    Proportion of study participants achieving a clinical response in Hidradenitis Suppurativa - Physician Global Assessment (HS-PGA) score An HS-PGA responder in period 1 was a participant who had an initial HS-PGA score of at least 3 at baseline (Day 1, inclusion criterion) that decreased by at least 2 points.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    		 Period 1: CJM112 High Dose (300mg) Period 1: Placebo
    Number of subjects analysed
    31
    32
    Units: participants
    10
    4
    Statistical analysis title
    		 Clinical responder rate at Period 1: Week 16
    Comparison groups
    Period 1: Placebo v Period 1: CJM112 High Dose (300mg)
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 posterior difference
    Point estimate
    0.194
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.004
         upper limit
    		 0.391

    Secondary: Clinical responder rate Period 1 at Week 2, 4, 8 and 12

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    End point title
    		 Clinical responder rate Period 1 at Week 2, 4, 8 and 12
    End point description
    Proportion of study participants achieving a clinical response in Hidradenitis Suppurativa - Physician Global Assessment (HS-PGA) score A HS-PGA responder in Period 1 is a study participant who had an initial HS-PGA score of at least 3 at Baseline (Day 1, inclusion criterion) that decreased by at least 2 points.
    End point type
    Secondary
    End point timeframe
    Week 2, 4, 8 and 12
    End point values
    		 Period 1: CJM112 High Dose (300mg) Period 1: Placebo
    Number of subjects analysed
    31
    32
    Units: participants
        Week 2
    4
    3
        Week 4
    6
    3
        Week 8
    5
    6
        Week 12
    7
    4
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK): Ctrough for CJM112 Period 1 and Period 2

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    End point title
    		 Pharmacokinetics (PK): Ctrough for CJM112 Period 1 and Period 2 [1]
    End point description
    Ctrough is the serum concentration that is just prior to the beginning of, or at the end, of a dosing interval (mass/volume) for Period 1 (week 16) and Period 2/End of Study (week 44)
    End point type
    Secondary
    End point timeframe
    Week 16 and Week 44
    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: no statistical analysis performed
    End point values
    		 Period 1: CJM112 High Dose (300mg) Extension Period 2: Placebo/CJM112 Low Dose (50mg) Extension Period 2: Placebo/CJM112 High Dose (300mg)
    Number of subjects analysed
    28
    13
    14
    Units: ug/mL
        arithmetic mean (standard deviation)
    21.4 ± 11.6
    3.1 ± 2.6
    24.4 ± 19.0
    No statistical analyses for this end point

    Secondary: Pharmacokinetic profile: T1/2 The terminal elimination half-life for Period 1 & Period 2/End of Study

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    End point title
    		 Pharmacokinetic profile: T1/2 The terminal elimination half-life for Period 1 & Period 2/End of Study [2]
    End point description
    T1/2 The terminal elimination half-life for Period 1 (Week 16) and Period 2/End of Study (Week 44)
    End point type
    Secondary
    End point timeframe
    Week 16, Week 44
    Notes
    [2] - 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: no statistical analysis performed
    End point values
    		 Period 1: CJM112 High Dose (300mg) Extension Period 2: Placebo/CJM112 Low Dose (50mg) Extension Period 2: Placebo/CJM112 High Dose (300mg)
    Number of subjects analysed
    26
    1
    7
    Units: days
        arithmetic mean (standard deviation)
    16.09 ± 3.500
    22.81 ± 0
    19.85 ± 3.807
    No statistical analyses for this end point

    Secondary: Immunogenicity - Incidence of ADA-positive and ADA-negative in participants with or without pre-existing antibodies in Period 1 and Period 2/End of Study

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    End point title
    		 Immunogenicity - Incidence of ADA-positive and ADA-negative in participants with or without pre-existing antibodies in Period 1 and Period 2/End of Study [3]
    End point description
    Immunogenicity - Incidence of semi-quantitative determination of anti-CJM112 antibodies or ADAs. ADA-positive and ADA-negative in participants with or without pre-existing antibodies Period 1 (week 16) and Period 2/End of Study (week 44)
    End point type
    Secondary
    End point timeframe
    Baseline, End of Study (Week 44)
    Notes
    [3] - 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: no statistical analysis performed
    End point values
    		 Period 1: CJM112 High Dose (300mg) Extension Period 2: Placebo/CJM112 Low Dose (50mg) Extension Period 2: Placebo/CJM112 High Dose (300mg)
    Number of subjects analysed
    33
    16
    15
    Units: participants
        Pre-existing Antibodies ADA negative
    2
    1
    7
        Pre-existing Antibodies ADA positive
    1
    1
    0
        NO Pre-existing Antibodies ADA negative
    21
    10
    9
        NO Pre-existing Antibodies ADA positive
    9
    4
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Period 1 CJM112 300 mg
    Reporting group description
    		 Period 1 CJM112 300 mg

    Reporting group title
    Period 1 Placebo
    Reporting group description
    		 Period 1 Placebo

    Reporting group title
    Extension Period 2 CJM112 300 mg/Placebo
    Reporting group description
    		 Extension Period 2 CJM112 300 mg/Placebo

    Reporting group title
    Extension Period 2 Placebo/CJM112 50 mg
    Reporting group description
    		 Extension Period 2 Placebo/CJM112 50 mg

    Reporting group title
    Extension Period 2 Placebo/CJM112 300 mg
    Reporting group description
    		 Extension Period 2 Placebo/CJM112 300 mg

    Serious adverse events
    		 Period 1 CJM112 300 mg Period 1 Placebo Extension Period 2 CJM112 300 mg/Placebo Extension Period 2 Placebo/CJM112 50 mg Extension Period 2 Placebo/CJM112 300 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 33 (3.03%)
    1 / 29 (3.45%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 33 (3.03%)
    0 / 29 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    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
    Infections and infestations
    Groin abscess
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    1 / 29 (3.45%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Period 1 CJM112 300 mg Period 1 Placebo Extension Period 2 CJM112 300 mg/Placebo Extension Period 2 Placebo/CJM112 50 mg Extension Period 2 Placebo/CJM112 300 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 33 (75.76%)
    23 / 33 (69.70%)
    20 / 29 (68.97%)
    13 / 16 (81.25%)
    14 / 15 (93.33%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 33 (9.09%)
    1 / 33 (3.03%)
    1 / 29 (3.45%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    3
    1
    1
    0
    1
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 33 (6.06%)
    1 / 33 (3.03%)
    1 / 29 (3.45%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    2
    1
    2
    0
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 29 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    0
    1
    Pain
         subjects affected / exposed
    1 / 33 (3.03%)
    2 / 33 (6.06%)
    1 / 29 (3.45%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    Pyrexia
         subjects affected / exposed
    3 / 33 (9.09%)
    1 / 33 (3.03%)
    3 / 29 (10.34%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    4
    1
    5
    0
    0
    Reproductive system and breast disorders
    Pruritus genital
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 29 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 33 (3.03%)
    2 / 33 (6.06%)
    2 / 29 (6.90%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    2
    2
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    2 / 33 (6.06%)
    3 / 33 (9.09%)
    0 / 29 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    2
    3
    0
    1
    0
    Rhinalgia
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 29 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 33 (3.03%)
    1 / 29 (3.45%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    1
    1
    0
    QRS axis abnormal
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 29 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    White blood cells urine
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 29 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 29 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    0
    1
    Procedural pain
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    1 / 29 (3.45%)
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    1
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    2 / 29 (6.90%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Headache
         subjects affected / exposed
    4 / 33 (12.12%)
    3 / 33 (9.09%)
    2 / 29 (6.90%)
    3 / 16 (18.75%)
    0 / 15 (0.00%)
         occurrences all number
    5
    3
    3
    5
    0
    Paraesthesia
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 29 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 33 (0.00%)
    0 / 29 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    2
    0
    0
    0
    1
    Sudden hearing loss
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 29 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Tinnitus
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 29 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Eye disorders
    Eye pruritus
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 29 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Eyelid cyst
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 29 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 33 (6.06%)
    0 / 33 (0.00%)
    2 / 29 (6.90%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 33 (0.00%)
    0 / 29 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    2 / 33 (6.06%)
    5 / 33 (15.15%)
    1 / 29 (3.45%)
    0 / 16 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    2
    5
    1
    0
    2
    Nausea
         subjects affected / exposed
    5 / 33 (15.15%)
    3 / 33 (9.09%)
    2 / 29 (6.90%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    6
    3
    3
    1
    0
    Toothache
         subjects affected / exposed
    1 / 33 (3.03%)
    3 / 33 (9.09%)
    0 / 29 (0.00%)
    2 / 16 (12.50%)
    0 / 15 (0.00%)
         occurrences all number
    1
    3
    0
    2
    0
    Vomiting
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 33 (3.03%)
    0 / 29 (0.00%)
    2 / 16 (12.50%)
    0 / 15 (0.00%)
         occurrences all number
    1
    2
    0
    2
    0
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 33 (0.00%)
    0 / 29 (0.00%)
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    0
    2
    1
    Dyshidrotic eczema
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 29 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    0
    1
    Hidradenitis
         subjects affected / exposed
    0 / 33 (0.00%)
    3 / 33 (9.09%)
    0 / 29 (0.00%)
    0 / 16 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    3
    0
    0
    2
    Intertrigo
         subjects affected / exposed
    2 / 33 (6.06%)
    1 / 33 (3.03%)
    0 / 29 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1
    0
    0
    1
    Pain of skin
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 33 (3.03%)
    0 / 29 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Pruritus
         subjects affected / exposed
    3 / 33 (9.09%)
    2 / 33 (6.06%)
    2 / 29 (6.90%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    3
    2
    2
    0
    0
    Rash
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 29 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    0
    1
    Skin exfoliation
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 29 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Urticaria
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 33 (3.03%)
    0 / 29 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 33 (0.00%)
    2 / 33 (6.06%)
    3 / 29 (10.34%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    4
    0
    1
    Back pain
         subjects affected / exposed
    5 / 33 (15.15%)
    0 / 33 (0.00%)
    1 / 29 (3.45%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    5
    0
    1
    0
    0
    Myalgia
         subjects affected / exposed
    0 / 33 (0.00%)
    2 / 33 (6.06%)
    1 / 29 (3.45%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    Tenosynovitis
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 29 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Infections and infestations
    Abscess
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 29 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Bronchitis
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    2 / 29 (6.90%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    2
    1
    0
    Conjunctivitis
         subjects affected / exposed
    2 / 33 (6.06%)
    0 / 33 (0.00%)
    1 / 29 (3.45%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    3
    0
    1
    0
    1
    Cystitis
         subjects affected / exposed
    3 / 33 (9.09%)
    0 / 33 (0.00%)
    1 / 29 (3.45%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    3
    0
    2
    0
    0
    Eyelid infection
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 29 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    0
    1
    Gastroenteritis
         subjects affected / exposed
    0 / 33 (0.00%)
    3 / 33 (9.09%)
    0 / 29 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    3
    0
    1
    0
    Influenza
         subjects affected / exposed
    3 / 33 (9.09%)
    1 / 33 (3.03%)
    2 / 29 (6.90%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    3
    1
    3
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    7 / 33 (21.21%)
    4 / 33 (12.12%)
    4 / 29 (13.79%)
    2 / 16 (12.50%)
    3 / 15 (20.00%)
         occurrences all number
    9
    4
    4
    2
    3
    Periorbital cellulitis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 33 (3.03%)
    0 / 29 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Skin infection
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 29 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    0
    1
    Tinea versicolour
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 29 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 33 (9.09%)
    0 / 33 (0.00%)
    1 / 29 (3.45%)
    2 / 16 (12.50%)
    0 / 15 (0.00%)
         occurrences all number
    3
    0
    1
    2
    0
    Urinary tract infection
         subjects affected / exposed
    2 / 33 (6.06%)
    2 / 33 (6.06%)
    1 / 29 (3.45%)
    3 / 16 (18.75%)
    0 / 15 (0.00%)
         occurrences all number
    2
    2
    1
    3
    0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 29 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    0
    1
    Hypomagnesaemia
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 29 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Vitamin D deficiency
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 29 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Sep 2015
    Amendment 1: The purpose of this amendment was to implement the request of Ethics Committee in Germany (Berlin) to allow screening for pre-existing HBV infections. Additional serological assessment was added to monitor for (chronic) HBV infection prior to the first application of the study drug. Screening for antibodies against HB core antigen (anti-HBc) – additional to HB surface antigen testing (HBsAg) was made mandatory and patients with a positive test result in either test were to be excluded from the study. In addition, the number of incisions was limited to one incision per period as this might influence primary endpoint of the study. Further, minor changes were made to inclusion-exclusion criteria to clarify at which point inclusion/exclusion criterion should be confirmed. Other minor modifications were made to improve readability or clarity.
    10 Oct 2016
    Amendment 2: The purpose of this amendment was to move evaluation of serum total IL-17A/F (heterodimer) from secondary to exploratory objectives. The total IL-17A/F assay in serum was validated according to most recent international guidelines and quality standards/SOPs defined by Novartis Pharma AG based on good laboratory practices. The selected immunoassay platform (Erenna from Singulex) was not GxP-validated. Thus, total IL-17A/F data were exploratory in nature. Therefore, the evaluation of total IL-17A/F in serum was moved from secondary to exploratory objectives.

    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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