Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A 24-week, multicenter, randomized, double-blind, parallel-arm, placebo-controlled extension study to assess the safety of CSJ117, when added to existing standard of care asthma therapy in patients ≥18 years of age

    Summary
    EudraCT number
    		 2020-002341-42
    Trial protocol
    		 CZ   HU   PL   SK   IT   LV   DE   BE   BG   FR  
    Global end of trial date
    08 Sep 2022

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CCSJ117A12201E1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04946318
    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
    08 Sep 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Sep 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the systemic pharmacokinetic (PK) properties of icenticaftor after a single oral dose of 300 mg in participants with mild, moderate, or severe hepatic impairment (HI) (Child-Pugh classification) as compared to matched healthy control participants with normal hepatic function.
    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
    08 Sep 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Philippines: 4
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    Bulgaria: 7
    Country: Number of subjects enrolled
    Czechia: 5
    Country: Number of subjects enrolled
    Germany: 12
    Country: Number of subjects enrolled
    Hungary: 6
    Country: Number of subjects enrolled
    Latvia: 5
    Country: Number of subjects enrolled
    Poland: 13
    Country: Number of subjects enrolled
    Russian Federation: 3
    Country: Number of subjects enrolled
    Slovakia: 1
    Country: Number of subjects enrolled
    Japan: 48
    Country: Number of subjects enrolled
    Argentina: 12
    Country: Number of subjects enrolled
    Canada: 3
    Country: Number of subjects enrolled
    United States: 16
    Worldwide total number of subjects
    136
    EEA total number of subjects
    50
    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)
    113
    From 65 to 84 years
    23
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants took part in 59 investigative sites in 14 countries.

    Pre-assignment
    Screening details
    		 The screening period of up to 3 days began after the participants had provided written informed consent.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 24 weeks CSJ117 8mg
    Arm description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and were treated once daily for 24 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 8 mg)
    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
    Once daily dosing of CSJ117 8 mg for 24 weeks.

    Arm title
    		 24 weeks CSJ117 4mg
    Arm description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and were treated once daily for 24 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 4 mg)
    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
    Once daily dosing of CSJ117 4 mg for 24 weeks.

    Arm title
    		 24 weeks CSJ117 2mg
    Arm description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and were treated once daily for 24 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 2 mg)
    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
    Once daily dosing of CSJ117 2 mg for 24 weeks.

    Arm title
    		 24 weeks CSJ117 1mg
    Arm description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and were treated once daily for 24 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 1 mg)
    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
    Once daily dosing of CSJ117 1 mg for 24 weeks.

    Arm title
    		 24-weeks CSJ117 0.5mg
    Arm description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and were treated once daily for 24 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 0.5 mg)
    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
    Once daily dosing of CSJ117 0.5 mg for 24 weeks.

    Arm title
    		 24-weeks Placebo
    Arm description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and were treated once daily for 24 weeks with Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder, hard capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    Once daily dosing of Placebo for 24 weeks.

    Arm title
    		 12 weeks wash-out + 12 weeks CSJ117 8mg
    Arm description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and received Placebo inhaled once daily for 12 weeks "washout period" and then they were treated once daily for 12 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 8 mg)
    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
    Placebo inhaled once daily for 12 weeks "washout period". Once daily dosing of CSJ117 8 mg for 12 weeks.

    Arm title
    		 12 weeks wash-out + 12 weeks CSJ117 4mg
    Arm description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and received Placebo inhaled once daily for 12 weeks "washout period" and then they were treated once daily for 12 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 4 mg)
    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
    Placebo inhaled once daily for 12 weeks "washout period". Once daily dosing of CSJ117 4 mg for 12 weeks.

    Arm title
    		 12 weeks wash-out + 12 weeks CSJ117 2mg
    Arm description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and received Placebo inhaled once daily for 12 weeks "washout period" and then they were treated once daily for 12 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 2 mg)
    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
    Placebo inhaled once daily for 12 weeks "washout period". Once daily dosing of CSJ117 2 mg for 12 weeks.

    Arm title
    		 12 weeks wash-out + 12 weeks CSJ117 1mg
    Arm description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and received Placebo inhaled once daily for 12 weeks "washout period" and then they were treated once daily for 12 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 1 mg)
    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
    Placebo inhaled once daily for 12 weeks "washout period". Once daily dosing of CSJ117 1 mg for 12 weeks.

    Arm title
    		 12 weeks wash-out + 12 weeks CSJ117 0.5mg
    Arm description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and received Placebo inhaled once daily for 12 weeks "washout period" and then they were treated once daily for 12 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 0.5 mg)
    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
    Placebo inhaled once daily for 12 weeks "washout period". Once daily dosing of CSJ117 0.5 mg for 12 weeks.

    Arm title
    		 12 weeks wash-out + 12 weeks Placebo
    Arm description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and received Placebo inhaled once daily for 12 weeks "washout period" and then they were treated once daily for 12 weeks with Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder, hard capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo inhaled once daily for 12 weeks "washout period". Once daily dosing of Placebo for 12 weeks.

    Arm title
    		 12 weeks drug-free + 12 weeks CSJ117 8mg
    Arm description
    		 Participants who entered the extension study after the last follow-up visit (Week 24) of the core study, therefore after a 12-week drug-free period, and were treated in the extension once daily for 12 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 8 mg)
    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
    Drug-free period (12 weeks). Once daily dosing of CSJ117 8 mg for 12 weeks.

    Arm title
    		 12 weeks drug-free + 12 weeks CSJ117 4mg
    Arm description
    		 Participants who entered the extension study after the last follow-up visit (Week 24) of the core study, therefore after a 12-week drug-free period, and were treated in the extension once daily for 12 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 4 mg)
    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
    Drug-free period (12 weeks). Once daily dosing of CSJ117 4 mg for 12 weeks.

    Arm title
    		 12 weeks drug-free + 12 weeks CSJ117 2mg
    Arm description
    		 Participants who entered the extension study after the last follow-up visit (Week 24) of the core study, therefore after a 12-week drug-free period, and were treated in the extension once daily for 12 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 2 mg)
    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
    Drug-free period (12 weeks). Once daily dosing of CSJ117 2 mg for 12 weeks.

    Arm title
    		 12 weeks drug-free + 12 weeks CSJ117 1mg
    Arm description
    		 Participants who entered the extension study after the last follow-up visit (Week 24) of the core study, therefore after a 12-week drug-free period, and were treated in the extension once daily for 12 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 1 mg)
    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
    Drug-free period (12 weeks). Once daily dosing of CSJ117 1 mg for 12 weeks.

    Arm title
    		 12 weeks drug-free + 12 weeks CSJ117 0.5mg
    Arm description
    		 Participants who entered the extension study after the last follow-up visit (Week 24) of the core study, therefore after a 12-week drug-free period, and were treated in the extension once daily for 12 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 0.5 mg)
    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
    Drug-free period (12 weeks). Once daily dosing of CSJ117 0.5 mg for 12 weeks.

    Arm title
    		 12 weeks drug-free + 12 weeks Placebo
    Arm description
    		 Participants who entered the extension study after the last follow-up visit (Week 24) of the core study, therefore after a 12-week drug-free period, and were treated in the extension once daily for 12 weeks with Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder, hard capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    Drug-free period (12 weeks). Once daily dosing of Placebo for 12 weeks.

    Number of subjects in period 1
    		24 weeks CSJ117 8mg 24 weeks CSJ117 4mg 24 weeks CSJ117 2mg 24 weeks CSJ117 1mg 24-weeks CSJ117 0.5mg 24-weeks Placebo 12 weeks wash-out + 12 weeks CSJ117 8mg 12 weeks wash-out + 12 weeks CSJ117 4mg 12 weeks wash-out + 12 weeks CSJ117 2mg 12 weeks wash-out + 12 weeks CSJ117 1mg 12 weeks wash-out + 12 weeks CSJ117 0.5mg 12 weeks wash-out + 12 weeks Placebo 12 weeks drug-free + 12 weeks CSJ117 8mg 12 weeks drug-free + 12 weeks CSJ117 4mg 12 weeks drug-free + 12 weeks CSJ117 2mg 12 weeks drug-free + 12 weeks CSJ117 1mg 12 weeks drug-free + 12 weeks CSJ117 0.5mg 12 weeks drug-free + 12 weeks Placebo
    Started
    8
    5
    3
    3
    5
    6
    7
    3
    2
    3
    1
    4
    18
    24
    10
    7
    9
    18
    Completed
    6
    5
    2
    1
    5
    2
    4
    2
    0
    1
    0
    3
    16
    22
    8
    7
    9
    15
    Not completed
    2
    0
    1
    2
    0
    4
    3
    1
    2
    2
    1
    1
    2
    2
    2
    0
    0
    3
         Consent withdrawn by subject
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
    1
         Adverse Event
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
         Study terminated by sponsor
    2
    -
    1
    2
    -
    3
    3
    1
    2
    2
    1
    1
    2
    1
    2
    -
    -
    2

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    24 weeks CSJ117 8mg
    Reporting group description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and were treated once daily for 24 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 8 mg)

    Reporting group title
    24 weeks CSJ117 4mg
    Reporting group description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and were treated once daily for 24 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 4 mg)

    Reporting group title
    24 weeks CSJ117 2mg
    Reporting group description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and were treated once daily for 24 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 2 mg)

    Reporting group title
    24 weeks CSJ117 1mg
    Reporting group description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and were treated once daily for 24 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 1 mg)

    Reporting group title
    24-weeks CSJ117 0.5mg
    Reporting group description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and were treated once daily for 24 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 0.5 mg)

    Reporting group title
    24-weeks Placebo
    Reporting group description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and were treated once daily for 24 weeks with Placebo

    Reporting group title
    12 weeks wash-out + 12 weeks CSJ117 8mg
    Reporting group description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and received Placebo inhaled once daily for 12 weeks "washout period" and then they were treated once daily for 12 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 8 mg)

    Reporting group title
    12 weeks wash-out + 12 weeks CSJ117 4mg
    Reporting group description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and received Placebo inhaled once daily for 12 weeks "washout period" and then they were treated once daily for 12 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 4 mg)

    Reporting group title
    12 weeks wash-out + 12 weeks CSJ117 2mg
    Reporting group description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and received Placebo inhaled once daily for 12 weeks "washout period" and then they were treated once daily for 12 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 2 mg)

    Reporting group title
    12 weeks wash-out + 12 weeks CSJ117 1mg
    Reporting group description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and received Placebo inhaled once daily for 12 weeks "washout period" and then they were treated once daily for 12 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 1 mg)

    Reporting group title
    12 weeks wash-out + 12 weeks CSJ117 0.5mg
    Reporting group description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and received Placebo inhaled once daily for 12 weeks "washout period" and then they were treated once daily for 12 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 0.5 mg)

    Reporting group title
    12 weeks wash-out + 12 weeks Placebo
    Reporting group description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and received Placebo inhaled once daily for 12 weeks "washout period" and then they were treated once daily for 12 weeks with Placebo

    Reporting group title
    12 weeks drug-free + 12 weeks CSJ117 8mg
    Reporting group description
    		 Participants who entered the extension study after the last follow-up visit (Week 24) of the core study, therefore after a 12-week drug-free period, and were treated in the extension once daily for 12 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 8 mg)

    Reporting group title
    12 weeks drug-free + 12 weeks CSJ117 4mg
    Reporting group description
    		 Participants who entered the extension study after the last follow-up visit (Week 24) of the core study, therefore after a 12-week drug-free period, and were treated in the extension once daily for 12 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 4 mg)

    Reporting group title
    12 weeks drug-free + 12 weeks CSJ117 2mg
    Reporting group description
    		 Participants who entered the extension study after the last follow-up visit (Week 24) of the core study, therefore after a 12-week drug-free period, and were treated in the extension once daily for 12 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 2 mg)

    Reporting group title
    12 weeks drug-free + 12 weeks CSJ117 1mg
    Reporting group description
    		 Participants who entered the extension study after the last follow-up visit (Week 24) of the core study, therefore after a 12-week drug-free period, and were treated in the extension once daily for 12 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 1 mg)

    Reporting group title
    12 weeks drug-free + 12 weeks CSJ117 0.5mg
    Reporting group description
    		 Participants who entered the extension study after the last follow-up visit (Week 24) of the core study, therefore after a 12-week drug-free period, and were treated in the extension once daily for 12 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 0.5 mg)

    Reporting group title
    12 weeks drug-free + 12 weeks Placebo
    Reporting group description
    		 Participants who entered the extension study after the last follow-up visit (Week 24) of the core study, therefore after a 12-week drug-free period, and were treated in the extension once daily for 12 weeks with Placebo

    Reporting group values
    		 24 weeks CSJ117 8mg 24 weeks CSJ117 4mg 24 weeks CSJ117 2mg 24 weeks CSJ117 1mg 24-weeks CSJ117 0.5mg 24-weeks Placebo 12 weeks wash-out + 12 weeks CSJ117 8mg 12 weeks wash-out + 12 weeks CSJ117 4mg 12 weeks wash-out + 12 weeks CSJ117 2mg 12 weeks wash-out + 12 weeks CSJ117 1mg 12 weeks wash-out + 12 weeks CSJ117 0.5mg 12 weeks wash-out + 12 weeks Placebo 12 weeks drug-free + 12 weeks CSJ117 8mg 12 weeks drug-free + 12 weeks CSJ117 4mg 12 weeks drug-free + 12 weeks CSJ117 2mg 12 weeks drug-free + 12 weeks CSJ117 1mg 12 weeks drug-free + 12 weeks CSJ117 0.5mg 12 weeks drug-free + 12 weeks Placebo Total
    Number of subjects
    		 8 5 3 3 5 6 7 3 2 3 1 4 18 24 10 7 9 18 136
    Age Categorical
    Units: Participants
        18 - <40 years
    		 0 2 1 0 2 2 1 0 0 0 0 0 2 6 3 1 1 5 26
        40 - <65 years
    		 7 3 1 2 3 4 4 3 2 3 1 4 12 13 6 5 5 9 87
        ≥65 years
    		 1 0 1 1 0 0 2 0 0 0 0 0 4 5 1 1 3 4 23
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 53.4 ( 10.64 ) 44.6 ( 16.43 ) 50.7 ( 24.91 ) 63.0 ( 10.58 ) 44.0 ( 11.60 ) 47.5 ( 12.63 ) 54.4 ( 15.33 ) 50.7 ( 9.29 ) 55.5 ( 4.95 ) 44.7 ( 3.21 ) 56.0 ( 0 ) 50.3 ( 6.65 ) 53.3 ( 12.18 ) 50.4 ( 13.69 ) 49.1 ( 14.76 ) 50.4 ( 14.21 ) 57.0 ( 12.40 ) 51.0 ( 14.79 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 5 3 0 2 3 3 4 0 1 2 1 3 14 15 7 4 7 11 85
        Male
    		 3 2 3 1 2 3 3 3 1 1 0 1 4 9 3 3 2 7 51
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    		 5 4 1 2 3 3 2 2 1 1 1 3 3 8 4 2 3 5 53
        Black or African American
    		 0 0 0 0 0 0 2 0 0 0 0 0 1 1 0 0 0 0 4
        White
    		 3 1 2 1 2 3 3 1 1 2 0 1 14 15 6 5 6 13 79

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    24 weeks CSJ117 8mg
    Reporting group description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and were treated once daily for 24 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 8 mg)

    Reporting group title
    24 weeks CSJ117 4mg
    Reporting group description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and were treated once daily for 24 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 4 mg)

    Reporting group title
    24 weeks CSJ117 2mg
    Reporting group description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and were treated once daily for 24 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 2 mg)

    Reporting group title
    24 weeks CSJ117 1mg
    Reporting group description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and were treated once daily for 24 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 1 mg)

    Reporting group title
    24-weeks CSJ117 0.5mg
    Reporting group description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and were treated once daily for 24 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 0.5 mg)

    Reporting group title
    24-weeks Placebo
    Reporting group description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and were treated once daily for 24 weeks with Placebo

    Reporting group title
    12 weeks wash-out + 12 weeks CSJ117 8mg
    Reporting group description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and received Placebo inhaled once daily for 12 weeks "washout period" and then they were treated once daily for 12 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 8 mg)

    Reporting group title
    12 weeks wash-out + 12 weeks CSJ117 4mg
    Reporting group description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and received Placebo inhaled once daily for 12 weeks "washout period" and then they were treated once daily for 12 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 4 mg)

    Reporting group title
    12 weeks wash-out + 12 weeks CSJ117 2mg
    Reporting group description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and received Placebo inhaled once daily for 12 weeks "washout period" and then they were treated once daily for 12 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 2 mg)

    Reporting group title
    12 weeks wash-out + 12 weeks CSJ117 1mg
    Reporting group description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and received Placebo inhaled once daily for 12 weeks "washout period" and then they were treated once daily for 12 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 1 mg)

    Reporting group title
    12 weeks wash-out + 12 weeks CSJ117 0.5mg
    Reporting group description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and received Placebo inhaled once daily for 12 weeks "washout period" and then they were treated once daily for 12 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 0.5 mg)

    Reporting group title
    12 weeks wash-out + 12 weeks Placebo
    Reporting group description
    		 Participants who entered the extension study after the last treatment visit (Week 12) of the core study and received Placebo inhaled once daily for 12 weeks "washout period" and then they were treated once daily for 12 weeks with Placebo

    Reporting group title
    12 weeks drug-free + 12 weeks CSJ117 8mg
    Reporting group description
    		 Participants who entered the extension study after the last follow-up visit (Week 24) of the core study, therefore after a 12-week drug-free period, and were treated in the extension once daily for 12 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 8 mg)

    Reporting group title
    12 weeks drug-free + 12 weeks CSJ117 4mg
    Reporting group description
    		 Participants who entered the extension study after the last follow-up visit (Week 24) of the core study, therefore after a 12-week drug-free period, and were treated in the extension once daily for 12 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 4 mg)

    Reporting group title
    12 weeks drug-free + 12 weeks CSJ117 2mg
    Reporting group description
    		 Participants who entered the extension study after the last follow-up visit (Week 24) of the core study, therefore after a 12-week drug-free period, and were treated in the extension once daily for 12 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 2 mg)

    Reporting group title
    12 weeks drug-free + 12 weeks CSJ117 1mg
    Reporting group description
    		 Participants who entered the extension study after the last follow-up visit (Week 24) of the core study, therefore after a 12-week drug-free period, and were treated in the extension once daily for 12 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 1 mg)

    Reporting group title
    12 weeks drug-free + 12 weeks CSJ117 0.5mg
    Reporting group description
    		 Participants who entered the extension study after the last follow-up visit (Week 24) of the core study, therefore after a 12-week drug-free period, and were treated in the extension once daily for 12 weeks with the same dose of CSJ117 they had received in the core study (CSJ117 0.5 mg)

    Reporting group title
    12 weeks drug-free + 12 weeks Placebo
    Reporting group description
    		 Participants who entered the extension study after the last follow-up visit (Week 24) of the core study, therefore after a 12-week drug-free period, and were treated in the extension once daily for 12 weeks with Placebo

    Subject analysis set title
    FAS 12 weeks CSJ117 8mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS 12 weeks CSJ117 8mg

    Subject analysis set title
    FAS 12 weeks CSJ117 4mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS 12 weeks CSJ117 4mg

    Subject analysis set title
    FAS 12 weeks CSJ117 2mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS 12 weeks CSJ117 2mg

    Subject analysis set title
    FAS 12weeks CSJ117 1mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS 12 weeks CSJ117 1mg

    Subject analysis set title
    FAS 12 weeks CSJ117 0.5mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS 12 weeks CSJ117 0.5mg

    Subject analysis set title
    FAS Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS Placebo

    Primary: Number of participants with treatment emergent adverse events (AEs) and serious adverse events (SAEs)

    		 Close Top of page
    End point title
    		 Number of participants with treatment emergent adverse events (AEs) and serious adverse events (SAEs) [1]
    End point description
    Number of participants with treatment emergent AEs, AEs led to study treatment discontinuation, SAEs and SAEs led to study treatment discontinuation. The Number of Subjects Analyzed differs as stated on the comment field for each column, in case of difference from Number of subjects that started the Arm. Treatment emergent AEs and SAEs were counted from first day of treatment of the core study (CCSJ117A12201C) and until 30 days after last day of treatment in the extension study. For participants who entered the extension study after the last follow-up visit (week 24) of the core study, AEs (if any) occurred from week 4 to week 12 of the drug free follow-up period were not counted as treatment emergent AEs.
    End point type
    Primary
    End point timeframe
    From start of treatment in the core study until 30 days after end of treatment in the extension study. Up to 48 weeks.
    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 conducted for this endpoint.
    End point values
    		 24 weeks CSJ117 8mg 24 weeks CSJ117 4mg 24 weeks CSJ117 2mg 24 weeks CSJ117 1mg 24-weeks CSJ117 0.5mg 24-weeks Placebo 12 weeks wash-out + 12 weeks CSJ117 8mg 12 weeks wash-out + 12 weeks CSJ117 4mg 12 weeks wash-out + 12 weeks CSJ117 2mg 12 weeks wash-out + 12 weeks CSJ117 1mg 12 weeks wash-out + 12 weeks CSJ117 0.5mg 12 weeks wash-out + 12 weeks Placebo 12 weeks drug-free + 12 weeks CSJ117 8mg 12 weeks drug-free + 12 weeks CSJ117 4mg 12 weeks drug-free + 12 weeks CSJ117 2mg 12 weeks drug-free + 12 weeks CSJ117 1mg 12 weeks drug-free + 12 weeks CSJ117 0.5mg 12 weeks drug-free + 12 weeks Placebo
    Number of subjects analysed
    8
    5
    3 [2]
    3 [3]
    5 [4]
    6 [5]
    7 [6]
    3 [7]
    2 [8]
    3 [9]
    1 [10]
    4 [11]
    18
    24
    10
    7 [12]
    9 [13]
    18
    Units: Participants
        At least one AE (0 to 12 weeks)
    2
    1
    2
    1
    0
    1
    2
    1
    0
    1
    0
    1
    6
    6
    3
    2
    4
    9
        At least one AE (week 12 to week 24 )
    2
    0
    2
    2
    1
    1
    2
    0
    1
    1
    0
    1
    1
    1
    1
    2
    2
    2
        At least one AE (week 24 to week 36)
    2
    0
    1
    0
    1
    1
    2
    0
    0
    0
    0
    2
    6
    10
    4
    4
    2
    4
        At least one AE (week 36 to week 48)
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    2
    2
    0
    0
    3
        At least one SAE (0 to 12 weeks)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        At least one SAE (week 12 to week 24 )
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        At least one SAE (week 24 to week 36)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
        At least one SAE (week 36 to week 48)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        AE leading to discontinuation (week 0 to week 48)
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        SAE leading to discontinuation (week 0 to week 48)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Notes
    [2] - n=2 (week 24 to week 36); n=0 (week 36 to week 48)
    [3] - n=0 (week 24 to week 36); n=0 (week 36 to week 48)
    [4] - n=0 (week 36 to week 48)
    [5] - n=5 (week 24 to week 36); n=0 (week 36 to week 48)
    [6] - n=6 (week 24 to week 36); n=0 (week 36 to week 48)
    [7] - n=0 (week 12 to week 24); n=0 (week 24 to week 36); n=0 (week 36 to week 48)
    [8] - n=0 (week 24 to week 36); n=0 (week 36 to week 48)
    [9] - n=0 (week 24 to week 36); n=0 (week 36 to week 48)
    [10] - n=0 (week 24 to week 36); n=0 (week 36 to week 48)
    [11] - n=3 (week 24 to week 36); n=0 (week 36 to week 48)
    [12] - n=0 (week 36 to week 48)
    [13] - n= 0 (week 36 to week 48)
    No statistical analyses for this end point

    Primary: Number of treatment emergent participant deaths and participant hospitalizations

    		 Close Top of page
    End point title
    		 Number of treatment emergent participant deaths and participant hospitalizations [14]
    End point description
    Number of treatment emergent participant deaths and participant hospitalizations (any visit to the hospital that required an overnight stay or an emergency room visit greater than 24 hours). Treatment emergent participant deaths and participant hospitalizations were counted from first day of treatment of the core study (CCSJ117A12201C) and until 30 days after last day of treatment in the extension study. For participants who entered the extension study after the last follow-up visit (week 24) of the core study, participant deaths and hospitalizations (if any) occurred from week 4 to week 12 of the drug free follow-up period were not counted as treatment emergent participant deaths and hospitalizations.
    End point type
    Primary
    End point timeframe
    From start of treatment in the core study until 30 days after end of treatment in the extension study. Up to 48 weeks.
    Notes
    [14] - 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 conducted for this endpoint.
    End point values
    		 24 weeks CSJ117 8mg 24 weeks CSJ117 4mg 24 weeks CSJ117 2mg 24 weeks CSJ117 1mg 24-weeks CSJ117 0.5mg 24-weeks Placebo 12 weeks wash-out + 12 weeks CSJ117 8mg 12 weeks wash-out + 12 weeks CSJ117 4mg 12 weeks wash-out + 12 weeks CSJ117 2mg 12 weeks wash-out + 12 weeks CSJ117 1mg 12 weeks wash-out + 12 weeks CSJ117 0.5mg 12 weeks wash-out + 12 weeks Placebo 12 weeks drug-free + 12 weeks CSJ117 8mg 12 weeks drug-free + 12 weeks CSJ117 4mg 12 weeks drug-free + 12 weeks CSJ117 2mg 12 weeks drug-free + 12 weeks CSJ117 1mg 12 weeks drug-free + 12 weeks CSJ117 0.5mg 12 weeks drug-free + 12 weeks Placebo
    Number of subjects analysed
    8
    5
    3
    3
    5
    6
    7
    3
    2
    3
    1
    4
    18
    24
    10
    7
    9
    18
    Units: Participants
        Deaths
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Hospitalizations
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Change from baseline in fractional exhaled Nitric Oxide (FeNO) levels (CSJ117 continuous treatment and placebo)

    		 Close Top of page
    End point title
    		 Change from baseline in fractional exhaled Nitric Oxide (FeNO) levels (CSJ117 continuous treatment and placebo) [15]
    End point description
    Fractional exhaled Nitric Oxide (FeNO) pre-dose measurements were done at the investigational sites prior to spirometry assessments. FeNO is defined as the mean of two serial measurements. The measurement of exhaled nitric oxide is widely accepted as a non-invasive marker of airway inflammation (inflammation leads to elevation of FeNO). The baseline FeNO pre-dose measurements were taken at the end of the run-in period of the core study. A negative average change from baseline in FeNO is considered a favourable outcome. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’. The Number of Subjects Analyzed differs as stated on the comment field for each column, in case of difference from Number of subjects that started the Arm.
    End point type
    Secondary
    End point timeframe
    Baseline (from core study), Weeks 2, 4, 8, 12, 14, 16, 20, 24, 26, 28, 32, 36, 38, 40 and 48.
    Notes
    [15] - 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 conducted for this endpoint.
    End point values
    		 24 weeks CSJ117 8mg 24 weeks CSJ117 4mg 24 weeks CSJ117 2mg 24 weeks CSJ117 1mg 24-weeks CSJ117 0.5mg FAS Placebo
    Number of subjects analysed
    7 [16]
    2 [17]
    2 [18]
    2 [19]
    1
    28 [20]
    Units: parts per billion (ppb)
    arithmetic mean (standard deviation)
        Week 2
    -5.1 ( 10.76 )
    -16.0 ( 8.49 )
    -22.5 ( 37.48 )
    -52.0 ( 999 )
    5.0 ( 999 )
    -2.1 ( 6.4 )
        Week 4
    -6.9 ( 12.51 )
    -13.5 ( 17.68 )
    -24.0 ( 32.53 )
    -57.0 ( 999 )
    6.0 ( 999 )
    0.6 ( 8.65 )
        Week 8
    -1.6 ( 18.25 )
    -13.0 ( 2.83 )
    -27.0 ( 42.43 )
    -53.0 ( 999 )
    3.0 ( 999 )
    0.3 ( 7.72 )
        Week 12
    -1.3 ( 14.58 )
    -8.5 ( 19.09 )
    -24.5 ( 43.13 )
    -50.0 ( 999 )
    7.0 ( 999 )
    -1.3 ( 12.23 )
        Week 14
    -2.9 ( 14.72 )
    -13.0 ( 7.07 )
    -47.0 ( 60.81 )
    -64.0 ( 999 )
    8.0 ( 999 )
    -2.7 ( 13.29 )
        Week 16
    -3.6 ( 16.25 )
    -20.0 ( 12.73 )
    -33.5 ( 58.69 )
    999 ( 999 )
    4.0 ( 999 )
    0.6 ( 12.34 )
        Week 20
    -2.3 ( 13.60 )
    -23.5 ( 24.75 )
    -32.0 ( 52.33 )
    -63.0 ( 999 )
    -1.0 ( 999 )
    -0.7 ( 9.99 )
        Week 24
    -4.0 ( 10.58 )
    -27.5 ( 20.51 )
    -89.0 ( 999 )
    -61.0 ( 999 )
    -5.0 ( 999 )
    0.6 ( 14.35 )
        Week 26
    -4.0 ( 7.51 )
    -34.0 ( 15.56 )
    -76.0 ( 999 )
    999 ( 999 )
    16.0 ( 999 )
    -1.9 ( 8.73 )
        Week 28
    1.2 ( 7.55 )
    -28.5 ( 7.78 )
    -69.0 ( 999 )
    999 ( 999 )
    8.0 ( 999 )
    -2.0 ( 13.05 )
        Week 32
    -1.3 ( 9.56 )
    -13.5 ( 0.71 )
    -80.0 ( 999 )
    999 ( 999 )
    -1.0 ( 999 )
    -1.2 ( 10.48 )
        Week 36
    -5.0 ( 5.96 )
    2.5 ( 20.51 )
    -72.0 ( 999 )
    999 ( 999 )
    4.0 ( 999 )
    -2.3 ( 23.85 )
        Week 38
    -1.5 ( 11.56 )
    11.5 ( 26.16 )
    999 ( 999 )
    999 ( 999 )
    0.0 ( 999 )
    -2.6 ( 11.41 )
        Week 40
    -4.3 ( 10.40 )
    -16.0 ( 999 )
    999 ( 999 )
    999 ( 999 )
    1.0 ( 999 )
    -3.5 ( 20.83 )
        Week 48
    -3.0 ( 999 )
    -21.0 ( 999 )
    999 ( 999 )
    999 ( 999 )
    0.0 ( 999 )
    2.5 ( 19.59 )
    Notes
    [16] - n=6 (weeks 24, 26, 28, 32); n=5 (week 36); n=4 (weeks 38, 40); n=1 (week 48)
    [17] - n=1 (weeks 40, 48)
    [18] - n=1 (weeks 24, 26, 28, 32, 36); n=0 (weeks 38, 40, 48)
    [19] - n=1 (weeks 2, 4, 8, 12, 14, 20, 24); n=0 (weeks 16, 26, 28, 32, 36, 38, 40, 48)
    [20] - n=26(weeks2,16,24) n=24(weeks20,26,28) n=22(week32)n=20(week36) n=17(week38)n=16(week40)n=10(week48)
    No statistical analyses for this end point

    Secondary: Change from baseline in fractional exhaled Nitric Oxide (FeNO) levels (CSJ117 interrupted treatment and placebo)

    		 Close Top of page
    End point title
    		 Change from baseline in fractional exhaled Nitric Oxide (FeNO) levels (CSJ117 interrupted treatment and placebo)
    End point description
    Fractional exhaled Nitric Oxide (FeNO) pre-dose measurements were done at the investigational sites prior to spirometry assessments. FeNO is defined as the mean of two serial measurements. The measurement of exhaled nitric oxide is widely accepted as a non-invasive marker of airway inflammation (inflammation leads to elevation of FeNO). The baseline FeNO pre-dose measurements were taken at the end of the run-in period of the core study. A negative average change from baseline in FeNO is considered a favourable outcome. The Number of Subjects Analyzed differs as stated on the comment field for each column, in case of difference from Number of subjects that started the Arm.
    End point type
    Secondary
    End point timeframe
    Baseline (from core study), Weeks 2, 4, 8, 12, 14, 16, 20, 24, 26, 28, 32, 36, 38, 40 and 48.
    End point values
    		 FAS 12 weeks CSJ117 8mg FAS 12 weeks CSJ117 4mg FAS 12 weeks CSJ117 2mg FAS 12weeks CSJ117 1mg FAS 12 weeks CSJ117 0.5mg FAS Placebo
    Number of subjects analysed
    26 [21]
    30 [22]
    13 [23]
    11 [24]
    14 [25]
    28 [26]
    Units: parts per billion (ppb)
    arithmetic mean (standard deviation)
        Week 2
    -2.7 ( 8.99 )
    -4.9 ( 13.85 )
    -10.4 ( 15.59 )
    -4.5 ( 9.83 )
    -4.3 ( 12.59 )
    -2.1 ( 6.4 )
        Week 4
    -1.5 ( 8.36 )
    -2.5 ( 7.59 )
    -12.2 ( 19.69 )
    -1.5 ( 6.92 )
    -0.1 ( 8.45 )
    0.6 ( 8.65 )
        Week 8
    3.3 ( 9.46 )
    -2.5 ( 9.39 )
    -8.5 ( 15.76 )
    -3.4 ( 7.47 )
    2.3 ( 9.16 )
    0.3 ( 7.72 )
        Week 12
    0.5 ( 9.51 )
    1.7 ( 17.12 )
    -3.5 ( 17.25 )
    -2.5 ( 10.02 )
    -5.9 ( 14.86 )
    -1.3 ( 12.23 )
        Week 14
    -0.7 ( 9.08 )
    0.6 ( 14.80 )
    -9.8 ( 16.43 )
    -5.5 ( 8.58 )
    -3.7 ( 21.54 )
    -2.7 ( 13.29 )
        Week 16
    -0.3 ( 9.03 )
    0.4 ( 13.49 )
    -11.6 ( 16.48 )
    -2.4 ( 12.30 )
    -5.1 ( 14.17 )
    0.6 ( 12.34 )
        Week 20
    0.5 ( 12.58 )
    -0.2 ( 19.14 )
    -10.7 ( 16.69 )
    -2.1 ( 8.17 )
    -6.1 ( 14.83 )
    -0.7 ( 9.99 )
        Week 24
    0.5 ( 8.86 )
    -1.4 ( 12.80 )
    -8.9 ( 17.03 )
    -3.5 ( 14.88 )
    0.3 ( 26.83 )
    0.6 ( 14.35 )
        Week 26
    3.7 ( 14.48 )
    2.4 ( 9.81 )
    -10.5 ( 18.28 )
    -6.0 ( 9.53 )
    0.8 ( 13.57 )
    -1.9 ( 8.73 )
        Week 28
    1.1 ( 11.89 )
    0.8 ( 17.41 )
    -14.0 ( 21.80 )
    -7.4 ( 10.38 )
    -2.4 ( 5.12 )
    -2.0 ( 13.05 )
        Week 32
    -2.2 ( 10.44 )
    -2.6 ( 11.50 )
    -13.3 ( 18.62 )
    -4.0 ( 8.31 )
    -1.8 ( 8.81 )
    -1.2 ( 10.48 )
        Week 36
    -1.3 ( 11.25 )
    -0.5 ( 14.89 )
    -15.6 ( 23.62 )
    -7.1 ( 9.52 )
    -1.2 ( 5.33 )
    -2.3 ( 23.85 )
        Week 38
    -0.5 ( 10.17 )
    -3.6 ( 10.18 )
    -10.1 ( 21.01 )
    -7.0 ( 9.73 )
    -4.7 ( 5.02 )
    -2.6 ( 11.41 )
        Week 40
    1.3 ( 7.69 )
    -1.1 ( 9.28 )
    -9.6 ( 21.23 )
    -8.6 ( 10.60 )
    -3.9 ( 6.60 )
    -3.5 ( 20.83 )
        Week 48
    5.0 ( 11.82 )
    -4.9 ( 13.66 )
    -17.3 ( 21.04 )
    -6.6 ( 11.76 )
    -4.1 ( 6.52 )
    2.5 ( 19.59 )
    Notes
    [21] - n=24(Wk8,16)n=23(Wk2,4,12,14,20,24,26)n=22(Wk28)n=19(Wk32)n=18(Wk36,38)n=17(Wk40)n=12(Wk48)
    [22] - n=29(Wk2,4)n=28(Wk8,14,20,24)n=27(Wk12,16,28)n=26(Wk26,36)n=23(Wk32)n=20(Wk38)n=18(Wk40)n=14(Wk48)
    [23] - n=12(weeks 2,4,8,14,16,20,24,) n=11 (week12) n=10(weeks 26,28,32) n=8 (weeks 36,38,40) n=6 (week 48)
    [24] - n=10 (weeks 2,26,28);n=9 (week 36) n=7 (weeks 32,38,40);n=5 (week 48)
    [25] - n=13(weeks 20,24);n=12(weeks 8,16) n=11(weeks 26,28);n=9(weeks 36,38,40);n=8(week 32);n=7(week 48)
    [26] - n=26(weeks2,16,24)n=24(weeks20,26,28)n=22(week32)n=20(week36)n=17(week38)n=16(week40)n=10(week48)
    No statistical analyses for this end point

    Secondary: Terminal Elimination half-life (T1/2) at Steady State

    		 Close Top of page
    End point title
    		 Terminal Elimination half-life (T1/2) at Steady State [27]
    End point description
    Terminal elimination half-life (T1/2) of CSJ117 calculated by non-compartmental methods based on CSJ117 serum concentrations. The PK sampling planned and executed was not sufficient to support the calculation of T1/2. The maximum numbers of samples collected on any day were 3 samples, including the predose sample, and majority of those samples were below the limit of quantification (BLQ). The insufficient PK sampling scheme coupled with the early termination of studies did not allow us to calculate T1/2.
    End point type
    Secondary
    End point timeframe
    Day 1 and Week 12(extension) (Weeks 12 and 24 overall):pre-dose, 2 and 4 hours post-dose; Weeks 2, 4, 8(extension) (Weeks 14, 16 and 20 overall):pre-dose and 4 hours post-dose; Weeks 14, 16, 20 and 24(extension) (Weeks 26, 28, 32 and 36 overall):pre-dose
    Notes
    [27] - 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 conducted for this endpoint.
    End point values
    		 24 weeks CSJ117 8mg 24 weeks CSJ117 4mg 24 weeks CSJ117 2mg 24 weeks CSJ117 1mg 24-weeks CSJ117 0.5mg 12 weeks wash-out + 12 weeks CSJ117 8mg 12 weeks wash-out + 12 weeks CSJ117 4mg 12 weeks wash-out + 12 weeks CSJ117 2mg 12 weeks wash-out + 12 weeks CSJ117 1mg 12 weeks wash-out + 12 weeks CSJ117 0.5mg 12 weeks drug-free + 12 weeks CSJ117 8mg 12 weeks drug-free + 12 weeks CSJ117 4mg 12 weeks drug-free + 12 weeks CSJ117 2mg 12 weeks drug-free + 12 weeks CSJ117 1mg 12 weeks drug-free + 12 weeks CSJ117 0.5mg
    Number of subjects analysed
    0 [28]
    0 [29]
    0 [30]
    0 [31]
    0 [32]
    0 [33]
    0 [34]
    0 [35]
    0 [36]
    0 [37]
    0 [38]
    0 [39]
    0 [40]
    0 [41]
    0 [42]
    Units: Days
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Notes
    [28] - The insufficient PK sampling scheme did not allow to calculate T1/2.
    [29] - The insufficient PK sampling scheme did not allow to calculate T1/2.
    [30] - The insufficient PK sampling scheme did not allow to calculate T1/2.
    [31] - The insufficient PK sampling scheme did not allow to calculate T1/2.
    [32] - The insufficient PK sampling scheme did not allow to calculate T1/2.
    [33] - The insufficient PK sampling scheme did not allow to calculate T1/2.
    [34] - The insufficient PK sampling scheme did not allow to calculate T1/2.
    [35] - The insufficient PK sampling scheme did not allow to calculate T1/2.
    [36] - The insufficient PK sampling scheme did not allow to calculate T1/2.
    [37] - The insufficient PK sampling scheme did not allow to calculate T1/2.
    [38] - The insufficient PK sampling scheme did not allow to calculate T1/2.
    [39] - The insufficient PK sampling scheme did not allow to calculate T1/2.
    [40] - The insufficient PK sampling scheme did not allow to calculate T1/2.
    [41] - The insufficient PK sampling scheme did not allow to calculate T1/2.
    [42] - The insufficient PK sampling scheme did not allow to calculate T1/2.
    No statistical analyses for this end point

    Secondary: Number of participants with anti-CSJ117 antibodies

    		 Close Top of page
    End point title
    		 Number of participants with anti-CSJ117 antibodies
    End point description
    Immunogenicity (antibody formation against CSJ117) was evaluated in serum by a validated bridging electrochemiluminescence immunoassay (ECLIA). The Number of Subjects Analyzed differs as stated on the comment field for each column, in case of difference from Number of subjects that started the Arm.
    End point type
    Secondary
    End point timeframe
    Day 1, Week 2, 4, 8, 12, 14, 16, 20, 24, 26, 28, 32, 36, 38, 40 and 48
    End point values
    		 24 weeks CSJ117 8mg 24 weeks CSJ117 4mg 24 weeks CSJ117 2mg 24 weeks CSJ117 1mg 24-weeks CSJ117 0.5mg 24-weeks Placebo 12 weeks wash-out + 12 weeks CSJ117 8mg 12 weeks wash-out + 12 weeks CSJ117 4mg 12 weeks wash-out + 12 weeks CSJ117 2mg 12 weeks wash-out + 12 weeks CSJ117 1mg 12 weeks wash-out + 12 weeks CSJ117 0.5mg 12 weeks wash-out + 12 weeks Placebo 12 weeks drug-free + 12 weeks CSJ117 8mg 12 weeks drug-free + 12 weeks CSJ117 4mg 12 weeks drug-free + 12 weeks CSJ117 2mg 12 weeks drug-free + 12 weeks CSJ117 1mg 12 weeks drug-free + 12 weeks CSJ117 0.5mg 12 weeks drug-free + 12 weeks Placebo
    Number of subjects analysed
    8 [43]
    5 [44]
    3 [45]
    3 [46]
    5 [47]
    6 [48]
    7 [49]
    3 [50]
    2 [51]
    3 [52]
    1 [53]
    4 [54]
    18 [55]
    24 [56]
    10 [57]
    7 [58]
    9 [59]
    18 [60]
    Units: Participants
        Day 1|Negative
    6
    5
    2
    3
    4
    4
    7
    3
    2
    3
    1
    4
    14
    22
    8
    6
    7
    15
        Week 2|Negative
    7
    5
    2
    2
    5
    3
    7
    3
    2
    3
    1
    4
    14
    21
    8
    5
    6
    13
        Week4|Negative
    5
    5
    2
    2
    5
    3
    5
    1
    2
    3
    1
    4
    11
    16
    6
    5
    6
    14
        Week 8|Negative
    1
    2
    0
    0
    4
    5
    3
    0
    1
    2
    1
    3
    6
    5
    3
    4
    1
    15
        Week 12|Negative
    0
    2
    0
    0
    3
    4
    3
    0
    1
    2
    0
    3
    4
    3
    2
    2
    0
    14
        Week 14|Negative
    0
    2
    0
    0
    2
    4
    2
    0
    1
    2
    0
    4
    6
    3
    2
    2
    0
    15
        Week 16|Negative
    0
    2
    0
    0
    3
    4
    1
    0
    1
    2
    0
    3
    5
    2
    2
    3
    0
    15
        Week 20|Negative
    1
    2
    0
    0
    3
    4
    2
    0
    1
    2
    0
    3
    5
    2
    4
    2
    1
    14
        Week 24|Negative
    0
    2
    0
    0
    3
    4
    2
    0
    1
    2
    0
    3
    6
    3
    3
    3
    3
    14
        Week 26|Negative
    1
    1
    0
    0
    2
    3
    2
    0
    0
    1
    0
    3
    6
    2
    3
    2
    1
    14
        Week 28|Negative
    1
    1
    0
    0
    1
    2
    2
    0
    0
    1
    0
    3
    4
    2
    3
    3
    0
    17
        Week 32|Negative
    1
    1
    0
    0
    0
    2
    2
    0
    0
    0
    0
    3
    6
    2
    3
    3
    0
    15
        Week 36|Negative
    1
    1
    0
    0
    0
    3
    2
    0
    0
    0
    0
    3
    5
    4
    3
    1
    0
    13
        Week 38|Negative
    1
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    2
    5
    1
    2
    1
    0
    12
        Week 40|Negative
    1
    1
    0
    0
    0
    1
    1
    0
    0
    0
    0
    2
    4
    2
    1
    1
    0
    11
        Week 48|Negative
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    3
    1
    2
    2
    0
    8
        Day 1|Positive
    2
    0
    1
    0
    1
    2
    0
    0
    0
    0
    0
    0
    4
    2
    2
    1
    2
    3
        Week 2|Positive
    1
    0
    1
    1
    0
    3
    0
    0
    0
    0
    0
    0
    4
    3
    2
    2
    3
    4
        Week4|Positive
    3
    0
    1
    1
    0
    3
    2
    2
    0
    0
    0
    0
    7
    8
    4
    2
    3
    4
        Week 8|Positive
    7
    3
    3
    3
    1
    1
    4
    3
    1
    1
    0
    1
    12
    19
    7
    3
    8
    3
        Week 12|Positive
    8
    3
    3
    3
    2
    1
    4
    3
    1
    1
    1
    1
    14
    21
    8
    5
    9
    4
        Week 14|Positive
    8
    3
    1
    3
    3
    2
    5
    3
    1
    1
    1
    0
    12
    21
    8
    5
    9
    3
        Week 16|Positive
    8
    3
    2
    3
    2
    1
    6
    3
    1
    1
    1
    0
    13
    22
    8
    4
    9
    3
        Week 20|Positive
    7
    3
    2
    3
    2
    1
    5
    3
    1
    1
    1
    0
    13
    22
    6
    5
    8
    3
        Week 24|Positive
    8
    3
    1
    3
    2
    1
    4
    3
    1
    1
    0
    0
    12
    20
    7
    4
    6
    4
        Week 26|Positive
    6
    4
    1
    1
    2
    0
    4
    2
    1
    1
    0
    0
    12
    21
    5
    5
    8
    4
        Week 28|Positive
    6
    4
    1
    1
    2
    1
    3
    2
    1
    1
    0
    0
    14
    21
    7
    4
    9
    1
        Week 32|Positive
    5
    1
    0
    0
    1
    0
    2
    2
    1
    1
    0
    0
    11
    20
    6
    4
    9
    2
        Week 36|Positive
    4
    4
    1
    1
    2
    0
    2
    2
    0
    1
    0
    0
    10
    18
    5
    6
    9
    2
        Week 38|Positive
    3
    1
    0
    0
    1
    0
    3
    2
    0
    1
    0
    0
    10
    18
    6
    5
    9
    2
        Week 40|Positive
    3
    0
    0
    0
    1
    0
    2
    2
    0
    1
    0
    0
    10
    16
    7
    5
    9
    2
        Week 48|Positive
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    8
    14
    4
    3
    7
    1
    Notes
    [43] - n=7(weeks 26,28) n=6(week 32) n=5(week 36) n=4(weeks 38,40) n=1(week 48)
    [44] - n=2(weeks 32,38) n=1(weeks 40,48)
    [45] - n=2(weeks 16,20) n=1(weeks 14,24,26,28,36) n=0(weeks 32,38,40,48)
    [46] - n=1(weeks 26,28,36) n=0(weeks 32,38,40,48)
    [47] - n=4(week 26) n=3(week 28) n=2(week 36) n=1(weeks 32,38,40,48)
    [48] - n=5(weeks 12,16,20,24) n=3(weeks 26,28,36) n=2(week 32) n=1(weeks 38,40) n=0(week 48)
    [49] - n=6(weeks 24,26) n=5(weeks 28) n=4(week 32,36) n=3(weeks 38,40) n=1(week 48)
    [50] - n=2(weeks 26,28,32,36,38,40) n=0(week 48)
    [51] - n=1(weeks 26,28,32) n=0 (weeks 36,38,40,48)
    [52] - n=2(weeks 26,28) n=1(weeks 32,36,38,40) n=0 (week 48)
    [53] - n=0(weeks 24,26,28,32,36,38,40,48)
    [54] - n=3(weeks 16,20,24,26,28,32,36) n=2(weeks 38,40) n=1(week 48)
    [55] - n=17(weeks 32) n=15(weeks 36,38) n=14(week 40) n=11(week 48)
    [56] - n=23(weeks 24,26,28) n=22(weeks 32,36) n=19(week 38) n=18(week 40) n=15(week 48)
    [57] - n=9(week 32) n=8(weeks 26,36,38,40) n=6(week 48)
    [58] - n=6(weeks 38,40) n=5(week 48)
    [59] - n=7(week 48)
    [60] - n=17(weeks 2,20,32) n=15(week 36) n=14(week 38) n=13(week 40) n=9(week 48)
    No statistical analyses for this end point

    Secondary: CSJ117 serum concentration

    		 Close Top of page
    End point title
    		 CSJ117 serum concentration [61]
    End point description
    CSJ117 concentration was determined in serum by a validated immunoassay method. Concentrations below the lower limit of quantification (LLOQ) were treated as “zero”. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’. The Number of Subjects Analyzed differs as stated on the comment field for each column, in case of difference from Number of subjects that started the Arm.
    End point type
    Secondary
    End point timeframe
    Day 1 and Week 12(extension) (Weeks 12 and 24 overall):pre-dose, 2 and 4 hours post-dose; Weeks 2, 4, 8(extension) (Weeks 14, 16 and 20 overall):pre-dose and 4 hours post-dose; Weeks 14, 16, 20 and 24(extension) (Weeks 26, 28, 32 and 36 overall):pre-dose
    Notes
    [61] - 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 conducted for this endpoint.
    End point values
    		 24 weeks CSJ117 8mg 24 weeks CSJ117 4mg 24 weeks CSJ117 2mg 24 weeks CSJ117 1mg 24-weeks CSJ117 0.5mg 12 weeks wash-out + 12 weeks CSJ117 8mg 12 weeks wash-out + 12 weeks CSJ117 4mg 12 weeks wash-out + 12 weeks CSJ117 2mg 12 weeks wash-out + 12 weeks CSJ117 1mg 12 weeks wash-out + 12 weeks CSJ117 0.5mg 12 weeks drug-free + 12 weeks CSJ117 8mg 12 weeks drug-free + 12 weeks CSJ117 4mg 12 weeks drug-free + 12 weeks CSJ117 2mg 12 weeks drug-free + 12 weeks CSJ117 1mg 12 weeks drug-free + 12 weeks CSJ117 0.5mg
    Number of subjects analysed
    8 [62]
    5 [63]
    3 [64]
    3 [65]
    5 [66]
    7 [67]
    3 [68]
    2 [69]
    3 [70]
    1 [71]
    18 [72]
    24 [73]
    10 [74]
    7 [75]
    9 [76]
    Units: ng/mL
    arithmetic mean (standard deviation)
        Day 1, pre-dose
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    4.81 ( 15.2 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
        Day 1, 2 hours post-dose
    0.698 ( 1.97 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    5.50 ( 13.7 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
        Day 1, 4 hours post-dose
    1.60 ( 2.98 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    1.40 ( 3.70 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.678 ( 2.88 )
    0.414 ( 2.03 )
    5.79 ( 14.7 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
        Week 2, pre-dose
    10.1 ( 7.65 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    8.49 ( 9.99 )
    1.93 ( 3.34 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    3.68 ( 4.54 )
    1.60 ( 3.31 )
    6.28 ( 15.8 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
        Week 2, 2 hours post-dose
    10.0 ( 7.46 )
    999 ( 999 )
    999 ( 999 )
    999 ( 999 )
    0.00 ( 0.00 )
    9.40 ( 6.68 )
    1.73 ( 3.00 )
    999 ( 999 )
    999 ( 999 )
    999 ( 999 )
    4.53 ( 4.91 )
    1.87 ( 3.95 )
    5.93 ( 14.9 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
        Week 4, pre-dose
    24.0 ( 36.8 )
    3.67 ( 3.40 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    9.15 ( 6.76 )
    2.14 ( 3.70 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    9.30 ( 15.2 )
    2.33 ( 3.89 )
    6.40 ( 17.1 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
        Week 4, 2 hours post-dose
    31.4 ( 49.8 )
    2.43 ( 3.36 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    9.55 ( 9.53 )
    1.86 ( 3.23 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    12.1 ( 16.7 )
    4.56 ( 6.07 )
    7.00 ( 16.1 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
        Week 8, pre-dose
    67.0 ( 56.3 )
    9.32 ( 16.4 )
    5.77 ( 5.96 )
    3.93 ( 6.81 )
    1.21 ( 2.70 )
    53.5 ( 90.8 )
    16.9 ( 12.5 )
    0.00 ( 0.00 )
    8.03 ( 13.9 )
    0.00 ( 0.00 )
    33.6 ( 40.1 )
    15.9 ( 16.6 )
    13.3 ( 19.0 )
    0.994 ( 2.63 )
    2.23 ( 4.43 )
        Week 8, 2 hours post-dose
    64.9 ( 46.5 )
    9.31 ( 16.9 )
    3.57 ( 6.18 )
    4.00 ( 6.93 )
    1.33 ( 2.98 )
    50.9 ( 88.6 )
    15.4 ( 9.84 )
    0.00 ( 0.00 )
    8.67 ( 15.0 )
    0.00 ( 0.00 )
    34.0 ( 44.0 )
    15.1 ( 15.0 )
    12.7 ( 18.8 )
    1.30 ( 3.44 )
    2.62 ( 5.23 )
        Week 12, pre-dose
    73.7 ( 62.4 )
    11.3 ( 19.4 )
    8.53 ( 9.84 )
    0.00 ( 0.00 )
    2.22 ( 4.96 )
    63.2 ( 104 )
    27.8 ( 24.6 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    31.6 ( 34.8 )
    18.8 ( 24.2 )
    13.0 ( 18.5 )
    3.73 ( 5.40 )
    3.23 ( 5.25 )
        Week 12, 2 hours post-dose
    79.5 ( 68.5 )
    12.4 ( 24.7 )
    9.74 ( 12.5 )
    0.00 ( 0.00 )
    1.83 ( 4.10 )
    27.4 ( 45.8 )
    29.7 ( 25.8 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    38.8 ( 39.7 )
    18.9 ( 24.0 )
    13.0 ( 18.2 )
    3.85 ( 5.61 )
    3.49 ( 5.54 )
        Week 12, 4 hours post-dose
    79.1 ( 69.5 )
    15.5 ( 24.8 )
    7.70 ( 9.28 )
    0.00 ( 0.00 )
    2.20 ( 4.92 )
    32.7 ( 58.8 )
    30.2 ( 27.2 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    40.7 ( 40.9 )
    18.8 ( 23.6 )
    13.7 ( 18.6 )
    3.78 ( 5.31 )
    3.74 ( 6.07 )
        Week 14, pre-dose
    50.8 ( 51.1 )
    16.8 ( 26.1 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    2.12 ( 4.74 )
    13.4 ( 25.8 )
    3.07 ( 5.32 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    8.14 ( 16.6 )
    2.07 ( 5.28 )
    7.54 ( 17.0 )
    0.00 ( 0.00 )
    0.663 ( 1.99 )
        Week 16, pre-dose
    49.3 ( 60.7 )
    17.2 ( 30.2 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    2.04 ( 4.56 )
    6.59 ( 13.5 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    2.66 ( 6.44 )
    0.773 ( 2.72 )
    6.47 ( 17.2 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
        Week 20, pre-dose
    43.3 ( 61.0 )
    16.5 ( 26.8 )
    0.00 ( 0.00 )
    2.40 ( 4.16 )
    1.19 ( 2.66 )
    1.17 ( 3.10 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    5.81 ( 15.4 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
        Week 24, pre-dose
    35.2 ( 47.8 )
    15.3 ( 22.4 )
    0.00 ( 0.00 )
    3.40 ( 5.89 )
    1.17 ( 2.62 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    999 ( 999 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    4.54 ( 11.2 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
        Week 26, pre-dose
    13.9 ( 31.0 )
    0.00 ( 0.00 )
    999 ( 999 )
    999 ( 999 )
    0.00 ( 0.00 )
    62.7 ( 81.0 )
    26.1 ( 23.9 )
    22.1 ( 999 )
    0.00 ( 0.00 )
    999 ( 999 )
    21.5 ( 31.3 )
    12.9 ( 26.0 )
    6.31 ( 15.6 )
    3.38 ( 6.64 )
    1.10 ( 3.29 )
        Week 28, pre-dose
    12.3 ( 27.5 )
    0.00 ( 0.00 )
    999 ( 999 )
    999 ( 999 )
    0.00 ( 0.00 )
    67.9 ( 89.0 )
    5.15 ( 7.28 )
    21.2 ( 999 )
    0.00 ( 0.00 )
    999 ( 999 )
    23.8 ( 52.5 )
    13.2 ( 25.0 )
    5.38 ( 17.0 )
    3.21 ( 8.50 )
    5.35 ( 13.9 )
        Week 32, pre-dose
    9.24 ( 20.7 )
    0.00 ( 0.00 )
    999 ( 999 )
    999 ( 999 )
    0.00 ( 0.00 )
    79.0 ( 120 )
    0.00 ( 0.00 )
    9.18 ( 999 )
    0.00 ( 0.00 )
    999 ( 999 )
    6.32 ( 11.1 )
    7.57 ( 14.0 )
    0.916 ( 2.59 )
    1.38 ( 3.65 )
    5.40 ( 12.1 )
        Week 36, pre-dose
    55.7 ( 105 )
    4.86 ( 6.87 )
    999 ( 999 )
    999 ( 999 )
    0.00 ( 0.00 )
    68.6 ( 105 )
    0.00 ( 0.00 )
    999 ( 999 )
    0.00 ( 999 )
    999 ( 999 )
    24.2 ( 45.0 )
    10.5 ( 18.9 )
    1.24 ( 3.51 )
    2.99 ( 4.70 )
    6.18 ( 14.8 )
        Week 38, 336 hours post-dose
    21.3 ( 42.6 )
    0.00 ( 0.00 )
    999 ( 999 )
    999 ( 999 )
    0.00 ( 0.00 )
    20.8 ( 36.0 )
    0.00 ( 0.00 )
    999 ( 999 )
    0.00 ( 999 )
    999 ( 999 )
    3.46 ( 5.81 )
    2.14 ( 5.44 )
    0.689 ( 1.95 )
    0.00 ( 0.00 )
    2.89 ( 8.67 )
        Week 40, 672 hours post-dose
    12.7 ( 25.3 )
    0.00 ( 0.00 )
    999 ( 999 )
    999 ( 999 )
    0.00 ( 0.00 )
    12.2 ( 21.1 )
    0.00 ( 0.00 )
    999 ( 999 )
    0.00 ( 999 )
    999 ( 999 )
    1.53 ( 3.16 )
    1.46 ( 3.66 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
        Week 48, 2016 hours post-dose
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    999 ( 999 )
    999 ( 999 )
    0.00 ( 0.00 )
    0.00 ( 999 )
    999 ( 999 )
    999 ( 999 )
    999 ( 999 )
    999 ( 999 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    Notes
    [62] - n=7(week 4, 2 hours post-dose; weeks 14,16,20,24) n=5(weeks 26,28,32,36) n=4(weeks38,40) n=1(week48)
    [63] - n=4(day 1, 4hrs post-dose, week 12, 2 hrs post-dose) n=2(weeks26,28,32,36,38) n=1(weeks 40,48)
    [64] - n=2(week 16) n=1(weeks 14,20,24) n=0(weeks 26,28,32,36,38,40,48)
    [65] - n=0(weeks 26,28,32,36,38,40,48)
    [66] - n=1 (weeks 26, 28, 32, 36, 38, 40, 48)
    [67] - n=6(week12, 2and 4hrs post-dose, week24) n=5(weeks26,28) n=4(weeks32,36) n=3(weeks38,40) n=1(week48)
    [68] - n=2(weeks24,26,28,32,36,38,40) n=0(week48)
    [69] - n=1(weeks26,28,32) n=0(weeks36,38,40,48)
    [70] - n=2(weeks26,28) n=0(weeks32,36,38,40) n=0(week48)
    [71] - n=0(weeks24,26,28,32,36,38,40,48)
    [72] - n=17(wk 4; 8 pre-ds; 12; 26) n=16(wk 8, 2hrs post-ds)n=15(wk32)n=14(wk 38,40) n=13(wk36) n=11(wk48)
    [73] - n=23(Day1,2hrs pst-ds;wk8,2hrs pst-d;12,pre-d)n=22(wk24,28,32) n=21(wk26,36)n=19/18/14(wk38/40/48)
    [74] - n=9(weeks 4 pre-dose;12 pre-dose, 2, 4 hrs post-dose;14,16,20,24)n=8(weeks26,32,36,38,40)n=6(week48)
    [75] - n=6 (weeks 36, 38, 40) n=5 (week 48)
    [76] - n=6 (week 48)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From first dose of double-blind treatment up to 12 weeks after last dose (Week 48).
    Adverse event reporting additional description
    For AE reporting, the “24 weeks”, the “12 weeks wash-out + 12 weeks” and the “12 weeks drug-free + 12 weeks” arms for a dose were pooled. AEs occurring during the 12 week wash-out or drug-free period were accounted for in the dose received prior to the wash-out or drug-free period.
    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
    CSJ117 4mg
    Reporting group description
    		 CSJ117 4mg

    Reporting group title
    CSJ117 2mg
    Reporting group description
    		 CSJ117 2mg

    Reporting group title
    CSJ117 1mg
    Reporting group description
    		 CSJ117 1mg

    Reporting group title
    CSJ117 0.5mg
    Reporting group description
    		 CSJ117 0.5mg

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Serious adverse events
    		 CSJ117 8mg CSJ117 4mg CSJ117 2mg CSJ117 1mg CSJ117 0.5mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 CSJ117 8mg CSJ117 4mg CSJ117 2mg CSJ117 1mg CSJ117 0.5mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 33 (51.52%)
    17 / 32 (53.13%)
    11 / 15 (73.33%)
    8 / 13 (61.54%)
    6 / 15 (40.00%)
    16 / 28 (57.14%)
    Vascular disorders
    Arteriosclerosis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Hypertension
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Pain
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Inflammation
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Fatigue
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Vaccination site swelling
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    Chronic rhinosinusitis with nasal polyps
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Asthma
         subjects affected / exposed
    3 / 33 (9.09%)
    4 / 32 (12.50%)
    5 / 15 (33.33%)
    2 / 13 (15.38%)
    1 / 15 (6.67%)
    5 / 28 (17.86%)
         occurrences all number
    3
    7
    6
    2
    2
    5
    Dysphonia
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    2 / 28 (7.14%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    Dyspnoea
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    2 / 15 (13.33%)
    0 / 13 (0.00%)
    1 / 15 (6.67%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    2
    0
    1
    0
    Epistaxis
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Productive cough
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Throat irritation
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 15 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    1
    0
    0
    1
    0
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Persistent depressive disorder
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Investigations
    Blood triglycerides increased
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Blood glucose increased
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 15 (6.67%)
    0 / 28 (0.00%)
         occurrences all number
    0
    1
    0
    0
    2
    0
    Blood cholesterol increased
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Lipase increased
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Chest injury
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Corneal abrasion
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Ligament sprain
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Skin abrasion
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Vaccination complication
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 15 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Tachycardia
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Nervous system disorders
    Spinal cord herniation
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Sciatica
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Monoparesis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Headache
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Dizziness
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Anaemia
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Leukocytosis
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Pancreatitis acute
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    Nausea
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    0
    1
    0
    0
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Dry mouth
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Dental caries
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Ingrowing nail
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Eczema
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Urticaria
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 15 (6.67%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Renal and urinary disorders
    Renal cyst
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Chronic kidney disease
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    1 / 15 (6.67%)
    1 / 13 (7.69%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Synovial cyst
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Back pain
         subjects affected / exposed
    1 / 33 (3.03%)
    2 / 32 (6.25%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    1 / 15 (6.67%)
    0 / 28 (0.00%)
         occurrences all number
    1
    2
    1
    0
    1
    0
    Rheumatic disorder
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Infections and infestations
    Herpes zoster
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Cystitis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    2 / 15 (13.33%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    1
    2
    0
    0
    0
    COVID-19
         subjects affected / exposed
    2 / 33 (6.06%)
    2 / 32 (6.25%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    2 / 15 (13.33%)
    2 / 28 (7.14%)
         occurrences all number
    2
    2
    0
    1
    2
    2
    Bronchitis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    1 / 15 (6.67%)
    0 / 28 (0.00%)
         occurrences all number
    0
    1
    1
    0
    1
    0
    Body tinea
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Acute sinusitis
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    1 / 15 (6.67%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    1
    0
    1
    1
    Laryngitis
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 33 (6.06%)
    0 / 32 (0.00%)
    1 / 15 (6.67%)
    1 / 13 (7.69%)
    0 / 15 (0.00%)
    3 / 28 (10.71%)
         occurrences all number
    3
    0
    1
    1
    0
    5
    Oral candidiasis
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Oral herpes
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    0
    Oropharyngeal candidiasis
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Tonsillitis
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Tooth abscess
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Rhinitis
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    Pyelitis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Pharyngitis
         subjects affected / exposed
    0 / 33 (0.00%)
    2 / 32 (6.25%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 15 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    2
    0
    1
    0
    1
    Papilloma viral infection
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 15 (6.67%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Otitis media
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    2 / 33 (6.06%)
    1 / 32 (3.13%)
    1 / 15 (6.67%)
    1 / 13 (7.69%)
    1 / 15 (6.67%)
    1 / 28 (3.57%)
         occurrences all number
    2
    1
    1
    1
    1
    1
    Tooth infection
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 33 (3.03%)
    3 / 32 (9.38%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 15 (6.67%)
    1 / 28 (3.57%)
         occurrences all number
    1
    4
    0
    0
    1
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Vaginal infection
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Varicella zoster virus infection
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Viral infection
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 33 (6.06%)
    0 / 32 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    3
    0
    1
    0
    0
    0
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    2 / 28 (7.14%)
         occurrences all number
    1
    0
    0
    0
    0
    2
    Dyslipidaemia
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/#/
    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.

    European Medicines Agency © 1995-Fri May 09 19:54:34 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA