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    Clinical Trial Results:
    A Phase 2a/2b, Multicenter, Randomized, Placebo and Active Comparator-controlled, Double-Blind, Dose-ranging Study to Evaluate the Safety and Efficacy of Bermekimab (JNJ-77474462) for the Treatment of Subjects with Moderate to Severe Hidradenitis Suppurativa

    Summary
    EudraCT number
    		 2020-002607-19
    Trial protocol
    		 DE   NL   ES  
    Global end of trial date
    12 Oct 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Oct 2023
    First version publication date
    29 Oct 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CR109063
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04988308
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    Welsh & McKeanRoads, P.O. Box 776, Spring House, United States, PA 19477
    Public contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.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
    12 Oct 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Oct 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of this trial was to evaluate the clinical efficacy of bermekimab in subjects with moderate to severe hidradenitis suppurativa (HS).
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Nov 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 9
    Country: Number of subjects enrolled
    Canada: 14
    Country: Number of subjects enrolled
    Germany: 32
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    Japan: 8
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    Poland: 20
    Country: Number of subjects enrolled
    United States: 62
    Worldwide total number of subjects
    151
    EEA total number of subjects
    58
    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)
    149
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 As per change in planned analysis, part 2 of this study was not conducted due to early termination because interim analysis 1 efficacy results met the prespecified futility criteria related to the primary endpoint. Hence, data for Part 2 and some secondary efficacy outcome measures (Parts 1 and 2) were not reported in this results summary.

    Period 1
    Period 1 title
    Placebo Controlled Period (Week 0-16)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Part 1: Placebo (Week 0-16)
    Arm description
    		 Subjects received placebo as subcutaneous (SC) injection from Week 0 through Week 15 and then subjects received bermekimab 1050 milligrams (mg) as SC injection at Week 16 in Part 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received placebo as SC injection from Week 0 through Week 15 in Part 1.

    Investigational medicinal product name
    Bermekimab
    Investigational medicinal product code
    Other name
    JNJ-77474462
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received bermekimab 1050 mg as SC injection at Week 16 in Part 1.

    Arm title
    		 Part 1: Bermekimab (Week 0-16)
    Arm description
    		 Subjects received bermekimab 1050 mg (3*350 mg) and 1 placebo SC injection at Week 0 followed by bermekimab 1050 mg (3*350 mg) as SC injection at Week 1 and every week thereafter through Week 16 in Part 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 1 placebo as SC injection at Week 0.

    Investigational medicinal product name
    Bermekimab
    Investigational medicinal product code
    Other name
    JNJ-77474462
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received bermekimab 1050 mg (3*350 mg) at Week 0 followed by bermekimab 1050 mg (3*350 mg) as SC injections at Week 1 and every week thereafter through Week 16 in Part 1.

    Arm title
    		 Part 1: Adalimumab (Week 0-16)
    Arm description
    		 Subjects received adalimumab 160 mg (4*40 mg) as SC injection at Week 0 and 3 placebo SC injections at Week 1 followed by adalimumab 80 mg (2*40 mg) as SC injection at Week 2 and 3 placebo SC injections at Week 3. Subjects received adalimumab 40 mg (1*40 mg) SC injection and 2 placebo SC injections at Week 4 and every week thereafter through Week 16 in Part 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 3 placebo SC injections at Week 1 followed by 3 placebo SC injections at Week 3. Subjects received 2 placebo SC injections at Week 4 and every week thereafter through Week 16 in Part 1.

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received adalimumab 160 mg (4*40 mg) as SC injection at Week 0 followed by adalimumab 80 mg (2*40 mg) as SC injection at Week 2. Subjects received adalimumab 40 mg (1*40 mg) SC injection at Week 4 and every week thereafter through Week 16 in Part 1.

    Number of subjects in period 1
    		Part 1: Placebo (Week 0-16) Part 1: Bermekimab (Week 0-16) Part 1: Adalimumab (Week 0-16)
    Started
    50
    51
    50
    Completed
    28
    30
    28
    Not completed
    22
    21
    22
         Consent withdrawn by subject
    2
    4
    4
         Death
    -
    -
    1
         Study terminated by sponsor
    6
    4
    3
         Unspecified
    10
    9
    14
         Lost to follow-up
    4
    4
    -
    Period 2
    Period 2 title
    Active Treatment+Safety F-U (Week 17-36)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Part 1: Placebo then Bermekimab (Week 17-36)
    Arm description
    		 Subjects who received placebo during placebo controlled period and then received bermekimab 1050 mg (3*350 mg) at Week 16 entered into active treatment + safety follow up (FU) period and received bermekimab 1050 mg as SC injection weekly through Week 31 in Part 1. All subjects were followed for safety through Week 36.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bermekimab
    Investigational medicinal product code
    Other name
    JNJ-77474462
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    At Week 16, subjects received 1050 mg as SC injection weekly through Week 31 in Part 1.

    Arm title
    		 Part 1: Bermekimab (Week 17-36)
    Arm description
    		 Subjects who received bermekimab 1050 mg at Week 16 during placebo controlled period entered into active treatment + safety FU period and continued to receive bermekimab 1050 mg (3*350 mg) as SC injection every week thereafter through Week 31. All subjects were followed for safety through Week 36.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bermekimab
    Investigational medicinal product code
    Other name
    JNJ-77474462
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received bermekimab 1050 mg (3*350 mg) as SC injection every week thereafter through Week 31.

    Arm title
    		 Part 1: Adalimumab (Week 17-36)
    Arm description
    		 Subjects who received adalimumab 40 mg as SC injection during placebo controlled period entered into active treatment + safety FU period and continued to receive adalimumab 40 mg as SC injection and 2 placebo SC injections weekly through Week 31 in Part 1. All subjects were followed for safety through Week 36.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 2 placebo SC injections weekly through Week 31 in Part 1.

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received adalimumab 40 mg as SC injection weekly through Week 31 in Part 1.

    Number of subjects in period 2
    		Part 1: Placebo then Bermekimab (Week 17-36) Part 1: Bermekimab (Week 17-36) Part 1: Adalimumab (Week 17-36)
    Started
    28
    30
    28
    Completed
    7
    9
    10
    Not completed
    21
    21
    18
         Consent withdrawn by subject
    3
    2
    1
         Study terminated by sponsor
    5
    6
    2
         Unspecified
    10
    10
    14
         Lost to follow-up
    3
    3
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part 1: Placebo (Week 0-16)
    Reporting group description
    		 Subjects received placebo as subcutaneous (SC) injection from Week 0 through Week 15 and then subjects received bermekimab 1050 milligrams (mg) as SC injection at Week 16 in Part 1.

    Reporting group title
    Part 1: Bermekimab (Week 0-16)
    Reporting group description
    		 Subjects received bermekimab 1050 mg (3*350 mg) and 1 placebo SC injection at Week 0 followed by bermekimab 1050 mg (3*350 mg) as SC injection at Week 1 and every week thereafter through Week 16 in Part 1.

    Reporting group title
    Part 1: Adalimumab (Week 0-16)
    Reporting group description
    		 Subjects received adalimumab 160 mg (4*40 mg) as SC injection at Week 0 and 3 placebo SC injections at Week 1 followed by adalimumab 80 mg (2*40 mg) as SC injection at Week 2 and 3 placebo SC injections at Week 3. Subjects received adalimumab 40 mg (1*40 mg) SC injection and 2 placebo SC injections at Week 4 and every week thereafter through Week 16 in Part 1.

    Reporting group values
    		 Part 1: Placebo (Week 0-16) Part 1: Bermekimab (Week 0-16) Part 1: Adalimumab (Week 0-16) Total
    Number of subjects
    		 50 51 50 151
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 49 51 49 149
        From 65 to 84 years
    		 1 0 1 2
        85 years and over
    		 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 38.1 ( 12.55 ) 36.7 ( 9.67 ) 35.7 ( 12.2 ) -
    Title for Gender
    Units: subjects
        Female
    		 25 30 28 83
        Male
    		 25 21 22 68

    End points

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    End points reporting groups
    Reporting group title
    Part 1: Placebo (Week 0-16)
    Reporting group description
    		 Subjects received placebo as subcutaneous (SC) injection from Week 0 through Week 15 and then subjects received bermekimab 1050 milligrams (mg) as SC injection at Week 16 in Part 1.

    Reporting group title
    Part 1: Bermekimab (Week 0-16)
    Reporting group description
    		 Subjects received bermekimab 1050 mg (3*350 mg) and 1 placebo SC injection at Week 0 followed by bermekimab 1050 mg (3*350 mg) as SC injection at Week 1 and every week thereafter through Week 16 in Part 1.

    Reporting group title
    Part 1: Adalimumab (Week 0-16)
    Reporting group description
    		 Subjects received adalimumab 160 mg (4*40 mg) as SC injection at Week 0 and 3 placebo SC injections at Week 1 followed by adalimumab 80 mg (2*40 mg) as SC injection at Week 2 and 3 placebo SC injections at Week 3. Subjects received adalimumab 40 mg (1*40 mg) SC injection and 2 placebo SC injections at Week 4 and every week thereafter through Week 16 in Part 1.
    Reporting group title
    Part 1: Placebo then Bermekimab (Week 17-36)
    Reporting group description
    		 Subjects who received placebo during placebo controlled period and then received bermekimab 1050 mg (3*350 mg) at Week 16 entered into active treatment + safety follow up (FU) period and received bermekimab 1050 mg as SC injection weekly through Week 31 in Part 1. All subjects were followed for safety through Week 36.

    Reporting group title
    Part 1: Bermekimab (Week 17-36)
    Reporting group description
    		 Subjects who received bermekimab 1050 mg at Week 16 during placebo controlled period entered into active treatment + safety FU period and continued to receive bermekimab 1050 mg (3*350 mg) as SC injection every week thereafter through Week 31. All subjects were followed for safety through Week 36.

    Reporting group title
    Part 1: Adalimumab (Week 17-36)
    Reporting group description
    		 Subjects who received adalimumab 40 mg as SC injection during placebo controlled period entered into active treatment + safety FU period and continued to receive adalimumab 40 mg as SC injection and 2 placebo SC injections weekly through Week 31 in Part 1. All subjects were followed for safety through Week 36.

    Subject analysis set title
    Part 1: Bermekimab (Week 0-36)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received bermekimab 1050 mg (3*350 mg) and 1 placebo as SC injection at Week 0 followed by bermekimab 1050 mg (3*350 mg) as SC injection at Week 1 and every week thereafter through Week 16 in Part 1. Subjects who received bermekimab 1050 mg (3*350 mg) at Week 16 entered into active treatment + safety follow up (FU) period and received bermekimab 1050 mg as SC injection weekly through Week 36 in Part 1.

    Primary: Part 1: Percentage of Subjects who Achieved Hidradenitis Suppurativa Clinical Response-50 (HiSCR50) at Week 16

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    End point title
    		 Part 1: Percentage of Subjects who Achieved Hidradenitis Suppurativa Clinical Response-50 (HiSCR50) at Week 16 [1]
    End point description
    HiSCR50 was defined as at least 50 percent (%) reduction in total abscess and inflammatory nodule counts (AN count) with no increase in abscess count and no increase in draining fistula count relative to baseline. The full analysis set (FAS) included all randomised subjects who received at least one administration of study intervention.
    End point type
    Primary
    End point timeframe
    Week 16
    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 statistics was done, no inferential statistical analysis was performed.
    End point values
    		 Part 1: Placebo (Week 0-16) Part 1: Bermekimab (Week 0-16) Part 1: Adalimumab (Week 0-16)
    Number of subjects analysed
    35
    35
    35
    Units: Percentage of subjects
        number (not applicable)
    37.1
    37.1
    57.1
    No statistical analyses for this end point

    Secondary: Part 1: Percentage of Subjects who Achieved HiSCR75 at Week 16

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    End point title
    		 Part 1: Percentage of Subjects who Achieved HiSCR75 at Week 16
    End point description
    HiSCR75 was defined as at least 75% reduction in total abscess and inflammatory nodule counts (AN count) with no increase in abscess count and no increase in draining fistula count relative to baseline. The FAS included all randomised subjects who received at least one administration of study intervention.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Part 1: Placebo (Week 0-16) Part 1: Bermekimab (Week 0-16) Part 1: Adalimumab (Week 0-16)
    Number of subjects analysed
    35
    35
    35
    Units: Percentage of subjects
        number (not applicable)
    25.7
    25.7
    40.0
    No statistical analyses for this end point

    Secondary: Part 1: Percentage of Subjects who Achieved HiSCR90 at Week 16

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    End point title
    		 Part 1: Percentage of Subjects who Achieved HiSCR90 at Week 16
    End point description
    HiSCR90 was defined as at least 90% reduction in total abscess and inflammatory nodule counts (AN count) with no increase in abscess count and no increase in draining fistula count relative to baseline. The FAS included all randomised subjects who received at least one administration of study intervention.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Part 1: Placebo (Week 0-16) Part 1: Bermekimab (Week 0-16) Part 1: Adalimumab (Week 0-16)
    Number of subjects analysed
    35
    35
    35
    Units: Percentage of subjects
        number (not applicable)
    14.3
    17.1
    22.9
    No statistical analyses for this end point

    Secondary: Part 1: Change from Baseline in the Abscess and Inflammatory Nodule (AN) Count at Week 16

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    End point title
    		 Part 1: Change from Baseline in the Abscess and Inflammatory Nodule (AN) Count at Week 16
    End point description
    Change from baseline in the AN count at Week 16 was reported. Abscess and inflammatory nodule were counted for the hidradenitis suppurativa (HS) affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions. The FAS included all randomised subjects who received at least one administration of study intervention. Here, 'N' (number of subjects analysed) signifies number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Part 1: Placebo (Week 0-16) Part 1: Bermekimab (Week 0-16) Part 1: Adalimumab (Week 0-16)
    Number of subjects analysed
    28
    29
    28
    Units: Abscess and inflammatory nodule
        arithmetic mean (standard deviation)
    -4.50 ( 5.088 )
    -5.31 ( 8.594 )
    -7.25 ( 4.774 )
    No statistical analyses for this end point

    Secondary: Part 1: Change from Baseline in Number of Abscess at Week 16

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    End point title
    		 Part 1: Change from Baseline in Number of Abscess at Week 16
    End point description
    Change from baseline in number of abscess at Week 16 was reported. The FAS included all randomised subjects who received at least one administration of study intervention. Here, 'N' (number of subjects analysed) signifies number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Part 1: Placebo (Week 0-16) Part 1: Bermekimab (Week 0-16) Part 1: Adalimumab (Week 0-16)
    Number of subjects analysed
    28
    29
    28
    Units: Abscess
        arithmetic mean (standard deviation)
    -0.86 ( 1.900 )
    -0.83 ( 3.071 )
    -1.46 ( 2.333 )
    No statistical analyses for this end point

    Secondary: Part 1: Change from Baseline in Number of Draining Fistula at Week 16

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    End point title
    		 Part 1: Change from Baseline in Number of Draining Fistula at Week 16
    End point description
    Change from baseline in number of draining fistula at Week 16 was reported. Draining fistula was defined as fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation. The FAS included all randomised subjects who received at least one administration of study intervention. Here, 'N' (number of subjects analysed) signifies number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Part 1: Placebo (Week 0-16) Part 1: Bermekimab (Week 0-16) Part 1: Adalimumab (Week 0-16)
    Number of subjects analysed
    28
    29
    28
    Units: Fistulas
        arithmetic mean (standard deviation)
    -0.04 ( 1.915 )
    -1.00 ( 1.626 )
    -0.96 ( 1.575 )
    No statistical analyses for this end point

    Secondary: Part 1: Percentage of Subjects with Hidradenitis Suppurativa-Investigator’s Global Assessment (HS-IGA) Score of Inactive (0), Almost Inactive (1), or Mild Activity (2) and with at least 2-grade Improvement Relative to Baseline at Week 16

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    End point title
    		 Part 1: Percentage of Subjects with Hidradenitis Suppurativa-Investigator’s Global Assessment (HS-IGA) Score of Inactive (0), Almost Inactive (1), or Mild Activity (2) and with at least 2-grade Improvement Relative to Baseline at Week 16
    End point description
    The HS-IGA documents the investigator's assessment of the subject's HS at a given timepoint. The anatomic region with the most severe HS activity at the baseline was evaluated for erythema, drainage, and pain and/or tenderness to palpation for each subject. Among subjects with score of moderate activity (3) or severe activity (4) at baseline, the same anatomic site selected for evaluation at the baseline were re-evaluated at Week 16. The subject's HS was assessed as inactive (0), almost inactive (1), mild activity (2), moderate activity (3), or severe activity (4). A higher score indicates more severe disease. The FAS included all randomised subjects who received at least one administration of study intervention. Here, 'N' (number of subjects analysed) signifies number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Part 1: Placebo (Week 0-16) Part 1: Bermekimab (Week 0-16) Part 1: Adalimumab (Week 0-16)
    Number of subjects analysed
    35
    35
    34
    Units: Percentage of subjects
    number (not applicable)
        HS-IGA scores of 0
    11.4
    17.1
    20.6
        HS-IGA scores of 0 or 1
    25.7
    25.7
    38.2
        HS-IGA scores of 0, 1, or 2
    28.6
    28.6
    38.2
    No statistical analyses for this end point

    Secondary: Part 1: Change from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Score at Week 16

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    End point title
    		 Part 1: Change from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Score at Week 16
    End point description
    HS4 was a dynamic severity assessment of HS. IHS4 score was arrived at by the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A total score of 3 or less signifies mild, 4-10 signifies moderate and 11 or higher signifies severe disease. Higher scores indicate more severity. The FAS included all randomised subjects who received at least one administration of study intervention. Here, 'N' (number of subjects analysed) signifies number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 16
    End point values
    		 Part 1: Placebo (Week 0-16) Part 1: Bermekimab (Week 0-16) Part 1: Adalimumab (Week 0-16)
    Number of subjects analysed
    28
    29
    28
    Units: scores on a scale
        arithmetic mean (standard deviation)
    -5.5 ( 10.38 )
    -10.1 ( 13.36 )
    -12.6 ( 9.15 )
    No statistical analyses for this end point

    Secondary: Part 1: Change from Baseline in Number of Inflammatory Nodules at Week 16

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    End point title
    		 Part 1: Change from Baseline in Number of Inflammatory Nodules at Week 16
    End point description
    Change from baseline in number of inflammatory nodules at Week 16 was reported. Inflammatory nodules arise from inflamed blood vessels (vasculitis) or adipose tissue (panniculitis). The FAS included all randomised subjects who received at least one administration of study intervention. Here, 'N' (number of subjects analysed) signifies number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Part 1: Placebo (Week 0-16) Part 1: Bermekimab (Week 0-16) Part 1: Adalimumab (Week 0-16)
    Number of subjects analysed
    28
    29
    28
    Units: inflammatory nodule
        arithmetic mean (standard deviation)
    -3.64 ( 5.258 )
    -4.48 ( 7.689 )
    -5.79 ( 4.306 )
    No statistical analyses for this end point

    Secondary: Part 1: Change from Baseline in Hidradenitis Suppurativa (HS)-Related Pain Symptom Score in the Past 24 Hours Based on Hidradenitis Suppurativa Symptom Diary (HSSD) Questionnaire at Week 16

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    End point title
    		 Part 1: Change from Baseline in Hidradenitis Suppurativa (HS)-Related Pain Symptom Score in the Past 24 Hours Based on Hidradenitis Suppurativa Symptom Diary (HSSD) Questionnaire at Week 16
    End point description
    HSSD is 7-item patient self-reported questionnaire that assesses 5 HS-related symptoms(pain, tenderness, hot skin feeling, odor, and itchiness). Subjects were asked to rate severity of each symptom on a 0-10 numerical rating scale, with 0=no symptom experience and 10=worst possible symptom experience. All 5 symptoms have a recall period of past 7 days, except for additional questions on pain which evaluate current pain and pain in past 24 hours with score range from 0=no symptom experience to 10=worst possible symptom experience. Total symptom score ranged from 0=no symptom to 10=worst possible symptom, was derived by averaging 5 individual scale scores that utilize past 7-day recall period. The FAS included all randomised subjects who received at least one administration of study intervention. Here, 'N'(number of subjects analysed)=number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Part 1: Placebo (Week 0-16) Part 1: Bermekimab (Week 0-16) Part 1: Adalimumab (Week 0-16)
    Number of subjects analysed
    20
    22
    20
    Units: scores on a scale
        arithmetic mean (standard deviation)
    -1.00 ( 2.461 )
    -0.41 ( 2.374 )
    -1.96 ( 2.326 )
    No statistical analyses for this end point

    Secondary: Serum Concentration of Bermekimab

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    End point title
    		 Serum Concentration of Bermekimab
    End point description
    Serum concentration of bermekimab was reported. As per planned analysis, this outcome measure was analyzed in a single arm for subjects who received bermekimab from Week 0 to Week 36. The pharmacokinetic (PK) analysis set included all subjects who received at least 1 dose of bermekimab and had at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number of subjects analysed) signifies number of subjects who were evaluable for this endpoint and 'n' (number analysed) signifies subjects who were evaluated at each specified timepoint.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 1, 4, 8, 12, 16, 20, 24, 28, 32, 36
    End point values
    		 Part 1: Bermekimab (Week 0-36)
    Number of subjects analysed
    50
    Units: micrograms per milliliter (mcg/mL)
    arithmetic mean (standard deviation)
        Week 0 (n=0)
    0.0 ( 0.0 )
        Week 1(n= 47)
    51.36 ( 20.354 )
        Week 4 (n= 36)
    78.46 ( 43.897 )
        Week 8 (n= 22)
    73.14 ( 37.583 )
        Week 12 (n= 22)
    72.45 ( 39.185 )
        Week 16 (n= 14)
    61.81 ( 42.092 )
        Week 20 (n= 12)
    74.68 ( 59.300 )
        Week 24 (n= 10)
    89.75 ( 50.940 )
        Week 28 (n= 7)
    66.30 ( 66.30 )
        Week 32 (n= 4)
    34.53 ( 36.160 )
        Week 36 (n= 4)
    4.63 ( 7.576 )
    No statistical analyses for this end point

    Secondary: Number of Subjects with Antibodies to Bermekimab

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    End point title
    		 Number of Subjects with Antibodies to Bermekimab
    End point description
    Number of subjects with antibodies to bermekimab was reported. As per planned analysis, this outcome measure was analyzed in a single arm for participants who received bermekimab from Week 0 to Week 36. The immunogenicity analysis set included all subjects who received at least 1 dose of bermekimab and who had at least 1 sample obtained after their first dose of bermekimab for the detection of antibodies to bermekimab.
    End point type
    Secondary
    End point timeframe
    From baseline up to Week 36
    End point values
    		 Part 1: Bermekimab (Week 0-36)
    Number of subjects analysed
    51
    Units: Subjects
    16
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: Week 17 to Week 36
    Adverse event reporting additional description
    The safety analysis set included all randomised subjects who received at least 1 dose of study intervention.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Part 1: Placebo (Week 0-16)
    Reporting group description
    		 Subjects received placebo as subcutaneous Subjects received placebo as subcutaneous (SC) injection from Weeks 0 through Week 15 and then subjects received bermekimab 1050 milligrams (mg) as SC injection at Week 16 in Part 1.

    Reporting group title
    Part 1: Bermekimab (Week 0-16)
    Reporting group description
    		 Subjects received bermekimab 1050 mg (3*350 mg) and 1 placebo as SC injection at Week 0 followed by bermekimab 1050 mg (3*350 mg) as SC injections at Week 1 and every week thereafter through Week 16 in Part 1.

    Reporting group title
    Part 1: Bermekimab (Week 17-36)
    Reporting group description
    		 Subjects who received Bermekimab 1050 mg at Week 16 during placebo controlled period entered into active treatment + safety FU period and continued to receive bermekimab 1050 mg (3*350 mg) as SC injection every week thereafter through Week 31. All subjects were followed for safety through Week 36.

    Reporting group title
    Part 1: Placebo then Bermekimab (Week 17-36)
    Reporting group description
    		 Subjects who received placebo during placebo controlled period and then received bermekimab 1050 mg (3*350 mg) at Week 16 entered into active treatment + safety follow up (FU) period and received 1050 mg as SC injection weekly through Week 31 in Part 1. All subjects were followed for safety through Week 36.

    Reporting group title
    Part 1: Adalimumab (Week 17-36)
    Reporting group description
    		 Subjects who received adalimumab 40 mg as SC injection during placebo controlled period entered into active treatment + safety FU period and continued to receive adalimumab 40 mg as SC injection and 2 placebo SC injections weekly through Week 31 in Part 1. All subjects were followed for safety through Week 36.

    Reporting group title
    Part 1: Adalimumab (Week 0-16)
    Reporting group description
    		 Subjects received adalimumab 160 mg (4*40 mg) as SC injection at Week 0 and 3 placebo SC injections at Week 1 followed by adalimumab 80 mg (2*40 mg) as SC injection at Week 2 and 3 placebo SC injections at Week 3. Subjects received adalimumab 40 mg (1*40 mg) SC injection and 2 placebo SC injections at Week 4 and every week thereafter through Week 16 in Part 1.

    Serious adverse events
    		 Part 1: Placebo (Week 0-16) Part 1: Bermekimab (Week 0-16) Part 1: Bermekimab (Week 17-36) Part 1: Placebo then Bermekimab (Week 17-36) Part 1: Adalimumab (Week 17-36) Part 1: Adalimumab (Week 0-16)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 51 (1.96%)
    1 / 30 (3.33%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    4 / 50 (8.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    1
         number of deaths resulting from adverse events
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 50 (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
    Injury, poisoning and procedural complications
    Toxicity to Various Agents
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 50 (2.00%)
         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 / 1
    Vascular disorders
    Arterial Occlusive Disease
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 50 (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
    Cardiac disorders
    Cardiac Failure Congestive
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 50 (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
    General disorders and administration site conditions
    Chest Pain
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 50 (2.00%)
         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
    Respiratory, thoracic and mediastinal disorders
    Pleural Effusion
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 50 (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
    Skin and subcutaneous tissue disorders
    Hidradenitis
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 50 (2.00%)
         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
    Infections and infestations
    Covid-19
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    1 / 30 (3.33%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 50 (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
    Cellulitis
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 50 (2.00%)
         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
    Pneumonia Mycoplasmal
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 50 (2.00%)
         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
    Skin Bacterial Infection
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 50 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Part 1: Placebo (Week 0-16) Part 1: Bermekimab (Week 0-16) Part 1: Bermekimab (Week 17-36) Part 1: Placebo then Bermekimab (Week 17-36) Part 1: Adalimumab (Week 17-36) Part 1: Adalimumab (Week 0-16)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 50 (42.00%)
    31 / 51 (60.78%)
    12 / 30 (40.00%)
    12 / 28 (42.86%)
    11 / 28 (39.29%)
    22 / 50 (44.00%)
    Investigations
    C-Reactive Protein Increased
         subjects affected / exposed
    1 / 50 (2.00%)
    3 / 51 (5.88%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    1
    3
    0
    0
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 50 (6.00%)
    6 / 51 (11.76%)
    0 / 30 (0.00%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    6 / 50 (12.00%)
         occurrences all number
    3
    9
    0
    1
    0
    9
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 50 (4.00%)
    1 / 51 (1.96%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    2
    2
    0
    0
    0
    3
    Injection Site Erythema
         subjects affected / exposed
    0 / 50 (0.00%)
    16 / 51 (31.37%)
    1 / 30 (3.33%)
    5 / 28 (17.86%)
    0 / 28 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    42
    4
    16
    0
    6
    Injection Site Pruritus
         subjects affected / exposed
    0 / 50 (0.00%)
    9 / 51 (17.65%)
    0 / 30 (0.00%)
    5 / 28 (17.86%)
    0 / 28 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    16
    0
    21
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 50 (2.00%)
    5 / 51 (9.80%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    4 / 50 (8.00%)
         occurrences all number
    3
    8
    0
    0
    20
    5
    Vomiting
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 51 (0.00%)
    0 / 30 (0.00%)
    2 / 28 (7.14%)
    1 / 28 (3.57%)
    3 / 50 (6.00%)
         occurrences all number
    4
    0
    0
    2
    1
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 50 (2.00%)
    3 / 51 (5.88%)
    0 / 30 (0.00%)
    1 / 28 (3.57%)
    1 / 28 (3.57%)
    0 / 50 (0.00%)
         occurrences all number
    1
    3
    0
    1
    1
    0
    Oropharyngeal Pain
         subjects affected / exposed
    1 / 50 (2.00%)
    3 / 51 (5.88%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 50 (0.00%)
         occurrences all number
    1
    3
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Hidradenitis
         subjects affected / exposed
    6 / 50 (12.00%)
    3 / 51 (5.88%)
    4 / 30 (13.33%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    1 / 50 (2.00%)
         occurrences all number
    7
    6
    4
    0
    1
    1
    Infections and infestations
    Bacterial Vaginosis
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    2 / 30 (6.67%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    2
    2
    0
    0
    0
    Covid-19
         subjects affected / exposed
    5 / 50 (10.00%)
    4 / 51 (7.84%)
    2 / 30 (6.67%)
    1 / 28 (3.57%)
    4 / 28 (14.29%)
    3 / 50 (6.00%)
         occurrences all number
    5
    4
    2
    1
    4
    3
    Nasopharyngitis
         subjects affected / exposed
    2 / 50 (4.00%)
    4 / 51 (7.84%)
    2 / 30 (6.67%)
    2 / 28 (7.14%)
    3 / 28 (10.71%)
    4 / 50 (8.00%)
         occurrences all number
    2
    4
    2
    2
    3
    4
    Upper Respiratory Tract Infection
         subjects affected / exposed
    2 / 50 (4.00%)
    4 / 51 (7.84%)
    3 / 30 (10.00%)
    1 / 28 (3.57%)
    2 / 28 (7.14%)
    3 / 50 (6.00%)
         occurrences all number
    2
    5
    3
    1
    2
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Jul 2021
    The purpose of this amendment-1 was to update overall protocol to make the FibroTx Patch assessment optional due to the potential unavailability of the FibroTx Patch kits; removed Hidradenitis Suppurativa Investigator’s Global Assessment from screening period; added electrocardiogram at Week 16; and updated inclusion/exclusion criteria.
    12 Aug 2022
    The purpose of this amendment-2 was to change the prospective dose regimens in Part 2 based on the emerging Phase 1 pharmacokinetic (PK) information on bermekimab as well as to test the every 2 weeks (q2w) regimen.

    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.
    Part 2 of this study was not conducted due to early termination as interim analysis 1 efficacy results met prespecified futility criteria related to primary endpoint. So, data for Part 2 and some secondary endpoint (Parts 1, 2) were not reported.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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