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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2a Study Investigating the Efficacy, Safety, Pharmacokinetic and Biomarker Profiles of CKD-506 Administered to Adult Subjects with Moderate-to-Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate

    Summary
    EudraCT number
    		 2018-001377-24
    Trial protocol
    		 CZ  
    Global end of trial date
    29 Oct 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Oct 2020
    First version publication date
    15 Oct 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    182RA18009
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04204603
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Chong Kun Dang Pharmaceutical Corporation (CKD)
    Sponsor organisation address
    8, Chungjeong-ro, Seodaemun-gu, Seoul, Korea, Republic of, 03742
    Public contact
    Clinical Trials information, Chong Kun Dang Pharmaceutical Corporation (CKD), hky1@ckdpharm.com
    Scientific contact
    Clinical Trials information, Chong Kun Dang Pharmaceutical Corporation (CKD), hky1@ckdpharm.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
    29 Oct 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Oct 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the effects of CKD-506 on signs and symptoms of RA in subjects with moderate-to-severe RA who are inadequate responders to methotrexate.
    Protection of trial subjects
    Any medications, therapies, or procedures (other than those excluded by the clinical study protocol) that are considered necessary to protect subject welfare and will not interfere with the study treatment may be given at the Investigator’s discretion. Subjects must have read and understood the informed consent form (ICF) and sign it.
    Background therapy
    		 methotrexate (MTX)
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Nov 2018
    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
    Poland: 34
    Country: Number of subjects enrolled
    Czech Republic: 15
    Country: Number of subjects enrolled
    Georgia: 17
    Country: Number of subjects enrolled
    Russian Federation: 16
    Country: Number of subjects enrolled
    Ukraine: 40
    Worldwide total number of subjects
    122
    EEA total number of subjects
    49
    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)
    102
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Screening period was 28 days

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo once daily (QD) for 12 weeks
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablet administrated orally once daily (QD)

    Arm title
    		 CKD-506 200 mg QD
    Arm description
    		 CKD-506 200 mg once daily (QD) for 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    CKD-506
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    CKD-506 tablet administered orally once daily (QD)

    Arm title
    		 CKD-506 400 mg QD
    Arm description
    		 CKD-506 400mg once daily (QD) for 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    CKD-506
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    CKD-506 tablet administered orally once daily (QD)

    Arm title
    		 CKD-506 600 mg QD
    Arm description
    		 CKD-506 600 mg once daily (QD) for 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    CKD-506
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    CKD-506 tablet administered orally once daily (QD)

    Number of subjects in period 1
    		Placebo CKD-506 200 mg QD CKD-506 400 mg QD CKD-506 600 mg QD
    Started
    31
    31
    30
    30
    Completed
    30
    30
    30
    25
    Not completed
    1
    1
    0
    5
         Consent withdrawn by subject
    -
    1
    -
    2
         Adverse event, non-fatal
    -
    -
    -
    2
         Protocol deviation
    1
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo once daily (QD) for 12 weeks

    Reporting group title
    CKD-506 200 mg QD
    Reporting group description
    		 CKD-506 200 mg once daily (QD) for 12 weeks

    Reporting group title
    CKD-506 400 mg QD
    Reporting group description
    		 CKD-506 400mg once daily (QD) for 12 weeks

    Reporting group title
    CKD-506 600 mg QD
    Reporting group description
    		 CKD-506 600 mg once daily (QD) for 12 weeks

    Reporting group values
    		 Placebo CKD-506 200 mg QD CKD-506 400 mg QD CKD-506 600 mg QD Total
    Number of subjects
    		 31 31 30 30 122
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 27 26 24 25 102
        From 65-84 years
    		 4 5 6 5 20
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54.5 ( 10.57 ) 52.8 ( 9.76 ) 53.3 ( 10.80 ) 52.6 ( 13.87 ) -
    Gender categorical
    Units: Subjects
        Female
    		 22 24 26 23 95
        Male
    		 9 7 4 7 27
    Methotrexate dose prior to baseline
    Units: mg/week
        arithmetic mean (standard deviation)
    		 16.8 ( 3.02 ) 15.9 ( 2.13 ) 17.2 ( 3.85 ) 16.5 ( 3.75 ) -
    Duration of RA disease
    Units: years
        arithmetic mean (standard deviation)
    		 4.7 ( 4.2 ) 5.8 ( 6.1 ) 6.9 ( 4.6 ) 5.1 ( 5.0 ) -
    Subject analysis sets

    Subject analysis set title
    Safety anaylsis set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Safety analysis set defined as ll subjects in the RND set who have taken at least one dose of study treatment.

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full analysis set defined as all Safety analysis set subjects who have a baseline and at least one post-dose 28 joint count Disease Activity Score based on C-Reactive Protein [DAS28(CRP)] value.

    Subject analysis sets values
    		 Safety anaylsis set Full analysis set
    Number of subjects
    122
    121
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    102
    101
        From 65-84 years
    20
    20
        85 years and over
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    53.3 ( 11.22 )
    ( )
    Gender categorical
    Units: Subjects
        Female
    95
        Male
    27
    Methotrexate dose prior to baseline
    Units: mg/week
        arithmetic mean (standard deviation)
    16.6 ( 3.25 )
    ( )
    Duration of RA disease
    Units: years
        arithmetic mean (standard deviation)
    5.6 ( 5.0 )
    ( )

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo once daily (QD) for 12 weeks

    Reporting group title
    CKD-506 200 mg QD
    Reporting group description
    		 CKD-506 200 mg once daily (QD) for 12 weeks

    Reporting group title
    CKD-506 400 mg QD
    Reporting group description
    		 CKD-506 400mg once daily (QD) for 12 weeks

    Reporting group title
    CKD-506 600 mg QD
    Reporting group description
    		 CKD-506 600 mg once daily (QD) for 12 weeks

    Subject analysis set title
    Safety anaylsis set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Safety analysis set defined as ll subjects in the RND set who have taken at least one dose of study treatment.

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full analysis set defined as all Safety analysis set subjects who have a baseline and at least one post-dose 28 joint count Disease Activity Score based on C-Reactive Protein [DAS28(CRP)] value.

    Primary: Change from Baseline in the 28 joint count Disease Activity Score based on C-reactive protein (DAS28[CRP]) at Week 12

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    End point title
    		 Change from Baseline in the 28 joint count Disease Activity Score based on C-reactive protein (DAS28[CRP]) at Week 12
    End point description
    End point type
    Primary
    End point timeframe
    Baseline (Week 0) and Week 12
    End point values
    		 Placebo CKD-506 200 mg QD CKD-506 400 mg QD CKD-506 600 mg QD Full analysis set
    Number of subjects analysed
    31
    31
    30
    29
    121
    Units: score
        arithmetic mean (standard deviation)
    -1.2 ( 1.04 )
    -1.0 ( 1.11 )
    -1.3 ( 0.89 )
    -1.2 ( 1.07 )
    -1.2 ( 1.02 )
    Statistical analysis title
    		 the dose-response trend
    Comparison groups
    Placebo v CKD-506 200 mg QD v CKD-506 600 mg QD v CKD-506 400 mg QD
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 > 0.5 [1]
    Method
    		 Mixed models analysis
    Parameter type
    		 the dose-trend hypothesis
    Confidence interval
    Notes
    [1] - The estimate for the dose-trend hypothesis at Week 12 was -0.551.

    Secondary: Response to treatment based on the American College of Rheumatology 20% response criteria (ACR20) at Week 12

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    End point title
    		 Response to treatment based on the American College of Rheumatology 20% response criteria (ACR20) at Week 12
    End point description
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo CKD-506 200 mg QD CKD-506 400 mg QD CKD-506 600 mg QD Full analysis set
    Number of subjects analysed
    31
    31
    30
    29
    121
    Units: subject
    15
    16
    18
    16
    65
    No statistical analyses for this end point

    Secondary: Response to treatment based on the American College of Rheumatology 50% response criteria (ACR50) at Week 12

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    End point title
    		 Response to treatment based on the American College of Rheumatology 50% response criteria (ACR50) at Week 12
    End point description
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo CKD-506 200 mg QD CKD-506 400 mg QD CKD-506 600 mg QD Full analysis set
    Number of subjects analysed
    31
    31
    30
    29
    121
    Units: subject
    8
    8
    9
    9
    34
    No statistical analyses for this end point

    Secondary: Response to treatment based on the American College of Rheumatology 70% response criteria (ACR70)

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    End point title
    		 Response to treatment based on the American College of Rheumatology 70% response criteria (ACR70)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo CKD-506 200 mg QD CKD-506 400 mg QD CKD-506 600 mg QD Full analysis set
    Number of subjects analysed
    31
    31
    30
    29
    121
    Units: subject
    2
    1
    1
    3
    7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    TEAEs are defined as AEs that first occurred, or worsened in severity, after the first administration of study treatment and prior to 28 days (4 weeks) after the last administration of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo once daily (QD) for 12 weeks

    Reporting group title
    CKD-506 200 mg QD
    Reporting group description
    		 CKD-506 200 mg once daily (QD) for 12 weeks

    Reporting group title
    CKD-506 400 mg QD
    Reporting group description
    		 CKD-506 400mg once daily (QD) for 12 weeks

    Reporting group title
    CKD-506 600 mg QD
    Reporting group description
    		 CKD-506 600 mg once daily (QD) for 12 weeks

    Serious adverse events
    		 Placebo CKD-506 200 mg QD CKD-506 400 mg QD CKD-506 600 mg QD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo CKD-506 200 mg QD CKD-506 400 mg QD CKD-506 600 mg QD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 31 (25.81%)
    5 / 31 (16.13%)
    5 / 30 (16.67%)
    14 / 30 (46.67%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    0
    1
    Immune system disorders
    Allergy to plants
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 30 (3.33%)
    2 / 30 (6.67%)
         occurrences all number
    0
    0
    1
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 30 (3.33%)
    2 / 30 (6.67%)
         occurrences all number
    0
    0
    1
    2
    Gamma-glutamyl transferase increased
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 31 (3.23%)
    1 / 30 (3.33%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    1
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 31 (3.23%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    0
    1
    Blood cholesterol increased
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    0
    1
    Blood glucose increased
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 31 (3.23%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood triglycerides increased
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    0
    1
    Blood uric acid increased
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    0
    1
    Liver function test increased
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    0
    1
    Low-density lipoprotein increased
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    0
    1
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 31 (3.23%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    0
    1
    Platelet count decreased
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    0
    1
    White blood cell count decreased
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cardiac disorders
    Sinus tachycardia
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    0
    0
    2
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    0
    0
    1
    Leukocytosis
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    0
    1
    Monocytopenia
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    0
    0
    2
    Enterocolitis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Food poisoning
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 31 (3.23%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastritis
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal pain
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    0
    1
    Hepatobiliary disorders
    Liver disorder
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    2 / 30 (6.67%)
    0 / 30 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Rash
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    2
    0
    0
    1
    Arthralgia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    0
    0
    1
    Bone pain
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Joint swelling
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    0
    0
    1
    Bronchitis
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    0
    1
    Cystitis
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Onychomycosis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 31 (3.23%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Oral herpes
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Periodontitis
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Dyslipidaemia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hyperlipidaemia
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 31 (3.23%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    0
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Sep 2018
    Themain purpose of this amendment was to Remove double barrier contraception in Inclusion Criteria.
    26 Dec 2018
    The main purpose of this amendment was to update the secondary/exploratory endpoint and assessment schedule, rescreening informationand clarify study procedure.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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