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    Clinical Trial Results:
    A Phase II, dose ranging, multicentre, double-blind, placebo controlled study to evaluate safety and efficacy of (R)-roscovitine in subjects with Cystic Fibrosis, homozygous for the F508del-CFTR mutation and chronically infected with Pseudomonas aeruginosa, a study involving 34 CF patients (24 treated, 10 controls).

    Summary
    EudraCT number
    		 2015-002911-13
    Trial protocol
    		 FR  
    Global end of trial date
    26 Jul 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 May 2021
    First version publication date
    05 May 2021
    Other versions
    Summary report(s)
    		 Final report

    Trial information

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    Trial identification
    Sponsor protocol code
    RB15.098
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02649751
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CHRU de Brest
    Sponsor organisation address
    2, avenue Foch, Brest, France, 29 609
    Public contact
    Florence MORVAN, CHRU de Brest, 00 +33298223319, florence.morvan@chu-brest.fr
    Scientific contact
    Florence MORVAN, CHRU de Brest, 00 +33298223319, florence.morvan@chu-brest.fr
    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
    26 Jul 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Jul 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jul 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to assess the safety of increasing doses of roscovitine administered orally for 4 cycles of 4 consecutive days (treatment “on”) separated by a 3 days treatment free period (treatment “off”) in adult CF subjects who are homozygous for F508del mutation.
    Protection of trial subjects
    - unblinding procedure via the National Poisons Centre (PAC) in Lyon, available 24/24 - IDSMB - Emergency Medical support and Subject card
    Background therapy
    		 Information regarding all prior and concomitant treatment, including the subject’s CF medication (i.e. long term inhaled antibiotics), other medications (including over-the-counter medications, supplemental oxygen, and complementary/alternative medicines) and non-drug therapies (including physical therapy and blood transfusions), administered from 28 days before the Screening (V1) through the Safety Follow-Up visit (V8) will be recorded in each subject’s source documents and on the Concomitant medications/Significant non-drug therapies CRF. Information recorded will include indications for use, dosage, route and dates of administration. For subjects who are screened but are not subsequently randomized in the study, details of prior medication will only be documented in the subjects’ source documents.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Feb 2016
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 2 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 34
    Worldwide total number of subjects
    34
    EEA total number of subjects
    34
    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)
    34
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment in 12 French centres from February 22nd, 2016 to July 26th, 2018.

    Pre-assignment
    Screening details
    		 49 patients have been recruited and 34 patients were randomized and treated. 15 screen failures : 4 without Pseudomonas aeruginosa + 1 non-inclusion criteria not respected with antibiotic taking + 4 exacerbation with antibiotics taken + 1 with sporanox taken (forbidden treatment) + 2 with HB1AC > 8% + 2 with FEV around 28 % + 1 with ALAT> 1.5ULN

    Pre-assignment period milestones [1]
    Number of subjects started
    		 49 [2]
    Intermediate milestone: Number of subjects
    group 1: 12
    Intermediate milestone: Number of subjects
    group 2: 12
    Intermediate milestone: Number of subjects
    group 3: 10
    Number of subjects completed
    		 34

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Protocol deviation: 2
    Reason: Number of subjects
    		 Non randomization criteria: 13
    Notes
    [1] - The number of subjects at the milestone is less than the number that completed the pre-assignment period. It is expected the number of subjects at the milestones will be greater than, or equal to the number that completed the pre-assignment period.
    Justification: The protocol provided for the replacement of non-randomized subjects. 49 subjects were therefore included but it is not possible to indicate this in the trial information. 36 randomized subjects were expected but only 34 were randomized. 12/12 in the first dose group 12/12 in the second dose group 10/12 in the third group
    [2] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The protocol provided for the replacement of non-randomized subjects. 49 subjects were therefore included but it is not possible to indicate this in the trial information. 36 randomized subjects were expected but only 34 were randomized. 12/12 in the first dose group 12/12 in the second dose group 10/12 in the third group
    Period 1
    Period 1 title
    All experimental groups (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor
    Blinding implementation details
    Throughout the trial, the study medication kit number(s) of a subject is given by the number on the medication label. Patients, investigators and the steering committee will remain blinded as to which study drug is administered. In the event of an emergency, the investigator will follow the emergency procedure via the National Poisons Centre (PAC) in Lyon, available 24/24.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo was administered orally for 4 cycles of 4 consecutive days (treatment “on”) separated by a 3 days treatment free period (treatment “off”) every 7 days for 28 days Treatment was provided by oral administration of capsules

    Arm title
    		 Group 1 IMPD
    Arm description
    		 200mg of seliciclib
    Arm type
    		 Experimental

    Investigational medicinal product name
    Seliciclib (CYC202, R-ROSCOVITINE)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg doses of seliciclib were administered orally for 4 cycles of 4 consecutive days (treatment “on”) separated by a 3 days treatment free period (treatment “off”) every 7 days for 28 days Treatment was provided by oral administration of capsules

    Arm title
    		 Group 2 IMPD
    Arm description
    		 400 mg of seliciclib
    Arm type
    		 Experimental

    Investigational medicinal product name
    Seliciclib (CYC202, R-ROSCOVITINE)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg doses of seliciclib were administered orally for 4 cycles of 4 consecutive days (treatment “on”) separated by a 3 days treatment free period (treatment “off”) every 7 days for 28 days Treatment was provided by oral administration of capsules

    Arm title
    		 Group 3 IMPD
    Arm description
    		 800 mg of seliciclib
    Arm type
    		 Experimental

    Investigational medicinal product name
    Seliciclib (CYC202, R-ROSCOVITINE)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    800 mg doses of seliciclib were administered orally for 4 cycles of 4 consecutive days (treatment “on”) separated by a 3 days treatment free period (treatment “off”) every 7 days for 28 days Treatment was provided by oral administration of capsules

    Number of subjects in period 1
    		Placebo Group 1 IMPD Group 2 IMPD Group 3 IMPD
    Started
    11
    8
    8
    7
    Completed
    11
    6
    6
    4
    Not completed
    0
    2
    2
    3
         One capsule lost
    -
    1
    -
    -
         Adverse event, non-fatal
    -
    1
    2
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    Group 1 IMPD
    Reporting group description
    		 200mg of seliciclib

    Reporting group title
    Group 2 IMPD
    Reporting group description
    		 400 mg of seliciclib

    Reporting group title
    Group 3 IMPD
    Reporting group description
    		 800 mg of seliciclib

    Reporting group values
    		 Placebo Group 1 IMPD Group 2 IMPD Group 3 IMPD Total
    Number of subjects
    		 11 8 8 7 34
    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)
    		 11 8 8 7 34
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 33.82 (21 to 50) 34.75 (28 to 50) 31.75 (22 to 41) 37.00 (28 to 51) -
    Gender categorical
    Units: Subjects
        Female
    		 5 3 4 3 15
        Male
    		 6 5 4 4 19

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    Group 1 IMPD
    Reporting group description
    		 200mg of seliciclib

    Reporting group title
    Group 2 IMPD
    Reporting group description
    		 400 mg of seliciclib

    Reporting group title
    Group 3 IMPD
    Reporting group description
    		 800 mg of seliciclib

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomised patients

    Primary: Safety evaluation

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    End point title
    		 Safety evaluation [1]
    End point description
    Safety of seliciclib vs. placebo, measured by incidence and severity of higher grade treatment-emergent adverse event until Day 56.
    End point type
    Primary
    End point timeframe
    Day 56
    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: safety evaluation correspond to a specific endpoint, the result are presented in an endpoint section
    End point values
    		 Placebo Group 1 IMPD Group 2 IMPD Group 3 IMPD
    Number of subjects analysed
    11
    8
    8
    7
    Units: Number of adverse events
        AE Grade 1
    4
    4
    0
    1
        AE Grade 2
    7
    4
    6
    5
        AE Grade 3
    0
    0
    1
    1
        AE Grade 4
    0
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Pseudomonas aeruginosa (P.A.)

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    End point title
    		 Pseudomonas aeruginosa (P.A.)
    End point description
    End point type
    Secondary
    End point timeframe
    Change from Day 1 to Day 28 in Pseudomonas aeruginosa (P.A.) log-concentration
    End point values
    		 Placebo Group 1 IMPD Group 2 IMPD Group 3 IMPD
    Number of subjects analysed
    11
    8
    8
    7
    Units: log-concentrati(D28)-log-concentrati(D1)
        arithmetic mean (standard deviation)
    -0.09 ( 1.38 )
    -0.38 ( 0.74 )
    -0.50 ( 1.31 )
    0.57 ( 0.98 )
    Statistical analysis title
    		 ANOVA (Placebo vs. 200mg)
    Comparison groups
    Placebo v Group 1 IMPD
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.502
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 ANOVA (Placebo vs. 400mg)
    Comparison groups
    Placebo v Group 2 IMPD
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.463
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 ANOVA (Placebo vs. 800mg)
    Comparison groups
    Placebo v Group 3 IMPD
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.359
    Method
    		 ANOVA
    Confidence interval

    Secondary: C-reactive protein (CRP)

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    End point title
    		 C-reactive protein (CRP)
    End point description
    End point type
    Secondary
    End point timeframe
    Change from Day 1 to Day 28 in C-reactive protein (CRP)
    End point values
    		 Placebo Group 1 IMPD Group 2 IMPD Group 3 IMPD
    Number of subjects analysed
    11
    8
    8
    7
    Units: CRP(D28)-CRP(D1)
        arithmetic mean (standard deviation)
    -2.67 ( 20.09 )
    -1.74 ( 4.22 )
    -3.88 ( 9.92 )
    2.31 ( 16.79 )
    Statistical analysis title
    		 ANOVA (Placebo vs. 200mg)
    Comparison groups
    Placebo v Group 1 IMPD
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.362
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 ANOVA (Placebo vs. 400mg)
    Comparison groups
    Placebo v Group 2 IMPD
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.182
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 ANOVA (Placebo vs. 800mg)
    Comparison groups
    Group 3 IMPD v Placebo
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.81
    Method
    		 ANOVA
    Confidence interval

    Secondary: Forced expiratory volume in 1 second (FEV1)

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    End point title
    		 Forced expiratory volume in 1 second (FEV1)
    End point description
    End point type
    Secondary
    End point timeframe
    Change from Day 1 to Day 28 in Forced expiratory volume in 1 second (FEV1)
    End point values
    		 Placebo Group 1 IMPD Group 2 IMPD Group 3 IMPD
    Number of subjects analysed
    11
    8
    8
    7
    Units: FEV1(D28)-FEV1(D1)
        arithmetic mean (standard deviation)
    -0.27 ( 2.62 )
    0.03 ( 2.73 )
    -1.25 ( 6.48 )
    -0.29 ( 1.11 )
    Statistical analysis title
    		 ANOVA (Placebo vs. 200mg)
    Comparison groups
    Placebo v Group 1 IMPD
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.394
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 ANOVA (Placebo vs. 400mg)
    Comparison groups
    Group 2 IMPD v Placebo
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.681
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 ANOVA (Placebo vs. 800mg)
    Comparison groups
    Placebo v Group 3 IMPD
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.417
    Method
    		 ANOVA
    Confidence interval

    Secondary: Body mass index (BMI)

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    End point title
    		 Body mass index (BMI)
    End point description
    End point type
    Secondary
    End point timeframe
    Change from Day 1 to Day 28 in Body mass index (BMI)
    End point values
    		 Placebo Group 1 IMPD Group 2 IMPD Group 3 IMPD
    Number of subjects analysed
    11
    8
    8
    7
    Units: BMI(D28)-BMI(D1)
        arithmetic mean (standard deviation)
    0.20 ( 0.45 )
    -0.24 ( 0.29 )
    0.19 ( 0.48 )
    -0.05 ( 0.24 )
    Statistical analysis title
    		 ANOVA (Placebo vs. 200mg)
    Comparison groups
    Placebo v Group 1 IMPD
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.05
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 ANOVA (Placebo vs. 400mg)
    Comparison groups
    Placebo v Group 2 IMPD
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 ANOVA (Placebo vs. 800mg)
    Comparison groups
    Placebo v Group 3 IMPD
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.218
    Method
    		 ANOVA
    Confidence interval

    Secondary: Sweat Chloride Concentration

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    End point title
    		 Sweat Chloride Concentration
    End point description
    End point type
    Secondary
    End point timeframe
    Change from Day 1 to Day 28 in Sweat Chloride Concentration
    End point values
    		 Placebo Group 1 IMPD Group 2 IMPD Group 3 IMPD
    Number of subjects analysed
    11
    8
    8
    7
    Units: Concentration(D28)-Concentration(D1)
        arithmetic mean (standard deviation)
    1.09 ( 6.14 )
    -1.93 ( 9.78 )
    2.14 ( 10.21 )
    3.71 ( 3.83 )
    Statistical analysis title
    		 ANOVA (Placebo vs. 200mg)
    Comparison groups
    Placebo v Group 1 IMPD
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.332
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 ANOVA (Placebo vs. 400mg)
    Comparison groups
    Placebo v Group 2 IMPD
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.823
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 ANOVA (Placebo vs. 800mg)
    Comparison groups
    Placebo v Group 3 IMPD
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.451
    Method
    		 ANOVA
    Confidence interval

    Secondary: Cystic Fibrosis Questionnaire-Revised

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    End point title
    		 Cystic Fibrosis Questionnaire-Revised
    End point description
    End point type
    Secondary
    End point timeframe
    Change from Day 1 to Day 28 in Cystic Fibrosis Questionnaire-Revised (CFQ-R)
    End point values
    		 Placebo Group 1 IMPD Group 2 IMPD Group 3 IMPD
    Number of subjects analysed
    11
    8
    8
    7
    Units: D28-D1
    arithmetic mean (standard deviation)
        Perception of health status
    -4.13 ( 13.71 )
    -6.82 ( 9.41 )
    -1.14 ( 13.25 )
    -16.88 ( 25.94 )
        Weight
    3.03 ( 23.35 )
    8.33 ( 15.43 )
    4.17 ( 27.82 )
    -4.76 ( 12.60 )
        Digestive symptoms
    3.03 ( 16.36 )
    -2.08 ( 30.13 )
    4.17 ( 19.42 )
    -2.38 ( 15.00 )
        Respiratory symptoms
    3.97 ( 6.63 )
    10.12 ( 15.57 )
    2.38 ( 16.30 )
    -5.44 ( 13.86 )
        Energy
    -3.79 ( 17.23 )
    -3.13 ( 11.73 )
    -5.21 ( 16.63 )
    -11.90 ( 9.45 )
        Physical
    3.03 ( 15.93 )
    -2.60 ( 8.61 )
    -3.65 ( 12.68 )
    0.00 ( 10.21 )
        Psychic
    0.00 ( 15.49 )
    3.33 ( 11.27 )
    2.50 ( 10.65 )
    -7.62 ( 11.17 )
        Role
    -1.79 ( 4.72 )
    -6.25 ( 12.50 )
    0.00 ( 0.00 )
    -2.08 ( 9.41 )
        Social
    -6.82 ( 12.81 )
    2.08 ( 15.27 )
    5.21 ( 12.55 )
    -5.95 ( 9.27 )
        Food
    1.52 ( 11.68 )
    4.17 ( 7.72 )
    -4.17 ( 11.79 )
    -2.38 ( 6.30 )
        Body Image
    -3.03 ( 11.21 )
    5.56 ( 18.78 )
    5.56 ( 18.78 )
    4.76 ( 17.98 )
        Marginalisation
    1.01 ( 18.89 )
    9.72 ( 9.27 )
    1.39 ( 16.20 )
    0.00 ( 6.42 )
        Treatments
    -9.09 ( 15.57 )
    4.17 ( 7.72 )
    0.00 ( 8.91 )
    2.38 ( 6.30 )
    No statistical analyses for this end point

    Secondary: Cytokines

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    End point title
    		 Cytokines
    End point description
    End point type
    Secondary
    End point timeframe
    Change from Day 1 to Day 28 in Cytokines (log-transformed)
    End point values
    		 Placebo Group 1 IMPD Group 2 IMPD Group 3 IMPD
    Number of subjects analysed
    11
    8
    8
    7
    Units: D28-D1
    log mean (standard deviation)
        IL-1beta
    0.03 ( 0.07 )
    0.02 ( 0.09 )
    -0.16 ( 0.19 )
    0.11 ( 0.16 )
        IL-8
    0.14 ( 0.38 )
    -0.40 ( 0.36 )
    0.01 ( 0.30 )
    0.16 ( 0.33 )
        MDC
    0.04 ( 0.24 )
    0.03 ( 0.12 )
    -0.09 ( 0.16 )
    -0.09 ( 0.25 )
        MIP-1beta
    0.07 ( 0.24 )
    -0.05 ( 0.13 )
    -0.12 ( 0.19 )
    -0.21 ( 0.23 )
    Statistical analysis title
    		 IL-1Beta - ANOVA (Placebo vs. 200mg)
    Comparison groups
    Placebo v Group 1 IMPD
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.472
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 IL-1Beta - ANOVA (Placebo vs. 400mg)
    Comparison groups
    Placebo v Group 2 IMPD
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.012
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 IL-1Beta - ANOVA (Placebo vs. 800mg)
    Comparison groups
    Group 3 IMPD v Placebo
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.762
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 IL-8 - ANOVA (Placebo vs. 200mg)
    Comparison groups
    Placebo v Group 1 IMPD
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.02
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 IL-8 - ANOVA (Placebo vs. 400mg)
    Comparison groups
    Placebo v Group 2 IMPD
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.631
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 IL-8 - ANOVA (Placebo vs. 800mg)
    Comparison groups
    Placebo v Group 3 IMPD
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 MDC - ANOVA (Placebo vs. 200mg)
    Comparison groups
    Placebo v Group 1 IMPD
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.368
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 MDC - ANOVA (Placebo vs. 400mg)
    Comparison groups
    Placebo v Group 2 IMPD
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.044
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 MDC - ANOVA (Placebo vs. 800mg)
    Comparison groups
    Placebo v Group 3 IMPD
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.316
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 MIP-1beta - ANOVA (Placebo vs. 200mg)
    Comparison groups
    Placebo v Group 1 IMPD
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.15
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 MIP-1beta - ANOVA (Placebo vs. 400mg)
    Comparison groups
    Placebo v Group 2 IMPD
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.052
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 MIP-1beta - ANOVA (Placebo vs. 800mg)
    Comparison groups
    Placebo v Group 3 IMPD
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.05
    Method
    		 ANOVA
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse event was recorded during all study duration. In case of unexpected withdrawal from the study, adverse event was recorded at least 28 days after the last treatment administration.
    Adverse event reporting additional description
    A regular investigator assessment was made by the investigator at each visit and a regular laboratory testing was done.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: safety evaluation correspond to a specific endpoint, the result are presented in an endpoint section

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Nov 2015
    Modification of the inclusion criteria about genotype + title modification
    08 Dec 2015
    Addition of a pain questionnaire + revalorization of the patient allowance + protocol update following with ANSM's remarks
    05 Jan 2016
    Update of the insurance company
    02 Feb 2016
    Summary corrections at the request of the coordinator + modifications of the safety paragraph following the first CSI meeting + modification of the evaluation schedule.
    05 Apr 2016
    Modifications of the centers and investigators list
    04 Oct 2016
    Modifications of the centers and investigators list
    13 Dec 2016
    Modifications of the centers and investigators list
    02 May 2017
    Modifications of the centers and investigators list
    05 Sep 2017
    Increase of the period of inclusion + possibility to recruit patients who had participated in previous groups
    09 Jan 2018
    Modifications of the consent letter + modifications of the exclusion criteria (hepatic criteria) and more controls of hepatic monitoring + modifications of investigators list

    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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