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    Clinical Trial Results:
    Multi-center, double-blind, randomised, placebo-controlled, phase IIa study to investigate efficacy, safety, tolerability, pharmacokinetics and pharmacogenomics of multiple intravenous doses of BI 655130 in patients with Palmoplantar Pustulosis (PPP)

    Summary
    EudraCT number
    2016-004573-40
    Trial protocol
    SE   DK   ES   DE  
    Global end of trial date
    14 Nov 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    11 Nov 2019
    First version publication date
    11 Nov 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1368-0015
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03135548
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Boehringer Ingelheim
    Sponsor organisation address
    Binger Strasse 173, Ingelheim am Rhein, Germany, 55216
    Public contact
    QRPE Processes and Systems Coordination, Clinical Trial Information Disclosure, Boehringer Ingelheim, 001 8002430127, clintriage.rdg@boehringer-ingelheim.com
    Scientific contact
    QRPE Processes and Systems Coordination, Clinical Trial Information Disclosure, Boehringer Ingelheim, 001 8002430127, 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
    17 Dec 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Jul 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Nov 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this trial was to investigate the safety and efficacy of BI 655130 in patients with PPP following multiple intravenous administrations of either low dose or high dose of BI 655130 compared with placebo.
    Protection of trial subjects
    Only patients that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All patients were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all patients was adhered to throughout the trial conduct. Rescue medication was allowed for all patients as required.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    15 Jun 2017
    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
    Denmark: 13
    Country: Number of subjects enrolled
    Canada: 19
    Country: Number of subjects enrolled
    Germany: 34
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    Spain: 4
    Country: Number of subjects enrolled
    Sweden: 3
    Worldwide total number of subjects
    79
    EEA total number of subjects
    60
    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)
    78
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This was a randomised, double-blind, placebo-controlled, parallel-design trial to investigate the safety and efficacy of BI 655130 in patients with Palmoplantar Pustulosis (PPP) following multiple intravenous administrations of either low dose or high dose compared with placebo.

    Pre-assignment
    Screening details
    All participants were screened for eligibility to participate in the trial. Participants attended specialist sites which would then ensured that all participants met all inclusion/exclusion criteria. Participants were not to be randomised to trial treatment if any one of the specific entry criteria were not met.

    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
    Investigator, Monitor, Carer, Data analyst, Assessor, Subject
    Blinding implementation details
    This was a double-blind trial.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    BI 655130 low dose
    Arm description
    Participants were administered low dose BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    BI 655130
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    low dose of BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks

    Arm title
    BI 655130 high dose
    Arm description
    Participants were administered high dose BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    BI 655130
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    high dose of BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks

    Arm title
    Placebo matching to BI 655130
    Arm description
    Participants were administered placebo matching to BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.
    Arm type
    Placebo

    Investigational medicinal product name
    Plcebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    placebo matching to BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks

    Number of subjects in period 1 [1]
    BI 655130 low dose BI 655130 high dose Placebo matching to BI 655130
    Started
    19
    19
    21
    Completed
    14
    15
    18
    Not completed
    5
    4
    3
         Other than listed
    -
    2
    2
         Consent withdrawn by subject
    2
    2
    1
         Lost to follow-up
    3
    -
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Baseline characteristics are based on patients who were randomized after successfully completing the screening period and received at least one dose of the trial medication.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BI 655130 low dose
    Reporting group description
    Participants were administered low dose BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.

    Reporting group title
    BI 655130 high dose
    Reporting group description
    Participants were administered high dose BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.

    Reporting group title
    Placebo matching to BI 655130
    Reporting group description
    Participants were administered placebo matching to BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.

    Reporting group values
    BI 655130 low dose BI 655130 high dose Placebo matching to BI 655130 Total
    Number of subjects
    19 19 21 59
    Age categorical
    Units: Subjects
    Age Continuous
    Safety analysis set (SAF): SAF included all randomised patients who received at least one dose of study drug.
    Units: years
        arithmetic mean (standard deviation)
    54.6 ± 7.7 49.4 ± 11.3 46.3 ± 11.7 -
    Sex: Female, Male
    SAF
    Units: Subjects
        Female
    16 16 17 49
        Male
    3 3 4 10
    Race (NIH/OMB)
    SAF
    Units: Subjects
        American Indian or Alaska Native
    0 0 0 0
        Asian
    0 0 1 1
        Native Hawaiian or Other Pacific Islander
    0 0 0 0
        Black or African American
    0 0 1 1
        White
    18 19 19 56
        More than one race
    1 0 0 1
        Unknown or Not Reported
    0 0 0 0
    Ethnicity (NIH/OMB)
    SAF
    Units: Subjects
        Hispanic or Latino
    2 3 1 6
        Not Hispanic or Latino
    17 16 20 53
        Unknown or Not Reported
    0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    BI 655130 low dose
    Reporting group description
    Participants were administered low dose BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.

    Reporting group title
    BI 655130 high dose
    Reporting group description
    Participants were administered high dose BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.

    Reporting group title
    Placebo matching to BI 655130
    Reporting group description
    Participants were administered placebo matching to BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.

    Primary: Percentage of participants with palmoplantar Pustular Psoriasis Area and Severity Index 50 (PPPASI50) at week 16

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    End point title
    Percentage of participants with palmoplantar Pustular Psoriasis Area and Severity Index 50 (PPPASI50) at week 16
    End point description
    ppPASI is modification of PASI score and investigator assessment of extent and severity of pustular and plaque lesions on the palms and soles presenting in PPP participants. This tool provides numeric scoring for participants overall PPP disease state, ranging from 0 to maximum 72, where 0 corresponds to no signs of psoriasis. It is a linear combination of the percent of surface area of skin that is affected on the palms and soles and the severity of Erythema(E), Pustules(P)(total), and scaling(Desquamation(D)). Missing values for severity or area of involvement were not imputed. ppPASI was calculated as a weighted sum of the scores obtained for E,P,D and Area affected(%)(where area assessed is glabrous skin on palms/soles)(A):[(E+P+D)xAx0.2(right palm)]+[(E+P+D)xAx0.2(left palm)]+[(E+P+D)xAx0.3(right sole)]+[(E+P+D)xAx0.3(left sole)]. Full analysis set included all patients in the SAF who had a baseline measurement available for primary endpoint,with no response imputation(FAS(NRI))
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    BI 655130 low dose BI 655130 high dose Placebo matching to BI 655130
    Number of subjects analysed
    19 [1]
    19 [2]
    21 [3]
    Units: Percentage of participants (%)
        number (not applicable)
    31.6
    31.6
    23.8
    Notes
    [1] - FAS (NRI)
    [2] - FAS (NRI)
    [3] - FAS (NRI)
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    95% confidence intervals (CI) are calculated using the method of Wilson/Newcombe. Unadjusted absolute risk difference versus placebo was calculated as the difference in the observed proportion of patients with ppPASI50 at Week 16 for each treatment scenario, for the FAS.
    Comparison groups
    BI 655130 low dose v Placebo matching to BI 655130
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    other [4]
    Method
    Wilson/Newcombe
    Parameter type
    Risk difference (RD)
    Point estimate
    0.078
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.19
         upper limit
    0.338
    Notes
    [4] - No formal hypothesis testing was performed in this trial.
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    95% CIs are calculated using the method of Wilson/Newcombe. Unadjusted absolute risk difference versus placebo was calculated as the difference in the observed proportion of patients with ppPASI50 at Week 16 for each treatment scenario, for the FAS.
    Comparison groups
    BI 655130 high dose v Placebo matching to BI 655130
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    other [5]
    Method
    Wilson/Newcombe
    Parameter type
    Risk difference (RD)
    Point estimate
    0.078
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.19
         upper limit
    0.338
    Notes
    [5] - No formal hypothesis testing was performed in this trial.

    Primary: Number of participants with drug-related Adverse Events (AEs)

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    End point title
    Number of participants with drug-related Adverse Events (AEs) [6]
    End point description
    Number of participants with drug-related AEs are presented. Safety analysis set (SAF): This set included all randomised patients who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    From first drug administration until 16 weeks after the last drug administration, up to 32 weeks.
    Notes
    [6] - 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: This endpoint was evaluated only descriptively. Thus, no statistical hypothesis were tested.
    End point values
    BI 655130 low dose BI 655130 high dose Placebo matching to BI 655130
    Number of subjects analysed
    19 [7]
    19 [8]
    21 [9]
    Units: Participants
    8
    8
    9
    Notes
    [7] - SAF
    [8] - SAF
    [9] - SAF
    No statistical analyses for this end point

    Secondary: ppPASI 75 at week 16

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    End point title
    ppPASI 75 at week 16
    End point description
    Percentage of participants who achieved >75% reduction in ppPASI score was assessed by ppPASI75. ppPASI is modification of PASI score and an investigator assessment of the extent and severity of pustular and plaque lesions on the palms and soles presenting in PPP participants. This tool provides a numeric scoring for participants overall PPP disease state, ranging from 0 to maximum 72, where 0 corresponds to no signs of psoriasis. It is a linear combination of the percent of surface area of skin that is affected on the palms and soles and the severity of Erythema (E), Pustules (P) (total), and scaling (Desquamation (D)). Missing values for severity or area of involvement were not imputed. ppPASI was calculated as a weighted sum of the scores obtained for E, P, D and Area affected (in%) (where area assessed is glabrous skin on the palms/ soles) (A): [(E+P+D) x A x 0.2 (right palm)] + [(E+P+D) x A x 0.2 (left palm)] + [(E+P+D) x A x 0.3 (right sole)] + [(E+P+D) x A x 0.3 (left sole)].
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    BI 655130 low dose BI 655130 high dose Placebo matching to BI 655130
    Number of subjects analysed
    19 [10]
    19 [11]
    21 [12]
    Units: Percentage of participnats (%)
        number (not applicable)
    0.0
    21.1
    9.5
    Notes
    [10] - FAS (NRI)
    [11] - FAS (NRI)
    [12] - FAS (NRI)
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    95% CIs are calculated using the method of Wilson/Newcombe. Unadjusted absolute risk difference versus placebo was calculated as the difference in the observed proportion of patients with ppPASI50 at Week 16 for each treatment scenario, for the FAS.
    Comparison groups
    BI 655130 low dose v Placebo matching to BI 655130
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    other [13]
    Method
    Wilson/Newcombe
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.095
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.289
         upper limit
    0.086
    Notes
    [13] - No formal hypothesis testing was performed in this trial.
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    95% CIs are calculated using the method of Wilson/Newcombe. Unadjusted absolute risk difference versus placebo was calculated as the difference in the observed proportion of patients with ppPASI50 at Week 16 for each treatment scenario, for the FAS.
    Comparison groups
    BI 655130 high dose v Placebo matching to BI 655130
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    other [14]
    Method
    Wilson/Newcombe
    Parameter type
    Risk difference (RD)
    Point estimate
    0.115
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.116
         upper limit
    0.348
    Notes
    [14] - No formal hypothesis testing was performed in this trial.

    Secondary: Percent change from baseline in the ppPASI at week 16

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    End point title
    Percent change from baseline in the ppPASI at week 16
    End point description
    ppPASI is modification of PASI score and an investigator assessment of extent and severity of pustular and plaque lesions on the palms and soles presenting in PPP participants. This tool provides numeric scoring for participants overall PPP disease state, ranging from 0 to maximum 72, where 0 corresponds to no signs of psoriasis. It is a linear combination of the percent of surface area of skin that is affected on the palms and soles and the severity of Erythema(E), Pustules(P)(total), and scaling(Desquamation(D)). Missing values for severity or area of involvement were not imputed. ppPASI was calculated as a weighted sum of the scores obtained for E,P,D and Area affected (in%) (where area assessed is glabrous skin on the palms/ soles) (A): [(E+P+D) x A x 0.2 (right palm)] + [(E+P+D) x A x 0.2 (left palm)] + [(E+P+D) x A x 0.3 (right sole)] + [(E+P+D) x A x 0.3 (left sole)]. Patients from FAS with observed cases (OC) were included for analysis of this endpoint.(FAS (OC))
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    BI 655130 low dose BI 655130 high dose Placebo matching to BI 655130
    Number of subjects analysed
    15 [15]
    14 [16]
    15 [17]
    Units: Unit on scale
        arithmetic mean (standard deviation)
    -32.74 ± 38.52
    -45.80 ± 27.00
    -39.97 ± 32.94
    Notes
    [15] - FAS (OC)
    [16] - FAS (OC)
    [17] - FAS (OC)
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    CIs were based on Student's t-distribution.
    Comparison groups
    BI 655130 low dose v Placebo matching to BI 655130
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    other [18]
    Method
    Student's t-distribution
    Parameter type
    Mean difference (final values)
    Point estimate
    7.24
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -20.01
         upper limit
    34.48
    Notes
    [18] - No formal hypothesis testing was performed in this trial.
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    CIs were based on Student's t-distribution.
    Comparison groups
    BI 655130 high dose v Placebo matching to BI 655130
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    other [19]
    Method
    Student's t-distribution
    Parameter type
    Mean difference (final values)
    Point estimate
    -5.82
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -28.35
         upper limit
    16.7
    Notes
    [19] - No formal hypothesis testing was performed in this trial.

    Secondary: Percentage of participants achieving treatment success (treatment success defined as achieving a clinical response of 0 or 1=clear/almost clear) via Palmoplantar Pustulosis Physicians Global Assessment (pppPGA) at week 16

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    End point title
    Percentage of participants achieving treatment success (treatment success defined as achieving a clinical response of 0 or 1=clear/almost clear) via Palmoplantar Pustulosis Physicians Global Assessment (pppPGA) at week 16
    End point description
    pppPGA was relied on the participant’s overall skin lesions status on the lesions of the most severely affected palmoplantar surface of the palms and sole was assessed by investigator as clear (0), almost clear (1), mild (2), moderate (3) and severe (4) at week 16. Score Wording were: 0 = Clear = No signs of PPP; no scaling or crusts or pustule remains. 1 = Almost clear = Slight scaling and/or erythema and / or slight crusts; very few new (yellow) and / or old (brown) pustules. 2 = Mild = Scaling and/or erythema and/or crusts; visible new (yellow) and/or old (brown) pustules of limited number and extent. 3 =Moderate = Prominent scaling and/or erythema and / or crusting; prominent new (yellow) and / or old (brown) pustules covering most of the area involved. 4 =Severe = Severe scaling and/or erythema and / or crusting; numerous new (yellow) or old (brown) pustules with and/or without major conflence covering the entire area of at least 2 palmoplantar surfaces.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    BI 655130 low dose BI 655130 high dose Placebo matching to BI 655130
    Number of subjects analysed
    19 [20]
    19 [21]
    21 [22]
    Units: Percentage of participants (%)
        number (not applicable)
    0.0
    15.8
    14.3
    Notes
    [20] - FAS (NRI)
    [21] - FAS (NRI)
    [22] - FAS (NRI)
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    95% CIs are calculated using the method of Wilson/Newcombe.
    Comparison groups
    BI 655130 low dose v Placebo matching to BI 655130
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    other [23]
    Method
    Wilson/Newcombe
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.143
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.346
         upper limit
    0.049
    Notes
    [23] - No formal hypothesis testing was performed in this trial.
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    95% CIs are calculated using the method of Wilson/Newcombe.
    Comparison groups
    BI 655130 high dose v Placebo matching to BI 655130
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    other [24]
    Method
    Wilson/Newcombe
    Parameter type
    Risk difference (RD)
    Point estimate
    0.015
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.213
         upper limit
    0.252
    Notes
    [24] - No formal hypothesis testing was performed in this trial.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first drug administration until 16 weeks after the last drug administration, up to 32 weeks.
    Adverse event reporting additional description
    Analysis set for safety presentation was Safety analysis set (SAF). SAF included all randomised patients who received at least one dose of study drug.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    BI 655130 low dose
    Reporting group description
    Participants were administered low dose BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.

    Reporting group title
    BI 655130 high dose
    Reporting group description
    Participants were administered high dose BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.

    Reporting group title
    Placebo matching to BI 655130
    Reporting group description
    Participants were administered placebo matching to BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.

    Serious adverse events
    BI 655130 low dose BI 655130 high dose Placebo matching to BI 655130
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    1 / 21 (4.76%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Nervous system disorders
    VIth nerve paralysis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Palmoplantar pustulosis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    BI 655130 low dose BI 655130 high dose Placebo matching to BI 655130
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 19 (89.47%)
    17 / 19 (89.47%)
    15 / 21 (71.43%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences all number
    0
    2
    0
    Haematoma
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Hot flush
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Hypertension
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences all number
    1
    2
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign neoplasm of thyroid gland
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Skin papilloma
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Administration site extravasation
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Catheter site haematoma
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Injection site bruising
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Oedema peripheral
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    1
    0
    1
    Pyrexia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 19 (5.26%)
    1 / 21 (4.76%)
         occurrences all number
    1
    1
    1
    Reproductive system and breast disorders
    Breast pain
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Dysmenorrhoea
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Epicondylitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Post-traumatic neck syndrome
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Procedural pain
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences all number
    2
    1
    0
    Thermal burn
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    Lipase increased
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 19 (10.53%)
    1 / 21 (4.76%)
         occurrences all number
    0
    3
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    1
    0
    1
    Amylase increased
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Blood urine present
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    C-reactive protein increased
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    White blood cells urine positive
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac disorders
    Bundle branch block
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiovascular disorder
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Leukocytosis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    2
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 19 (15.79%)
    2 / 19 (10.53%)
    1 / 21 (4.76%)
         occurrences all number
    3
    2
    1
    Asthma
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Catarrh
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Dysphonia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Epistaxis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 19 (5.26%)
    1 / 21 (4.76%)
         occurrences all number
    1
    1
    1
    Rhinitis allergic
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 19 (21.05%)
    6 / 19 (31.58%)
    7 / 21 (33.33%)
         occurrences all number
    8
    8
    10
    Burning sensation
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Presyncope
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    1
    0
    1
    Sciatica
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Somnolence
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Syncope
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Tension headache
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Eye disorders
    Eye inflammation
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Lacrimation increased
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Ocular hyperaemia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Vitreous floaters
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    1
    0
    2
    Abdominal pain upper
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    1
    Diarrhoea
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 19 (5.26%)
    1 / 21 (4.76%)
         occurrences all number
    1
    1
    1
    Dry mouth
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Flatulence
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Gastric ulcer
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Gastritis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Palmoplantar pustulosis
         subjects affected / exposed
    2 / 19 (10.53%)
    3 / 19 (15.79%)
    3 / 21 (14.29%)
         occurrences all number
    2
    3
    3
    Acne
         subjects affected / exposed
    1 / 19 (5.26%)
    2 / 19 (10.53%)
    0 / 21 (0.00%)
         occurrences all number
    1
    2
    0
    Alopecia
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 19 (10.53%)
    0 / 21 (0.00%)
         occurrences all number
    0
    2
    0
    Pruritus
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 19 (10.53%)
    0 / 21 (0.00%)
         occurrences all number
    0
    2
    0
    Psoriasis
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 19 (10.53%)
    1 / 21 (4.76%)
         occurrences all number
    0
    2
    1
    Angioedema
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Dermal cyst
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Dermatitis acneiform
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Dermatitis contact
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    1
    0
    1
    Erythema
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences all number
    1
    1
    0
    Hyperkeratosis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Nail dystrophy
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Urticaria
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 19 (15.79%)
    2 / 19 (10.53%)
    1 / 21 (4.76%)
         occurrences all number
    3
    2
    1
    Back pain
         subjects affected / exposed
    1 / 19 (5.26%)
    2 / 19 (10.53%)
    1 / 21 (4.76%)
         occurrences all number
    1
    2
    1
    Myalgia
         subjects affected / exposed
    2 / 19 (10.53%)
    0 / 19 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    2
    0
    0
    Muscle spasms
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    0
    2
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Osteoarthritis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Pain in extremity
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    1
    Pain in jaw
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Psoriatic arthropathy
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    1
    0
    1
    Metabolism and nutrition disorders
    Alcohol intolerance
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Diabetes mellitus
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    5 / 19 (26.32%)
    8 / 19 (42.11%)
    8 / 21 (38.10%)
         occurrences all number
    10
    9
    9
    Urinary tract infection
         subjects affected / exposed
    1 / 19 (5.26%)
    3 / 19 (15.79%)
    1 / 21 (4.76%)
         occurrences all number
    1
    3
    1
    Oral herpes
         subjects affected / exposed
    2 / 19 (10.53%)
    0 / 19 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    2
    0
    0
    Rhinitis
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 19 (5.26%)
    2 / 21 (9.52%)
         occurrences all number
    1
    2
    2
    Bronchitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Cystitis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    1
    Gastroenteritis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Periodontitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Sinusitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Aug 2017
    With the first protocol amendment, he biopsy procedure was clarified and the pain visual analogue scale (VAS) description was aligned with the instructions given to the patients.
    08 May 2018
    With the second protocol amendment, the interim analysis once 75% of patients had completed 16 weeks of study was added.

    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
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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