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    Clinical Trial Results:
    A 12-week randomized, participant-and investigator-blinded, placebo-controlled, parallel group study to explore the efficacy, pharmacodynamics, safety, and pharmacokinetics of two doses of inhaled CSJ117 in adults with Chronic Obstructive Pulmonary Disease (COPD)

    Summary
    EudraCT number
    		 2021-000692-36
    Trial protocol
    		 FR   HU   DE   BE   CZ  
    Global end of trial date
    15 Sep 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Sep 2023
    First version publication date
    30 Sep 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CCSJ117B12201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04882124
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    Novartis Campus, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 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
    15 Sep 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Sep 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the trial was to assess the effect of CSJ117 on disease/symptom burden after 12 Weeks of treatment.
    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
    24 Sep 2021
    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
    Australia: 1
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    Czechia: 8
    Country: Number of subjects enrolled
    Hungary: 9
    Country: Number of subjects enrolled
    Japan: 3
    Country: Number of subjects enrolled
    United States: 15
    Worldwide total number of subjects
    37
    EEA total number of subjects
    17
    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)
    10
    From 65 to 84 years
    26
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted across 15 centers in 6 countries.

    Pre-assignment
    Screening details
    		 Eligible participants underwent screening assessments for up to 2 Weeks prior to entering the 2-Week run-in period. During the run-in period, participants had baseline assessments prior to being randomized into the treatment period. Eligible participants were stratified by eosinophil levels and randomized 1:1:1 to the arms.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CSJ117 8mg
    Arm description
    		 Intervention: Drug: CSJ117
    Arm type
    		 Experimental

    Investigational medicinal product name
    CSJ117
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder, hard capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    CSJ117 8 mg oral inhaled once daily over 12 weeks. Delivered via Concept1 device.

    Arm title
    		 CSJ117 4mg
    Arm description
    		 Intervention: Drug: CSJ117
    Arm type
    		 Experimental

    Investigational medicinal product name
    CSJ117
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder, hard capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    CSJ117 4 mg oral inhaled once daily over 12 weeks. Delivered via Concept1 device.

    Arm title
    		 CSJ117 Placebo
    Arm description
    		 Intervention: Drug: Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    CSJ117
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder, hard capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo oral inhaled once daily over 12 weeks. Delivered via Concept1 device.

    Number of subjects in period 1
    		CSJ117 8mg CSJ117 4mg CSJ117 Placebo
    Started
    11
    16
    10
    Completed
    3
    3
    4
    Not completed
    8
    13
    6
         Consent withdrawn by subject
    -
    2
    -
         Study terminated by sponsor
    8
    11
    5
         Protocol deviation
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CSJ117 8mg
    Reporting group description
    		 Intervention: Drug: CSJ117

    Reporting group title
    CSJ117 4mg
    Reporting group description
    		 Intervention: Drug: CSJ117

    Reporting group title
    CSJ117 Placebo
    Reporting group description
    		 Intervention: Drug: Placebo

    Reporting group values
    		 CSJ117 8mg CSJ117 4mg CSJ117 Placebo Total
    Number of subjects
    		 11 16 10 37
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 3 5 2 10
        From 65-84 years
    		 8 11 7 26
        85 years and over
    		 0 0 1 1
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 67.0 ( 7.35 ) 67.9 ( 7.55 ) 68.4 ( 8.45 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 6 11 2 19
        Male
    		 5 5 8 18
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 1 1 1 3
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 1 1 2 4
        White
    		 9 14 7 30
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    CSJ117 8mg
    Reporting group description
    		 Intervention: Drug: CSJ117

    Reporting group title
    CSJ117 4mg
    Reporting group description
    		 Intervention: Drug: CSJ117

    Reporting group title
    CSJ117 Placebo
    Reporting group description
    		 Intervention: Drug: Placebo

    Primary: Change from baseline to week 12 in E-RS score

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    End point title
    		 Change from baseline to week 12 in E-RS score [1]
    End point description
    The Evaluating Respiratory Symptoms (E-RS) scale is based on the 11 respiratory symptom items included in the Exacerbations of Chronic Pulmonary Disease (EXACT) Tool (a validated 14-item electronic questionnaire). These 11 items generate a total score of 0-40, with higher scores indicating more severe respiratory symptoms.
    End point type
    Primary
    End point timeframe
    Baseline, week 12
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was performed.
    End point values
    		 CSJ117 8mg CSJ117 4mg CSJ117 Placebo
    Number of subjects analysed
    3
    3
    4
    Units: score on a scale
        arithmetic mean (standard deviation)
    -2.7 ( 1.72 )
    -1.1 ( 8.91 )
    -0.1 ( 3.46 )
    No statistical analyses for this end point

    Secondary: Change from baseline to week 12 in CAT score

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    End point title
    		 Change from baseline to week 12 in CAT score
    End point description
    The COPD assessment test (CAT) is a short instrument used to quantify the symptom burden of COPD and will be used to assess the health status of participants. The assessment consists of 8 items, each presented as a semantic 6-point differential scale, providing a total score of 0-40. A higher score indicates a worse health status.
    End point type
    Secondary
    End point timeframe
    Baseline, 12 weeks
    End point values
    		 CSJ117 8mg CSJ117 4mg CSJ117 Placebo
    Number of subjects analysed
    3
    3
    4
    Units: score on a scale
        arithmetic mean (standard deviation)
    -1.3 ( 9.07 )
    -8.0 ( 14.80 )
    -2.8 ( 5.38 )
    No statistical analyses for this end point

    Secondary: Change from baseline to week 12 in SGRQ-C score

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    End point title
    		 Change from baseline to week 12 in SGRQ-C score
    End point description
    The St. George Respiratory Questionnaire for COPD patients Specific Version (SGRQ-C) contains 40 items divided into two parts covering three aspects of health related to COPD: symptoms, activity and impacts. Total score ranges between 0 and 100, with higher scores indicating greater impairment of health status.
    End point type
    Secondary
    End point timeframe
    Baseline, 12 weeks
    End point values
    		 CSJ117 8mg CSJ117 4mg CSJ117 Placebo
    Number of subjects analysed
    3
    2
    4
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -2.7 ( 3.57 )
    -31.1 ( 49.37 )
    -6.1 ( 18.85 )
    No statistical analyses for this end point

    Secondary: Number of participants with response in E-RS total score decrease from baseline to week 12

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    End point title
    		 Number of participants with response in E-RS total score decrease from baseline to week 12
    End point description
    The Evaluating Respiratory Symptoms (E-RS) scale is based on the 11 respiratory symptom items included in the Exacerbations of Chronic Pulmonary Disease (EXACT) Tool (a validated 14-item electronic questionnaire). These 11 items generate a total score of 0-40, with higher scores indicating more severe respiratory symptoms. Response in E-RS total score is defined as a decrease of at least 1.5 points from baseline to week 12.
    End point type
    Secondary
    End point timeframe
    Baseline, week 12
    End point values
    		 CSJ117 8mg CSJ117 4mg CSJ117 Placebo
    Number of subjects analysed
    3
    3
    4
    Units: participants
    2
    1
    1
    No statistical analyses for this end point

    Secondary: Response in CAT in total score decrease from baseline to week 12

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    End point title
    		 Response in CAT in total score decrease from baseline to week 12
    End point description
    The COPD assessment test (CAT) is a short instrument used to quantify the symptom burden of COPD and will be used to assess the health status of participants. The assessment consists of 8 items, each presented as a semantic 6-point differential scale, providing a total score of 0-40. A higher score indicates a worse health status. Response in CAT total score is defined as a decrease of at least 1.5 points from baseline to week 12.
    End point type
    Secondary
    End point timeframe
    Baseline, week 12
    End point values
    		 CSJ117 8mg CSJ117 4mg CSJ117 Placebo
    Number of subjects analysed
    3
    3
    4
    Units: Participants
    1
    1
    3
    No statistical analyses for this end point

    Secondary: Response in SGRQ-C in total score decrease from baseline to week 12

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    End point title
    		 Response in SGRQ-C in total score decrease from baseline to week 12
    End point description
    The St. George Respiratory Questionnaire for COPD patients Specific Version (SGRQ-C) contains 40 items divided into two parts covering three aspects of health related to COPD: symptoms, activity and impacts. Total score ranges between 0 and 100, with higher scores indicating greater impairment of health status. Response in SGRQ-C total score is defined as a decrease of at least 1.5 points from baseline to week 12.
    End point type
    Secondary
    End point timeframe
    Baseline, week 12
    End point values
    		 CSJ117 8mg CSJ117 4mg CSJ117 Placebo
    Number of subjects analysed
    3
    2
    4
    Units: Participants
    1
    1
    3
    No statistical analyses for this end point

    Secondary: Change from baseline in trough FEV1 after 2, 6, and 12 weeks of treatment

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    End point title
    		 Change from baseline in trough FEV1 after 2, 6, and 12 weeks of treatment
    End point description
    Forced expiratory volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The Number of Subjects Analyzed differs as stated on the first column for each row.
    End point type
    Secondary
    End point timeframe
    Baseline, 2, 6 and 12 weeks
    End point values
    		 CSJ117 8mg CSJ117 4mg CSJ117 Placebo
    Number of subjects analysed
    11
    13
    10
    Units: Liter
    arithmetic mean (standard deviation)
        Week 2 – 15 minutes Pre Dose (n=11,13,10)
    0.0232 ( 0.07951 )
    -0.0459 ( 0.16803 )
    0.0443 ( 0.22652 )
        Week 6 – 15 minutes Pre Dose (n=9,8,6)
    0.0231 ( 0.11984 )
    -0.0724 ( 0.14150 )
    -0.0582 ( 0.06159 )
        Week 12 – 15 minutes Pre Dose (n=3,3,4)
    0.0583 ( 0.09464 )
    -0.0617 ( 0.20057 )
    -0.0170 ( 0.05063 )
    No statistical analyses for this end point

    Secondary: Puffs of rescue medication per day

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    End point title
    		 Puffs of rescue medication per day
    End point description
    Puffs of rescue med per day as captured by electronic diary
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 CSJ117 8mg CSJ117 4mg CSJ117 Placebo
    Number of subjects analysed
    3
    4
    4
    Units: number of puffs per day
        arithmetic mean (standard deviation)
    3.3370 ( 2.50242 )
    3.7727 ( 3.90345 )
    2.0987 ( 2.37543 )
    No statistical analyses for this end point

    Secondary: Time to COPD exacerbations via EXACT

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    End point title
    		 Time to COPD exacerbations via EXACT
    End point description
    Time to COPD exacerbations based on the Exacerbations of Chronic Pulmonary Disease (EXACT) tool. Symptom-defined COPD exacerbations identified by the EXACT instrument (EXACT-defined exacerbations) are defined as a persistent increase from baseline in total EXACT score of ≥ 9 points for 3 consecutive days or ≥ 12 points for 2 consecutive days. The analysis could not be performed due to the limited number of participants and observations and was removed from the Statistical Analysis Plan (SAP).
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 CSJ117 8mg CSJ117 4mg CSJ117 Placebo
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    Units: days
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Notes
    [2] - The analysis could not be performed due to the limited number of participants.
    [3] - The analysis could not be performed due to the limited number of participants.
    [4] - The analysis could not be performed due to the limited number of participants.
    No statistical analyses for this end point

    Secondary: Rate and severity of COPD exacerbations via EXACT

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    End point title
    		 Rate and severity of COPD exacerbations via EXACT
    End point description
    Rate and severity of COPD exacerbations based on the Exacerbations of chronic obstructive pulmonary disease tool (EXACT). Symptom-defined COPD exacerbations identified by the EXACT instrument (EXACT-defined exacerbations) are defined as a persistent increase from baseline in total EXACT score of ≥ 9 points for 3 consecutive days or ≥ 12 points for 2 consecutive days. The analysis could not be performed due to the limited number of participants and observations and was removed from the Statistical Analysis Plan (SAP).
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 CSJ117 8mg CSJ117 4mg CSJ117 Placebo
    Number of subjects analysed
    0 [5]
    0 [6]
    0 [7]
    Units: Number of exacerbations
    Notes
    [5] - The analysis could not be performed due to the limited number of participants.
    [6] - The analysis could not be performed due to the limited number of participants.
    [7] - The analysis could not be performed due to the limited number of participants.
    No statistical analyses for this end point

    Secondary: Time to COPD exacerbations via healthcare resource utilization (HCRU) defined exacerbations

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    End point title
    		 Time to COPD exacerbations via healthcare resource utilization (HCRU) defined exacerbations
    End point description
    Time to COPD exacerbations for healthcare resource utilization (HCRU) defined exacerbations. A healthcare resource utilization (HCRU)-defined exacerbation is defined as an acute worsening of respiratory symptoms (consisting of at least 2 of the following symptoms: dyspnea, cough, sputum volume, sputum purulence, chest tightness or wheeze) that requires a change in treatment. The analysis could not be performed due to the limited number of participants and observations.
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 CSJ117 8mg CSJ117 4mg CSJ117 Placebo
    Number of subjects analysed
    0 [8]
    0 [9]
    0 [10]
    Units: days
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Notes
    [8] - The analysis could not be performed due to the limited number of participants.
    [9] - The analysis could not be performed due to the limited number of participants.
    [10] - The analysis could not be performed due to the limited number of participants.
    No statistical analyses for this end point

    Secondary: Rate and severity of COPD exacerbations for healthcare resource utilization (HCRU) defined exacerbations

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    End point title
    		 Rate and severity of COPD exacerbations for healthcare resource utilization (HCRU) defined exacerbations
    End point description
    Rate and severity of COPD exacerbations based on the Health Care Resource Utilization (HCRU). A healthcare resource utilization (HCRU)-defined exacerbation is defined as an acute worsening of respiratory symptoms (consisting of at least 2 of the following symptoms: dyspnea, cough, sputum volume, sputum purulence, chest tightness or wheeze) that requires a change in treatment.
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 CSJ117 8mg CSJ117 4mg CSJ117 Placebo
    Number of subjects analysed
    11
    16
    10
    Units: Number of exacerbations
        Moderate exacerbations
    2
    7
    2
        Severe exacerbations
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Pre-dose trough concentration (Ctrough) of CSJ117

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    End point title
    		 Pre-dose trough concentration (Ctrough) of CSJ117 [11]
    End point description
    To assess pharmacokinetic (PK) parameters of CSJ117 based on total serum concentrations. The Number of Subjects Analyzed differs as stated on the first column for each row.
    End point type
    Secondary
    End point timeframe
    pre-dose on Day 1, Week 2, 6 and 12
    Notes
    [11] - 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: PK was not analyzed for participants receiving Placebo.
    End point values
    		 CSJ117 8mg CSJ117 4mg
    Number of subjects analysed
    11
    16
    Units: ng/mL
    arithmetic mean (standard deviation)
        Day 1 (n=11, 16)
    0 ( 0 )
    0 ( 0 )
        Week 2 (n=11, 15)
    10.5 ( 4.80 )
    6.03 ( 6.96 )
        Week 6 (n=9, 8)
    21.8 ( 15.2 )
    9.42 ( 6.54 )
        Week 12 (n=3, 3)
    51.4 ( 45.1 )
    38.9 ( 41.1 )
    No statistical analyses for this end point

    Secondary: Accumulation ratio (Racc) of CSJ117

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    End point title
    		 Accumulation ratio (Racc) of CSJ117
    End point description
    To assess PK parameters of CSJ117 based on total serum concentrations. The analysis could not be performed due to the limited number of participants and observations.
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 CSJ117 8mg CSJ117 4mg CSJ117 Placebo
    Number of subjects analysed
    0 [12]
    0 [13]
    0 [14]
    Units: ratio
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Notes
    [12] - The analysis could not be performed due to the limited number of participants.
    [13] - The analysis could not be performed due to the limited number of participants.
    [14] - The analysis could not be performed due to the limited number of participants.
    No statistical analyses for this end point

    Secondary: Number of participants with anti-drug antibodies

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    End point title
    		 Number of participants with anti-drug antibodies
    End point description
    Number of participants with anti-drug antibodies at any visit
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 CSJ117 8mg CSJ117 4mg CSJ117 Placebo
    Number of subjects analysed
    11
    16
    10
    Units: participants
    10
    11
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from first dose of study treatment until end of study treatment plus 55 days post treatment, up to a maximum duration of 20 weeks.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    CSJ117 8mg
    Reporting group description
    		 CSJ117 8mg

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    CSJ117 4mg
    Reporting group description
    		 CSJ117 4mg

    Serious adverse events
    		 CSJ117 8mg Placebo CSJ117 4mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    2 / 16 (12.50%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Arthritis bacterial
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 CSJ117 8mg Placebo CSJ117 4mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 11 (36.36%)
    5 / 10 (50.00%)
    9 / 16 (56.25%)
    Investigations
    Urinary occult blood positive
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    C-reactive protein increased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    Road traffic accident
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    Wound
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    Nervous system disorders
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    2
    Headache
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Migraine
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    Paraesthesia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Duodenal ulcer
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Throat irritation
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Cough
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    2 / 11 (18.18%)
    1 / 10 (10.00%)
    4 / 16 (25.00%)
         occurrences all number
    2
    0
    7
    Musculoskeletal and connective tissue disorders
    Neck pain
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Gastroenteritis viral
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    COVID-19
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Skin infection
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Herpes zoster
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    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
    29 Jun 2021
    The protocol was amended to allow for a shortened run-in period, and clarify ambiguity in the protocol by eliminating linguistic errors and inconsistencies. Recruitment for the study has not been initiated as of the time of this protocol amendment finalization.

    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
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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