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    Clinical Trial Results:
    A Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CC-99677 in Subjects with Active Ankylosing Spondylitis

    Summary
    EudraCT number
    		 2019-004108-37
    Trial protocol
    		 DE   CZ   PL  
    Global end of trial date
    21 Feb 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Mar 2024
    First version publication date
    08 Mar 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CC-99677-AS-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.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
    16 May 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Feb 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Evaluate the Efficacy and Safety of CC-99677 in Subjects with Active Ankylosing Spondylitis
    Protection of trial subjects
    he study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial participants were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Aug 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
    China: 1
    Country: Number of subjects enrolled
    Czechia: 45
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    Poland: 90
    Country: Number of subjects enrolled
    Romania: 1
    Country: Number of subjects enrolled
    Spain: 15
    Country: Number of subjects enrolled
    Türkiye: 7
    Country: Number of subjects enrolled
    United States: 3
    Worldwide total number of subjects
    167
    EEA total number of subjects
    156
    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)
    166
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 167 participants treated

    Period 1
    Period 1 title
    Week 0 - Week 12 (Placebo-Controlled)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo Biologic Naive
    Arm description
    		 Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
    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
    QD PO

    Arm title
    		 CC-99677 60 mg Biologic Naive
    Arm description
    		 CC-99677 60 mg Biologic Naive QD PO
    Arm type
    		 Experimental

    Investigational medicinal product name
    CC-99677
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    60 mg QD PO

    Arm title
    		 CC-99677 150 mg Biologic Naive
    Arm description
    		 CC-99677 150 mg Biologic Naive QD PO
    Arm type
    		 Experimental

    Investigational medicinal product name
    CC-99677
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    150 mg QD PO

    Arm title
    		 Placebo Biologic Failure
    Arm description
    		 Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
    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
    QD PO

    Arm title
    		 CC-99677 60 mg Biologic Failure
    Arm description
    		 CC-99677 60 mg Biologic Failure QD PO
    Arm type
    		 Experimental

    Investigational medicinal product name
    CC-99677
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    60 mg QD PO

    Arm title
    		 CC-99677 150 mg Biologic Failure
    Arm description
    		 CC-99677 150 mg Biologic Failure QD PO
    Arm type
    		 Experimental

    Investigational medicinal product name
    CC-99677
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    150 mg QD PO

    Number of subjects in period 1
    		Placebo Biologic Naive CC-99677 60 mg Biologic Naive CC-99677 150 mg Biologic Naive Placebo Biologic Failure CC-99677 60 mg Biologic Failure CC-99677 150 mg Biologic Failure
    Started
    49
    49
    49
    5
    7
    8
    Completed
    42
    42
    39
    3
    5
    7
    Not completed
    7
    7
    10
    2
    2
    1
         Consent withdrawn by subject
    1
    1
    2
    -
    2
    -
         Protocol Deviation
    1
    -
    -
    -
    -
    -
         Adverse event, non-fatal
    -
    -
    -
    1
    -
    -
         Study terminated by sponsor
    5
    6
    7
    1
    -
    1
         Other reasons
    -
    -
    1
    -
    -
    -
    Period 2
    Period 2 title
    Week 12 - Week 52 (Long-Term Extension)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo Biologic Naive
    Arm description
    		 Placebo Biologic Naive QD PO
    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
    QD PO

    Arm title
    		 CC-99677 60 mg Biologic Naive
    Arm description
    		 CC-99677 60 mg Biologic Naive QD PO
    Arm type
    		 Experimental

    Investigational medicinal product name
    CC-99677
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    60 mg QD PO

    Arm title
    		 CC-99677 150 mg Biologic Naive
    Arm description
    		 CC-99677 150 mg Biologic Naive QD PO
    Arm type
    		 Experimental

    Investigational medicinal product name
    CC-99677
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    150 mg QD PO

    Arm title
    		 Placebo Biologic Failure
    Arm description
    		 Placebo Biologic Failure QD PO
    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
    QD PO

    Arm title
    		 CC-99677 60 mg Biologic Failure
    Arm description
    		 CC-99677 60 mg Biologic Failure QD PO
    Arm type
    		 Experimental

    Investigational medicinal product name
    CC-99677
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    60 mg QD PO

    Arm title
    		 CC-99677 150 mg Biologic Failure
    Arm description
    		 CC-99677 150 mg Biologic Failure QD PO
    Arm type
    		 Experimental

    Investigational medicinal product name
    CC-99677
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    150 mg QD PO

    Number of subjects in period 2
    		Placebo Biologic Naive CC-99677 60 mg Biologic Naive CC-99677 150 mg Biologic Naive Placebo Biologic Failure CC-99677 60 mg Biologic Failure CC-99677 150 mg Biologic Failure
    Started
    42
    42
    39
    3
    5
    7
    Re-randomized to CC-99677 60 mg
    21
    0
    0 [1]
    2
    0
    0
    Re-randomized to CC-99677 150 mg
    21
    0
    0 [2]
    1
    0
    0
    Completed
    1
    0
    1
    0
    0
    0
    Not completed
    41
    42
    38
    3
    5
    7
         Adverse event, serious fatal
    1
    -
    -
    -
    -
    -
         Consent withdrawn by subject
    2
    1
    3
    1
    1
    2
         Adverse event, non-fatal
    -
    1
    -
    -
    -
    1
         Study terminated by sponsor
    34
    35
    30
    1
    4
    4
         Other reasons
    3
    5
    5
    1
    -
    -
         Lost to follow-up
    1
    -
    -
    -
    -
    -
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Only participants from the placebo group are re-randomized
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Only participants from the placebo group are re-randomized

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo Biologic Naive
    Reporting group description
    		 Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation

    Reporting group title
    CC-99677 60 mg Biologic Naive
    Reporting group description
    		 CC-99677 60 mg Biologic Naive QD PO

    Reporting group title
    CC-99677 150 mg Biologic Naive
    Reporting group description
    		 CC-99677 150 mg Biologic Naive QD PO

    Reporting group title
    Placebo Biologic Failure
    Reporting group description
    		 Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation

    Reporting group title
    CC-99677 60 mg Biologic Failure
    Reporting group description
    		 CC-99677 60 mg Biologic Failure QD PO

    Reporting group title
    CC-99677 150 mg Biologic Failure
    Reporting group description
    		 CC-99677 150 mg Biologic Failure QD PO

    Reporting group values
    		 Placebo Biologic Naive CC-99677 60 mg Biologic Naive CC-99677 150 mg Biologic Naive Placebo Biologic Failure CC-99677 60 mg Biologic Failure CC-99677 150 mg Biologic Failure Total
    Number of subjects
    		 49 49 49 5 7 8 167
    Age categorical
    Units:
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44.1 ( 10.27 ) 40.5 ( 11.78 ) 40.4 ( 9.75 ) 43.8 ( 7.16 ) 44.4 ( 10.06 ) 42.5 ( 9.46 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 8 6 12 1 1 0 28
        Male
    		 41 43 37 4 6 8 139
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 1 0 0 0 0 1
        Asian
    		 1 0 1 0 0 0 2
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0 0
        Black or African American
    		 0 0 0 0 0 0 0
        White
    		 48 48 48 5 7 8 164
        More than one race
    		 0 0 0 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 2 2 0 0 0 0 4
        Not Hispanic or Latino
    		 47 47 49 5 7 8 163
        Unknown or Not Reported
    		 0 0 0 0 0 0 0

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Placebo Biologic Naive
    Reporting group description
    		 Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation

    Reporting group title
    CC-99677 60 mg Biologic Naive
    Reporting group description
    		 CC-99677 60 mg Biologic Naive QD PO

    Reporting group title
    CC-99677 150 mg Biologic Naive
    Reporting group description
    		 CC-99677 150 mg Biologic Naive QD PO

    Reporting group title
    Placebo Biologic Failure
    Reporting group description
    		 Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation

    Reporting group title
    CC-99677 60 mg Biologic Failure
    Reporting group description
    		 CC-99677 60 mg Biologic Failure QD PO

    Reporting group title
    CC-99677 150 mg Biologic Failure
    Reporting group description
    		 CC-99677 150 mg Biologic Failure QD PO
    Reporting group title
    Placebo Biologic Naive
    Reporting group description
    		 Placebo Biologic Naive QD PO

    Reporting group title
    CC-99677 60 mg Biologic Naive
    Reporting group description
    		 CC-99677 60 mg Biologic Naive QD PO

    Reporting group title
    CC-99677 150 mg Biologic Naive
    Reporting group description
    		 CC-99677 150 mg Biologic Naive QD PO

    Reporting group title
    Placebo Biologic Failure
    Reporting group description
    		 Placebo Biologic Failure QD PO

    Reporting group title
    CC-99677 60 mg Biologic Failure
    Reporting group description
    		 CC-99677 60 mg Biologic Failure QD PO

    Reporting group title
    CC-99677 150 mg Biologic Failure
    Reporting group description
    		 CC-99677 150 mg Biologic Failure QD PO

    Primary: Percentage of Participants who Achieve ASAS 20 at Week 12

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    End point title
    		 Percentage of Participants who Achieve ASAS 20 at Week 12
    End point description
    Percentage of participants who achieve an improvement in disease activity from baseline of ≥ 20% and ≥ 1 unit in at least 3 of the 4 SpondyloArthritis International Society (ASAS) domains on a scale of 0 to 10, and no worsening from baseline of ≥ 20% and ≥ 1 unit in the remaining domain on a scale of 0 to 10. Baseline is the last non-missing value on or before the date of the first dose of investigational product. The four ASAS Domains are: – Patient Global Assessment of Disease (0 to 10 unit Numerical Rating Scale [NRS]); – Total Back Pain NRS; – Function (the Bath Ankylosing Spondylitis Functional Index [BASFI] score NRS); – Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] NRS Questions #5 and #6 for morning stiffness).
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 Placebo Biologic Naive CC-99677 60 mg Biologic Naive CC-99677 150 mg Biologic Naive Placebo Biologic Failure CC-99677 60 mg Biologic Failure CC-99677 150 mg Biologic Failure
    Number of subjects analysed
    41
    43
    41
    3
    6
    7
    Units: Percentage of Participants
        number (not applicable)
    48.8
    51.2
    56.1
    66.7
    83.3
    57.1
    Statistical analysis title
    		 CC-99677 150 mg - Placebo
    Comparison groups
    Placebo Biologic Naive v CC-99677 150 mg Biologic Naive
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.512
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Stratified difference
    Point estimate
    7.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.8
         upper limit
    		 27.5
    Statistical analysis title
    		 CC-99677 60 mg - Placebo
    Comparison groups
    Placebo Biologic Naive v CC-99677 60 mg Biologic Naive
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.829
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Stratified difference
    Point estimate
    2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.2
         upper limit
    		 22.7

    Secondary: Percentage of Participants who Achieve ASAS 40 at Week 12

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    End point title
    		 Percentage of Participants who Achieve ASAS 40 at Week 12
    End point description
    Percentage of participants who achieve an improvement in disease activity from baseline of ≥ 40% and ≥ 2 unit in at least 3 of the 4 SpondyloArthritis International Society (ASAS) domains on a scale of 0 to 10, and no worsening at all from baseline in the remaining domain. Baseline is the last non-missing value on or before the date of the first dose of investigational product. The four ASAS Domains are: – Patient Global Assessment of Disease (0 to 10 unit Numerical Rating Scale [NRS]); – Total Back Pain NRS; – Function (the Bath Ankylosing Spondylitis Functional Index [BASFI] score NRS); – Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] NRS Questions #5 and #6 for morning stiffness).
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo Biologic Naive CC-99677 60 mg Biologic Naive CC-99677 150 mg Biologic Naive Placebo Biologic Failure CC-99677 60 mg Biologic Failure CC-99677 150 mg Biologic Failure
    Number of subjects analysed
    41
    43
    41
    3
    6
    7
    Units: Percentage of Participants
        number (not applicable)
    22.0
    25.6
    34.1
    33.3
    50.0
    28.6
    Statistical analysis title
    		 CC-99677 150 mg - Placebo
    Comparison groups
    Placebo Biologic Naive v CC-99677 150 mg Biologic Naive
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.219
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Stratfied difference
    Point estimate
    12.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.2
         upper limit
    		 30.5
    Statistical analysis title
    		 CC-99677 60 mg - Placebo
    Comparison groups
    Placebo Biologic Naive v CC-99677 60 mg Biologic Naive
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.725
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Stratified difference
    Point estimate
    3.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.9
         upper limit
    		 21

    Secondary: Change from Baseline in Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP) at Week 12

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    End point title
    		 Change from Baseline in Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP) at Week 12
    End point description
    ASDAS-CRP is a score of disease activity that combines patient reported assessments of back pain (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] question 2), duration of morning stiffness (BASDAI question 6), peripheral joint pain and/or swelling (BASDAI question 3), general wellbeing, and CRP in a weighted manner. The cut-off values for disease activity states and improvement scores are defined as follows: <1.3 inactive disease, ≥1.3 and <2.1 low disease activity, ≥2.1 and ≤3.5 high disease activity and 3.5 very high disease activity. The minimum clinically important difference (MCID) are defined as: change of at least 1.1 unit for ‘clinically important improvement’ and change of at least 2.0 units for ‘major improvement’. Baseline is the last non-missing value on or before the date of the first dose of investigational product. ASDAS-CRP Formula: 0.12xBack Pain+0.06xDuration of Morning Stiffness+0.11xPatient Global+0.07xPeripheral Pain/Swelling+0.58xln(CRP+1)
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Placebo Biologic Naive CC-99677 60 mg Biologic Naive CC-99677 150 mg Biologic Naive Placebo Biologic Failure CC-99677 60 mg Biologic Failure CC-99677 150 mg Biologic Failure
    Number of subjects analysed
    40
    43
    41
    3
    5
    7
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -0.69 ( 0.856 )
    -0.87 ( 0.681 )
    -0.80 ( 0.869 )
    -0.84 ( 0.621 )
    -1.02 ( 0.464 )
    -0.44 ( 0.323 )
    Statistical analysis title
    		 CC-99677 150 mg - Placebo
    Comparison groups
    Placebo Biologic Naive v CC-99677 150 mg Biologic Naive
    Number of subjects included in analysis
    81
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.488
    Method
    		 Longitudinal data analysis model
    Parameter type
    		 Difference in Adjusted Means
    Point estimate
    -0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.45
         upper limit
    		 0.22
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.168
    Statistical analysis title
    		 CC-99677 60 mg - Placebo
    Comparison groups
    Placebo Biologic Naive v CC-99677 60 mg Biologic Naive
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.299
    Method
    		 Longitudinal data analysis model
    Parameter type
    		 Difference in Adjusted Means
    Point estimate
    -0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 0.16
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.167

    Secondary: Change from Baseline in BASDAI at Week 12

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    End point title
    		 Change from Baseline in BASDAI at Week 12
    End point description
    Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a composite score based on a self-administered survey of six questions using a 0 to 10 unit numerical rating scale (NRS) that assesses five major symptoms of AS during the last week: 1) fatigue; 2) spinal pain; 3) peripheral joint pain/swelling; 4) areas of localized tenderness; 5a) morning stiffness severity upon wakening; 5b) morning stiffness duration upon wakening. To give each of the five symptoms equal weighting, the mean of the two scores relating to morning stiffness is taken. The resulting 0 to 50 score is divided by 5 to give a final 0 to 10 BASDAI score. A BASDAI score of 4 or greater is considered to be indicative of active AS disease. Baseline is the last non-missing value on or before the date of the first dose of investigational product.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Placebo Biologic Naive CC-99677 60 mg Biologic Naive CC-99677 150 mg Biologic Naive Placebo Biologic Failure CC-99677 60 mg Biologic Failure CC-99677 150 mg Biologic Failure
    Number of subjects analysed
    43
    43
    41
    3
    6
    7
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -1.88 ( 1.862 )
    -1.96 ( 1.494 )
    -2.03 ( 2.080 )
    -1.63 ( 0.651 )
    -2.20 ( 1.394 )
    -1.43 ( 1.517 )
    Statistical analysis title
    		 CC-99677 150 mg - Placebo
    Comparison groups
    Placebo Biologic Naive v CC-99677 150 mg Biologic Naive
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.668
    Method
    		 Longitudinal data analysis model
    Parameter type
    		 Difference in Adjusted Means
    Point estimate
    -0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.95
         upper limit
    		 0.61
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.393
    Statistical analysis title
    		 CC-99677 60 mg - Placebo
    Comparison groups
    Placebo Biologic Naive v CC-99677 60 mg Biologic Naive
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.97
    Method
    		 Longitudinal data analysis model
    Parameter type
    		 Difference in Adjusted Means
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.76
         upper limit
    		 0.79
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.391

    Secondary: Change from Baseline in BASFI at Week 12

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    End point title
    		 Change from Baseline in BASFI at Week 12
    End point description
    Bath Ankylosing Spondylitis Functional Index (BASFI) is a composite score based on a self administered survey of ten questions using a 0 to 10 unit numerical rating scale (NRS) that assesses degree of mobility and functional ability during the last week. The questionnaire consists of eight questions regarding function in AS and the two last questions reflecting ability to cope with everyday life. The left-hand box of 0 represents “easy,” and the right-hand box represents "impossible.” The resulting 0 to 100 score is divided by 10 to give a final 0 to 10 BASFI score. A higher BASFI score correlates to reduced functional ability. Baseline is the last non-missing value on or before the date of the first dose of investigational product.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Placebo Biologic Naive CC-99677 60 mg Biologic Naive CC-99677 150 mg Biologic Naive Placebo Biologic Failure CC-99677 60 mg Biologic Failure CC-99677 150 mg Biologic Failure
    Number of subjects analysed
    41
    43
    41
    3
    6
    7
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -1.22 ( 1.727 )
    -1.33 ( 1.985 )
    -1.28 ( 2.542 )
    -1.77 ( 0.850 )
    -1.47 ( 1.841 )
    -1.29 ( 0.703 )
    Statistical analysis title
    		 CC-99677 150 mg - Placebo
    Comparison groups
    Placebo Biologic Naive v CC-99677 150 mg Biologic Naive
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.545
    Method
    		 Longitudinal data analysis model
    Parameter type
    		 Difference in Adjusted Means
    Point estimate
    0.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.57
         upper limit
    		 1.08
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.417
    Statistical analysis title
    		 CC-99677 60 mg - Placebo
    Comparison groups
    Placebo Biologic Naive v CC-99677 60 mg Biologic Naive
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.89
    Method
    		 Longitudinal data analysis model
    Parameter type
    		 Difference in Adjusted Means
    Point estimate
    0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.77
         upper limit
    		 0.88
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.416

    Secondary: Change from Baseline in the SPARCC SI Joint Score at Week 12

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    End point title
    		 Change from Baseline in the SPARCC SI Joint Score at Week 12
    End point description
    Change from Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) scores of the sacroiliac joints. The SPARCC assesses 16 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include Medial epicondyle (left/right [L/R]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis. Baseline is the last non-missing value on or before the date of the first dose of investigational product.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Placebo Biologic Naive CC-99677 60 mg Biologic Naive CC-99677 150 mg Biologic Naive Placebo Biologic Failure CC-99677 60 mg Biologic Failure CC-99677 150 mg Biologic Failure
    Number of subjects analysed
    38
    43
    39
    3
    5
    7
    Units: Units on a scale
        arithmetic mean (standard deviation)
    0.25 ( 3.168 )
    -0.81 ( 5.453 )
    -1.72 ( 6.084 )
    -0.17 ( 1.258 )
    -3.00 ( 7.608 )
    -3.00 ( 4.093 )
    Statistical analysis title
    		 CC-99677 150 mg - Placebo
    Comparison groups
    Placebo Biologic Naive v CC-99677 150 mg Biologic Naive
    Number of subjects included in analysis
    77
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.33
    Method
    		 Longitudinal data analysis model
    Parameter type
    		 Difference in Adjusted Means
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.02
         upper limit
    		 1.03
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.022
    Statistical analysis title
    		 CC-99677 60 mg - Placebo
    Comparison groups
    Placebo Biologic Naive v CC-99677 60 mg Biologic Naive
    Number of subjects included in analysis
    81
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.778
    Method
    		 Longitudinal data analysis model
    Parameter type
    		 Difference in Adjusted Means
    Point estimate
    -0.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.26
         upper limit
    		 1.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.999

    Secondary: Change from Baseline in the SPARCC Spine Score at Week 12

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    End point title
    		 Change from Baseline in the SPARCC Spine Score at Week 12
    End point description
    Change from Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) scores of the total spine. All 23 disco-vertebral units (DVU) of the spine (from C2 to S1) were scored for bone marrow edema. A single DVU has 18 scoring units, and each has score of 0 or 1, bringing the maximum total score to 414, the sum ranges from 0 to 414 with higher scores reflecting worse disease. Baseline is the last non-missing value on or before the date of the first dose of investigational product.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Placebo Biologic Naive CC-99677 60 mg Biologic Naive CC-99677 150 mg Biologic Naive Placebo Biologic Failure CC-99677 60 mg Biologic Failure CC-99677 150 mg Biologic Failure
    Number of subjects analysed
    38
    43
    39
    3
    5
    7
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -0.92 ( 7.557 )
    -1.53 ( 8.331 )
    -1.86 ( 7.081 )
    -8.17 ( 7.371 )
    -2.40 ( 5.128 )
    -2.71 ( 8.640 )
    Statistical analysis title
    		 CC-99677 60 mg - Placebo
    Comparison groups
    Placebo Biologic Naive v CC-99677 60 mg Biologic Naive
    Number of subjects included in analysis
    81
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.6
    Method
    		 Longitudinal data analysis model
    Parameter type
    		 Difference in Adjusted Means
    Point estimate
    -0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.93
         upper limit
    		 2.28
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.567
    Statistical analysis title
    		 CC-99677 150 mg - Placebo
    Comparison groups
    Placebo Biologic Naive v CC-99677 150 mg Biologic Naive
    Number of subjects included in analysis
    77
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.416
    Method
    		 Longitudinal data analysis model
    Parameter type
    		 Difference in Adjusted Means
    Point estimate
    -1.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.49
         upper limit
    		 1.87
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.605

    Secondary: Percent Change from Baseline in hsCRP at Week 12

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    End point title
    		 Percent Change from Baseline in hsCRP at Week 12
    End point description
    Percent change from baseline in high-sensitivity C-reactive protein (hsCRP). Baseline is the last non-missing value on or before the date of the first dose of investigational product.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Placebo Biologic Naive CC-99677 60 mg Biologic Naive CC-99677 150 mg Biologic Naive Placebo Biologic Failure CC-99677 60 mg Biologic Failure CC-99677 150 mg Biologic Failure
    Number of subjects analysed
    42
    43
    41
    3
    5
    7
    Units: mg/L
        arithmetic mean (standard deviation)
    72.83 ( 474.199 )
    -1.43 ( 64.157 )
    20.88 ( 130.181 )
    -13.68 ( 55.618 )
    8.52 ( 66.057 )
    452.34 ( 1226.664 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Participants were assessed for deaths (all-causes) from their first dose to their study completion (Up to approximately 17 months). SAEs and NSAEs were assessed from first dose up to 28 days post last dose (Up to approximately 4 months).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    CC-99677 150 mg Biologic Naive
    Reporting group description
    		 CC-99677 150 mg Biologic Naive QD PO only

    Reporting group title
    CC-99677 60 mg Biologic Naive
    Reporting group description
    		 CC-99677 60 mg Biologic Naive QD PO only

    Reporting group title
    Placebo Biologic Naive
    Reporting group description
    		 Placebo Biologic Naive QD PO only

    Reporting group title
    Placebo to CC-99677 150 mg Biologic Naive
    Reporting group description
    		 Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 150 mg PO QD through Week 64 or until early discontinuation

    Reporting group title
    Placebo to CC-99677 60 mg Biologic Failure
    Reporting group description
    		 Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 60 mg PO QD through Week 64 or until early discontinuation

    Reporting group title
    CC-99677 150 mg Biologic Failure
    Reporting group description
    		 CC-99677 150 mg Biologic Failure QD PO

    Reporting group title
    CC-99677 60 mg Biologic Failure
    Reporting group description
    		 CC-99677 60 mg Biologic Failure QD PO

    Reporting group title
    Placebo Biologic Failure
    Reporting group description
    		 Placebo Biologic Failure QD PO

    Reporting group title
    Placebo to CC-99677 150 mg Biologic Failure
    Reporting group description
    		 Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 150 mg PO QD through Week 64 or until early discontinuation

    Reporting group title
    Placebo to CC-99677 60 mg Biologic Naive
    Reporting group description
    		 Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 60 mg PO QD through Week 64 or until early discontinuation

    Serious adverse events
    		 CC-99677 150 mg Biologic Naive CC-99677 60 mg Biologic Naive Placebo Biologic Naive Placebo to CC-99677 150 mg Biologic Naive Placebo to CC-99677 60 mg Biologic Failure CC-99677 150 mg Biologic Failure CC-99677 60 mg Biologic Failure Placebo Biologic Failure Placebo to CC-99677 150 mg Biologic Failure Placebo to CC-99677 60 mg Biologic Naive
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    1 / 7 (14.29%)
    3 / 21 (14.29%)
    0 / 2 (0.00%)
    3 / 8 (37.50%)
    0 / 7 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to peritoneum
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 7 (0.00%)
    1 / 21 (4.76%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Clavicle fracture
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 7 (0.00%)
    1 / 21 (4.76%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 7 (0.00%)
    1 / 21 (4.76%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    1 / 7 (14.29%)
    0 / 21 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Psychotic disorder
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Oral candidiasis
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 CC-99677 150 mg Biologic Naive CC-99677 60 mg Biologic Naive Placebo Biologic Naive Placebo to CC-99677 150 mg Biologic Naive Placebo to CC-99677 60 mg Biologic Failure CC-99677 150 mg Biologic Failure CC-99677 60 mg Biologic Failure Placebo Biologic Failure Placebo to CC-99677 150 mg Biologic Failure Placebo to CC-99677 60 mg Biologic Naive
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 49 (22.45%)
    26 / 49 (53.06%)
    0 / 7 (0.00%)
    8 / 21 (38.10%)
    1 / 2 (50.00%)
    6 / 8 (75.00%)
    4 / 7 (57.14%)
    1 / 2 (50.00%)
    1 / 1 (100.00%)
    7 / 21 (33.33%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 49 (0.00%)
    2 / 49 (4.08%)
    0 / 7 (0.00%)
    1 / 21 (4.76%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    0
    0
    1
    0
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 49 (2.04%)
    3 / 49 (6.12%)
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    1
    3
    0
    0
    0
    0
    0
    1
    0
    1
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 49 (2.04%)
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    Transaminases increased
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 7 (0.00%)
    1 / 21 (4.76%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Rib fracture
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 49 (2.04%)
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    1 / 7 (14.29%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    1
    1
    0
    0
    0
    Radiculopathy
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Headache
         subjects affected / exposed
    2 / 49 (4.08%)
    3 / 49 (6.12%)
    0 / 7 (0.00%)
    2 / 21 (9.52%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    2
    3
    0
    2
    0
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 49 (2.04%)
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    0
    1
    Eye disorders
    Swelling of eyelid
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Iridocyclitis
         subjects affected / exposed
    0 / 49 (0.00%)
    3 / 49 (6.12%)
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    4
    0
    0
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Aphthous ulcer
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 49 (2.04%)
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    2
    0
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 49 (2.04%)
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Pneumothorax
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    5
    0
    0
    0
    0
    Psychiatric disorders
    Depressed mood
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Ankylosing spondylitis
         subjects affected / exposed
    0 / 49 (0.00%)
    2 / 49 (4.08%)
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    1
    0
    0
    0
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    2 / 49 (4.08%)
    8 / 49 (16.33%)
    0 / 7 (0.00%)
    1 / 21 (4.76%)
    0 / 2 (0.00%)
    2 / 8 (25.00%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    1 / 1 (100.00%)
    4 / 21 (19.05%)
         occurrences all number
    2
    8
    0
    1
    0
    2
    0
    0
    1
    4
    Genital candidiasis
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Gingivitis
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 49 (2.04%)
    0 / 7 (0.00%)
    1 / 21 (4.76%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    1
    0
    0
    0
    Laryngitis
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    4 / 49 (8.16%)
    3 / 49 (6.12%)
    0 / 7 (0.00%)
    1 / 21 (4.76%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    5
    3
    0
    1
    0
    1
    0
    0
    0
    1
    Oral candidiasis
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Otitis media
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Pharyngitis
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 49 (0.00%)
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    2
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 49 (2.04%)
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    0
    1
    Pulpitis dental
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Rhinitis
         subjects affected / exposed
    2 / 49 (4.08%)
    1 / 49 (2.04%)
    0 / 7 (0.00%)
    2 / 21 (9.52%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    4
    1
    0
    2
    0
    0
    0
    0
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 7 (0.00%)
    0 / 21 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Viral infection
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 49 (2.04%)
    0 / 7 (0.00%)
    1 / 21 (4.76%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    2 / 7 (28.57%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    0
    2
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 49 (0.00%)
    6 / 49 (12.24%)
    0 / 7 (0.00%)
    2 / 21 (9.52%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    7
    0
    3
    0
    1
    0
    0
    0
    1
    Tonsillitis
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 7 (0.00%)
    1 / 21 (4.76%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Nov 2020
    Objectives and study design update
    16 Jun 2021
    Study design and endpoints update
    21 Sep 2022
    Endpoints and contact information update

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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