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    Clinical Trial Results:
    An open-label, long-term extension trial of spesolimab treatment in adult patients with Hidradenitis Suppurativa (HS)

    Summary
    EudraCT number
    		 2020-005587-55
    Trial protocol
    		 FR   HU   DE   NO   CZ   NL   BE   IT   ES  
    Global end of trial date
    26 Apr 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Apr 2025
    First version publication date
    26 Apr 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1368-0067
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04876391
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Boehringer Ingelheim
    Sponsor organisation address
    Binger Strasse 173, Ingelheim am Rhein, Germany, 55216
    Public contact
    Boehringer Ingelheim, Call Center, Boehringer Ingelheim, 001 018002430127, clintriage.rdg@boehringer-ingelheim.com
    Scientific contact
    Boehringer Ingelheim, Call Center, Boehringer Ingelheim, 001 018002430127, clintriage.rdg@boehringer-ingelheim.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
    14 Jun 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Apr 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Apr 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this trial was to assess the long-term safety of spesolimab in patients with hidradenitis suppurativa (HS) who had completed the proof-of-clinical-concept (PoCC) trial 1368-0052 and were qualified for entry into this trial. The secondary objectives were to evaluate efficacy at a lower dose than tested in PoCC trial.
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct. Rescue medication was allowed for all subjects as required.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Aug 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
    Spain: 1
    Country: Number of subjects enrolled
    Poland: 5
    Country: Number of subjects enrolled
    Norway: 1
    Country: Number of subjects enrolled
    Netherlands: 4
    Country: Number of subjects enrolled
    Australia: 8
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    Czechia: 2
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Germany: 7
    Country: Number of subjects enrolled
    Italy: 4
    Country: Number of subjects enrolled
    United States: 7
    Worldwide total number of subjects
    45
    EEA total number of subjects
    28
    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)
    45
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This multinational, multicenter, open-label extension of the Proof of Concept Clinical (PoCC) trial 1368-0052 included a 104-week treatment period and a 16-week safety follow-up. Subjects from the PoCC trial were enrolled to assess the long-term safety of spesolimab in hidradenitis suppurativa (HS) and to evaluate efficacy at a lower dose.

    Pre-assignment
    Screening details
    		 All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    This is an open label trial.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Prior Placebo (PP)
    Arm description
    		 Subjects in the placebo arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 1200 mg intravenous (i.v.) loading dose of spesolimab plus subcutaneous (s.c.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Spesolimab 1200 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects in the placebo arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 1200 mg intravenous (i.v.) loading dose of spesolimab at Visit 1, followed by 600 mg subcutaneous (s.c.) doses every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.

    Investigational medicinal product name
    Spesolimab-matching placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects from the placebo arm of the 1368-0052 PoCC trial will receive a subcutaneous (s.c.) administration of placebo matching 600 mg spesolimab at Visit 1.

    Arm title
    		 Prior Spesolimab (PS)
    Arm description
    		 Subjects in the active arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 600 mg subcutaneous (s.c.) loading dose of spesolimab plus intravenous (i.v.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Spesolimab-matching placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects from the active arm of the 1368-0052 PoCC trial will receive an intravenous (i.v.) infusion of placebo matching 1200 mg spesolimab at Visit 1.

    Investigational medicinal product name
    Spesolimab 600 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects in the active arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 600 mg subcutaneous (s.c.) dose of spesolimab at Visit 1, followed by 600 mg s.c. doses every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.

    Number of subjects in period 1
    		Prior Placebo (PP) Prior Spesolimab (PS)
    Started
    15
    30
    Completed
    7
    9
    Not completed
    8
    21
         Consent withdrawn by subject
    1
    10
         Personal reasons
    -
    1
         Adverse event, non-fatal
    3
    1
         Patient non-compliance
    -
    1
         Lost to follow-up
    2
    4
         Withdrawn as per protocol
    2
    2
         Lack of efficacy
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Prior Placebo (PP)
    Reporting group description
    		 Subjects in the placebo arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 1200 mg intravenous (i.v.) loading dose of spesolimab plus subcutaneous (s.c.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.

    Reporting group title
    Prior Spesolimab (PS)
    Reporting group description
    		 Subjects in the active arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 600 mg subcutaneous (s.c.) loading dose of spesolimab plus intravenous (i.v.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.

    Reporting group values
    		 Prior Placebo (PP) Prior Spesolimab (PS) Total
    Number of subjects
    		 15 30 45
    Age categorical
    Safety Analysis Set (SAF): This subject set included all subjects who were enrolled and received at least one dose of the study drug.
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 15 30 45
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Safety Analysis Set (SAF): This subject set included all subjects who were enrolled and received at least one dose of the study drug.
    Units: years
        arithmetic mean (standard deviation)
    		 35.7 ( 10.7 ) 35.5 ( 10.8 ) -
    Sex: Female, Male
    Safety Analysis Set (SAF): This subject set included all subjects who were enrolled and received at least one dose of the study drug.
    Units: Subjects
        Female
    		 8 19 27
        Male
    		 7 11 18
    Race (NIH/OMB)
    Safety Analysis Set (SAF): This subject set included all subjects who were enrolled and received at least one dose of the study drug.
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 2 4 6
        Native Hawaiian or Other Pacific Islander
    		 0 1 1
        Black or African American
    		 2 2 4
        White
    		 11 19 30
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 4 4
    Ethnicity (NIH/OMB)
    Safety Analysis Set (SAF): This subject set included all subjects who were enrolled and received at least one dose of the study drug.
    Units: Subjects
        Hispanic or Latino
    		 1 1 2
        Not Hispanic or Latino
    		 14 25 39
        Unknown or Not Reported
    		 0 4 4

    End points

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    End points reporting groups
    Reporting group title
    Prior Placebo (PP)
    Reporting group description
    		 Subjects in the placebo arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 1200 mg intravenous (i.v.) loading dose of spesolimab plus subcutaneous (s.c.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.

    Reporting group title
    Prior Spesolimab (PS)
    Reporting group description
    		 Subjects in the active arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 600 mg subcutaneous (s.c.) loading dose of spesolimab plus intravenous (i.v.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.

    Subject analysis set title
    Prior Placebo (PP)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects in the placebo arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 1200 mg intravenous (i.v.) loading dose of spesolimab plus subcutaneous (s.c.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.

    Subject analysis set title
    Prior Spesolimab (PS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects in the active arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 600 mg subcutaneous (s.c.) loading dose of spesolimab plus intravenous (i.v.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.

    Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [1]
    End point description
    TEAEs were defined as all adverse events (AEs) occurring from the start of treatment in this extension trial to the end of its residual effect period. AEs that began during the on-treatment period of the parent Proof of Concept and Confirmatory (PoCC) trial (1368-0052) and were still ongoing in this extension trial will also be considered as treatment-emergent.
    End point type
    Primary
    End point timeframe
    From drug administration until the end of maintenance treatment period (120 weeks). This period includes the Residual effect period (REP) (i.e., 16 weeks after the last study treatment).
    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: All statistical assessments were performed in an explorative manner in the safety analysis set (SAF) using descriptive statistics.
    End point values
    		 Prior Placebo (PP) Prior Spesolimab (PS)
    Number of subjects analysed
    15
    30
    Units: Subjects
    15
    28
    No statistical analyses for this end point

    Secondary: Percent change in total abscess and inflammatory nodule (AN) count from baseline up to Week 12

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    End point title
    		 Percent change in total abscess and inflammatory nodule (AN) count from baseline up to Week 12
    End point description
    Percentage change from baseline in total abscess and inflammatory nodule count at Week 12= [(Total Abscess at Week 12 + Total Inflammatory Nodule at Week 12) - (Total Abscess at baseline + Total Inflammatory Nodule at baseline)] *100/ (Total Abscess at baseline + Total Inflammatory Nodule at baseline). Percentage change from baseline in total abscess and inflammatory nodule count at Week 12 was modelled using a restricted maximum likelihood (REML)-based mixed effect model with repeated measures (MMRM) approach, accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, prior use of TNF inhibitor and the fixed continuous effects of baseline at each visit (Weeks 1, 2, 4, 6, 8, 10, and 12) as well as random effect of each visit. Baseline refers to the last measurement prior to the start of spesolimab.
    End point type
    Secondary
    End point timeframe
    MMRM included measurements from baseline (Week 12 of 1368-0052) and at Weeks 1, 2, 4, 6, 8, 10, and 12 after first drug administration. MMRM estimates of percent change in draining fistula from baseline to Week 12 is reported.
    End point values
    		 Prior Placebo (PP) Prior Spesolimab (PS)
    Number of subjects analysed
    12
    26
    Units: Percentage change
        least squares mean (standard error)
    -18.3 ( 19.2 )
    -35.0 ( 12.7 )
    No statistical analyses for this end point

    Secondary: Achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) up to Week 12

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    End point title
    		 Achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) up to Week 12
    End point description
    HiSCR is defined as at least a 50% reduction in the total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline. Percentage of subjects with achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 is reported. Percentage of subjects with achievement of HiSCR at Week 12 was calculated as: number of subjects with achievement of HiSCR at Week 12/number of subjects analyzed * 100.
    End point type
    Secondary
    End point timeframe
    At baseline (Week 0) and at Week 12.
    End point values
    		 Prior Placebo (PP) Prior Spesolimab (PS)
    Number of subjects analysed
    12
    27
    Units: Percentage of subjects
        number (confidence interval 95%)
    33.3 (13.8 to 60.9)
    40.7 (24.5 to 59.3)
    No statistical analyses for this end point

    Secondary: Percentage change in total draining fistula (DF) count from baseline up to Week 12

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    End point title
    		 Percentage change in total draining fistula (DF) count from baseline up to Week 12
    End point description
    Percentage change from baseline in draining fistula at Week 12 was calculated as: [(total draining fistula at Week 12) - (total draining fistula at baseline)] * 100 %/ (total draining fistula at baseline). Percentage change from baseline in in draining fistula count at Week 12 was modelled using a restricted maximum likelihood (REML)-based mixed effect model with repeated measures (MMRM) approach, accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, prior use of TNF inhibitor and the fixed continuous effects of baseline at each visit (Weeks 1, 2, 4, 6, 8, 10, and 12) as well as random effect of each visit. Baseline refers to the last measurement prior to the start of spesolimab. Unstructured covariance matrix was used.
    End point type
    Secondary
    End point timeframe
    MMRM included measurements from baseline (Week 12 of 1368-0052) and at Weeks 1, 2, 4, 6, 8, 10, and 12 after first drug administration. MMRM estimates of percentage change in draining fistula from baseline to Week 12 is reported.
    End point values
    		 Prior Placebo (PP) Prior Spesolimab (PS)
    Number of subjects analysed
    11
    21
    Units: Percentage change
        least squares mean (standard error)
    25.4 ( 25.5 )
    -44.6 ( 18.1 )
    No statistical analyses for this end point

    Secondary: Change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) value up to Week 12

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    End point title
    		 Change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) value up to Week 12
    End point description
    The IHS4 assesses the hidradenitis suppurativa (HS) severity and the resulting IHS4 score is arrived at by= number of nodules * 1 + number of abscesses * 2 + number of draining tunnels (fistulae or sinuses) * 4. A total score of 3 or less signifies mild, 4-10 signifies moderate and 11 or higher signifies severe disease. The minimum score is 0 while the maximum score is variable and depends on the counts of nodules, abscesses, and draining tunnels (fistulae or sinuses). Absolute change from baseline in IHS4 value at Week 12 was modelled using a restricted maximum likelihood (REML)-based mixed effect model with repeated measures (MMRM) approach, accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, prior use of TNF inhibitor and the fixed continuous effects of baseline at each visit (Weeks 1, 2, 4, 6, 8, 10, and 12) as well as random effect of each visit. Baseline refers to the last measurement prior to the start of spesolimab.
    End point type
    Secondary
    End point timeframe
    MMRM included measurements at baseline (Week 0) and at Weeks 1, 2, 4, 6, 8, 10, and 12 after first drug administration. MMRM estimates of absolute change in IHS4 from baseline to Week 12 is reported.
    End point values
    		 Prior Placebo (PP) Prior Spesolimab (PS)
    Number of subjects analysed
    13
    26
    Units: Score on a scale
        least squares mean (standard error)
    -3.1 ( 4.8 )
    -10.5 ( 3.3 )
    No statistical analyses for this end point

    Secondary: Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) score of 0 or 1 up to Week 12

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    End point title
    		 Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) score of 0 or 1 up to Week 12
    End point description
    HS-PGA documents the physician’s assessment of the subject’s HS at a given timepoint. The score ranges from 0 to 5, where: 0=clear - no abscesses, draining fistula, inflammatory nodules or noninflammatory nodules); 1=minimal - no abscesses, draining fistula or inflammatory nodules and the presence of noninflammatory nodules); 2=mild - no abscesses or draining fistula and 1-4 inflammatory nodules, or 1 abscess or draining tunnel and no inflammatory nodules); 3=moderate - no abscesses or draining fistula and ≥5 inflammatory nodules, or 1 abscess or draining fistula and ≥1 inflammatory nodule, or 2-5 abscesses or draining fistula and <10 inflammatory nodules); 4=severe - 2-5 abscesses or draining fistula and ≥10 inflammatory nodules); 5=very severe - >5 abscesses or draining fistula). Percentage of subjects with achievement of HS-PGA score of 0 or 1 at Week 12 was calculated as: number of subjects with achievement of HS-PGA score of 0 or 1 at Week 12/number of subjects analyzed *100.
    End point type
    Secondary
    End point timeframe
    At Week 12.
    End point values
    		 Prior Placebo (PP) Prior Spesolimab (PS)
    Number of subjects analysed
    13
    27
    Units: Percentage of subjects
        number (confidence interval 95%)
    0 (0 to 22.8)
    3.7 (0.7 to 18.3)
    No statistical analyses for this end point

    Secondary: Absolute change from baseline in Hidradenitis Suppurativa Area and Severity Index (HASI) score up to Week 12

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    End point title
    		 Absolute change from baseline in Hidradenitis Suppurativa Area and Severity Index (HASI) score up to Week 12
    End point description
    The HASI assesses HS severity across four domains: erythema, induration, open ulcer, and draining fistula, scored on a 0 (none) to 3 (severe/extensive) Likert scale for each body region. For body surface area (BSA) assessment, the number of palms (one palm indicates 1% of the patient’s BSA) involved for each body region (head, right axilla, left axilla, anterior chest, back, anterior bathing trunk, posterior bathing trunk, other) is assessed and converted to a percentage of that region. An area score was assigned to each region using the approach (0 = none, 1 = 1–9%, 2 = 10–29%, 3 = 30–49%, 4 = 50–69%, 5 = 70–89%, 6 = 90– 100%). Scores for the four domains of HS are summed and adjusted for the area affected, and the score of each area are summed to calculate the total HASI score, which ranges from 0 (no disease) to 72 (severe disease). The Least Squares Mean (Standard Error (SE)) was derived from mixed effect model with repeated measures (MMRM).
    End point type
    Secondary
    End point timeframe
    MMRM included measurements at baseline (Week 0) and at Weeks 1, 2, 4, 6, 8, 10, and 12 after first drug administration. MMRM estimates of absolute change from baseline in HASI score at Week 12 is reported.
    End point values
    		 Prior Placebo (PP) Prior Spesolimab (PS)
    Number of subjects analysed
    13
    26
    Units: Score on a scale
        least squares mean (standard error)
    5.0 ( 8.9 )
    -22.8 ( 6.1 )
    No statistical analyses for this end point

    Secondary: Occurrence of at least one flare (defined as at least 25 % increase in AN count with a minimum increase of 2 relative to baseline) up to Week 12

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    End point title
    		 Occurrence of at least one flare (defined as at least 25 % increase in AN count with a minimum increase of 2 relative to baseline) up to Week 12
    End point description
    Percentage of subjects with occurrence of at least one flare at Week 12. Flare was defined as at least 25 % increase in abscess and inflammatory nodule count with a minimum increase of 2 relative to baseline. Percentage of patients with occurrence of at least one flare at Week 12 was calculated as: number of patients with occurrence of at least one flare at Week 12/number of subjects analyzed * 100.
    End point type
    Secondary
    End point timeframe
    From drug administration until the end of maintenance treatment period including Residual effect period (REP) (i.e., 16 weeks after the last study treatment)
    End point values
    		 Prior Placebo (PP) Prior Spesolimab (PS)
    Number of subjects analysed
    12
    27
    Units: Percentage of subjects
        number (confidence interval 95%)
    8.3 (1.5 to 35.4)
    14.8 (5.9 to 32.5)
    No statistical analyses for this end point

    Secondary: Achievement of at least 30% reduction from baseline in Numerical Rating Scale (NRS30) in Patient’s Global Assessment of HS Pain up to Week 12

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    End point title
    		 Achievement of at least 30% reduction from baseline in Numerical Rating Scale (NRS30) in Patient’s Global Assessment of HS Pain up to Week 12
    End point description
    The analysis assessed the percentage of subjects who achieved at least a 30% reduction from baseline in the Numerical Rating Scale (NRS30) for the subject’s Global Assessment of HS Pain by Week 12. The HS Pain Numerical Rating Scale (NRS) measures HS-related pain severity, with a recall period of 24 hours and responses on an 11-point scale from 0 (no pain) to 10 (worst possible pain). For pain analysis, a weekly average of daily assessments was calculated at each visit, based on recorded values before the visit. Weeks with at least four reported daily values were included, ignoring any missing daily values. The percentage of subjects achieving at least a 30% reduction from baseline in NRS30 by Week 12 was calculated as the number of subjects meeting this criterion divided by the total number of subjects analyzed * 100.
    End point type
    Secondary
    End point timeframe
    At baseline (Week 0) and at Week 12.
    End point values
    		 Prior Placebo (PP) Prior Spesolimab (PS)
    Number of subjects analysed
    12
    27
    Units: Percentage of subjects
        number (confidence interval 95%)
    25.0 (8.9 to 53.2)
    36.0 (20.2 to 55.5)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality, AEs and SAEs: From drug administration until the end of maintenance treatment period (120 weeks). This period includes the Residual effect period (REP) (i.e., 16 weeks after the last study treatment).
    Adverse event reporting additional description
    Safety Analysis Set (SAF): The safety analysis set includes all subjects who received at least one dose of the trial drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Prior Spesolimab (PS)
    Reporting group description
    		 Subjects in the active arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 600 mg subcutaneous (s.c.) loading dose of spesolimab plus intravenous (i.v.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.

    Reporting group title
    Prior Placebo (PP)
    Reporting group description
    		 Subjects in the placebo arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 1200 mg intravenous (i.v.) loading dose of spesolimab plus subcutaneous (s.c.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.

    Serious adverse events
    		 Prior Spesolimab (PS) Prior Placebo (PP)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 30 (20.00%)
    4 / 15 (26.67%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Road traffic accident
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 15 (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
    Guillain-Barre syndrome
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Pancreatitis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Hidradenitis
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Acute psychosis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute hepatitis C
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Latent tuberculosis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulval abscess
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         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
    		 Prior Spesolimab (PS) Prior Placebo (PP)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 30 (90.00%)
    15 / 15 (100.00%)
    General disorders and administration site conditions
    Injection site haematoma
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 15 (6.67%)
         occurrences all number
    2
    7
    Axillary pain
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Chest pain
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Fatigue
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    3
    0
    Feeling hot
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    21
    Influenza like illness
         subjects affected / exposed
    3 / 30 (10.00%)
    0 / 15 (0.00%)
         occurrences all number
    3
    0
    Injection site bruising
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Injection site erythema
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1
    Injection site pain
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    3
    0
    Injection site pruritus
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    3
    0
    Injection site swelling
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Pyrexia
         subjects affected / exposed
    4 / 30 (13.33%)
    0 / 15 (0.00%)
         occurrences all number
    4
    0
    Swelling face
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 15 (6.67%)
         occurrences all number
    5
    12
    Heavy menstrual bleeding
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 15 (13.33%)
         occurrences all number
    2
    2
    Cough
         subjects affected / exposed
    3 / 30 (10.00%)
    0 / 15 (0.00%)
         occurrences all number
    4
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Investigations
    Amylase increased
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    Bacterial test positive
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    Blood fibrinogen increased
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Blood pressure increased
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    C-reactive protein increased
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Haemoglobin decreased
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Heart rate irregular
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Lipase increased
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    Mycobacterium test positive
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Platelet count increased
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Foot fracture
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Head injury
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Ligament sprain
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Sunburn
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Cardiac disorders
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Sinus tachycardia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Nervous system disorders
    Paraesthesia
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Lethargy
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    4 / 30 (13.33%)
    1 / 15 (6.67%)
         occurrences all number
    11
    6
    Dizziness
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Eye disorders
    Vision blurred
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 15 (6.67%)
         occurrences all number
    3
    1
    Abdominal pain upper
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Diarrhoea
         subjects affected / exposed
    4 / 30 (13.33%)
    1 / 15 (6.67%)
         occurrences all number
    6
    1
    Dyspepsia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Toothache
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Vomiting
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 15 (6.67%)
         occurrences all number
    4
    1
    Skin and subcutaneous tissue disorders
    Skin haemorrhage
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Rosacea
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Rash
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Pruritus
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    3
    0
    Intertrigo
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Urticaria
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    3
    Erythema
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    23
    Eczema
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Acne
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    3
    0
    Hidradenitis
         subjects affected / exposed
    10 / 30 (33.33%)
    8 / 15 (53.33%)
         occurrences all number
    27
    17
    Renal and urinary disorders
    Leukocyturia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Sacral pain
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    4 / 30 (13.33%)
    0 / 15 (0.00%)
         occurrences all number
    5
    0
    Myalgia
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 15 (13.33%)
         occurrences all number
    2
    2
    Fistula
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    Back pain
         subjects affected / exposed
    6 / 30 (20.00%)
    0 / 15 (0.00%)
         occurrences all number
    8
    0
    Arthralgia
         subjects affected / exposed
    3 / 30 (10.00%)
    1 / 15 (6.67%)
         occurrences all number
    3
    1
    Arthritis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Infections and infestations
    Abscess sweat gland
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Anal abscess
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    COVID-19
         subjects affected / exposed
    13 / 30 (43.33%)
    1 / 15 (6.67%)
         occurrences all number
    16
    1
    Erythrasma
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Gastroenteritis
         subjects affected / exposed
    3 / 30 (10.00%)
    0 / 15 (0.00%)
         occurrences all number
    4
    0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Influenza
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Nail infection
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    4 / 30 (13.33%)
    3 / 15 (20.00%)
         occurrences all number
    5
    6
    Pilonidal disease
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Sinusitis
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    3
    Tinea cruris
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    3
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Jul 2022
    The wording of two secondary endpoints was adapted to clarify and make them more informative. The phrase "Number of patients having at least one flare (defined as at least 25% increase in AN count with a minimum increase of 2 relative to baseline) up to Week 12" was changed to "Occurrence of at least one flare...," and "Number of patients having at least 30% reduction from baseline in Numerical Rating Scale (NRS30) in Patient’s Global Assessment of HS Pain up to Week 12" was revised to "Achievement of at least 30% reduction..." Several minor changes were made to the flow chart and text in different Clinical Trial Protocol (CTP) sections to ensure consistent wording throughout the CTP, Investigator Site File (ISF), and Trial Statistical Analysis Plan (TSAP). Additional information regarding peripheral neuropathy was added as a mitigation strategy to address the three cases reported as Guillain-Barré syndrome in spesolimab trials. The decision-making process regarding the continuation of trial treatment for patients receiving rescue therapy was also updated, allowing investigators to decide independently without needing prior discussion with the sponsor. To improve pain relief options for patients over the two-year trial period, synthetic opioids and tramadol were removed from the restricted medications list, allowing their use for both HS and non-HS indications. The requirement for investigators to write a report on the Columbia-Suicide Severity Rating Scale (C-SSRS) was replaced by a simpler confirmation in the source notes. Additionally, peripheral neuropathy was added as an Adverse Event of Special Interest (AESI) to update reporting requirements and ensure that all cases are analyzed promptly.

    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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