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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled study to determine tolerability and safety of different dosages of SUBLIVAC FIX Mite mixture in patients with allergic rhinitis / rhinoconjunctivitis caused by house dust mites.

    Summary
    EudraCT number
    		 2014-002047-18
    Trial protocol
    		 DE  
    Global end of trial date
    19 Nov 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Jan 2017
    First version publication date
    25 Jan 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    SM/0044
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02345278
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    HAL Allergy
    Sponsor organisation address
    J.H. Oortweg 15-17, Leiden, Netherlands, NL-2333 CH
    Public contact
    Head of Clinical Development & Pharmacovigilance, HAL Allergy, + 31 881959000, pjdkam@hal-allergy.com
    Scientific contact
    Head of Clinical Development & Pharmacovigilance, HAL Allergy, + 31 881959000, pjdkam@hal-allergy.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
    26 Jul 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Nov 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Nov 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Determination of the tolerability and safety by local and systemic reactions of different SUBLIVAC FIX Mite mixture dosages during 1 month of treatment in patients with HDM induced allergic rhinitis/rhinoconjunctivitis in comparison with placebo
    Protection of trial subjects
    First dosing of each patient was performed at the investigational site under supervision of the investigator. Adding higher dose groups was done using a staggered design, following safety evaluation by a Data Safety Monitoring Board (DSMB). Accordingly the 50,000 AUN/ml treatment group was started following safety evaluation of the first 10 days treatment period of 12 patients on 25,000 AUN/ml. Similarly 100,000 AUN/ml was started following evaluation of the first 10 days treatment with 50,000 AUN/ml in 12 patients. In addition safety was evaluated in a blinded fashion at weekly intervals during the entire treatment phase of the study.
    Background therapy
    		 No background therapy was used
    Evidence for comparator
    		 No active comparator was used
    Actual start date of recruitment
    30 Apr 2015
    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
    Germany: 81
    Worldwide total number of subjects
    81
    EEA total number of subjects
    81
    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)
    81
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment took place from May to August 2015.

    Pre-assignment
    Screening details
    		 Male/female patients, 18-60 years of age with house dust mites allergy as assessed by: 1. Presence of allergic rhinitis or rhinoconjunctivitis induced by HDM for at least 1 year, 2. Positive SPT to HDM D. pter or D. far, 3. Allergen specific serum IgE (ssIgE) level in serum for HDM D. pter or D. far (> 0.7 U/ml).

    Period 1
    Period 1 title
    Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    The randomisation code list was stored in a sealed envelope in the department of Clinical Data Management of the CRO in a locked cupboard. The data manager responsible for creation and release of the randomisation list was not involved in this study until after data base lock and routine unblinding. A copy of the randomisation list was stored at a study independent person of the sponsor responsible for labelling and packing of the trial material, in order to warrant allocation concealment.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 IMP-Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    SUBLIVAC FIX Mites placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal drops
    Routes of administration
    Sublingual use
    Dosage and administration details
    Up dosing phase: 1 drop on 1st day, 2nd day 2 drops, till 5 drops on 5th day. Maintenance phase: maintenance dose of 5 drops (daily) started from 6th day

    Arm title
    		 IMP 10,000
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    SUBLIVAC FIX Mites 10,000AUN/ml
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal solution
    Routes of administration
    Sublingual use
    Dosage and administration details
    Up dosing phase: 1 drop on 1st day, 2nd day 2 drops, till 5 drops on 5th day. Maintenance phase: maintenance dose of 5 drops (daily) started from 6th day

    Arm title
    		 IMP 25,000
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    SUBLIVAC FIX Mites 25,000 AUN/ml
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal drops
    Routes of administration
    Sublingual use
    Dosage and administration details
    Up dosing phase: 1 drop on 1st day, 2nd day 2 drops, till 5 drops on 5th day. Maintenance phase: maintenance dose of 5 drops (daily) started from 6th day

    Arm title
    		 IMP-50,000
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    SUBLIVAC FIX Mites 50,000 AUN/ml
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal drops
    Routes of administration
    Sublingual use
    Dosage and administration details
    Up dosing phase: 1 drop on 1st day, 2nd day 2 drops, till 5 drops on 5th day. Maintenance phase: maintenance dose of 5 drops (daily) started from 6th day

    Arm title
    		 IMP-100,000
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    SUBLIVAC FIX Mites 100,000 AUN/ml
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal drops
    Routes of administration
    Sublingual use
    Dosage and administration details
    Up dosing phase: 1 drop on 1st day, 2nd day 2 drops, till 5 drops on 5th day. Maintenance phase: maintenance dose of 5 drops (daily) started from 6th day

    Number of subjects in period 1
    		IMP-Placebo IMP 10,000 IMP 25,000 IMP-50,000 IMP-100,000
    Started
    16
    16
    16
    17
    16
    Completed
    16
    16
    16
    14
    14
    Not completed
    0
    0
    0
    3
    2
         Adverse event, non-fatal
    -
    -
    -
    1
    1
         Pregnancy
    -
    -
    -
    1
    -
         Lost to follow-up
    -
    -
    -
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    IMP-Placebo
    Reporting group description
    		 -

    Reporting group title
    IMP 10,000
    Reporting group description
    		 -

    Reporting group title
    IMP 25,000
    Reporting group description
    		 -

    Reporting group title
    IMP-50,000
    Reporting group description
    		 -

    Reporting group title
    IMP-100,000
    Reporting group description
    		 -

    Reporting group values
    		 IMP-Placebo IMP 10,000 IMP 25,000 IMP-50,000 IMP-100,000 Total
    Number of subjects
    		 16 16 16 17 16 81
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0
        Adults (18-64 years)
    		 16 16 16 17 16 81
        From 65-84 years
    		 0 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 31.13 (19 to 53) 28.13 (18 to 49) 37.44 (27 to 60) 35.53 (22 to 50) 31.63 (18 to 50) -
    Gender categorical
    Units: Subjects
        Female
    		 8 8 6 10 6 38
        Male
    		 8 8 10 7 10 43

    End points

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    End points reporting groups
    Reporting group title
    IMP-Placebo
    Reporting group description
    		 -

    Reporting group title
    IMP 10,000
    Reporting group description
    		 -

    Reporting group title
    IMP 25,000
    Reporting group description
    		 -

    Reporting group title
    IMP-50,000
    Reporting group description
    		 -

    Reporting group title
    IMP-100,000
    Reporting group description
    		 -

    Primary: Occurrence and severity of local reactions of different doses of SUBLIVAC Fix Mites compared to placebo

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    End point title
    		 Occurrence and severity of local reactions of different doses of SUBLIVAC Fix Mites compared to placebo [1]
    End point description
    Occurrence and severity were assessed on basis of all local reactions observed during the treatment period of one month (from start till end of study). These reactions were selected from all treatment emergent adverse events considering their presentation (local and systemic). Results are presented by number of patients with at least one local reaction, per treatment group. For this endpoint descriptive statistics were used.
    End point type
    Primary
    End point timeframe
    The first month of treatment, i.e. the total treatment period of the study
    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: Only descriptive statistics were performed.
    End point values
    		 IMP-Placebo IMP 10,000 IMP 25,000 IMP-50,000 IMP-100,000
    Number of subjects analysed
    16
    16
    16
    17
    16
    Units: number of patients
        Mild
    4
    8
    6
    6
    6
        Moderate
    0
    0
    0
    0
    1
        Severe
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Occurrence and severity of systemic reactions of different doses of SUBLIVAC Fix Mites compared to placebo

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    End point title
    		 Occurrence and severity of systemic reactions of different doses of SUBLIVAC Fix Mites compared to placebo [2]
    End point description
    Occurrence and severity were assessed on basis of all systemic reactions observed during the treatment period of one month (from start till end of study). These reactions were selected from all treatment emergent adverse events considering their presentation (local and systemic). Results are presented by number of patients with at least one local reaction, per treatment group. For this endpoint descriptive statistics were used.
    End point type
    Primary
    End point timeframe
    The first month of treatment, i.e. the total treatment period of the study.
    Notes
    [2] - 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: Only descriptive statistics were performed.
    End point values
    		 IMP-Placebo IMP 10,000 IMP 25,000 IMP-50,000 IMP-100,000
    Number of subjects analysed
    16
    16
    16
    17
    16
    Units: number of patients
        Mild
    3
    5
    1
    2
    3
        Moderate
    2
    1
    0
    1
    0
        Severe
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All Treatment Emergent Adverse Events have been reported from start to the end of treatment period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    IMP-Placebo
    Reporting group description
    		 -

    Reporting group title
    IMP-10,000
    Reporting group description
    		 -

    Reporting group title
    IMP-25,000
    Reporting group description
    		 -

    Reporting group title
    IMP-50,000
    Reporting group description
    		 -

    Reporting group title
    IMP-100,000
    Reporting group description
    		 -

    Serious adverse events
    		 IMP-Placebo IMP-10,000 IMP-25,000 IMP-50,000 IMP-100,000
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Nervous system disorders
    Carpal tunnel syndrome
    Additional description: Patient was hospitalized and underwent surgery because of bilateral carpal tunnel syndrome
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 IMP-Placebo IMP-10,000 IMP-25,000 IMP-50,000 IMP-100,000
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 16 (50.00%)
    11 / 16 (68.75%)
    9 / 16 (56.25%)
    11 / 17 (64.71%)
    10 / 16 (62.50%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    General disorders and administration site conditions
    Administration site reaction
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Malaise
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    2 / 17 (11.76%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Dyspnoea
         subjects affected / exposed
    2 / 16 (12.50%)
    3 / 16 (18.75%)
    1 / 16 (6.25%)
    1 / 17 (5.88%)
    1 / 16 (6.25%)
         occurrences all number
    3
    6
    1
    3
    1
    Dyspnoea exertional
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Nasal discomfort
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Nasal obstruction
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    1
    0
    0
    0
    1
    Nasal oedema
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    9
    0
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Pharyngeal oedema
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    1 / 16 (6.25%)
    2 / 16 (12.50%)
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    1
    2
    2
    0
    1
    Sneezing
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Throat irritation
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 16 (12.50%)
    1 / 16 (6.25%)
    1 / 17 (5.88%)
    1 / 16 (6.25%)
         occurrences all number
    0
    7
    1
    2
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    Blood bilirubin increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    Nervous system disorders
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    Headache
         subjects affected / exposed
    1 / 16 (6.25%)
    2 / 16 (12.50%)
    1 / 16 (6.25%)
    3 / 17 (17.65%)
    1 / 16 (6.25%)
         occurrences all number
    1
    5
    1
    5
    1
    Paraesthesia
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Sinus headache
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Lymph node pain
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    Ear and labyrinth disorders
    Ear pruritus
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    1
    1
    0
    2
    Vertigo
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    0
    0
    1
    Eye disorders
    Eye pruritus
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    1
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    2
    0
    1
    Gastric disorder
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Glossitis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    5
    Hypoaesthesia oral
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    2 / 16 (12.50%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    2
    0
    7
    0
    20
    Lip swelling
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    6
    Nausea
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    0
    0
    1
    Oedema mouth
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    0
    1
    Oral discomfort
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    Oral pruritus
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    1
    0
    0
    10
    Paraesthesia oral
         subjects affected / exposed
    3 / 16 (18.75%)
    4 / 16 (25.00%)
    3 / 16 (18.75%)
    0 / 17 (0.00%)
    3 / 16 (18.75%)
         occurrences all number
    3
    6
    5
    0
    3
    Swollen tongue
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    4 / 16 (25.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    5
    0
    0
    Tongue pruritus
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    3 / 17 (17.65%)
    0 / 16 (0.00%)
         occurrences all number
    0
    5
    0
    7
    0
    Skin and subcutaneous tissue disorders
    Blister
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Pruritus
         subjects affected / exposed
    3 / 16 (18.75%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    5
    1
    0
    0
    0
    Rash
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    0
    1
    0
    Urticaria
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Infections and infestations
    Gastrointestinal infection
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    Nasopharyngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    2
    1
    1
    1
    0
    Tonsillitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0

    More information

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    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.
    None reported
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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