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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled, parallel-group study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CDZ173 in patients with primary Sjögren’s syndrome.

    Summary
    EudraCT number
    		 2014-004616-12
    Trial protocol
    		 DE   HU   PL  
    Global end of trial date
    17 May 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 May 2018
    First version publication date
    31 May 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CCDZ173X2203
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02775916
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 May 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 May 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety and tolerability of CDZ173 in patients with primary Sjögren’s syndrome. To compare the effect of CDZ173 versus placebo on the patient reported outcome of primary Sjögren’s syndrome patients after 12 weeks of treatment (study Week 13 (Day 85)).
    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
    01 Jun 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 22
    Country: Number of subjects enrolled
    Hungary: 8
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    26
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 30 patients were randomized in a ratio of 2:1 to receive either CDZ173 or placebo (twice daily at approximately 12 hour intervals) during the 12-week treatment period.

    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, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CDZ173
    Arm description
    		 Capsule
    Arm type
    		 Experimental

    Investigational medicinal product name
    CDZ173
    Investigational medicinal product code
    CDZ173
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    CDZ173 70mg oral capsule twice a day for 12 weeks

    Arm title
    		 Placebo
    Arm description
    		 Capsule matching Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    CDZ173
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo oral capsule twice a day for 12 weeks

    Number of subjects in period 1
    		CDZ173 Placebo
    Started
    20
    10
    Completed
    17
    10
    Not completed
    3
    0
         Adverse event, non-fatal
    1
    -
         Subject/Guardian Decision
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CDZ173
    Reporting group description
    		 Capsule

    Reporting group title
    Placebo
    Reporting group description
    		 Capsule matching Placebo

    Reporting group values
    		 CDZ173 Placebo Total
    Number of subjects
    		 20 10 30
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 17 9 26
        From 65-84 years
    		 3 1 4
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 48.7 ± 13.85 44.7 ± 11.58 -
    Sex: Female, Male
    Units: Subjects
        Female
    		 17 9 26
        Male
    		 3 1 4
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0 0
        Not Hispanic or Latino
    		 20 10 30
        Unknown or Not Reported
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    CDZ173
    Reporting group description
    		 Capsule

    Reporting group title
    Placebo
    Reporting group description
    		 Capsule matching Placebo

    Primary: Safety and tolerability of CDZ173 in patients with primary Sjögren’s syndrome up to Day 85 No statistical analysis was planned for this primary outcome.

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    End point title
    		 Safety and tolerability of CDZ173 in patients with primary Sjögren’s syndrome up to Day 85 No statistical analysis was planned for this primary outcome. [1]
    End point description
    Safety and tolerability of CDZ173 in patients with primary Sjögren’s syndrome up to End of Treatment Day 85
    End point type
    Primary
    End point timeframe
    up to Day 85
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this primary outcome
    End point values
    		 CDZ173 Placebo
    Number of subjects analysed
    20
    10
    Units: count of participants
        Participants with at least one AE|
    20
    8
        Participants with at least one SAE|
    1
    0
        Death|
    0
    0
    No statistical analyses for this end point

    Primary: Change from Baseline in the EULAR Sjögren's Syndrome Patient Reported Intensity (ESSPRI) after 12 weeks of Treatment Day 85

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    End point title
    		 Change from Baseline in the EULAR Sjögren's Syndrome Patient Reported Intensity (ESSPRI) after 12 weeks of Treatment Day 85
    End point description
    The ESSPRI is an established disease outcome measure for Sjögren’s syndrome. It consists of a questionnaire developed to assess the patients' symptoms in primary Sjögren's syndrome and covered the three key subjective areas of discomfort, i.e., dryness, pain and fatigue. The full questionnaire had 21 questions. Subsequently, it was noted that the first three questions, Likert scales ranging from 0 – 10, captured the essence of the ESSPRI. This abbreviated version was used to define the “minimal clinically important improvement” (0.67 – 1) and the “patient-acceptable symptom state” (<5) Patients were asked to complete the full ESSPRI questionnaire. However, the mean of the first three questions was used for the primary analysis and for the assessment of eligibility. A reduction from baseline (or, a negative change from baseline) in ESSPRI indicates improvement in patients.
    End point type
    Primary
    End point timeframe
    Baseline and 12 weeks (Day 85)
    End point values
    		 CDZ173 Placebo
    Number of subjects analysed
    12
    9
    Units: total score
        arithmetic mean (standard deviation)
    -1.778 ± 2.4509
    -0.741 ± 1.3517
    Statistical analysis title
    		 Change from Baseline in the ESSPRI at Day 85
    Comparison groups
    CDZ173 v Placebo
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.343
         upper limit
    		 1.937
    Variability estimate
    Standard deviation
    Dispersion value
    1.332

    Secondary: Change from Baseline in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) after 12 weeks of Treatment Day 85

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    End point title
    		 Change from Baseline in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) after 12 weeks of Treatment Day 85
    End point description
    The ESSDAI is an established disease outcome measure for Sjögren’s syndrome. The instrument contains 12 organ-specific domains contributing to disease activity. For each domain, features of disease activity are scored in 3 or 4 levels according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score. A reduction from baseline (i.e., a negative change from baseline) in the ESSDAI score is indicative of improvement in a patient.
    End point type
    Secondary
    End point timeframe
    Baseline and 12 weeks (Day 85)
    End point values
    		 CDZ173 Placebo
    Number of subjects analysed
    12
    9
    Units: total score
        least squares mean (standard error)
    -2.82 ± 1.165
    -3.34 ± 1.168
    Statistical analysis title
    		 Change from Baseline in the ESSDAI at Day 85
    Comparison groups
    CDZ173 v Placebo
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.52
         upper limit
    		 3.55
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.466

    Secondary: Change from Baseline in the Short Form (36) Health Survey (SF-36) after 12 weeks of Treatment Day 85

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    End point title
    		 Change from Baseline in the Short Form (36) Health Survey (SF-36) after 12 weeks of Treatment Day 85
    End point description
    The Short Form Health Survey is a survey evaluating individual patient’s health status which also monitors and compares patients’ disease burden. The SF-36 consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health), which are the weighted sums of the questions in their section. An increase in SF-36 score from baseline (i.e., a positive change from baseline) indicates improvement in patients
    End point type
    Secondary
    End point timeframe
    Baseline and 12 weeks (Day 85)
    End point values
    		 CDZ173 Placebo
    Number of subjects analysed
    12
    9
    Units: total score
    least squares mean (standard error)
        Physical Component Summary Score|
    4.82 ± 2.235
    4.42 ± 2.425
        Mental Component Summary Score|
    5.43 ± 3.415
    1.10 ± 3.792
    Statistical analysis title
    		 Change from Baseline in SF-36 Physical at Day 85
    Comparison groups
    CDZ173 v Placebo
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.08
         upper limit
    		 6.89
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.119
    Statistical analysis title
    		 Change from Baseline in SF-36 Mental at Day 85
    Comparison groups
    CDZ173 v Placebo
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    4.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.27
         upper limit
    		 13.93
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.615

    Secondary: Change in Baseline in Multidimensional Fatigue Inventory (MFI) after 12 weeks of Treatment (Day 85)

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    End point title
    		 Change in Baseline in Multidimensional Fatigue Inventory (MFI) after 12 weeks of Treatment (Day 85)
    End point description
    The Multidimensional Fatigue Inventory is a 20-item self-report instrument designed to measure fatigue that covered the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity. A reduction from baseline (i.e., a negative change from baseline) in MFI indicates improvement in patients.
    End point type
    Secondary
    End point timeframe
    Baseline and 12 weeks (Day 85)
    End point values
    		 CDZ173 Placebo
    Number of subjects analysed
    12
    9
    Units: total score
        least squares mean (standard error)
    -8.80 ± 5.557
    -2.25 ± 5.774
    Statistical analysis title
    		 Change in Baseline in MFI at Day 85
    Comparison groups
    CDZ173 v Placebo
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -6.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21.76
         upper limit
    		 8.66
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.27

    Secondary: Change from Baseline in Physician global assessment of the patient's overall disease activity (Physician VAS) after 12 weeks of Treatment Day 85

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    End point title
    		 Change from Baseline in Physician global assessment of the patient's overall disease activity (Physician VAS) after 12 weeks of Treatment Day 85
    End point description
    A reduction from baseline (i.e., a negative change from baseline) in physician global VAS assessment score indicates improvement in patients.
    End point type
    Secondary
    End point timeframe
    Baseline and 12 weeks (Day 85)
    End point values
    		 CDZ173 Placebo
    Number of subjects analysed
    12
    9
    Units: total score
        least squares mean (standard error)
    -10.06 ± 6.584
    0.91 ± 7.699
    Statistical analysis title
    		 Change from Baseline in Physician VAS at Day 85
    Comparison groups
    CDZ173 v Placebo
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -10.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30.94
         upper limit
    		 9
    Variability estimate
    Standard error of the mean
    Dispersion value
    9.626

    Secondary: Change from Baseline in Patient's global assessment of their disease activity (VAS) after 12 weeks of treatment Day 85

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    End point title
    		 Change from Baseline in Patient's global assessment of their disease activity (VAS) after 12 weeks of treatment Day 85
    End point description
    A reduction from baseline (or, a negative change from baseline) in patient global VAS assessment score indicates improvement in patients.
    End point type
    Secondary
    End point timeframe
    Baseline and 12 weeks
    End point values
    		 CDZ173 Placebo
    Number of subjects analysed
    12
    9
    Units: total score
        least squares mean (standard error)
    -4.83 ± 7.268
    2.87 ± 8.412
    Statistical analysis title
    		 Change from Baseline in VAS at Day 85
    Comparison groups
    CDZ173 v Placebo
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -7.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29.75
         upper limit
    		 14.37
    Variability estimate
    Standard error of the mean
    Dispersion value
    10.595

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    70 mg CDZ173 bid
    Reporting group description
    		 70 mg CDZ173 bid

    Reporting group title
    Placebo bid
    Reporting group description
    		 Placebo bid

    Serious adverse events
    		 70 mg CDZ173 bid Placebo bid
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 70 mg CDZ173 bid Placebo bid
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 20 (95.00%)
    8 / 10 (80.00%)
    Vascular disorders
    Phlebitis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Headache
         subjects affected / exposed
    7 / 20 (35.00%)
    1 / 10 (10.00%)
         occurrences all number
    11
    3
    Paraesthesia
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    General disorders and administration site conditions
    Chest Discomfort
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 10 (10.00%)
         occurrences all number
    2
    2
    Chills
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    2 / 20 (10.00%)
    1 / 10 (10.00%)
         occurrences all number
    2
    1
    Feeling Cold
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Pyrexia
         subjects affected / exposed
    2 / 20 (10.00%)
    1 / 10 (10.00%)
         occurrences all number
    2
    1
    Eye disorders
    Dry Eye
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Abdominal Pain Upper
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Diarrhoea
         subjects affected / exposed
    5 / 20 (25.00%)
    1 / 10 (10.00%)
         occurrences all number
    7
    1
    Flatulence
         subjects affected / exposed
    1 / 20 (5.00%)
    3 / 10 (30.00%)
         occurrences all number
    5
    3
    Nausea
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Toothache
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Dyspnoea
         subjects affected / exposed
    3 / 20 (15.00%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Nasal Congestion
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Oropharyngeal Pain
         subjects affected / exposed
    3 / 20 (15.00%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Skin and subcutaneous tissue disorders
    Dry Skin
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    4
    0
    Eczema
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Hyperhidrosis
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Rash
         subjects affected / exposed
    10 / 20 (50.00%)
    1 / 10 (10.00%)
         occurrences all number
    13
    2
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Back Pain
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Sjogren's Syndrome
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Infected Bite
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Tooth Infection
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Upper Respiratory Tract Infection
         subjects affected / exposed
    3 / 20 (15.00%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Vaginal Infection
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    7 / 20 (35.00%)
    4 / 10 (40.00%)
         occurrences all number
    9
    5
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Sep 2016
    Amendment 1: The main purpose of this amendment was to include changes in contraceptive requirements based on results from drug-drug interaction study CCDZ173X2104 on hormonal contraception. Exclusion criterion #12 was modified to allow enrolment of women of child-bearing potential using hormonal contraception. In addition, changes were made in the Introduction, and Risks and Benefits sections to reflect the updates in the latest Investigator Brochure. Finally, specifications in inclusion and exclusion criteria, some minor changes, including clarifications on stopping rules, biomarkers assessments, infection monitoring, and typographical corrections, were made to the protocol.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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