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    Clinical Trial Results:
    A Phase 4, Double-Blind, Randomized, Placebo-Controlled Multicenter Study to Assess the Safety and Efficacy of Adalimumab Used in Conjunction with Surgery in Subjects with Moderate to Severe Hidradenitis Suppurativa

    Summary
    EudraCT number
    		 2015-005161-23
    Trial protocol
    		 DK   SE   NL   GB   DE   IE   PT   GR   BE   ES   CZ   IT  
    Global end of trial date
    17 Oct 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 May 2020
    First version publication date
    22 May 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M15-574
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02808975
    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, 001 800-633-9110,
    Scientific contact
    Christine Jean, AbbVie, christine.jean@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
    17 Oct 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Oct 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This was an interventional, randomized, double-blind (DB), placebo-controlled study. The study duration included a 30-day Screening Period, an initial 12-week DB treatment pre-surgery period (Period A), a 2-week peri-operative period with continuation of weekly DB study drug administration (Period B), and a subsequent 10-week DB treatment post-operative period (Period C). The projected size of the surgical excision established by the designated surgeon during the Screening Period was recorded. In Period B, the designated surgeon measured and recorded the surface area of the actual surgery, with surgery occurring during Week 13. Surgery and post-operative management (e.g., hospitalization, surgical wound care) was per local practice. No study drug was administered at Week 24, the final study visit. Participants were able to begin commercial product (as prescribed by the participants's physician) after all Week 24 procedures were completed.
    Protection of trial subjects
    Participant read and understood information provided about the study and gave written permission.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Jun 2016
    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
    Canada: 14
    Country: Number of subjects enrolled
    Colombia: 1
    Country: Number of subjects enrolled
    United States: 14
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    Mexico: 2
    Country: Number of subjects enrolled
    Russian Federation: 15
    Country: Number of subjects enrolled
    Turkey: 3
    Country: Number of subjects enrolled
    Netherlands: 13
    Country: Number of subjects enrolled
    Norway: 5
    Country: Number of subjects enrolled
    Poland: 12
    Country: Number of subjects enrolled
    Portugal: 5
    Country: Number of subjects enrolled
    Romania: 4
    Country: Number of subjects enrolled
    Spain: 19
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    Czech Republic: 8
    Country: Number of subjects enrolled
    Denmark: 7
    Country: Number of subjects enrolled
    France: 8
    Country: Number of subjects enrolled
    Germany: 45
    Country: Number of subjects enrolled
    Greece: 23
    Worldwide total number of subjects
    206
    EEA total number of subjects
    157
    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)
    206
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study included a 30-day screening period.

    Pre-assignment
    Screening details
    		 Eligible subjects must have had skin lesions diagnostic of Hidradenitis Suppurativa (HS) for at least 1 year prior to the Baseline visit and a requirement for surgery of HS lesions in a single axilla or unilateral inguinal region.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Period A: Day 1- 4 subcutaneous (SC) injections; Week 2- 2 SC injections; Weeks 4-12- 1 SC injection each week Period B: Weeks 13-14- 1 SC injection each week Period C: Weeks 15-23- 1 SC injection each week
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections administered as described in arm description

    Arm title
    		 Adalimumab
    Arm description
    		 Period A: Day 1- 4 subcutaneous (SC) 40 mg injections; Week 2- 2 SC 40 mg injections; Weeks 4-12- 1 SC 40 mg injection each week Period B: Weeks 13-14- 1 SC 40 mg injection each week Period C: Weeks 15-23- 1 SC 40 mg injection each week
    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
    Subcutaneous injections administered as described in arm description

    Number of subjects in period 1
    		Placebo Adalimumab
    Started
    103
    103
    Completed
    81
    84
    Not completed
    22
    19
         Adverse event, non-fatal
    3
    4
         Other, not specified
    5
    1
         Planned HS surgery performed prior to Week 13
    1
    -
         Withdrew consent
    9
    8
         Lost to follow-up
    4
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Period A: Day 1- 4 subcutaneous (SC) injections; Week 2- 2 SC injections; Weeks 4-12- 1 SC injection each week Period B: Weeks 13-14- 1 SC injection each week Period C: Weeks 15-23- 1 SC injection each week

    Reporting group title
    Adalimumab
    Reporting group description
    		 Period A: Day 1- 4 subcutaneous (SC) 40 mg injections; Week 2- 2 SC 40 mg injections; Weeks 4-12- 1 SC 40 mg injection each week Period B: Weeks 13-14- 1 SC 40 mg injection each week Period C: Weeks 15-23- 1 SC 40 mg injection each week

    Reporting group values
    		 Placebo Adalimumab Total
    Number of subjects
    		 103 103 206
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 36.8 ( 10.81 ) 38.5 ( 11.71 ) -
    Gender categorical
    Units: Subjects
        Female
    		 55 51 106
        Male
    		 48 52 100

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Period A: Day 1- 4 subcutaneous (SC) injections; Week 2- 2 SC injections; Weeks 4-12- 1 SC injection each week Period B: Weeks 13-14- 1 SC injection each week Period C: Weeks 15-23- 1 SC injection each week

    Reporting group title
    Adalimumab
    Reporting group description
    		 Period A: Day 1- 4 subcutaneous (SC) 40 mg injections; Week 2- 2 SC 40 mg injections; Weeks 4-12- 1 SC 40 mg injection each week Period B: Weeks 13-14- 1 SC 40 mg injection each week Period C: Weeks 15-23- 1 SC 40 mg injection each week

    Primary: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12

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    End point title
    		 Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
    End point description
    HiSCR is defined as at least a 50% reduction in the abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline.
    End point type
    Primary
    End point timeframe
    At Week 12
    End point values
    		 Placebo Adalimumab
    Number of subjects analysed
    103 [1]
    103 [2]
    Units: percentage of participants
        number (confidence interval 95%)
    34.0 (24.8 to 43.1)
    47.6 (37.9 to 57.2)
    Notes
    [1] - All participants who were randomized at Baseline; non-responder imputation used for missing data
    [2] - All participants who were randomized at Baseline; non-responder imputation used for missing data
    Statistical analysis title
    		 Superiority statistical analysis
    Comparison groups
    Placebo v Adalimumab
    Number of subjects included in analysis
    206
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.049 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [3] - Across all strata, P-value calculated from Cochran-Mantel-Haenszel test adjusted for strata. Stratum containing zero count: 0.1 added to each cell.

    Secondary: Percentage of Participants Achieving HiSCR-es at Week 12

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    End point title
    		 Percentage of Participants Achieving HiSCR-es at Week 12
    End point description
    Hidradenitis Suppurativa Clinical Response-es (HiSCR-es) is defined as at least a 50% reduction in the abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline, excluding the Hidradenitis Suppurativa surgical site.
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    		 Placebo Adalimumab
    Number of subjects analysed
    103 [4]
    103 [5]
    Units: percentage of participants
        number (confidence interval 95%)
    35.0 (25.7 to 44.2)
    47.6 (37.9 to 57.2)
    Notes
    [4] - All participants who were randomized at Baseline; non-responder imputation used for missing data
    [5] - All participants who were randomized at Baseline; non-responder imputation used for missing data
    Statistical analysis title
    		 Superiority statistical analysis
    Comparison groups
    Placebo v Adalimumab
    Number of subjects included in analysis
    206
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.067 [6]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [6] - Across all strata, P-value calculated from Cochran-Mantel-Haenszel test adjusted for strata. Stratum containing zero count: 0.1 added to each cell.

    Secondary: Percentage of Participants Achieving HiSCR-es at Week 24

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    End point title
    		 Percentage of Participants Achieving HiSCR-es at Week 24
    End point description
    Hidradenitis Suppurativa Clinical Response-es (HiSCR-es) is defined as at least a 50% reduction in the abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline, excluding the Hidradenitis Suppurativa surgical site.
    End point type
    Secondary
    End point timeframe
    At Week 24
    End point values
    		 Placebo Adalimumab
    Number of subjects analysed
    103 [7]
    103 [8]
    Units: percentage of participants
        number (confidence interval 95%)
    31.1 (22.1 to 40.0)
    51.5 (41.8 to 61.1)
    Notes
    [7] - All participants who were randomized at Baseline; non-responder imputation used for missing data
    [8] - All participants who were randomized at Baseline; non-responder imputation used for missing data
    Statistical analysis title
    		 Superiority statistical analysis
    Comparison groups
    Placebo v Adalimumab
    Number of subjects included in analysis
    206
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003 [9]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [9] - Across all strata, P-value calculated from Cochran-Mantel-Haenszel test adjusted for strata. Stratum containing zero count: 0.1 added to each cell.

    Secondary: Percent change in the surface area of the Hidradenitis Suppurativa (HS) surgical site from Baseline to Week 12

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    End point title
    		 Percent change in the surface area of the Hidradenitis Suppurativa (HS) surgical site from Baseline to Week 12
    End point description
    The projected size of the surgical excision established by the designated surgeon during the Screening Period (calculated from a tracing of the outer perimeter onto an acetate sheet or equivalent) was recorded by the study physician. The change in the surface area of the projected HS surgical site from Baseline to Week 12 was documented.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 12
    End point values
    		 Placebo Adalimumab
    Number of subjects analysed
    79 [10]
    76 [11]
    Units: percent change from Baseline
        least squares mean (confidence interval 95%)
    26.233 (-31.684 to 84.150)
    68.190 (8.485 to 127.896)
    Notes
    [10] - Observed case (OC) analysis; all participants who were randomized at the Baseline visit
    [11] - Observed case (OC) analysis; all participants who were randomized at the Baseline visit
    Statistical analysis title
    		 Superiority statistical analysis
    Comparison groups
    Placebo v Adalimumab
    Number of subjects included in analysis
    155
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.313 [12]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [12] - Across all strata, P-values are calculated from ANCOVA with stratum, baseline value, and treatment in the model.

    Secondary: Percentage of Participants at Week 12 That Require a Less Extensive Surgery than the Surgical Plan (Determined at Baseline) or No Surgery

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    End point title
    		 Percentage of Participants at Week 12 That Require a Less Extensive Surgery than the Surgical Plan (Determined at Baseline) or No Surgery
    End point description
    The projected size of the surgical excision established by the designated surgeon during the Screening Period (calculated from a tracing of the outer perimeter onto an acetate sheet or equivalent) was recorded by the study physician. The change in the surface area of the projected HS surgical site from Baseline to Week 12 was documented, and the percentage of participants at Week 12 requiring a less extensive surgery than the surgical plan (determined at Baseline) or no surgery as determined by the designated surgeon was recorded.
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    		 Placebo Adalimumab
    Number of subjects analysed
    87 [13]
    82 [14]
    Units: percentage of participants
        number (confidence interval 95%)
    43.7 (33.3 to 54.1)
    46.3 (35.5 to 57.1)
    Notes
    [13] - Observed case (OC) analysis; all participants who were randomized at the Baseline visit
    [14] - Observed case (OC) analysis; all participants who were randomized at the Baseline visit
    Statistical analysis title
    		 Superiority statistical analysis
    Comparison groups
    Placebo v Adalimumab
    Number of subjects included in analysis
    169
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.746 [15]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [15] - Across all strata, P-value calculated from Cochran-Mantel-Haenszel test adjusted for strata. Stratum containing zero count: 0.1 added to each cell.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
    Adverse event reporting additional description
    TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Period A: Day 1- 4 subcutaneous (SC) injections; Week 2- 2 SC injections; Weeks 4-12- 1 SC injection each week Period B: Weeks 13-14- 1 SC injection each week Period C: Weeks 15-23- 1 SC injection each week

    Reporting group title
    Adalimumab
    Reporting group description
    		 Period A: Day 1- 4 subcutaneous (SC) 40 mg injections; Week 2- 2 SC 40 mg injections; Weeks 4-12- 1 SC 40 mg injection each week Period B: Weeks 13-14- 1 SC 40 mg injection each week Period C: Weeks 15-23- 1 SC 40 mg injection each week

    Serious adverse events
    		 Placebo Adalimumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 103 (2.91%)
    7 / 103 (6.80%)
         number of deaths (all causes)
    0
    2
         number of deaths resulting from adverse events
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Testis cancer
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiovascular disorder
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Ruptured cerebral aneurysm
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Hidradenitis
         subjects affected / exposed
    2 / 103 (1.94%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Blastocystis infection
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Adalimumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    43 / 103 (41.75%)
    48 / 103 (46.60%)
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    8 / 103 (7.77%)
    14 / 103 (13.59%)
         occurrences all number
    9
    14
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    6 / 103 (5.83%)
    2 / 103 (1.94%)
         occurrences all number
    7
    2
    Headache
         subjects affected / exposed
    14 / 103 (13.59%)
    13 / 103 (12.62%)
         occurrences all number
    29
    13
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 103 (3.88%)
    6 / 103 (5.83%)
         occurrences all number
    4
    6
    Skin and subcutaneous tissue disorders
    Hidradenitis
         subjects affected / exposed
    15 / 103 (14.56%)
    14 / 103 (13.59%)
         occurrences all number
    19
    17
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 103 (0.97%)
    6 / 103 (5.83%)
         occurrences all number
    1
    6
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    19 / 103 (18.45%)
    19 / 103 (18.45%)
         occurrences all number
    24
    23

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 May 2016
    - Updated Benefits and Risks to include all known potential risks associated with adalimumab - Clarified requirements regarding tuberculosis (TB) screening and prophylaxis requirements - Excluded subjects with suspicion of sepsis, cytomegalovirus infection, listeriosis, or other opportunistic infections (exclusion criterion #15) - Excluded subjects with interstitial lung disease (ILD) (exclusion criterion #19) - Specified that breastfeeding should be avoided for at least 5 months following the last dose of adalimumab (exclusion criterion #21) - Updated prohibited therapy, to define high-dose systemic corticosteroids - Updated contraception recommendations - Specified that patients that develop TB or any other serious or opportunistic infection must discontinue study treatment - Updated Adverse Events of Serious Interest (AESI) to include data collection and analysis of AEs concerning the surgical site
    30 Nov 2016
    - Updated Screening Period to be no less than 7 days - Clarified that stratification at randomization was for worst Hurley stage across all body regions (not only the surgical site) - Excluded subjects over 65 years old (inclusion criterion #1) - Clarified details regarding serum and urine pregnancy testing - Clarified non-authorized surgery details for exclusion (exclusion criterion #4) - Clarified referring surgeon responsibilities, including who calculates the size of the actual surgical surface area - Clarified timing of visit windows - Clarified prior, concomitant, and prohibited therapy - Added digital imaging at Week 20
    13 Dec 2017
    - Updated the planned number of sites - Added that the 95% confidence interval (CI) of treatment difference will also be provided - Added a sensitivity analysis controlling for change from baseline in body weight using logistic regression models, for the primary efficacy endpoint - Incorporated changes form Administrative Change 1

    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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