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    Clinical Trial Results:
    A randomized, subject- and investigator-blinded, placebocontrolled, multi-center, multiple dose study to assess the efficacy and safety of CJM112 in patients with inadequately controlled moderate to severe asthma

    Summary
    EudraCT number
    		 2017-000205-21
    Trial protocol
    		 DE   DK   BE   SK  
    Global end of trial date
    08 Jul 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Jul 2020
    First version publication date
    19 Jul 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CCJM112X2204
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03299686
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharmaceuticals
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharmaceuticals, 41 613241111, novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharmaceuticals, 41 613241111, Novartis.email@novartis.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
    08 Jul 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jul 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine whether treatment with CJM112 in subjects with inadequately controlled moderate to severe asthma leads to an improvement in airflow obstruction.
    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
    06 Nov 2017
    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
    Argentina: 4
    Country: Number of subjects enrolled
    Belgium: 7
    Country: Number of subjects enrolled
    Denmark: 14
    Country: Number of subjects enrolled
    France: 7
    Country: Number of subjects enrolled
    Germany: 38
    Country: Number of subjects enrolled
    Israel: 10
    Country: Number of subjects enrolled
    Slovakia: 7
    Country: Number of subjects enrolled
    United States: 31
    Worldwide total number of subjects
    118
    EEA total number of subjects
    73
    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)
    82
    From 65 to 84 years
    36
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were from Argentina (2), Belgium (3), Germany (5), Denmark (4), France (2), Israel (3), Slovakia (2), The United States (7)

    Pre-assignment
    Screening details
    		 After an initial screening visit, run-in period and baseline assessments, the eligible subjects entered the treatment period and were randomized in a 3:2 ratio to one of the two treatment groups.

    Period 1
    Period 1 title
    Treatment Epoch
    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
    		 CJM112 300 mg
    Arm description
    		 Study treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    CJM112
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg CJM112 subcutaneous injection

    Arm title
    		 Placebo
    Arm description
    		 Placebo to CJM112
    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
    300 mg placebo subcutaneous injection

    Number of subjects in period 1
    		CJM112 300 mg Placebo
    Started
    70
    48
    Completed
    59
    44
    Not completed
    11
    4
         Physician decision
    1
    -
         Consent withdrawn by subject
    2
    -
         Adverse event, non-fatal
    8
    4
    Period 2
    Period 2 title
    Follow-up Epoch
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CJM112 300 mg
    Arm description
    		 Study treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    CJM112
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg CJM112 subcutaneous injection

    Arm title
    		 Placebo
    Arm description
    		 Placebo to CJM112
    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
    300 mg placebo subcutaneous injection

    Number of subjects in period 2
    		CJM112 300 mg Placebo
    Started
    59
    44
    Completed
    59
    43
    Not completed
    0
    1
         Consent withdrawn by subject
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CJM112 300 mg
    Reporting group description
    		 Study treatment

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo to CJM112

    Reporting group values
    		 CJM112 300 mg Placebo Total
    Number of subjects
    		 70 48 118
    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)
    		 47 35 82
        From 65-84 years
    		 23 13 36
        85 years and over
    		 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 57.1 ± 12.79 55.9 ± 11.62 -
    Sex: Female, Male
    Units: Participants
        Female
    		 39 32 71
        Male
    		 31 16 47
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    		 2 0 2
        Black or African American
    		 6 1 7
        Other
    		 1 0 1
        White
    		 61 47 108

    End points

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    End points reporting groups
    Reporting group title
    CJM112 300 mg
    Reporting group description
    		 Study treatment

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo to CJM112
    Reporting group title
    CJM112 300 mg
    Reporting group description
    		 Study treatment

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo to CJM112

    Primary: Change from baseline Forced Expiratory Volume in one second (FEV1)with protocol-defined informative prior

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    End point title
    		 Change from baseline Forced Expiratory Volume in one second (FEV1)with protocol-defined informative prior
    End point description
    The primary efficacy analysis assessed the effect of CJM112 on the absolute change from baseline in trough FEV1 in mL compared to placebo on Day 92. Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline measurement was defined as the baseline visit pre-bronchodilator spirometry assessment.
    End point type
    Primary
    End point timeframe
    Baseline, Day 92
    End point values
    		 CJM112 300 mg Placebo
    Number of subjects analysed
    53
    36
    Units: Liters
        arithmetic mean (standard deviation)
    0.043 ± 0.031
    0.016 ± 0.030
    Statistical analysis title
    		 Mean difference
    Statistical analysis description
    Probability CJM112 better than placebo is 0.7374. Lower limit and upper limit represents the Credibility Interval from the Bayesian analysis.
    Comparison groups
    Placebo v CJM112 300 mg
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Bayesian linear repeated measures model
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.027
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -0.029
         upper limit
    		 0.082
    Variability estimate
    Standard deviation
    Dispersion value
    0.043

    Secondary: Change from baseline Forced Expiratory Volume 1 (FEV1) % of predicted

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    End point title
    		 Change from baseline Forced Expiratory Volume 1 (FEV1) % of predicted
    End point description
    The secondary efficacy analyses assessed the effect of CJM112 on the absolute change from baseline in trough FEV1 in % of predicted compared to placebo on Day 92. Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. FEV1% of predicted is defined as FEV1% of the patient divided by the average FEV1% in the population for any person of similar age, sex and body composition. Pre-bronchodilator FEV1% of predicted was directly provided as part of the spirometry assessment.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 92
    End point values
    		 CJM112 300 mg Placebo
    Number of subjects analysed
    53
    36
    Units: Percent
        least squares mean (standard error)
    1.064 ± 0.914
    0.151 ± 1.105
    Statistical analysis title
    		 Mean difference
    Comparison groups
    CJM112 300 mg v Placebo
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.263 [1]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.913
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -0.939
         upper limit
    		 2.766
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.434
    Notes
    [1] - 1-sided p-value; p-value smaller than 0.1 is considered as statistically significant

    Secondary: Change from baseline in Asthma Control Questionnaire 6 (ACQ6) score

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    End point title
    		 Change from baseline in Asthma Control Questionnaire 6 (ACQ6) score
    End point description
    The ACQ-6 is a validated asthma assessment tool that consists of 6 self-assessment questions. Each item on the ACQ-6 has a possible score ranging from 0 to 6 and the total score is the mean of all responses. The seven-point response scale: 0 = 'totally controlled' and 6 = 'severely uncontrolled.' Negative change from baseline values indicate improved asthma control.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 92
    End point values
    		 CJM112 300 mg Placebo
    Number of subjects analysed
    56
    41
    Units: units on scale
        least squares mean (standard error)
    -0.93 ± 0.09
    -0.71 ± 0.11
    Statistical analysis title
    		 Mean difference
    Comparison groups
    CJM112 300 mg v Placebo
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.061 [2]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.22
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -0.41
         upper limit
    		 -0.04
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Notes
    [2] - 1-sided p-value; p-value smaller than 0.1 is considered as statistically significant

    Secondary: Change from baseline in Asthma Control Questionnaire 7 (ACQ7) score

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    End point title
    		 Change from baseline in Asthma Control Questionnaire 7 (ACQ7) score
    End point description
    The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue medication use and 1 on airway calibre (FEV1 % predicted). All seven items are scored on a 7-point Likert scale, with 0 indicating total control and 6 indicating poor control. The questions are equally weighted and the total score is the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the participant while the last question was completed by the study investigator using data from the Master Scope spirometer. A negative change from baseline indicates improvement in lung function.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 92
    End point values
    		 CJM112 300 mg Placebo
    Number of subjects analysed
    53
    36
    Units: units on scale
        least squares mean (standard error)
    -0.83 ± 0.08
    -0.60 ± 0.10
    Statistical analysis title
    		 Mean difference
    Comparison groups
    CJM112 300 mg v Placebo
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.04 [3]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.23
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 -0.06
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.13
    Notes
    [3] - 1-sided p-value; p-value smaller than 0.1 is considered as statistically significant

    Secondary: Percentage of patients with at least 0.5 decrease in ACQ7 score

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    End point title
    		 Percentage of patients with at least 0.5 decrease in ACQ7 score
    End point description
    The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue medication use and 1 on airway calibre (FEV1 % predicted). All seven items are scored on a 7-point Likert scale, with 0 indicating total control and 6 indicating poor control. The questions are equally weighted and the total score is the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the participant while the last question was completed by the study investigator using data from the Master Scope spirometer. A negative change from baseline indicates improvement in lung function. An ACQ7 responder is defined as a patient with a decrease in score of greater or equal to 0.5 when compared to baseline. No statistical analysis was planned for this primary outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 92
    End point values
    		 CJM112 300 mg Placebo
    Number of subjects analysed
    53
    36
    Units: Percentage
        number (not applicable)
    71.7
    52.8
    No statistical analyses for this end point

    Secondary: Percentage of patients with Adverse Events (AEs) leading to discontinuation of study treatment

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    End point title
    		 Percentage of patients with Adverse Events (AEs) leading to discontinuation of study treatment
    End point description
    Number of patients with at least one adverse event leading to discontinuation of study treatment. No statistical analysis was planned for this primary outcome.
    End point type
    Secondary
    End point timeframe
    85 days
    End point values
    		 CJM112 300 mg Placebo
    Number of subjects analysed
    70
    48
    Units: Percentage
        number (not applicable)
    11.4
    8.3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events
    Adverse event reporting additional description
    Any sign or symptom that occurs during the study treatment plus the 91 days post treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    CJM112 300 mg
    Reporting group description
    		 CJM112 300 mg

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Serious adverse events
    		 CJM112 300 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 70 (4.29%)
    2 / 48 (4.17%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Stress cardiomyopathy
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthmatic crisis
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 CJM112 300 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    55 / 70 (78.57%)
    38 / 48 (79.17%)
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    2
    Fatigue
         subjects affected / exposed
    4 / 70 (5.71%)
    3 / 48 (6.25%)
         occurrences all number
    4
    6
    Injection site haematoma
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 48 (2.08%)
         occurrences all number
    1
    2
    Oedema peripheral
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 48 (2.08%)
         occurrences all number
    1
    1
    Pyrexia
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 48 (2.08%)
         occurrences all number
    1
    1
    Reproductive system and breast disorders
    Prostatitis
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    16 / 70 (22.86%)
    13 / 48 (27.08%)
         occurrences all number
    20
    15
    Cough
         subjects affected / exposed
    4 / 70 (5.71%)
    4 / 48 (8.33%)
         occurrences all number
    5
    4
    Dysphonia
         subjects affected / exposed
    2 / 70 (2.86%)
    0 / 48 (0.00%)
         occurrences all number
    2
    0
    Dyspnoea
         subjects affected / exposed
    2 / 70 (2.86%)
    0 / 48 (0.00%)
         occurrences all number
    2
    0
    Epistaxis
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Haemoptysis
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Nasal congestion
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    3 / 70 (4.29%)
    3 / 48 (6.25%)
         occurrences all number
    5
    3
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 70 (0.00%)
    2 / 48 (4.17%)
         occurrences all number
    0
    2
    Amylase increased
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Blood bicarbonate decreased
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Blood cholesterol increased
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 48 (2.08%)
         occurrences all number
    1
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 48 (2.08%)
         occurrences all number
    1
    1
    Blood creatinine increased
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 48 (2.08%)
         occurrences all number
    1
    2
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 48 (2.08%)
         occurrences all number
    1
    1
    Blood potassium increased
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Blood triglycerides increased
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Lipase increased
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Protein urine present
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    2
    Red blood cell sedimentation rate increased
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Arthropod sting
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Fall
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Ligament sprain
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Rib fracture
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Spinal compression fracture
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Subcutaneous haematoma
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Cardiac disorders
    Arrhythmia supraventricular
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    4 / 70 (5.71%)
    0 / 48 (0.00%)
         occurrences all number
    5
    0
    Headache
         subjects affected / exposed
    8 / 70 (11.43%)
    6 / 48 (12.50%)
         occurrences all number
    11
    7
    Intercostal neuralgia
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Migraine
         subjects affected / exposed
    2 / 70 (2.86%)
    0 / 48 (0.00%)
         occurrences all number
    2
    0
    Sciatica
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Constipation
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    3 / 70 (4.29%)
    3 / 48 (6.25%)
         occurrences all number
    3
    3
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 70 (2.86%)
    1 / 48 (2.08%)
         occurrences all number
    2
    1
    Nausea
         subjects affected / exposed
    3 / 70 (4.29%)
    2 / 48 (4.17%)
         occurrences all number
    10
    2
    Proctalgia
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Toothache
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 48 (2.08%)
         occurrences all number
    1
    1
    Vomiting
         subjects affected / exposed
    0 / 70 (0.00%)
    2 / 48 (4.17%)
         occurrences all number
    0
    3
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 70 (1.43%)
    3 / 48 (6.25%)
         occurrences all number
    2
    3
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 70 (4.29%)
    1 / 48 (2.08%)
         occurrences all number
    3
    1
    Back pain
         subjects affected / exposed
    3 / 70 (4.29%)
    5 / 48 (10.42%)
         occurrences all number
    3
    5
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Limb discomfort
         subjects affected / exposed
    2 / 70 (2.86%)
    0 / 48 (0.00%)
         occurrences all number
    4
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Osteoarthritis
         subjects affected / exposed
    0 / 70 (0.00%)
    2 / 48 (4.17%)
         occurrences all number
    0
    2
    Pain in extremity
         subjects affected / exposed
    2 / 70 (2.86%)
    0 / 48 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    5 / 70 (7.14%)
    3 / 48 (6.25%)
         occurrences all number
    5
    4
    Conjunctivitis
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Cystitis
         subjects affected / exposed
    2 / 70 (2.86%)
    1 / 48 (2.08%)
         occurrences all number
    7
    1
    Gastroenteritis
         subjects affected / exposed
    2 / 70 (2.86%)
    1 / 48 (2.08%)
         occurrences all number
    2
    1
    Gastroenteritis viral
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 70 (2.86%)
    0 / 48 (0.00%)
         occurrences all number
    2
    0
    Nasopharyngitis
         subjects affected / exposed
    16 / 70 (22.86%)
    6 / 48 (12.50%)
         occurrences all number
    23
    6
    Oral candidiasis
         subjects affected / exposed
    4 / 70 (5.71%)
    0 / 48 (0.00%)
         occurrences all number
    5
    0
    Oral herpes
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Pharyngitis
         subjects affected / exposed
    1 / 70 (1.43%)
    2 / 48 (4.17%)
         occurrences all number
    1
    2
    Respiratory tract infection
         subjects affected / exposed
    2 / 70 (2.86%)
    1 / 48 (2.08%)
         occurrences all number
    2
    1
    Respiratory tract infection viral
         subjects affected / exposed
    2 / 70 (2.86%)
    1 / 48 (2.08%)
         occurrences all number
    2
    1
    Rhinitis
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    2
    Sinusitis
         subjects affected / exposed
    3 / 70 (4.29%)
    0 / 48 (0.00%)
         occurrences all number
    3
    0
    Tooth abscess
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 70 (5.71%)
    2 / 48 (4.17%)
         occurrences all number
    4
    3
    Urinary tract infection
         subjects affected / exposed
    1 / 70 (1.43%)
    2 / 48 (4.17%)
         occurrences all number
    1
    2
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 70 (2.86%)
    1 / 48 (2.08%)
         occurrences all number
    3
    1
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Aug 2017
    - Immunogenicity assessment was added on study Day 15 to implement the recommendation from the Health Authority - Monitoring for hypersensitivity and anaphylaxis to the standard safety procedures was included to monitor all subjects post-injection for hypersensitivity and anaphylaxis events - Correct drug concentration was updated - Anaphylaxis was added as an example of clinically significant events that could lead to discontinuation of dosing - Assessment of oxygen saturation by pulse oximetry was included.
    15 May 2018
    - Protocol synopsis section was updated to reflect additional exclusioncriteria related to smoking/inhaling marijuana, e-cigarettes, and other recreational foreign substances other than nicotine or tobacco products - Clinical data sections were updated with information on Hidradenitis Suppurativa studies with CJM112 - Exploratory objectives were updated to include 1-FEV3/FVC and 1-FEV6/FVC - Baseline window changed to D-5 to D-2 and study design was updated accordingly - Inclusion criteria for IgE and eosinophils were changed to clarify that values should be < 150 IU/ mL (for IgE levels) and < 300/μL (for eosinophils levels) both at screening and baseline visits - Exclusion criteria related to smoking/inhaling marijuana, e-cigarettes, and other recreational foreign substances other than nicotine or tobacco products was added - Dietary and smoking restrictions were updated to a requirement, instead of a suggestion - Section 6.4 was updated to reflect the fact that there were no unblinded staff at the sites - Visit 201 was included in the study schedule

    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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