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    Clinical Trial Results:
    A Phase 2, Long-Term Extension (LTE) Study With Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT)

    Summary
    EudraCT number
    		 2020-001690-72
    Trial protocol
    		 NL   HU   DE   BG   IT  
    Global end of trial date
    03 Jan 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jan 2025
    First version publication date
    04 Jan 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    M20-186
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04451772
    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, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Scientific contact
    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
    03 Jan 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jan 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will evaluate how well elsubrutinib and upadacitinib given alone or as the ABBV-599 combination (elsubrutinib/upadacitinib) works within the body, in participants who completed study M19-130. This study will assess the change in disease symptoms. ABBV-599 is an investigational drug being developed for the treatment of Systemic Lupus Erythematosus (SLE). Adult participants with a diagnosis of SLE will be enrolled and will receive oral elsubrutinib capsules and/or oral upadacitinib tablets once daily for up to 56 weeks. Participants who were receiving elsubrutinib and/or upadacitnib in M19-130 will continue to receive the same treatment in this study. Participants who were receiving placebo in M19-130 will be re-randomized to one of the 2 combination treatment arms in this study.
    Protection of trial subjects
    Subjects or their legally authorized representative (if required per local regulations) must have understood and personally, voluntarily signed and dated an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures. In Japan, subjects under 20 years of age must have voluntarily signed and dated an informed consent, in addition to their parent or legal guardian. Legally authorized representation did not apply in the case of Germany and France, and protected persons such as minors, adults under guardianship, pregnant women, persons deprived of their liberty and persons incapable or unable to express their consent were not included in the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Jul 2020
    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
    Argentina: 19
    Country: Number of subjects enrolled
    Australia: 3
    Country: Number of subjects enrolled
    Bulgaria: 3
    Country: Number of subjects enrolled
    China: 6
    Country: Number of subjects enrolled
    Colombia: 15
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Hungary: 9
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Japan: 13
    Country: Number of subjects enrolled
    Korea, Republic of: 1
    Country: Number of subjects enrolled
    Mexico: 15
    Country: Number of subjects enrolled
    New Zealand: 3
    Country: Number of subjects enrolled
    Poland: 9
    Country: Number of subjects enrolled
    Puerto Rico: 10
    Country: Number of subjects enrolled
    Spain: 9
    Country: Number of subjects enrolled
    Taiwan: 16
    Country: Number of subjects enrolled
    United Kingdom: 4
    Country: Number of subjects enrolled
    United States: 46
    Worldwide total number of subjects
    185
    EEA total number of subjects
    34
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    180
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects who completed Study M19-130 were eligible to enroll in this study. Only those subjects who met all of the specified eligibility criteria had the option to enter this long-term extension (LTE) study to receive continued therapy, provided the subject was willing and the investigator believed that continuing therapy was appropriate.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ABBV-599 High Dose -> ABBV-599 High Dose
    Arm description
    		 Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elsubrutinib
    Investigational medicinal product code
    Other name
    ABBV-105
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsule; Oral

    Investigational medicinal product name
    Upadacitinib
    Investigational medicinal product code
    Other name
    ABT-494, RINVOQ
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Film-coated tablet; Oral

    Arm title
    		 Els Pbo/Upa 30 mg -> Els Pbo/Upa 30 mg
    Arm description
    		 Participants received placebo capsules for elsubrutinib once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo for Elsubrutinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsule; Oral

    Investigational medicinal product name
    Upadacitinib
    Investigational medicinal product code
    Other name
    ABT-494, RINVOQ
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Film-coated tablet; Oral

    Arm title
    		 Els Pbo/Upa Pbo -> ABBV-599 High Dose
    Arm description
    		 Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day in the current study (M20-186) for up to 56 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elsubrutinib
    Investigational medicinal product code
    Other name
    ABBV-105
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsule; Oral

    Investigational medicinal product name
    Upadacitinib
    Investigational medicinal product code
    Other name
    ABT-494, RINVOQ
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Film-coated tablet; Oral

    Arm title
    		 ABBV-599 Low -> ABBV-599 Low
    Arm description
    		 Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elsubrutinib
    Investigational medicinal product code
    Other name
    ABBV-105
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsule; Oral

    Investigational medicinal product name
    Upadacitinib
    Investigational medicinal product code
    Other name
    ABT-494, RINVOQ
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Film-coated tablet; Oral

    Arm title
    		 Els 60 mg/Upa Pbo -> Els 60 mg/Upa Pbo
    Arm description
    		 Participants received elsubrutinib 60 mg capsules once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elsubrutinib
    Investigational medicinal product code
    Other name
    ABBV-105
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsule; Oral

    Investigational medicinal product name
    Placebo for Upadacitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Film-coated tablet; Oral

    Arm title
    		 Els + Upa Pbo -> ABBV-599 Low
    Arm description
    		 Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in the current study (M20-186) for up to 56 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elsubrutinib
    Investigational medicinal product code
    Other name
    ABBV-105
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsule; Oral

    Investigational medicinal product name
    Upadacitinib
    Investigational medicinal product code
    Other name
    ABT-494, RINVOQ
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Film-coated tablet; Oral

    Number of subjects in period 1
    		ABBV-599 High Dose -> ABBV-599 High Dose Els Pbo/Upa 30 mg -> Els Pbo/Upa 30 mg Els Pbo/Upa Pbo -> ABBV-599 High Dose ABBV-599 Low -> ABBV-599 Low Els 60 mg/Upa Pbo -> Els 60 mg/Upa Pbo Els + Upa Pbo -> ABBV-599 Low
    Started
    45
    47
    35
    19
    25
    14
    Completed
    41
    38
    31
    6
    1
    1
    Not completed
    4
    9
    4
    13
    24
    13
         Sponsor decision based on interim analysis data
    -
    -
    -
    11
    23
    9
         Adverse event, non-fatal
    1
    -
    1
    1
    -
    3
         Other, not specified
    1
    2
    1
    -
    -
    1
         Withdrawal by subject
    2
    7
    2
    1
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ABBV-599 High Dose -> ABBV-599 High Dose
    Reporting group description
    		 Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.

    Reporting group title
    Els Pbo/Upa 30 mg -> Els Pbo/Upa 30 mg
    Reporting group description
    		 Participants received placebo capsules for elsubrutinib once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.

    Reporting group title
    Els Pbo/Upa Pbo -> ABBV-599 High Dose
    Reporting group description
    		 Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day in the current study (M20-186) for up to 56 weeks.

    Reporting group title
    ABBV-599 Low -> ABBV-599 Low
    Reporting group description
    		 Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.

    Reporting group title
    Els 60 mg/Upa Pbo -> Els 60 mg/Upa Pbo
    Reporting group description
    		 Participants received elsubrutinib 60 mg capsules once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.

    Reporting group title
    Els + Upa Pbo -> ABBV-599 Low
    Reporting group description
    		 Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in the current study (M20-186) for up to 56 weeks.

    Reporting group values
    		 ABBV-599 High Dose -> ABBV-599 High Dose Els Pbo/Upa 30 mg -> Els Pbo/Upa 30 mg Els Pbo/Upa Pbo -> ABBV-599 High Dose ABBV-599 Low -> ABBV-599 Low Els 60 mg/Upa Pbo -> Els 60 mg/Upa Pbo Els + Upa Pbo -> ABBV-599 Low Total
    Number of subjects
    		 45 47 35 19 25 14 185
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.8 ( 11.39 ) 42.5 ( 12.00 ) 40.6 ( 11.75 ) 38.3 ( 10.52 ) 41.2 ( 11.60 ) 42.5 ( 11.57 ) -
    Gender categorical
    Units: Subjects
        Female
    		 42 42 35 18 24 14 175
        Male
    		 3 5 0 1 1 0 10
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 3 0 2 1 2 0 8
        Asian
    		 6 10 12 6 3 2 39
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0 0
        Black or African American
    		 2 6 0 1 1 1 11
        White
    		 32 26 20 10 16 10 114
        More than one race
    		 2 5 1 1 3 1 13
        Unknown or Not Reported
    		 0 0 0 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    ABBV-599 High Dose -> ABBV-599 High Dose
    Reporting group description
    		 Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.

    Reporting group title
    Els Pbo/Upa 30 mg -> Els Pbo/Upa 30 mg
    Reporting group description
    		 Participants received placebo capsules for elsubrutinib once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.

    Reporting group title
    Els Pbo/Upa Pbo -> ABBV-599 High Dose
    Reporting group description
    		 Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day in the current study (M20-186) for up to 56 weeks.

    Reporting group title
    ABBV-599 Low -> ABBV-599 Low
    Reporting group description
    		 Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.

    Reporting group title
    Els 60 mg/Upa Pbo -> Els 60 mg/Upa Pbo
    Reporting group description
    		 Participants received elsubrutinib 60 mg capsules once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.

    Reporting group title
    Els + Upa Pbo -> ABBV-599 Low
    Reporting group description
    		 Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in the current study (M20-186) for up to 56 weeks.

    Primary: Number of Participants With Treatment-Emergent Adverse Events

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    End point title
    		 Number of Participants With Treatment-Emergent Adverse Events [1]
    End point description
    Adverse event (AE): any untoward medical occurrence in a patient/clinical investigation subject administered a pharmaceutical product and which doesn't necessarily have a causal relationship with this Tx. Serious adverse event (SAE): an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs) are defined as an adverse event with an onset date that is on or after the first dose of study drug from Study M20-186, and no more than 30 days after the last dose of study drug from Study M20-186. For more details on adverse events please see the Adverse Event section. Analysis population: subjects rcvd ≥ 1 dose of study drug in Study M20-186, grouped by Tx rcvd
    End point type
    Primary
    End point timeframe
    From the first dose of study drug in Study M20-186 up to 30 days after the last dose of study drug, up to 442 days
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive data are summarized for this end point per protocol.
    End point values
    		 ABBV-599 High Dose -> ABBV-599 High Dose Els Pbo/Upa 30 mg -> Els Pbo/Upa 30 mg Els Pbo/Upa Pbo -> ABBV-599 High Dose ABBV-599 Low -> ABBV-599 Low Els 60 mg/Upa Pbo -> Els 60 mg/Upa Pbo Els + Upa Pbo -> ABBV-599 Low
    Number of subjects analysed
    45
    47
    35
    19
    25
    14
    Units: participants
        Any TEAE
    34
    31
    30
    11
    11
    7
        TESAE
    5
    5
    1
    2
    1
    2
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4

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    End point title
    		 Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 [2]
    End point description
    SLE Responder Index (SRI)-4 is defined as follows with all criteria compared to Baseline in Study M19-130: • ≥4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score • No worsening of the overall condition (< 0.3 point increase in Physician's Global Assessment [PhGA]) • No new British Isles Lupus Assessment Group (BILAG) A or more than 1 new BILAG B disease activity scores (i.e., no organ system changes from baseline B/C/D/E to A and no more than 1 organ system changes from baseline C/D/E to B). A letter score is assigned to each organ system with following indications: A = severe, B = moderate, C = mild, D = inactive with prior history, and E = inactive with no history. Analysis population: Full Analysis Set: all randomized subjects who received at least 1 dose of study drug in Study M20-186; as observed (AO) analysis.
    End point type
    Secondary
    End point timeframe
    Baseline of Study M19-130 (Week 0), Weeks 56, 64, 72, 80, 88, 96, 104
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: When 50% of planned participants in Study M19-130 had completed Week 24 or withdrawn from the study, the ABBV-599 Low Dose and elsubrutinib 60 mg treatment groups were terminated as these groups did not meet projected efficacy. Per protocol, terminated groups were removed from the efficacy analyses.
    End point values
    		 ABBV-599 High Dose -> ABBV-599 High Dose Els Pbo/Upa 30 mg -> Els Pbo/Upa 30 mg Els Pbo/Upa Pbo -> ABBV-599 High Dose
    Number of subjects analysed
    45
    46
    35
    Units: percentage of participants
    number (confidence interval 95%)
        Week 56 (n=45, 46, 35)
    71.1 (57.9 to 84.4)
    76.1 (63.8 to 88.4)
    54.3 (37.8 to 70.8)
        Week 64 (n=44, 45, 34)
    70.5 (57.0 to 83.9)
    75.6 (63.0 to 88.1)
    58.8 (42.3 to 75.4)
        Week 72 (n=41, 45, 34)
    80.5 (68.4 to 92.6)
    88.9 (79.7 to 98.1)
    64.7 (48.6 to 80.8)
        Week 80 (n=40, 45, 33)
    75.0 (61.6 to 88.4)
    82.2 (71.1 to 93.4)
    57.6 (40.7 to 74.4)
        Week 88 (n=40, 42, 33)
    82.5 (70.7 to 94.3)
    85.7 (75.1 to 96.3)
    48.5 (31.4 to 65.5)
        Week 96 (n=41, 39, 32)
    82.9 (71.4 to 94.4)
    76.9 (63.7 to 90.1)
    62.5 (45.7 to 79.3)
        Week 104 (n=41, 39, 31)
    85.4 (74.5 to 96.2)
    82.1 (70.0 to 94.1)
    61.3 (44.1 to 78.4)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response

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    End point title
    		 Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response [3]
    End point description
    BICLA is a composite responder index. Achievement of BICLA response is defined as improvement in all initial A and B BILAG scores, with no more than one new BILAG B score without worsening of the overall condition (no worsening in Physician's Global Assessment [PhGA], < 0.3 point increase) and no worsening of the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score. Analysis population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug in Study M20-186; as observed (AO) analysis.
    End point type
    Secondary
    End point timeframe
    Baseline of Study M19-130 (Week 0), Weeks 56, 64, 72, 80, 88, 96, 104
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: When 50% of planned participants in Study M19-130 had completed Week 24 or withdrawn from the study, the ABBV-599 Low Dose and elsubrutinib 60 mg treatment groups were terminated as these groups did not meet projected efficacy. Per protocol, terminated groups were removed from the efficacy analyses.
    End point values
    		 ABBV-599 High Dose -> ABBV-599 High Dose Els Pbo/Upa 30 mg -> Els Pbo/Upa 30 mg Els Pbo/Upa Pbo -> ABBV-599 High Dose
    Number of subjects analysed
    45
    46
    35
    Units: percentage of participants
    number (confidence interval 95%)
        Week 56 (n=45, 46, 35)
    73.3 (60.4 to 86.3)
    67.4 (53.8 to 80.9)
    60.0 (43.8 to 76.2)
        Week 64 (n=44, 45, 34)
    75.0 (62.2 to 87.8)
    84.4 (73.9 to 95.0)
    55.9 (39.2 to 72.6)
        Week 72 (n=41, 45, 34)
    73.2 (59.6 to 86.7)
    88.9 (79.7 to 98.1)
    61.8 (45.4 to 78.1)
        Week 80 (n=40, 45, 33)
    70.0 (55.8 to 84.2)
    77.8 (65.6 to 89.9)
    57.6 (40.7 to 74.4)
        Week 88 (n=40, 42, 33)
    80.0 (67.6 to 92.4)
    85.7 (75.1 to 96.3)
    57.6 (40.7 to 74.4)
        Week 96 (n=41, 39, 32)
    78.0 (65.4 to 90.7)
    76.9 (63.7 to 90.1)
    59.4 (42.4 to 76.4)
        Week 104 (n=41, 39, 31)
    78.0 (65.4 to 90.7)
    69.2 (54.7 to 83.7)
    54.8 (37.3 to 72.4)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Daily Prednisone Dose Over Time

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    End point title
    		 Change From Baseline in Daily Prednisone Dose Over Time [4]
    End point description
    Participants’current use of steroid therapy was assessed at each study visit, and the amount of daily prednisone was documented. Analysis population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug in Study M20-186; as observed (AO) analysis.
    End point type
    Secondary
    End point timeframe
    Baseline of M19-130 (Week 0), Weeks 56, 64, 72, 80, 88, 96, 104
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: When 50% of planned participants in Study M19-130 had completed Week 24 or withdrawn from the study, the ABBV-599 Low Dose and elsubrutinib 60 mg treatment groups were terminated as these groups did not meet projected efficacy. Per protocol, terminated groups were removed from the efficacy analyses.
    End point values
    		 ABBV-599 High Dose -> ABBV-599 High Dose Els Pbo/Upa 30 mg -> Els Pbo/Upa 30 mg Els Pbo/Upa Pbo -> ABBV-599 High Dose
    Number of subjects analysed
    45
    47
    35
    Units: mg
    arithmetic mean (standard deviation)
        Week 56 (n=45, 47, 35)
    -3.9 ( 5.96 )
    -3.5 ( 5.99 )
    -4.9 ( 6.99 )
        Week 64 (n=45, 46, 35)
    -4.2 ( 5.51 )
    -3.7 ( 5.97 )
    -5.0 ( 6.87 )
        Week 72 (n=42, 46, 34)
    -4.0 ( 6.59 )
    -4.9 ( 7.23 )
    -5.2 ( 6.88 )
        Week 80 (n=41, 45, 34)
    -5.1 ( 5.96 )
    -4.4 ( 8.05 )
    -5.2 ( 6.88 )
        Week 88 (n=41, 42, 33)
    -5.5 ( 5.83 )
    -5.2 ( 6.02 )
    -6.2 ( 7.04 )
        Week 96 (n=41, 40, 32)
    -5.5 ( 5.88 )
    -5.7 ( 5.78 )
    -7.3 ( 6.54 )
        Week 104 (n=41, 39, 31)
    -5.8 ( 6.02 )
    -5.5 ( 5.65 )
    -7.7 ( 6.64 )
    No statistical analyses for this end point

    Secondary: Number of Flares Per Patient-year by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLE Disease Activity Index (SLEDAI) Flare Index Through Week 104

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    End point title
    		 Number of Flares Per Patient-year by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLE Disease Activity Index (SLEDAI) Flare Index Through Week 104 [5]
    End point description
    The SELENA SLEDAI flare index defines mild/moderate or severe SLE flares using the SLEDAI score, definitions of worsening signs and symptoms, treatment changes, and Physician's Global Assessment of Disease Activity. Analysis population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug in Study M20-186; as observed (AO) analysis.
    End point type
    Secondary
    End point timeframe
    From Week 56 through Week 104
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: When 50% of planned participants in Study M19-130 had completed Week 24 or withdrawn from the study, the ABBV-599 Low Dose and elsubrutinib 60 mg treatment groups were terminated as these groups did not meet projected efficacy. Per protocol, terminated groups were removed from the efficacy analyses.
    End point values
    		 ABBV-599 High Dose -> ABBV-599 High Dose Els Pbo/Upa 30 mg -> Els Pbo/Upa 30 mg Els Pbo/Upa Pbo -> ABBV-599 High Dose
    Number of subjects analysed
    45
    47
    35
    Units: Events per patient-year
    number (confidence interval 95%)
        Mild/Moderate
    0.62 (0.39 to 0.84)
    1.41 (1.06 to 1.75)
    1.39 (0.99 to 1.78)
        Severe
    0.00 (0.00 to 0.00)
    0.04 (-0.02 to 0.10)
    0.17 (0.03 to 0.31)
        Overall
    0.62 (0.39 to 0.84)
    1.45 (1.10 to 1.80)
    1.56 (1.14 to 1.97)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study.
    Adverse event reporting additional description
    Median time on follow-up was for 422 days for the ABBV-599 High -> ABBV-599 High group; 423 days for the Upa -> Upa and Pbo -> ABBV-599 High groups; 245 days for the ABBV-599 Low -> ABBV-599 Low group; 163 days for the Els -> Els group; and 142.5 days for the Pbo -> ABBV-599 Low group.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    ABBV-599 High Dose -> ABBV-599 High Dose
    Reporting group description
    		 Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg filmcoated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.

    Reporting group title
    Els Pbo/Upa 30 mg -> Els Pbo/Upa 30 mg
    Reporting group description
    		 Participants received placebo capsules for elsubrutinib once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.

    Reporting group title
    Els Pbo/Upa Pbo -> ABBV-599 High Dose
    Reporting group description
    		 Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day in the current study (M20-186) for up to 56 weeks.

    Reporting group title
    ABBV-599 Low -> ABBV-599 Low
    Reporting group description
    		 Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg filmcoated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.

    Reporting group title
    Els 60 mg/Upa Pbo -> Els 60 mg/Upa Pbo
    Reporting group description
    		 Participants received elsubrutinib 60 mg capsules once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.

    Reporting group title
    Els + Upa Pbo -> ABBV-599 Low
    Reporting group description
    		 Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in the current study (M20-186) for up to 56 weeks.

    Serious adverse events
    		 ABBV-599 High Dose -> ABBV-599 High Dose Els Pbo/Upa 30 mg -> Els Pbo/Upa 30 mg Els Pbo/Upa Pbo -> ABBV-599 High Dose ABBV-599 Low -> ABBV-599 Low Els 60 mg/Upa Pbo -> Els 60 mg/Upa Pbo Els + Upa Pbo -> ABBV-599 Low
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 45 (11.11%)
    5 / 47 (10.64%)
    1 / 35 (2.86%)
    2 / 19 (10.53%)
    1 / 25 (4.00%)
    2 / 14 (14.29%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    UTERINE LEIOMYOMA
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    FRACTURED SACRUM
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    JOINT DISLOCATION
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 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
    LUMBAR VERTEBRAL FRACTURE
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    PELVIC FRACTURE
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    SUBDURAL HAEMATOMA
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SKULL FRACTURED BASE
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    TRAUMATIC INTRACRANIAL HAEMORRHAGE
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    ABORTION INDUCED
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Nervous system disorders
    CEREBRAL HAEMATOMA
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    NERVOUS SYSTEM DISORDER
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    LUMBAR RADICULOPATHY
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    1 / 35 (2.86%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    MIGRAINE
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    General disorders and administration site conditions
    SEROSITIS
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 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
    OEDEMA PERIPHERAL
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    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
    Gastrointestinal disorders
    UPPER GASTROINTESTINAL HAEMORRHAGE
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Reproductive system and breast disorders
    CERVICAL DYSPLASIA
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    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
    Musculoskeletal and connective tissue disorders
    SYSTEMIC LUPUS ERYTHEMATOSUS
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    ABSCESS LIMB
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    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
    COVID-19
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 47 (2.13%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 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
    ESCHERICHIA SEPSIS
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 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
    GASTROENTERITIS
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
    1 / 25 (4.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    TONSILLITIS
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 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
    Metabolism and nutrition disorders
    HYPOGLYCAEMIA
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    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
    		 ABBV-599 High Dose -> ABBV-599 High Dose Els Pbo/Upa 30 mg -> Els Pbo/Upa 30 mg Els Pbo/Upa Pbo -> ABBV-599 High Dose ABBV-599 Low -> ABBV-599 Low Els 60 mg/Upa Pbo -> Els 60 mg/Upa Pbo Els + Upa Pbo -> ABBV-599 Low
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 45 (53.33%)
    18 / 47 (38.30%)
    30 / 35 (85.71%)
    11 / 19 (57.89%)
    4 / 25 (16.00%)
    6 / 14 (42.86%)
    Vascular disorders
    HAEMATOMA
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    4
    0
    1
    0
    0
    HYPERTENSION
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 47 (2.13%)
    0 / 35 (0.00%)
    2 / 19 (10.53%)
    0 / 25 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    0
    2
    0
    1
    HYPOTENSION
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    GRANULOMA
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    OEDEMA
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    INFLUENZA LIKE ILLNESS
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    PYREXIA
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 47 (2.13%)
    1 / 35 (2.86%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    2
    1
    1
    1
    0
    0
    OEDEMA PERIPHERAL
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    1 / 25 (4.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    Reproductive system and breast disorders
    HEAVY MENSTRUAL BLEEDING
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    DYSPNOEA
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    2 / 35 (5.71%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    2
    0
    0
    0
    NASAL CONGESTION
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    HYPERSENSITIVITY PNEUMONITIS
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    SINUS PAIN
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Psychiatric disorders
    INSOMNIA
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    1 / 35 (2.86%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Investigations
    NEUTROPHIL COUNT DECREASED
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    1 / 35 (2.86%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    2
    0
    1
    1
    0
    0
    Injury, poisoning and procedural complications
    ANIMAL BITE
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    2 / 35 (5.71%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    FALL
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    IMMUNISATION REACTION
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    LOWER LIMB FRACTURE
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    SKIN LACERATION
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    2
    0
    2
    0
    0
    Congenital, familial and genetic disorders
    TYPE V HYPERLIPIDAEMIA
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    PYLORIC STENOSIS
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Cardiac disorders
    MITRAL VALVE INCOMPETENCE
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Nervous system disorders
    MIGRAINE
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    3 / 35 (8.57%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    HEADACHE
         subjects affected / exposed
    2 / 45 (4.44%)
    1 / 47 (2.13%)
    2 / 35 (5.71%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    3
    1
    2
    1
    0
    0
    DIZZINESS
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    BRAIN OEDEMA
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    POST HERPETIC NEURALGIA
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    1 / 35 (2.86%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    SYNCOPE
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Blood and lymphatic system disorders
    LEUKOCYTOSIS
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    ANAEMIA
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    IRON DEFICIENCY ANAEMIA
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    THROMBOCYTOSIS
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Eye disorders
    CATARACT
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    1 / 35 (2.86%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    DRY EYE
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Gastrointestinal disorders
    ABDOMINAL PAIN
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    CONSTIPATION
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    2 / 35 (5.71%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    DUODENAL ULCER
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    GASTRITIS
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    1 / 35 (2.86%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    0
    1
    0
    0
    1
    GASTROOESOPHAGEAL REFLUX DISEASE
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    1 / 35 (2.86%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    0
    1
    0
    0
    1
    IMPAIRED GASTRIC EMPTYING
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    LARGE INTESTINAL ULCER
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    VOMITING
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    NAUSEA
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 47 (2.13%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    2
    1
    0
    1
    0
    1
    Skin and subcutaneous tissue disorders
    RASH
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    2 / 35 (5.71%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    2
    1
    0
    0
    PRURITUS
         subjects affected / exposed
    4 / 45 (8.89%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    5
    0
    0
    0
    0
    0
    CUTANEOUS VASCULITIS
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    ACNE
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    2 / 35 (5.71%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    0
    SKIN ULCER
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Renal and urinary disorders
    LUPUS NEPHRITIS
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    PROTEINURIA
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    BACK PAIN
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    0
    1
    0
    1
    ARTHRALGIA
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    2 / 35 (5.71%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    0
    2
    0
    0
    1
    CONNECTIVE TISSUE DISORDER
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    MUSCLE SPASMS
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Infections and infestations
    CELLULITIS
         subjects affected / exposed
    0 / 45 (0.00%)
    3 / 47 (6.38%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
    1 / 25 (4.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    6
    0
    0
    1
    0
    COVID-19
         subjects affected / exposed
    8 / 45 (17.78%)
    11 / 47 (23.40%)
    7 / 35 (20.00%)
    0 / 19 (0.00%)
    1 / 25 (4.00%)
    0 / 14 (0.00%)
         occurrences all number
    8
    11
    7
    0
    1
    0
    DIVERTICULITIS
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    EAR INFECTION
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
    1 / 25 (4.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    GASTROENTERITIS
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    2 / 35 (5.71%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    0
    EPSTEIN-BARR VIRUS INFECTION
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    HERPES ZOSTER
         subjects affected / exposed
    2 / 45 (4.44%)
    1 / 47 (2.13%)
    1 / 35 (2.86%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    2
    1
    1
    0
    0
    1
    ORAL HERPES
         subjects affected / exposed
    2 / 45 (4.44%)
    2 / 47 (4.26%)
    2 / 35 (5.71%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    2
    2
    2
    0
    0
    0
    NASOPHARYNGITIS
         subjects affected / exposed
    3 / 45 (6.67%)
    2 / 47 (4.26%)
    2 / 35 (5.71%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    4
    2
    2
    0
    0
    0
    MYCOPLASMA INFECTION
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    OTITIS MEDIA
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    1 / 35 (2.86%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    2
    1
    1
    0
    0
    TINEA PEDIS
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    2 / 35 (5.71%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    TINEA VERSICOLOUR
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    SINUSITIS
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    TONSILLITIS
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    4 / 45 (8.89%)
    3 / 47 (6.38%)
    6 / 35 (17.14%)
    0 / 19 (0.00%)
    1 / 25 (4.00%)
    0 / 14 (0.00%)
         occurrences all number
    5
    4
    7
    0
    1
    0
    URINARY TRACT INFECTION
         subjects affected / exposed
    7 / 45 (15.56%)
    3 / 47 (6.38%)
    6 / 35 (17.14%)
    3 / 19 (15.79%)
    1 / 25 (4.00%)
    1 / 14 (7.14%)
         occurrences all number
    9
    7
    8
    4
    1
    1
    VAGINAL INFECTION
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
    0 / 25 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Metabolism and nutrition disorders
    HYPOCALCAEMIA
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    TYPE 2 DIABETES MELLITUS
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    HYPONATRAEMIA
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    HYPOMAGNESAEMIA
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    HYPOKALAEMIA
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 35 (0.00%)
    2 / 19 (10.53%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Jul 2020
    Version 2.0/Amendment 1 • Revised the objectives to assess longer term safety, tolerability, and efficacy data • Added a reassessment of treatment assignments based on Study M19-130 interim analysis • Clarified eligibility criteria referring to active, chronic, or recurrent viral or bacterial infections • Added leflunomide, cyclosporine and tacrolimus to list of permitted concomitant medications • Added discontinuation criteria for subjects with serious infections and/or TB
    28 Oct 2020
    Version 3.0/Amendment 2 • Incorporated necessary protocol modifications to account for COVID-19 infections • Added 2 additional efficacy endpoints: change in PhGA from M19-130 Baseline and change in PtGA from M19-130 Baseline • Added the following as areas of safety interest: active TB; adjudicated GI perforations; and adjudicated embolic and thrombotic events (non- cardiac, non-CNS) including venous thromboembolic events defined as pulmonary embolism and deep vein thrombosis • Removed the following from the list of areas of safety interest: increased serum creatinine and CPK elevation • Added further clarification that Study M20-186 is primarily a study of longer-term safety and that efficacy outcomes are considered secondary
    26 Oct 2021
    Version 4.0/Amendment 3 • Treatment groups were clarified based on the completed Study M19-130 Interim Analysis • Clarified that subjects will need to successfully complete 48 weeks of Study M19-130 on placebo or a group that is currently active after the planned Study M19-130 Interim Analysis and meet all eligibility criteria to be considered eligible to enroll into LTE Study M20-186 • Added the statement, "At the Sponsor's discretion, doses of study drug(s) selected for continuation in LTE Study M20-186 may be reassigned or discontinued at any time based on the outcome assessment of the Study M19-130 Interim Analysis." • Added the statement, "If the study is partially terminated, a subject in a terminated group will be asked to return for a PD visit and to perform a 30-day follow-up phone call after the last dose of study drug."

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

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