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    Clinical Trial Results:
    A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment

    Summary
    EudraCT number
    		 2021-000648-23
    Trial protocol
    		 ES   DE   HU   NL   IT   PL   AT  
    Global end of trial date
    24 Jul 2023

    Results information
    Results version number
    		 v1
    This version publication date
    03 Aug 2024
    First version publication date
    03 Aug 2024
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    M20-370
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04972968
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AbbVie Deutschland GmbH & Co. KG
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6 4UB
    Public contact
    Global Medical Services, AbbVie, Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Scientific contact
    Global Medical Services, AbbVie, Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.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
    24 Jul 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jul 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Polymyalgia rheumatica (PMR) is an inflammatory disease causing shoulder, hip, and neck pain and stiffness, in adults aged 50 years or older. This study evaluates how safe and effective ABBV-154 is in participants with glucocorticoid-dependent PMR. AEs and change in disease activity will be assessed. ABBV-154 is an investigational drug being evaluated for the treatment of PMR. Participants will be randomized into 1 of 4 treatment groups or arms, each arm receiving a different treatment. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 160 participants, of at least 50 years of age, with PMR will be enrolled in the study at approximately 95 sites worldwide. The study is comprised of a 52 week double-blind, placebo-controlled period and a follow-up visit 70 days after the last dose of the study drug. All participants will receive a glucocorticoid taper along with the assigned dose of ABBV-154 or placebo, subcutaneously (SC) every other week (EOW).
    Protection of trial subjects
    The investigator or his/her representative will explain the nature of the study to the subject, the benefits and risks anticipated from participation in the study, and answer all questions regarding this study. Prior to any study-related screening procedures being performed on the subject or any medications being discontinued by the subject in order to participate in this study, the informed consent statement will be reviewed, signed, and dated by the subject, the person who administered the informed consent, and any other signatories according to local requirements. A copy of the signed informed consent will be given to the subject and the original will be placed in the subject's medical record. An entry must also be made in the subject's dated source documents to confirm that informed consent was obtained prior to any study-related procedures and that the subject received a signed copy.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Sep 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 6
    Country: Number of subjects enrolled
    Austria: 3
    Country: Number of subjects enrolled
    Canada: 5
    Country: Number of subjects enrolled
    France: 8
    Country: Number of subjects enrolled
    Germany: 19
    Country: Number of subjects enrolled
    Hungary: 27
    Country: Number of subjects enrolled
    Italy: 5
    Country: Number of subjects enrolled
    Japan: 22
    Country: Number of subjects enrolled
    Netherlands: 3
    Country: Number of subjects enrolled
    New Zealand: 16
    Country: Number of subjects enrolled
    Poland: 12
    Country: Number of subjects enrolled
    Spain: 10
    Country: Number of subjects enrolled
    United Kingdom: 10
    Country: Number of subjects enrolled
    United States: 35
    Worldwide total number of subjects
    181
    EEA total number of subjects
    87
    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)
    43
    From 65 to 84 years
    134
    85 years and over
    4

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 181 glucocorticoid dependent PMR subjects were randomized into 4 groups and dosed for 52 wks. Subjects were dosed SC: Placebo, ABBV-154 (40mg, 150mg, or 340mg) with a glucocorticoid taper EOW. Beginning at Wk 3, subjects were to taper prednisone/prednisolone per protocol-defined glucocorticoid taper schedule to 0mg prednisone equivalent by Wk 24.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants will receive placebo SC EOW for 52 Weeks. In addition, participants will receive a glucocorticoid oral tablet taper. Placebo: Subcutaneous Injection; Glucocorticoid: Oral Tablet
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants will receive placebo SC EOW for 52 Weeks. In addition, participants will receive a glucocorticoid oral tablet taper. Placebo: Subcutaneous Injection; Glucocorticoid: Oral Tablet

    Investigational medicinal product name
    Glucocorticoid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants in this group received 40mg dose of ABBV-154 SC EOW for 52 Weeks. In addition, participants received a glucocorticoid oral tablet taper. ABBV-154: 40mg SC; Glucocorticoid: Oral Tablet

    Arm title
    		 ABBV-154, 40mg SC
    Arm description
    		 Participants in this group received 40mg dose of ABBV-154 SC EOW for 52 Weeks. In addition, participants received a glucocorticoid oral tablet taper. ABBV-154: 40mg SC; Glucocorticoid: Oral Tablet
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABBV-154
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants in this group received 40mg dose of ABBV-154 SC EOW for 52 Weeks. In addition, participants received a glucocorticoid oral tablet taper. ABBV-154: 40mg SC; Glucocorticoid: Oral Tablet

    Investigational medicinal product name
    Glucocorticoid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants in this group received 40mg dose of ABBV-154 SC EOW for 52 Weeks. In addition, participants received a glucocorticoid oral tablet taper. ABBV-154: 40mg SC; Glucocorticoid: Oral Tablet

    Arm title
    		 ABBV-154, 150mg SC
    Arm description
    		 Participants in this group received 150mg dose of ABBV-154 SC EOW for 52 Weeks. In addition, participants received a glucocorticoid oral tablet taper. ABBV-154: 150mg SC; Glucocorticoid: Oral Tablet
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABBV-154
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants in this group received 150mg dose of ABBV-154 SC EOW for 52 Weeks. In addition, participants received a glucocorticoid oral tablet taper. ABBV-154: 150mg SC; Glucocorticoid: Oral Tablet

    Investigational medicinal product name
    Glucocorticoid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants in this group received 150mg dose of ABBV-154 SC EOW for 52 Weeks. In addition, participants received a glucocorticoid oral tablet taper. ABBV-154: 150mg SC; Glucocorticoid: Oral Tablet

    Arm title
    		 ABBV-154, 340mg SC
    Arm description
    		 Participants in this group received 340mg dose of ABBV-154 SC EOW for 52 Weeks. In addition, participants received a glucocorticoid oral tablet taper. ABBV-154: 340mg SC; Glucocorticoid: Oral Tablet
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABBV-154
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants in this group received 340mg dose of ABBV-154 SC EOW for 52 Weeks. In addition, participants received a glucocorticoid oral tablet taper. ABBV-154: 340mg SC; Glucocorticoid: Oral Tablet

    Investigational medicinal product name
    Glucocorticoid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants in this group received 340mg dose of ABBV-154 SC EOW for 52 Weeks. In addition, participants received a glucocorticoid oral tablet taper. ABBV-154: 340mg SC; Glucocorticoid: Oral Tablet

    Number of subjects in period 1
    		Placebo ABBV-154, 40mg SC ABBV-154, 150mg SC ABBV-154, 340mg SC
    Started
    50
    42
    45
    44
    Completed
    12
    8
    8
    7
    Not completed
    38
    34
    37
    37
         Consent withdrawn by subject
    7
    4
    3
    2
         Adverse event, non-fatal
    3
    1
    1
    7
         Not specified
    1
    -
    1
    1
         Study terminated by sponsor
    25
    28
    32
    27
         Lack of efficacy
    2
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants will receive placebo SC EOW for 52 Weeks. In addition, participants will receive a glucocorticoid oral tablet taper. Placebo: Subcutaneous Injection; Glucocorticoid: Oral Tablet

    Reporting group title
    ABBV-154, 40mg SC
    Reporting group description
    		 Participants in this group received 40mg dose of ABBV-154 SC EOW for 52 Weeks. In addition, participants received a glucocorticoid oral tablet taper. ABBV-154: 40mg SC; Glucocorticoid: Oral Tablet

    Reporting group title
    ABBV-154, 150mg SC
    Reporting group description
    		 Participants in this group received 150mg dose of ABBV-154 SC EOW for 52 Weeks. In addition, participants received a glucocorticoid oral tablet taper. ABBV-154: 150mg SC; Glucocorticoid: Oral Tablet

    Reporting group title
    ABBV-154, 340mg SC
    Reporting group description
    		 Participants in this group received 340mg dose of ABBV-154 SC EOW for 52 Weeks. In addition, participants received a glucocorticoid oral tablet taper. ABBV-154: 340mg SC; Glucocorticoid: Oral Tablet

    Reporting group values
    		 Placebo ABBV-154, 40mg SC ABBV-154, 150mg SC ABBV-154, 340mg SC Total
    Number of subjects
    		 50 42 45 44 181
    Age categorical
    Units: Subjects
        < 65 years
    		 9 16 12 6 43
        65 - < 75 years
    		 24 17 20 31 92
        ≥ 75 years
    		 17 9 13 7 46
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 71.0 ( 7.15 ) 67.5 ( 7.98 ) 69.8 ( 8.34 ) 69.1 ( 6.23 ) -
    Gender categorical
    Units: Subjects
        Female
    		 33 30 25 29 117
        Male
    		 17 12 20 15 64
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 1 0 2 2 5
        Not Hispanic or Latino
    		 49 42 43 42 176
        Unknown or Not Reported
    		 0 0 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        White
    		 42 37 41 39 159
        Black or African American
    		 0 0 0 0 0
        Asian
    		 8 5 4 5 22
        American Indian or Alaska Native
    		 0 0 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        Multiple
    		 0 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants will receive placebo SC EOW for 52 Weeks. In addition, participants will receive a glucocorticoid oral tablet taper. Placebo: Subcutaneous Injection; Glucocorticoid: Oral Tablet

    Reporting group title
    ABBV-154, 40mg SC
    Reporting group description
    		 Participants in this group received 40mg dose of ABBV-154 SC EOW for 52 Weeks. In addition, participants received a glucocorticoid oral tablet taper. ABBV-154: 40mg SC; Glucocorticoid: Oral Tablet

    Reporting group title
    ABBV-154, 150mg SC
    Reporting group description
    		 Participants in this group received 150mg dose of ABBV-154 SC EOW for 52 Weeks. In addition, participants received a glucocorticoid oral tablet taper. ABBV-154: 150mg SC; Glucocorticoid: Oral Tablet

    Reporting group title
    ABBV-154, 340mg SC
    Reporting group description
    		 Participants in this group received 340mg dose of ABBV-154 SC EOW for 52 Weeks. In addition, participants received a glucocorticoid oral tablet taper. ABBV-154: 340mg SC; Glucocorticoid: Oral Tablet

    Primary: Time to Flare

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    End point title
    		 Time to Flare
    End point description
    Flare is defined as, presence of clinical signs and symptoms of PMR and requirement to increase the glucocorticoid dose per investigator. Analysis Population Description: ITT Population
    End point type
    Primary
    End point timeframe
    Week 24
    End point values
    		 Placebo ABBV-154, 40mg SC ABBV-154, 150mg SC ABBV-154, 340mg SC
    Number of subjects analysed
    50
    42
    45
    44
    Units: Count of Participants
        number (not applicable)
    33
    18
    18
    9
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v ABBV-154, 40mg SC
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.012 [1]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.273
         upper limit
    		 0.878
    Notes
    [1] - P-value ≤ 0.05 Stratified by baseline randomization stratification factors [Glucocorticoid use at Baseline (≥ 10 mg/day; < 10 mg/day prednisone equivalent)]
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v ABBV-154, 150mg SC
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004 [2]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.443
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.248
         upper limit
    		 0.794
    Notes
    [2] - P-value ≤ 0.01 Stratified by baseline randomization stratification factors [Glucocorticoid use at Baseline(≥ 10 mg/day; < 10 mg/day prednisone equivalent)]
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Placebo v ABBV-154, 340mg SC
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [3]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.198
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.094
         upper limit
    		 0.419
    Notes
    [3] - P-value ≤ 0.001 Stratified by baseline randomization stratification factors [Glucocorticoid use at Baseline(≥ 10 mg/day; < 10 mg/day prednisone equivalent)]

    Secondary: Change from Baseline in Glucocorticoid Dose

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    End point title
    		 Change from Baseline in Glucocorticoid Dose
    End point description
    Change from Baseline in glucocorticoid dose. Analysis Population Description: ITT Population
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Placebo ABBV-154, 40mg SC ABBV-154, 150mg SC ABBV-154, 340mg SC
    Number of subjects analysed
    36
    28
    29
    30
    Units: mg
        arithmetic mean (standard deviation)
    -4.96 ( 3.943 )
    -6.29 ( 3.384 )
    -7.40 ( 3.554 )
    -7.88 ( 3.398 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v ABBV-154, 40mg SC
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.039 [4]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -1.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.08
         upper limit
    		 -0.08
    Notes
    [4] - P-value ≤ 0.05; P-value based on ANCOVA adjusting for baseline randomization stratification factors (GC use at baseline)
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v ABBV-154, 150mg SC
    Number of subjects included in analysis
    65
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [5]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.15
         upper limit
    		 -1.16
    Notes
    [5] - P-value ≤ 0.001; P-value based on an ANCOVA model adjusting for baseline randomization stratification factors (GC use at baseline) 95% CI based on an ANCOVA model adjusting for baseline randomization stratification factors (GC use at baseline)
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Placebo v ABBV-154, 340mg SC
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [6]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.49
         upper limit
    		 -1.52
    Notes
    [6] - P-value ≤ 0.001; P-value based on an ANCOVA model adjusting for baseline randomization stratification factors (GC use at baseline) 95% CI based on an ANCOVA model adjusting for baseline randomization stratification factors (GC use at baseline)

    Secondary: Cumulative Glucocorticoid Dose

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    End point title
    		 Cumulative Glucocorticoid Dose
    End point description
    Cumulative glucocorticoid dose. Analysis Population Description: ITT Population
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Placebo ABBV-154, 40mg SC ABBV-154, 150mg SC ABBV-154, 340mg SC
    Number of subjects analysed
    36
    28
    29
    30
    Units: Glucocorticoid dose (mg)
        arithmetic mean (standard deviation)
    984.576 ( 524.6579 )
    823.411 ( 397.9403 )
    734.310 ( 332.3137 )
    759.450 ( 381.1683 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v ABBV-154, 40mg SC
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.144 [7]
    Method
    		 ANCOVA
    Parameter type
    		 Median difference (net)
    Point estimate
    -88.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -208.04
         upper limit
    		 30.71
    Notes
    [7] - P-value and 95% CI based on an Analysis of covariance (ANCOVA) model adjusting for baseline randomization stratification factors [GC use at baseline (≥ 10 mg/day; < 10 mg/day prednisone equivalent)
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v ABBV-154, 150mg SC
    Number of subjects included in analysis
    65
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007 [8]
    Method
    		 ANCOVA
    Parameter type
    		 Median difference (net)
    Point estimate
    -164.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -283.62
         upper limit
    		 -45.89
    Notes
    [8] - P-value ≤ 0.01 P-value and 95% CI are based on an Analysis of covariance (ANCOVA) model adjusting for baseline randomization stratification factors [Glucocorticoid use at baseline (≥ 10 mg/day; < 10 mg/day prednisone] equivalent)
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Placebo v ABBV-154, 340mg SC
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003 [9]
    Method
    		 ANCOVA
    Parameter type
    		 Median difference (net)
    Point estimate
    -182.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -300.52
         upper limit
    		 -64.58
    Notes
    [9] - P-value ≤ 0.01 P-value and 95% CI based on an Analysis of covariance (ANCOVA) model adjusting for baseline randomization stratification factors [Glucocorticoid use at baseline (≥ 10 mg/day; <10 mg/day prednisone equivalent)

    Secondary: Percentage of Participants Achieving Flare-Free State

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    End point title
    		 Percentage of Participants Achieving Flare-Free State
    End point description
    Percentage of participants achieving flare-free state. Analysis Population Description: ITT Population
    End point type
    Secondary
    End point timeframe
    Up to Week 24
    End point values
    		 Placebo ABBV-154, 40mg SC ABBV-154, 150mg SC ABBV-154, 340mg SC
    Number of subjects analysed
    39
    28
    32
    34
    Units: participants
        number (not applicable)
    11
    13
    15
    24
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    ABBV-154, 40mg SC v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.107 [10]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Median difference (net)
    Point estimate
    18.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4
         upper limit
    		 41.4
    Notes
    [10] - From Cochran-Mantel-Haenszel test adjusting for baseline randomization stratification factors [Glucocorticoid (GC) use at baseline (≥ 10 mg/day; < 10 mg/day prednisone equivalent); Length of prior GC treatment for PMR (≤ 1 year; > 1 year)].
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v ABBV-154, 150mg SC
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.092 [11]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Median difference (net)
    Point estimate
    18.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.1
         upper limit
    		 41
    Notes
    [11] - P-value ≤ 0.1 Cochran-Mantel-Haenszel test adjusting for baseline randomization stratification factors [Glucocorticoid use at baseline (≥ 10 mg/day; < 10 mg/day prednisone equivalent); Length of prior GC treatment for PMR (≤ 1 year; > 1 year)].
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Placebo v ABBV-154, 340mg SC
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [12]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Median difference (net)
    Point estimate
    41.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 21.4
         upper limit
    		 62.3
    Notes
    [12] - P-value ≤ 0.001 Cochran-Mantel-Haenszel test adjusting for baseline randomization stratification factors [Glucocorticoid use at baseline (≥ 10 mg/day; < 10 mg/day prednisone equivalent); Length of prior GC treatment for PMR (≤ 1 year; > 1 year)].

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality were reported from enrollment to the end of study, median time on follow up was 288.5, 292.0, 300.0, and 299.0 Days for Placebo and ABBV-154 (40mg/150mg/340mg), respectively.
    Adverse event reporting additional description
    Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug within 70 days after the last dose of study drug; mean duration on study drug was 235.2, 239.9, 234.6 and 230.3 days for Placebo and ABBV-154 (40mg/150mg/340mg), respectively.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects will receive placebo SC EOW for 52 weeks. In addition, subjects will receive a glucocorticoid oral tablet taper. Placebo: Subcutaneous Injection Glucocorticoid: Oral Tablet

    Reporting group title
    ABBV-154_340mg_SC_EOW
    Reporting group description
    		 Subjects in this group received 340mg dose of ABBV-154 SC EOW for 52 weeks. In addition, subjects received a glucocorticoid oral tablet taper. ABBV-154: Subcutaneous Injection Glucocorticoid: Oral Tablet

    Reporting group title
    ABBV-154_150mg_SC_EOW
    Reporting group description
    		 Subjects in this group received 150mg dose of ABBV-154 SC EOWfor 52 weeks. In addition, subjects received a glucocorticoid oral tablet taper. ABBV-154: Subcutaneous Injection Glucocorticoid: Oral Tablet

    Reporting group title
    ABBV-154_40mg_SC_EOW
    Reporting group description
    		 Subjects in this group received 40mg dose of ABBV-154 SC EOW for 52 weeks. In addition, participants received a glucocorticoid oral tablet taper. ABBV-154: Subcutaneous Injection Glucocorticoid: Oral Tablet

    Serious adverse events
    		 Placebo ABBV-154_340mg_SC_EOW ABBV-154_150mg_SC_EOW ABBV-154_40mg_SC_EOW
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 50 (16.00%)
    9 / 44 (20.45%)
    8 / 45 (17.78%)
    5 / 42 (11.90%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    ACUTE MYELOID LEUKAEMIA
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 44 (2.27%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PROSTATE CANCER
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 44 (2.27%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    ATRIAL SEPTAL DEFECT
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    CORONARY ARTERY DISEASE
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 44 (0.00%)
    1 / 45 (2.22%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ATRIAL FIBRILLATION
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 44 (0.00%)
    1 / 45 (2.22%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SUPRAVENTRICULAR TACHYCARDIA
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 44 (0.00%)
    1 / 45 (2.22%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    VENTRICULAR EXTRASYSTOLES
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 44 (0.00%)
    1 / 45 (2.22%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    LEFT VENTRICULAR FAILURE
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    DIZZINESS
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SCIATICA
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 44 (2.27%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    THALAMIC INFARCTION
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    INGUINAL HERNIA
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PANCREATIC PSEUDOCYST
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PANCREATITIS
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    FEMALE GENITAL TRACT FISTULA
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    CHOLANGITIS ACUTE
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    DYSPNOEA AT REST
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    OSTEOARTHRITIS
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 44 (0.00%)
    1 / 45 (2.22%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    APPENDICITIS PERFORATED
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    CELLULITIS
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 44 (2.27%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    LOWER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 44 (0.00%)
    1 / 45 (2.22%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PERITONITIS
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PNEUMONIA
         subjects affected / exposed
    0 / 50 (0.00%)
    4 / 44 (9.09%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PNEUMONIA PNEUMOCOCCAL
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 44 (2.27%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 44 (0.00%)
    1 / 45 (2.22%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SEPSIS
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    URINARY TRACT INFECTION
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 44 (2.27%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    UROSEPSIS
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 44 (0.00%)
    1 / 45 (2.22%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    DEHYDRATION
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    DIABETES MELLITUS
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo ABBV-154_340mg_SC_EOW ABBV-154_150mg_SC_EOW ABBV-154_40mg_SC_EOW
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 50 (54.00%)
    37 / 44 (84.09%)
    30 / 45 (66.67%)
    25 / 42 (59.52%)
    Injury, poisoning and procedural complications
    CONTUSION
         subjects affected / exposed
    0 / 50 (0.00%)
    3 / 44 (6.82%)
    2 / 45 (4.44%)
    2 / 42 (4.76%)
         occurrences all number
    0
    7
    2
    2
    SKIN LACERATION
         subjects affected / exposed
    0 / 50 (0.00%)
    2 / 44 (4.55%)
    1 / 45 (2.22%)
    3 / 42 (7.14%)
         occurrences all number
    0
    2
    1
    5
    Vascular disorders
    HYPERTENSION
         subjects affected / exposed
    5 / 50 (10.00%)
    3 / 44 (6.82%)
    4 / 45 (8.89%)
    1 / 42 (2.38%)
         occurrences all number
    5
    3
    4
    1
    Nervous system disorders
    DIZZINESS
         subjects affected / exposed
    3 / 50 (6.00%)
    2 / 44 (4.55%)
    1 / 45 (2.22%)
    0 / 42 (0.00%)
         occurrences all number
    3
    2
    1
    0
    HEADACHE
         subjects affected / exposed
    2 / 50 (4.00%)
    5 / 44 (11.36%)
    4 / 45 (8.89%)
    3 / 42 (7.14%)
         occurrences all number
    2
    10
    4
    3
    Blood and lymphatic system disorders
    NEUTROPENIA
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 44 (0.00%)
    3 / 45 (6.67%)
    0 / 42 (0.00%)
         occurrences all number
    0
    0
    4
    0
    General disorders and administration site conditions
    INJECTION SITE ERYTHEMA
         subjects affected / exposed
    0 / 50 (0.00%)
    2 / 44 (4.55%)
    3 / 45 (6.67%)
    2 / 42 (4.76%)
         occurrences all number
    0
    5
    4
    3
    INJECTION SITE PAIN
         subjects affected / exposed
    0 / 50 (0.00%)
    3 / 44 (6.82%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
         occurrences all number
    0
    3
    0
    0
    INJECTION SITE RASH
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 44 (2.27%)
    3 / 45 (6.67%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    7
    2
    OEDEMA PERIPHERAL
         subjects affected / exposed
    0 / 50 (0.00%)
    3 / 44 (6.82%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
         occurrences all number
    0
    3
    0
    0
    PYREXIA
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 44 (0.00%)
    1 / 45 (2.22%)
    0 / 42 (0.00%)
         occurrences all number
    3
    0
    1
    0
    FATIGUE
         subjects affected / exposed
    2 / 50 (4.00%)
    2 / 44 (4.55%)
    4 / 45 (8.89%)
    3 / 42 (7.14%)
         occurrences all number
    2
    2
    5
    3
    Gastrointestinal disorders
    DIARRHOEA
         subjects affected / exposed
    4 / 50 (8.00%)
    3 / 44 (6.82%)
    2 / 45 (4.44%)
    2 / 42 (4.76%)
         occurrences all number
    4
    4
    2
    3
    NAUSEA
         subjects affected / exposed
    2 / 50 (4.00%)
    3 / 44 (6.82%)
    2 / 45 (4.44%)
    3 / 42 (7.14%)
         occurrences all number
    3
    4
    2
    3
    Respiratory, thoracic and mediastinal disorders
    COUGH
         subjects affected / exposed
    0 / 50 (0.00%)
    4 / 44 (9.09%)
    1 / 45 (2.22%)
    1 / 42 (2.38%)
         occurrences all number
    0
    4
    1
    1
    Skin and subcutaneous tissue disorders
    HYPERHIDROSIS
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 44 (0.00%)
    1 / 45 (2.22%)
    3 / 42 (7.14%)
         occurrences all number
    1
    0
    1
    4
    RASH
         subjects affected / exposed
    2 / 50 (4.00%)
    3 / 44 (6.82%)
    2 / 45 (4.44%)
    2 / 42 (4.76%)
         occurrences all number
    2
    3
    2
    2
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    3 / 50 (6.00%)
    3 / 44 (6.82%)
    6 / 45 (13.33%)
    4 / 42 (9.52%)
         occurrences all number
    5
    5
    6
    4
    OSTEOARTHRITIS
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 44 (0.00%)
    3 / 45 (6.67%)
    1 / 42 (2.38%)
         occurrences all number
    1
    0
    3
    1
    ROTATOR CUFF SYNDROME
         subjects affected / exposed
    3 / 50 (6.00%)
    1 / 44 (2.27%)
    3 / 45 (6.67%)
    2 / 42 (4.76%)
         occurrences all number
    3
    1
    4
    2
    Infections and infestations
    COVID-19
         subjects affected / exposed
    9 / 50 (18.00%)
    7 / 44 (15.91%)
    5 / 45 (11.11%)
    9 / 42 (21.43%)
         occurrences all number
    9
    7
    5
    9
    NASOPHARYNGITIS
         subjects affected / exposed
    3 / 50 (6.00%)
    7 / 44 (15.91%)
    4 / 45 (8.89%)
    4 / 42 (9.52%)
         occurrences all number
    4
    9
    5
    5
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    2 / 50 (4.00%)
    2 / 44 (4.55%)
    3 / 45 (6.67%)
    2 / 42 (4.76%)
         occurrences all number
    2
    2
    3
    3
    URINARY TRACT INFECTION
         subjects affected / exposed
    5 / 50 (10.00%)
    6 / 44 (13.64%)
    2 / 45 (4.44%)
    3 / 42 (7.14%)
         occurrences all number
    9
    9
    5
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Jul 2021
    Version 2.0: Global Amendment updated the synopsis, investigational plan, randomization/drug assignment, statistical analysis for efficacy, prohibited medications and therapy, disease activity and flare assessment language, study drug dosage clarification, toxicity management language, complaints and adverse events language, treatments administered language, selection and timing of dose for each subject.
    21 Feb 2022
    Version 3.0: Global Amendment updated the synopsis, investigational plan, overall study design and figure, randomization assignment, sample size, key eligibility criteria, prohibited medications and therapy, withdrawal of subjects and discontinuation language, toxicity management, and appendices language.

    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.
    AbbVie has decided to discontinue further subject enrollment in the M20-370 (ABBV-154) study. This decision is not based on a safety or an efficacy signal; rather this decision was made because of a change in AbbVie’s development.
    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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