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    Clinical Trial Results:
    A Randomized, Double-Blind, Double-Dummy, Active Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Subjects with Moderate to Severe Rheumatoid Arthritis

    Summary
    EudraCT number
    		 2018-003053-21
    Trial protocol
    		 PL  
    Global end of trial date
    26 Aug 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Jun 2021
    First version publication date
    10 Jun 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M16-560
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03823391
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AbbVie
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6-4UB
    Public contact
    Global Medical Services, AbbVie, 001 800-633-9110, abbvieclinicaltrials@abbvie.com
    Scientific contact
    Global Medical Services, AbbVie, 001 800-633-9110, 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
    26 Aug 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Aug 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. To assess the safety, tolerability, and efficacy of ABBV-3373 administered every other week (EOW) intravenously (IV) in subjects with moderately to severely active rheumatoid arthritis (RA) on background methotrexate (MTX). 2. To compare clinical efficacy of ABBV-3373 with adalimumab and to test the concept that an anti-tumor necrosis factor (TNF) antibody-drug-conjugate (ADC) has the potential to provide superior efficacy than the traditional anti-TNF antibody in RA.
    Protection of trial subjects
    Subject read and understood the information provided about the study and gave written permission.
    Background therapy
    		 Subjects must have been on oral or parenteral methotrexate (MTX) therapy ≥ 3 months and on a stable prescription of 15 to 25 mg/week (or ≥ 10 mg/week in subjects intolerant of MTX at doses ≥ 15 mg/week) for ≥ 4 weeks prior to the first dose of study drug. Subjects were expected to be able to continue on stable dose of MTX for the duration of study participation.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Mar 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Hungary: 15
    Country: Number of subjects enrolled
    Israel: 6
    Country: Number of subjects enrolled
    Poland: 3
    Country: Number of subjects enrolled
    Puerto Rico: 5
    Country: Number of subjects enrolled
    United States: 19
    Worldwide total number of subjects
    48
    EEA total number of subjects
    18
    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)
    38
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants with moderately to severely active rheumatoid arthritis (RA) on background methotrexate were enrolled at 14 sites in the United States and Puerto Rico, Poland, Hungary, and Israel.

    Pre-assignment
    Screening details
    		 Subjects were randomly assigned in a 2:1 ratio to either ABBV-3373 or adalimumab. Randomization was stratified by current use of systemic glucocorticoid and prior exposure to non-anti-TNF biologics or targeted synthetic disease-modifying antirheumatic drugs (DMARDs) for less than 3 months and terminated not due to lack of efficacy or intolerance.

    Period 1
    Period 1 title
    Period 1: Baseline to Week 12
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Adalimumab
    Arm description
    		 Participants received 80 mg adalimumab by subcutaneous injection once every other week (EOW) and placebo to ABBV-3373 by intravenous infusion EOW for 12 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    HUMIRA™
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered at 80 mg EOW for 12 weeks.

    Investigational medicinal product name
    Placebo to ABBV-3373
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered EOW for 12 weeks.

    Arm title
    		 ABBV-3373
    Arm description
    		 Participants received 100 mg ABBV-3373 by intravenous infusion EOW and placebo to adalimumab by subcutaneous injection EOW for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABBV-3373
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered at 100 mg EOW for 12 weeks.

    Investigational medicinal product name
    Placebo to Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered EOW for 12 weeks.

    Number of subjects in period 1
    		Adalimumab ABBV-3373
    Started
    17
    31
    Completed
    17
    31
    Period 2
    Period 2 title
    Period 2: Week 12 to Week 24
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Adalimumab / Adalimumab
    Arm description
    		 Participants continued to receive 80 mg adalimumab by subcutaneous injection EOW from Week 12 to Week 24.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    HUMIRA™
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered at 80 mg EOW for 12 weeks.

    Arm title
    		 ABBV-3373 / Placebo
    Arm description
    		 Participants received placebo to adalimumab by subcutaneous injection EOW from Week 12 to Week 24.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo to Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered EOW for 12 weeks.

    Number of subjects in period 2
    		Adalimumab / Adalimumab ABBV-3373 / Placebo
    Started
    17
    31
    Completed
    15
    30
    Not completed
    2
    1
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Adalimumab
    Reporting group description
    		 Participants received 80 mg adalimumab by subcutaneous injection once every other week (EOW) and placebo to ABBV-3373 by intravenous infusion EOW for 12 weeks.

    Reporting group title
    ABBV-3373
    Reporting group description
    		 Participants received 100 mg ABBV-3373 by intravenous infusion EOW and placebo to adalimumab by subcutaneous injection EOW for 12 weeks.

    Reporting group values
    		 Adalimumab ABBV-3373 Total
    Number of subjects
    		 17 31 48
    Age categorical
    Units: Subjects
        < 40 years
    		 0 5 5
        40 - 65 years
    		 13 21 34
        ≥ 65 years
    		 4 5 9
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54.0 ± 10.21 52.8 ± 13.14 -
    Gender categorical
    Units: Subjects
        Female
    		 14 24 38
        Male
    		 3 7 10
    Race
    Units: Subjects
        White
    		 16 28 44
        Black
    		 1 2 3
        Other
    		 0 1 1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 3 8 11
        Not Hispanic or Latino
    		 14 23 37
    Baseline Use of Systemic Glucocorticoids
    Randomization was stratified by current use of systemic glucocorticoid (≤ 7.5 mg/day prednisone equivalent) for treatment of rheumatoid arthritis at Baseline).
    Units: Subjects
        Yes
    		 5 11 16
        No
    		 12 20 32
    Prior Exposure to Non-anti-TNF or Targeted Synthetic DMARDs
    Randomization was stratified by prior exposure to non-anti-TNF biologics or targeted synthetic DMARDs (< 3 months and terminated not due to lack of efficacy or intolerance).
    Units: Subjects
        Yes
    		 0 0 0
        No
    		 17 31 48
    Duration of RA Symptoms
    Units: years
        arithmetic mean (standard deviation)
    		 5.9 ± 3.22 8.0 ± 8.73 -
    Duration of RA Diagnosis
    Units: years
        arithmetic mean (standard deviation)
    		 3.5 ± 3.09 5.0 ± 6.02 -
    Disease Activity Score 28 C-reactive protein (DAS28[CRP])
    The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and high-sensitivity C-reactive protein (hsCRP) (in mg/L). Scores on the DAS28 (CRP) range from 0.96 to approximately 10, where higher scores indicate more disease activity.
    Units: scores on a scale
        arithmetic mean (standard deviation)
    		 5.6 ± 0.71 5.6 ± 0.92 -

    End points

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    End points reporting groups
    Reporting group title
    Adalimumab
    Reporting group description
    		 Participants received 80 mg adalimumab by subcutaneous injection once every other week (EOW) and placebo to ABBV-3373 by intravenous infusion EOW for 12 weeks.

    Reporting group title
    ABBV-3373
    Reporting group description
    		 Participants received 100 mg ABBV-3373 by intravenous infusion EOW and placebo to adalimumab by subcutaneous injection EOW for 12 weeks.
    Reporting group title
    Adalimumab / Adalimumab
    Reporting group description
    		 Participants continued to receive 80 mg adalimumab by subcutaneous injection EOW from Week 12 to Week 24.

    Reporting group title
    ABBV-3373 / Placebo
    Reporting group description
    		 Participants received placebo to adalimumab by subcutaneous injection EOW from Week 12 to Week 24.

    Primary: Change from Baseline to Week 12 in Disease Activity Score (DAS) 28 (C-reactive Protein [CRP])

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    End point title
    		 Change from Baseline to Week 12 in Disease Activity Score (DAS) 28 (C-reactive Protein [CRP]) [1]
    End point description
    The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a visual analog scale [VAS] from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0.96 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity. Subjects in the full analysis set (randomized subjects who received at least 1 dose of the study drug) with non-missing Baseline and at least one post-baseline value are included in the analysis.
    End point type
    Primary
    End point timeframe
    Baseline and Week 12
    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: Two primary comparisons were performed between ABBV-3373 and adalimumab. The first was the comparison of ABBV-3373 to historical adalimumab reference value -2.13 based on a meta-analysis from 3 historical adalimumab studies. The second comparison was ABBV-3373 to adalimumab with combined in-trial and historical adalimumab data in which the success criterion was posterior probability of ABBV-3373 better than adalimumab >95%. The results of these analyses are reported in the attachment below.
    End point values
    		 Adalimumab ABBV-3373
    Number of subjects analysed
    17
    31
    Units: scores on a scale
        least squares mean (standard error)
    -2.51 ± 0.293
    -2.65 ± 0.215
    Attachments
    		 Primary Analysis of the Primary Endpoint
    No statistical analyses for this end point

    Secondary: Change from Baseline to Week 12 in Clinical Disease Activity Index (CDAI)

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    End point title
    		 Change from Baseline to Week 12 in Clinical Disease Activity Index (CDAI)
    End point description
    The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient Global Assessment of Disease Activity and Physician Global Assessment of Disease Activity both measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 76 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity. Subjects in the full analysis set with non-missing Baseline and at least one post-baseline value were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Adalimumab ABBV-3373
    Number of subjects analysed
    17
    31
    Units: score on a scale
        least squares mean (standard error)
    -26.30 ± 2.656
    -27.99 ± 1.955
    Statistical analysis title
    		 In-study Analysis of CDAI
    Comparison groups
    Adalimumab v ABBV-3373
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.601 [2]
    Method
    		 Mixed-effect model repeated measurement
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -1.69
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -7.08
         upper limit
    		 3.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.207
    Notes
    [2] - Mixed-effect model repeated measurement (MMRM) analysis with unstructured variance-covariance matrix, including treatment, visit, stratification factors, and treatment-by-visit interaction as fixed factors and Baseline value as covariate.

    Secondary: Change from Baseline in Simplified Disease Activity Index (SDAI)

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    End point title
    		 Change from Baseline in Simplified Disease Activity Index (SDAI)
    End point description
    The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), Patient Global Assessment of Disease Activity and Physician Global Assessment of Disease Activity both measured on a VAS from 0-10 cm and level of CRP (in mg/dL; normal < 1 mg/dL). The SDAI has a range from 0 to 86, with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity. Subjects in the full analysis set with non-missing Baseline and at least one post-baseline value were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Adalimumab ABBV-3373
    Number of subjects analysed
    17
    31
    Units: score on a scale
        least squares mean (standard error)
    -27.42 ± 2.659
    -28.50 ± 1.961
    Statistical analysis title
    		 In-study Analysis of SDAI
    Comparison groups
    Adalimumab v ABBV-3373
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.737 [3]
    Method
    		 Mixed-effect model repeated measurement
    Parameter type
    		 LS Mean Difference
    Point estimate
    -1.08
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -6.47
         upper limit
    		 4.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.205
    Notes
    [3] - Mixed-effect model repeated measurement (MMRM) analysis with unstructured variance-covariance matrix, including treatment, visit, stratification factors, and treatment-by-visit interaction as fixed factors and Baseline value as covariate.

    Secondary: Change from Baseline to Week 12 in DAS28 (Erythrocyte Sedimentation Rate [ESR])

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    End point title
    		 Change from Baseline to Week 12 in DAS28 (Erythrocyte Sedimentation Rate [ESR])
    End point description
    The DAS28 (ESR) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and ESR (in mm/hr). Scores on the DAS28 (ESR) range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline indicates improvement in disease activity. Subjects in the full analysis set with non-missing Baseline and at least one post-baseline value were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Adalimumab ABBV-3373
    Number of subjects analysed
    17
    31
    Units: score on a scale
        least squares mean (standard error)
    -2.55 ± 0.344
    -2.76 ± 0.254
    Statistical analysis title
    		 In-study Analysis of DAS28 (ESR)
    Comparison groups
    Adalimumab v ABBV-3373
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.612 [4]
    Method
    		 Mixed-effect model repeated measurement
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.21
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.92
         upper limit
    		 0.49
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.418
    Notes
    [4] - Mixed-effect model repeated measurement analysis with unstructured variance-covariance matrix, including treatment, visit, stratification factors, and treatment-by-visit interaction as fixed factors and Baseline value as covariate.

    Secondary: Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28 (CRP) at Week 12

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    End point title
    		 Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28 (CRP) at Week 12
    End point description
    The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0.96 to approximately 10, where higher scores indicate more disease activity. A DAS28 (CRP) score less than or equal to 3.2 indicates low disease activity. Subjects in the full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom DAS28 (CRP) data were missing at Week 12 were considered non-responders.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Adalimumab ABBV-3373
    Number of subjects analysed
    17
    31
    Units: percentage of participants
        number (confidence interval 90%)
    58.8 (39.2 to 78.5)
    54.8 (40.1 to 69.5)
    Statistical analysis title
    		 In-study Analysis of LDA
    Comparison groups
    Adalimumab v ABBV-3373
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.877 [5]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Response Rate Difference
    Point estimate
    -4
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -28.5
         upper limit
    		 20.5
    Notes
    [5] - Cochran-Mantel-Haenszel test adjusting for stratification factors

    Secondary: Percentage of Participants with an American College of Rheumatology 50% (ACR50) Response at Week 12

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    End point title
    		 Percentage of Participants with an American College of Rheumatology 50% (ACR50) Response at Week 12
    End point description
    Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: 1. ≥ 50% improvement in 68-tender joint count; 2. ≥ 50% improvement in 66-swollen joint count; and 3. ≥ 50% improvement in at least 3 of the 5 following parameters: • Physician global assessment of disease activity • Patient global assessment of disease activity • Patient assessment of pain • Health Assessment Questionnaire - Disability Index (HAQ-DI) • High-sensitivity C-reactive protein (hsCRP). Subjects in the full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Adalimumab ABBV-3373
    Number of subjects analysed
    17
    31
    Units: percentage of participants
        number (confidence interval 90%)
    64.7 (45.6 to 83.8)
    51.6 (36.8 to 66.4)
    Statistical analysis title
    		 In-study Analysis of ACR50
    Comparison groups
    Adalimumab v ABBV-3373
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.426 [6]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Response Rate Difference
    Point estimate
    -13.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -37.2
         upper limit
    		 11
    Notes
    [6] - Cochran-Mantel-Haenszel test adjusting for stratification factors.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Period 1: ABBV-3373
    Reporting group description
    		 Participants received 100 mg ABBV-3373 by intravenous infusion EOW and placebo to adalimumab by subcutaneous injection EOW for 12 weeks.

    Reporting group title
    Period 1: Adalimumab
    Reporting group description
    		 Participants received 80 mg adalimumab by subcutaneous injection EOW and placebo to ABBV-3373 by intravenous infusion EOW for 12 weeks.

    Reporting group title
    Period 2: ABBV-3773 / Placebo
    Reporting group description
    		 Participants received placebo to adalimumab by subcutaneous injection EOW from Week 12 to Week 24.

    Reporting group title
    Period 2: Adalimumab / Adalimumab
    Reporting group description
    		 Participants continued to receive 80 mg adalimumab by subcutaneous injection EOW from Week 12 to Week 24.

    Serious adverse events
    		 Period 1: ABBV-3373 Period 1: Adalimumab Period 2: ABBV-3773 / Placebo Period 2: Adalimumab / Adalimumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 31 (12.90%)
    0 / 17 (0.00%)
    0 / 30 (0.00%)
    2 / 16 (12.50%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    General disorders and administration site conditions
    NON-CARDIAC CHEST PAIN
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 17 (0.00%)
    0 / 30 (0.00%)
    0 / 16 (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
    Immune system disorders
    ANAPHYLACTIC SHOCK
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 17 (0.00%)
    0 / 30 (0.00%)
    0 / 16 (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
    Infections and infestations
    BREAST ABSCESS
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 17 (0.00%)
    0 / 30 (0.00%)
    1 / 16 (6.25%)
         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
    BRONCHITIS
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 17 (0.00%)
    0 / 30 (0.00%)
    1 / 16 (6.25%)
         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
    1 / 31 (3.23%)
    0 / 17 (0.00%)
    0 / 30 (0.00%)
    0 / 16 (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
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 17 (0.00%)
    0 / 30 (0.00%)
    0 / 16 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Period 1: ABBV-3373 Period 1: Adalimumab Period 2: ABBV-3773 / Placebo Period 2: Adalimumab / Adalimumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 31 (12.90%)
    12 / 17 (70.59%)
    7 / 30 (23.33%)
    12 / 16 (75.00%)
    Investigations
    BLOOD PRESSURE INCREASED
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 17 (5.88%)
    0 / 30 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    LIVER FUNCTION TEST ABNORMAL
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 17 (0.00%)
    0 / 30 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    MYCOPLASMA TEST POSITIVE
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 17 (0.00%)
    0 / 30 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Vascular disorders
    HYPERTENSION
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 17 (5.88%)
    0 / 30 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 17 (5.88%)
    0 / 30 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    2
    1
    0
    1
    HYPOAESTHESIA
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 17 (5.88%)
    0 / 30 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    SCIATICA
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 17 (0.00%)
    0 / 30 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Blood and lymphatic system disorders
    LEUKOPENIA
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 17 (0.00%)
    0 / 30 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    General disorders and administration site conditions
    INFUSION SITE BRUISING
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 17 (5.88%)
    0 / 30 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    INJECTION SITE PRURITUS
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 17 (0.00%)
    0 / 30 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    OEDEMA PERIPHERAL
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 17 (0.00%)
    0 / 30 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    PYREXIA
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 17 (0.00%)
    0 / 30 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Immune system disorders
    DRUG HYPERSENSITIVITY
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 17 (0.00%)
    0 / 30 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    TYPE I HYPERSENSITIVITY
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 17 (5.88%)
    0 / 30 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Eye disorders
    PERIORBITAL SWELLING
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 17 (0.00%)
    0 / 30 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal disorders
    ABDOMINAL DISCOMFORT
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 17 (5.88%)
    0 / 30 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    MOUTH SWELLING
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 17 (0.00%)
    0 / 30 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    NAUSEA
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 17 (0.00%)
    0 / 30 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    BRONCHIAL HYPERREACTIVITY
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 17 (5.88%)
    0 / 30 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    OROPHARYNGEAL PAIN
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 17 (0.00%)
    0 / 30 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    PRURITUS
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 17 (5.88%)
    0 / 30 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    0
    1
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 17 (5.88%)
    0 / 30 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    MUSCULOSKELETAL PAIN
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 17 (0.00%)
    1 / 30 (3.33%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    1
    MYALGIA
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 17 (5.88%)
    0 / 30 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    OSTEOARTHRITIS
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 17 (0.00%)
    0 / 30 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    RHEUMATOID ARTHRITIS
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 17 (0.00%)
    3 / 30 (10.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Infections and infestations
    BRONCHITIS
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 17 (0.00%)
    0 / 30 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    1
    0
    0
    1
    GASTROENTERITIS VIRAL
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 17 (5.88%)
    0 / 30 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    NASOPHARYNGITIS
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 17 (5.88%)
    3 / 30 (10.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    1
    3
    2
    ORAL HERPES
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 17 (5.88%)
    0 / 30 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    0
    1
    SINUSITIS
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 17 (0.00%)
    1 / 30 (3.33%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    1
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 17 (0.00%)
    2 / 30 (6.67%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    2
    1
    URINARY TRACT INFECTION
         subjects affected / exposed
    2 / 31 (6.45%)
    2 / 17 (11.76%)
    1 / 30 (3.33%)
    1 / 16 (6.25%)
         occurrences all number
    2
    2
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Nov 2019
    The purpose of this version was to communicate new safety findings regarding a case of anaphylactic shock throughout the protocol.
    20 Nov 2019
    Major changes included: - changed study from Phase 1b to Phase 2a; - added a secondary objective to compare adalimumab with synthetic control to establish assay sensitivity; - added clarifications for potentially used concomitant medications; - updated statistical details for clarity; - removed interim efficacy analysis.
    14 Mar 2020
    The purpose of this version was to add the evaluation of another ADC cohort (ABBV-154) in addition to the ABBV-3373 cohort.
    26 Aug 2020
    The purpose of this version was to remove the ABBV-154 cohort.

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

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

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