Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED CLINICAL TRIAL OF THE SAFETY AND EFFICACY OF ANAKINRA IN PATIENTS WITH HIDRADENITIS SUPPURATIVA (PROTOCOL: HIDRA03)

    Summary
    EudraCT number
    		 2011-005145-12
    Trial protocol
    		 GR  
    Global end of trial date
    01 Aug 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Jan 2023
    First version publication date
    07 Jan 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    HIDRA03
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01558375
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Athens, Medical School
    Sponsor organisation address
    Rimini 1, Chaidari, Athens, Greece,
    Public contact
    Theodora Kanni, University of Athens, Medical School, 0030 2105831985, kannidora@med.uoa.gr
    Scientific contact
    Theodora Kanni, University of Athens, Medical School, 0030 2105831985, kannidora@med.uoa.gr
    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
    30 Sep 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Aug 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The safety and efficacy of anakinra in patients with HS of Hurley II and III stage disease.
    Protection of trial subjects
    No specific measures taken.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Apr 2012
    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
    Greece: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    19
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study was conducted at the Outpatient Department of Immunology of Infectious Diseases of Attikon University Hospital, Greece. The first patient was recruited on 3rd April 2012 and the last patient was recruited on 31st January 2014. A total of 20 patients were enrolled.

    Pre-assignment
    Screening details
    		 Inclusion criteria: 1) written informed consent provided by the patient, 2) age 18 years or older, 3) diagnosis of HS, and 4) Hurley stage II or III HS. Screening: history/physical examination; skin tuberculin test; chest radiograph; serology for HIV and hepatitis virus B and C; white blood cell count, serum creatinine level, liver biochemistry

    Period 1
    Period 1 title
    Treatment Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    The randomized sequence was generated by an independent biostatistician. Anakinra was provided in single-use, prefilled glass syringes with 27-gauge needles. The syringes contained 100mg of anakinra in a volume of 0.67 mL. Identical placebo syringes contained 0.67 mL of sterile water for injection. The placebo and anakinra syringes were identical in appearance to ensure masking.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Anakinra arm
    Arm description
    		 A total of 20 patients were enrolled in the study. Patients selected for enrollment were randomized at a 1:1 ratio to receive placebo or anakinra subcutaneously once daily for 12 weeks. Therefore, 10 patients were randomised to receive anakinra.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Anakinra
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients selected for enrollment were randomized at a 1:1 ratio to receive placebo or anakinra subcutaneously once daily for 12 weeks. Anakinra was provided in single use, prefilled glass syringes with 27-gauge needles. The syringes contained 100mg of anakinra in a volume of 0.67 mL.

    Arm title
    		 Placebo arm
    Arm description
    		 A total of 20 patients were enrolled in the study. Patients selected for enrollment were randomized at a 1:1 ratio to receive placebo or anakinra subcutaneously once daily for 12 weeks. Therefore, 10 patients were randomised to receive placebo.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Sterile water for injection
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled injector
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients selected for enrollment were randomized at a 1:1 ratio to receive placebo or anakinra subcutaneously once daily for 12 weeks. Placebo was provided in single use, prefilled glass syringes with 27-gauge needles. The syringes contained sterile water for injection in a volume of 0.67 mL.

    Number of subjects in period 1
    		Anakinra arm Placebo arm
    Started
    10
    10
    Completed
    10
    10
    Period 2
    Period 2 title
    Follow-up Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Anakinra arm
    Arm description
    		 A total of 20 patients were enrolled in the study. Patients selected for enrollment were randomized at a 1:1 ratio to receive placebo or anakinra subcutaneously once daily for 12 weeks. Therefore, 10 patients were randomized to receive anakinra. After treatment, patients were followed up from week 13 to week 24. The patients and investigators were masked to the administered treatment.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Placebo arm
    Arm description
    		 A total of 20 patients were enrolled in the study. Patients selected for enrollment were randomized at a 1:1 ratio to receive placebo or anakinra subcutaneously once daily for 12 weeks. Therefore, 10 patients were randomized to receive placebo. After treatment, patients were followed up from week 13 to week 24. The patients and investigators were masked to the administered treatment.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Anakinra arm Placebo arm
    Started
    10
    10
    Completed
    9
    10
    Not completed
    1
    0
         Lost to follow-up
    1
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Anakinra arm
    Reporting group description
    		 A total of 20 patients were enrolled in the study. Patients selected for enrollment were randomized at a 1:1 ratio to receive placebo or anakinra subcutaneously once daily for 12 weeks. Therefore, 10 patients were randomised to receive anakinra.

    Reporting group title
    Placebo arm
    Reporting group description
    		 A total of 20 patients were enrolled in the study. Patients selected for enrollment were randomized at a 1:1 ratio to receive placebo or anakinra subcutaneously once daily for 12 weeks. Therefore, 10 patients were randomised to receive placebo.

    Reporting group values
    		 Anakinra arm Placebo arm Total
    Number of subjects
    		 10 10 20
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 8 10 18
        From 65-84 years
    		 1 0 1
        Not recorded
    		 1 0 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.8 ± 13.8 36.0 ± 11.3 -
    Gender categorical
    Units: Subjects
        Female
    		 4 5 9
        Male
    		 5 5 10
        Not recorded
    		 1 0 1
    Family history of HS
    Units: Subjects
        Yes
    		 3 5 8
        No
    		 6 5 11
        Not recorded
    		 1 0 1
    Smoking
    Units: Subjects
        Yes
    		 8 8 16
        No
    		 1 2 3
        Not recorded
    		 1 0 1
    Staphylococcus aureus nasal carriage
    Units: Subjects
        Yes
    		 0 0 0
        No
    		 9 10 19
        Not recorded
    		 1 0 1
    Hypothyrodism
    Units: Subjects
        Yes
    		 2 2 4
        No
    		 7 8 15
        Not recorded
    		 1 0 1
    Past treatment for HS: Incision and drainage
    Units: Subjects
        Yes
    		 3 3 6
        No
    		 6 7 13
        Not recorded
    		 1 0 1
    Past treatment for HS: Debridement
    Units: Subjects
        Yes
    		 1 1 2
        No
    		 8 9 17
        Not recorded
    		 1 0 1
    Past treatment for HS: Antibiotic
    Units: Subjects
        Yes
    		 6 9 15
        No
    		 3 1 4
        Not recorded
    		 1 0 1
    Past treatment for HS: Anti-tumor necrosis factor
    Units: Subjects
        Yes
    		 4 3 7
        No
    		 5 7 12
        Not recorded
    		 1 0 1
    Affected skin area: Axillae
    Units: Subjects
        Yes
    		 5 7 12
        No
    		 4 3 7
        Not recorded
    		 1 0 1
    Affected skin area: Submammary or inframammary fold
    Units: Subjects
        Yes
    		 2 2 4
        No
    		 7 8 15
        Not recorded
    		 1 0 1
    Affected skin area: Inguinal and crural fold
    Units: Subjects
        Yes
    		 9 7 16
        No
    		 0 3 3
        Not recorded
    		 1 0 1
    Affected skin area: Perianal
    Units: Subjects
        Yes
    		 2 2 4
        No
    		 7 8 15
        Not recorded
    		 1 0 1
    Affected skin area: Gluteal
    Units: Subjects
        Yes
    		 4 4 8
        No
    		 5 6 11
        Not recorded
    		 1 0 1
    Affected skin area: Scrotum
    Units: Subjects
        Yes
    		 1 2 3
        No
    		 8 8 16
        Not recorded
    		 1 0 1
    Affected skin area: Pubic
    Units: Subjects
        Yes
    		 3 1 4
        No
    		 6 9 15
        Not recorded
    		 1 0 1
    Hurley stage of HS
    Units: Subjects
        II
    		 6 4 10
        III
    		 3 6 9
        Not recorded
    		 1 0 1
    Time since HS onset
    Units: years
        arithmetic mean (standard deviation)
    		 12.3 ± 6.7 11.1 ± 6.8 -
    Body mass index, mean
    Units: kilogram(s)/square meter
        arithmetic mean (standard deviation)
    		 27.8 ± 5.1 27.9 ± 6.8 -
    Exacerbations per month
    Units: number
        median (full range (min-max))
    		 2 (1 to 10) 2 (1 to 16) -
    HS severity: DLQI
    Units: number
        arithmetic mean (standard deviation)
    		 20.7 ± 5.9 14.3 ± 8.4 -
    HS severity: VAS score
    Units: number
        arithmetic mean (standard deviation)
    		 67.0 ± 19.8 55.0 ± 20.3 -
    HS severity: VAS score for pain
    Units: number
        arithmetic mean (standard deviation)
    		 54.4 ± 22.9 60.5 ± 21.7 -
    HS severity: Disease activity score
    Units: number
        arithmetic mean (standard deviation)
    		 186.9 ± 112.9 113.4 ± 94.9 -
    HS severity: Sartorius score
    Units: number
        arithmetic mean (standard deviation)
    		 104.6 ± 54.2 82.0 ± 58.9 -
    Lesion count: Inflammatory nodule
    Units: Number of lesion per subject
        median (full range (min-max))
    		 6 (4 to 23) 4 (3 to 30) -
    Lesion count: Noninflammatory nodule
    Units: Number of lesion per subject
        median (full range (min-max))
    		 1 (0 to 23) 3 (0 to 13) -
    Lesion count: Draining fistula
    Units: Number of lesion per subject
        median (full range (min-max))
    		 3 (1 to 40) 2 (0 to 23) -
    Lesion count: Nondraining fistula
    Units: Number of lesion per subject
        median (full range (min-max))
    		 0 (0 to 7) 0 (0 to 1) -
    Lesion count: Scar
    Units: Number of lesion per subject
        median (full range (min-max))
    		 0 (0 to 19) 6 (0 to 102) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Anakinra arm
    Reporting group description
    		 A total of 20 patients were enrolled in the study. Patients selected for enrollment were randomized at a 1:1 ratio to receive placebo or anakinra subcutaneously once daily for 12 weeks. Therefore, 10 patients were randomised to receive anakinra.

    Reporting group title
    Placebo arm
    Reporting group description
    		 A total of 20 patients were enrolled in the study. Patients selected for enrollment were randomized at a 1:1 ratio to receive placebo or anakinra subcutaneously once daily for 12 weeks. Therefore, 10 patients were randomised to receive placebo.
    Reporting group title
    Anakinra arm
    Reporting group description
    		 A total of 20 patients were enrolled in the study. Patients selected for enrollment were randomized at a 1:1 ratio to receive placebo or anakinra subcutaneously once daily for 12 weeks. Therefore, 10 patients were randomized to receive anakinra. After treatment, patients were followed up from week 13 to week 24. The patients and investigators were masked to the administered treatment.

    Reporting group title
    Placebo arm
    Reporting group description
    		 A total of 20 patients were enrolled in the study. Patients selected for enrollment were randomized at a 1:1 ratio to receive placebo or anakinra subcutaneously once daily for 12 weeks. Therefore, 10 patients were randomized to receive placebo. After treatment, patients were followed up from week 13 to week 24. The patients and investigators were masked to the administered treatment.

    Primary: The decrease of disease activity scores from the baseline visit to the end of treatment

    		 Close Top of page
    End point title
    		 The decrease of disease activity scores from the baseline visit to the end of treatment
    End point description
    The primary end point was the safety and efficacy of anakinra in patients with Hurley stage II or III HS based on decreased disease activity scores from the baseline visit to the end of treatment. Furthermore, the 2 study arms were compared regarding their DLQI, VAS score, development of serious adverse events, and HS severity (disease activity score, Sartorius score, and HiSCR) over the course of their visits.
    End point type
    Primary
    End point timeframe
    From the baseline to week 12 (end of treatment).
    End point values
    		 Anakinra arm Placebo arm
    Number of subjects analysed
    9
    10
    Units: number of patients
    7
    2
    Attachments
    		 Decrease of disease activity scores (Baseline-EOT)
    Statistical analysis title
    		 Fisher 2-sided test
    Comparison groups
    Anakinra arm v Placebo arm
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.023
    Method
    		 Fisher 2-sided
    Confidence interval

    Secondary: Change of the DLQI score at weeks 12 and 24 from baseline visit

    		 Close Top of page
    End point title
    		 Change of the DLQI score at weeks 12 and 24 from baseline visit
    End point description
    The primary end point was the safety and efficacy of anakinra in patients with Hurley stage II or III HS based on decreased disease activity scores from the baseline visit to the end of treatment. Furthermore, the 2 study arms were compared regarding their DLQI, VAS score, development of serious adverse events, and HS severity (disease activity score, Sartorius score, and HiSCR) over the course of their visits.
    End point type
    Secondary
    End point timeframe
    Weeks 12 and 24.
    End point values
    		 Anakinra arm Placebo arm Anakinra arm Placebo arm
    Number of subjects analysed
    9
    10
    9
    10
    Units: 100% percentage
    arithmetic mean (standard error)
        Question 1
    -30.5 ± 12.19
    -33.3 ± 16.33
    0 ± 15.8
    -35.71 ± 17.97
        Question 2
    -22.2 ± 10.24
    -4.16 ± 10.24
    0 ± 27.38
    -38.09 ± 15.3
        Question 3
    -23.81 ± 17.56
    33.33 ± 39.4
    -25 ± 25
    9.32 ± 32.9
        Question 4
    -28.57 ± 21.42
    0 ± 0
    -16.6 ± 21.08
    -2.08 ± 18.69
        Question 5
    -19.04 ± 17.97
    39.58 ± 35.62
    -2.77 ± 19.97
    -2.38 ± 18.69
        Question 6
    -33.33 ± 17.81
    25 ± 41.18
    -8.33 ± 7.33
    26.19 ± 36.27
        Question 7
    -41.67 ± 20.09
    7.4 ± 12.17
    10 ± 12
    -4.16 ± 16.88
        Question 8
    -8.33 ± 7.33
    18.75 ± 23.02
    -8.33 ± 7.33
    2.38 ± 23.69
        Question 9
    -7.14 ± 3.14
    50 ± 26.72
    -25 ± 17.07
    28.57 ± 27
        Question 10
    21.42 ± 28.57
    -7.14 ± 22.92
    8.33 ± 15.36
    19.44 ± 30.9
    Attachments
    		 Untitled (Filename: Change of the DLQI score at weeks 12 and 24 from baseline visit.PNG)
    Statistical analysis title
    		 Mann-Whitney test
    Comparison groups
    Placebo arm v Anakinra arm v Anakinra arm v Placebo arm
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Change of the VAS score at weeks 12 and 24 from baseline visit

    		 Close Top of page
    End point title
    		 Change of the VAS score at weeks 12 and 24 from baseline visit
    End point description
    The primary end point was the safety and efficacy of anakinra in patients with Hurley stage II or III HS based on decreased disease activity scores from the baseline visit to the end of treatment. Furthermore, the 2 study arms were compared regarding their DLQI, VAS score, development of serious adverse events, and HS severity (disease activity score, Sartorius score, and HiSCR) over the course of their visits.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 12 and 24
    End point values
    		 Anakinra arm Placebo arm Anakinra arm Placebo arm
    Number of subjects analysed
    9
    10
    9
    10
    Units: 100% percentage of change
        arithmetic mean (standard error)
    -12.4608 ± 13.05674
    -16.1107 ± 15.89520
    -5.2618 ± 16.26598
    -18.2353 ± 17.48042
    Attachments
    		 Untitled (Filename: Change of the VAS score at weeks 12 and 24 from baseline visit.PNG)
    Statistical analysis title
    		 Wilcoxon (Mann-Whitney)
    Comparison groups
    Anakinra arm v Placebo arm v Placebo arm v Anakinra arm
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Development of serious adverse events over the course of the study visits

    		 Close Top of page
    End point title
    		 Development of serious adverse events over the course of the study visits
    End point description
    The primary end point was the safety and efficacy of anakinra in patients with Hurley stage II or III HS based on decreased disease activity scores from the baseline visit to the end of treatment. Furthermore, the 2 study arms were compared regarding their DLQI, VAS score, development of serious adverse events, and HS severity (disease activity score, Sartorius score, and HiSCR) over the course of their visits.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 12 and 24.
    End point values
    		 Anakinra arm Placebo arm Anakinra arm Placebo arm
    Number of subjects analysed
    9
    10
    9
    10
    Units: number
    0
    0
    0
    0
    Statistical analysis title
    		 Mann-Whitney test
    Comparison groups
    Anakinra arm v Placebo arm v Anakinra arm v Placebo arm
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Change of the Sartorius score at weeks 12 and 24 from baseline visit

    		 Close Top of page
    End point title
    		 Change of the Sartorius score at weeks 12 and 24 from baseline visit
    End point description
    The primary end point was the safety and efficacy of anakinra in patients with Hurley stage II or III HS based on decreased disease activity scores from the baseline visit to the end of treatment. Furthermore, the 2 study arms were compared regarding their DLQI, VAS score, development of serious adverse events, and HS severity (disease activity score, Sartorius score, and HiSCR) over the course of their visits.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 12 and 24.
    End point values
    		 Anakinra arm Placebo arm Anakinra arm Placebo arm
    Number of subjects analysed
    9
    10
    9
    10
    Units: 100% percentage
        arithmetic mean (standard error)
    0.7658 ± 6.14684
    -0.1335 ± 2.67418
    5.3007 ± 9.68679
    4.2435 ± 1.90589
    Attachments
    		 Untitled (Filename: Change of the Sartorius score at weeks 12 and 24 from baseline visit.PNG)
    Statistical analysis title
    		 Mann-Whitney test
    Comparison groups
    Anakinra arm v Placebo arm v Anakinra arm v Placebo arm
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: The effects of anakinra on the time to a new exacerbation of HS

    		 Close Top of page
    End point title
    		 The effects of anakinra on the time to a new exacerbation of HS
    End point description
    Secondary end points were the effects of anakinra on the time to a new exacerbation of HS and on the ex vivo function of PBMCs. This latter effect was defined by the difference in cytokine production by PBMCs between the 2 study arms over the course of the study visits.
    End point type
    Secondary
    End point timeframe
    Weeks 0,12 and 24.
    End point values
    		 Anakinra arm Placebo arm Anakinra arm Placebo arm
    Number of subjects analysed
    9
    10
    9
    10
    Units: cumulative % of patients
        number (not applicable)
    11.1
    77.8
    33.3
    88.9
    Attachments
    		 Untitled (Filename: The effects of anakinra on the time to a new exacerbation of HS.PNG)
    Statistical analysis title
    		 Log-rank test
    Comparison groups
    Anakinra arm v Placebo arm
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.01
    Method
    		 Logrank
    Confidence interval

    Secondary: The effects of anakinra on the ex vivo function of PBMCs

    		 Close Top of page
    End point title
    		 The effects of anakinra on the ex vivo function of PBMCs
    End point description
    Secondary end points were the effects of anakinra on the time to a new exacerbation of HS and on the ex vivo function of PBMCs. This latter effect was defined by the difference in cytokine production by PBMCs between the 2 study arms over the course of the study visits. Peripheral blood mononuclear cells of patients randomized to placebo (n = 10) and to anakinra (n = 9) were isolated and stimulated with bacterial lipopolysaccharide (LPS), phytohemagglutin (PHA), and heat-killed isolates of Candida albicans (C albicans ) and of Staphylococcus aureus (S aureus). Depicted here as concentrations at week 0 (baseline), week 12 (the end of treatment), and week 24 (the end of follow-up).
    End point type
    Secondary
    End point timeframe
    Weeks 0, 12 and 24
    End point values
    		 Anakinra arm Placebo arm Anakinra arm Placebo arm
    Number of subjects analysed
    9
    10
    9
    10
    Units: picogram(s)/millilitre(s)
    arithmetic mean (standard error)
        TNFα stimulated with bacterial lipopolysaccharide
    285.1 ± 90.1
    2068.7 ± 1173.1
    1300.3 ± 904.5
    1528.5 ± 557.8
        TNFα stimulated with Candida albicans
    13280.3 ± 9299.1
    15341.2 ± 4314.8
    11093.8 ± 2829.2
    19694 ± 6504.9
        TNFα stimulated with Staphylococcus aureus
    737 ± 492.3
    1187.9 ± 408.8
    2788.5 ± 2010
    7128.3 ± 2477.2
        IL-1β stimulated with bacterial lipopolysaccharide
    6573.3 ± 3149.5
    4438.8 ± 694.3
    4080.5 ± 1124
    4656.5 ± 1278.3
        IL-1β stimulated with Candida albicans
    6935 ± 3961.2
    3017.5 ± 1313.2
    5840 ± 1690.7
    7028.2 ± 2372
        IL-1β stimulated with Staphylococcus aureus
    2046.6 ± 957.1
    793.8 ± 149.6
    2137 ± 1275.9
    1838.3 ± 995.2
        IL-6 stimulated with bacterial lipopolysaccharide
    31583.2 ± 8663
    40506.2 ± 10995.3
    20438.8 ± 5964.4
    31339 ± 10886.8
        IL-6 stimulated with Candida albicans
    16541.6 ± 7214.6
    19518.8 ± 4543.5
    11836.7 ± 3194.2
    17075 ± 2844.7
        IL-6 stimulated with Staphylococcus aureus
    9800 ± 1501.3
    20725 ± 5116.7
    11657.3 ± 3282.5
    20333.3 ± 4287.9
        IL-10 stimulated with phytohemagglutin
    398 ± 132
    316.5 ± 156.2
    304.3 ± 65.9
    219.14 ± 94
        IL-10 stimulated with Candida albicans
    220.8 ± 140.2
    329.1 ± 153.1
    92.3 ± 39.5
    186.8 ± 78.6
        IL-10 stimulated with Staphylococcus aureus
    101.6 ± 32.5
    249.9 ± 92.1
    101.14 ± 38.7
    134.8 ± 63.6
        IL-17 stimulated with phytohemagglutin
    2415.8 ± 636.5
    3602.8 ± 1340.5
    3122.8 ± 649.7
    2133.5 ± 392.3
        IL-17 stimulated with Candida albicans
    1025.1 ± 513.1
    701.5 ± 242
    894.3 ± 247.8
    767.1 ± 164.7
        IL-17 stimulated with Staphylococcus aureus
    589.1 ± 129.5
    1457.1 ± 660.1
    1327.1 ± 501.7
    1395.7 ± 394.7
        IL-22 stimulated with phytohemagglutin
    5726.7 ± 1018.2
    3744.3 ± 1316.3
    6897.8 ± 1124
    2665.7 ± 561.8
        IL-22 stimulated with Candida albicans
    7784.2 ± 2500.2
    5598.5 ± 1648.9
    5409.3 ± 1300
    8184.3 ± 2138.5
        IL-22 stimulated with Staphylococcus aureus
    4025 ± 2207.5
    2446.4 ± 764.6
    3288.3 ± 859.6
    3130.7 ± 821.5
        INFγ stimulated with phytohemagglutin
    1309 ± 458.9
    1326.1 ± 181.6
    5229.7 ± 3872.2
    1704 ± 654.1
        INFγ stimulated with Candida albicans
    2338.7 ± 1805.7
    31641.8 ± 10994.8
    16145 ± 10967
    36377.1 ± 8229
        INFγ stimulated with Staphylococcus aureus
    4420.8 ± 3845.5
    483.4 ± 316.4
    11521 ± 11375
    1672 ± 995
    Attachments
    		 Untitled (Filename: The difference in Interferon γ production by PBMCs over the course of the study visits.PNG)
    Untitled (Filename: The difference in Interleukin 1β production by PBMCs over the course of the study visits.PNG)
    Untitled (Filename: The difference in Interleukin 6 production by PBMCs over the course of the study visits.PNG)
    Untitled (Filename: The difference in Interleukin 10 production by PBMCs over the course of the study visits.PNG)
    Untitled (Filename: The difference in Interleukin 17 production by PBMCs over the course of the study visits.PNG)
    Untitled (Filename: The difference in Interleukin 22 production by PBMCs over the course of the study visits.PNG)
    Untitled (Filename: The difference in TNF production by PBMCs over the course of the study visits.PNG)
    Statistical analysis title
    		 Mann-Whitney test
    Comparison groups
    Anakinra arm v Placebo arm v Anakinra arm v Placebo arm
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05 [1]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [1] - TNFα(S aureus) wk.24 -placebo: P= .03 vs baseline IL-6(LPS) wk.12 -anakinra: P= .046 vs baseline IL-22(PHA) wk.24 -anakinra: P= .02 vs placebo IFNγ(C albicans) wk.12 -placebo: P= .04 vs placebo IFNγ(C albicans) wk.12 -anakinra: P= .02 vs baseline

    Secondary: Change of the VAS score for pain at weeks 12 and 24 from baseline visit

    		 Close Top of page
    End point title
    		 Change of the VAS score for pain at weeks 12 and 24 from baseline visit
    End point description
    The primary end point was the safety and efficacy of anakinra in patients with Hurley stage II or III HS based on decreased disease activity scores from the baseline visit to the end of treatment. Furthermore, the 2 study arms were compared regarding their DLQI, VAS score, development of serious adverse events, and HS severity (disease activity score, Sartorius score, and HiSCR) over the course of their visits.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 12 and 24.
    End point values
    		 Anakinra arm Placebo arm Anakinra arm Placebo arm
    Number of subjects analysed
    9
    10
    9
    10
    Units: 100% percentage
        arithmetic mean (standard error)
    -8.1406 ± 16.81452
    -2.3979 ± 21.06458
    -34.8280 ± 22.11349
    -18.6642 ± 17.00527
    Attachments
    		 Untitled (Filename: Change of the VAS score for pain at weeks 12 and 24 from baseline visit.PNG)
    Statistical analysis title
    		 Mann-Whitney test
    Comparison groups
    Anakinra arm v Placebo arm v Anakinra arm v Placebo arm
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Post-hoc: Change of the HiSCR score at weeks 12 and 24 from baseline visit

    		 Close Top of page
    End point title
    		 Change of the HiSCR score at weeks 12 and 24 from baseline visit
    End point description
    The primary end point was the safety and efficacy of anakinra in patients with Hurley stage II or III HS based on decreased disease activity scores from the baseline visit to the end of treatment. Furthermore, the 2 study arms were compared regarding their DLQI, VAS score, development of serious adverse events, and HS severity (disease activity score, Sartorius score, and HiSCR) over the course of their visits.
    End point type
    Post-hoc
    End point timeframe
    Weeks 0, 12 and 24.
    End point values
    		 Anakinra arm Placebo arm Anakinra arm Placebo arm
    Number of subjects analysed
    9
    10
    9
    10
    Units: number
    7
    3
    3
    1
    Attachments
    		 Untitled (Filename: Change of the HiSQR score at weeks 12 and 24 from baseline visit.PNG)
    Statistical analysis title
    		 Fisher 2-sided test
    Comparison groups
    Anakinra arm v Placebo arm v Anakinra arm v Placebo arm
    Number of subjects included in analysis
    38
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.037
    Method
    		 Fisher exact
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Weeks 4, 8, 12, 16, 20 and 24
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5.0
    Reporting groups
    Reporting group title
    Anakinra arm
    Reporting group description
    		 A total of 20 patients were enrolled in the study. Patients selected for enrollment were randomized at a 1:1 ratio to receive placebo or anakinra subcutaneously once daily for 12 weeks. Therefore, 10 patients were randomised to receive anakinra.

    Reporting group title
    Placebo arm
    Reporting group description
    		 A total of 20 patients were enrolled in the study. Patients selected for enrollment were randomized at a 1:1 ratio to receive placebo or anakinra subcutaneously once daily for 12 weeks. Therefore, 10 patients were randomised to receive placebo.

    Serious adverse events
    		 Anakinra arm Placebo arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Anakinra arm Placebo arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 10 (30.00%)
    1 / 10 (10.00%)
    General disorders and administration site conditions
    Swelling​ at the injection site
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Diarrhea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Vaginal candidiasis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    The main limitation of the study was the few patients involved owing to the fact that this was a pilot study to validate the effect of an anti-IL strategy in HS. Despite the few enrolled patients, the results of anakinra use to treat HS are promising

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26579854
    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.

    European Medicines Agency © 1995-Thu May 02 14:15:47 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA