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    Clinical Trial Results:
    A randomized, subject and investigator blinded, placebo-controlled multicenter study to assess the efficacy and safety of CMK389 in patients with moderate to severe atopic dermatitis.

    Summary
    EudraCT number
    		 2020-003406-31
    Trial protocol
    		 HU   DE   FR   CZ   ES  
    Global end of trial date
    13 Dec 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Dec 2023
    First version publication date
    21 Dec 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CCMK389B12201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04836858
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    Novartis Campus, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, novartis.email@novartis.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
    13 Dec 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Dec 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the trial was to assess the efficacy of CMK389 in participants with moderate to severe atopic dermatitis.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Apr 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
    Czechia: 15
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Germany: 38
    Country: Number of subjects enrolled
    Hungary: 3
    Country: Number of subjects enrolled
    Poland: 8
    Country: Number of subjects enrolled
    Spain: 3
    Worldwide total number of subjects
    71
    EEA total number of subjects
    71
    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)
    71
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants took part in 18 investigative sites in 6 countries.

    Pre-assignment
    Screening details
    		 There was a screening period of up to 4 weeks to assess participants eligibility.

    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, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CMK389 10mg/kg i.v.
    Arm description
    		 CMK389 10 mg/kg monthly i.v. dose
    Arm type
    		 Experimental

    Investigational medicinal product name
    CMK389
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    CMK389 10mg/kg intravenously monthly

    Arm title
    		 CMK389 300mg s.c.
    Arm description
    		 CMK389 300mg monthly s.c. dose
    Arm type
    		 Experimental

    Investigational medicinal product name
    CMK389
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    CMK389 300 mg subcutaneous monthly

    Arm title
    		 Placebo i.v.
    Arm description
    		 Placebo monthly i.v. dose
    Arm type
    		 Placebo

    Investigational medicinal product name
    CMK389
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo intravenously monthly

    Arm title
    		 Placebo s.c.
    Arm description
    		 Placebo monthly s.c. dose
    Arm type
    		 Placebo

    Investigational medicinal product name
    CMK389
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo subcutaneous monthly

    Number of subjects in period 1 [1]
    		CMK389 10mg/kg i.v. CMK389 300mg s.c. Placebo i.v. Placebo s.c.
    Started
    34
    17
    8
    8
    Completed
    30
    17
    8
    6
    Not completed
    4
    0
    0
    2
         Adverse events
    -
    -
    -
    1
         Subject/Guardian decision
    3
    -
    -
    1
         Lost to follow-up
    1
    -
    -
    -
    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: There were 4 participants who were randomized to the CMK389 10 mg/kg i.v. group but never received any dose of study treatment. They have not been included in the tables of Disposition and Baseline Characteristics.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CMK389 10mg/kg i.v.
    Reporting group description
    		 CMK389 10 mg/kg monthly i.v. dose

    Reporting group title
    CMK389 300mg s.c.
    Reporting group description
    		 CMK389 300mg monthly s.c. dose

    Reporting group title
    Placebo i.v.
    Reporting group description
    		 Placebo monthly i.v. dose

    Reporting group title
    Placebo s.c.
    Reporting group description
    		 Placebo monthly s.c. dose

    Reporting group values
    		 CMK389 10mg/kg i.v. CMK389 300mg s.c. Placebo i.v. Placebo s.c. Total
    Number of subjects
    		 34 17 8 8 67
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 34 17 8 8 67
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 33.7 ( 9.86 ) 34.1 ( 11.35 ) 35.3 ( 8.86 ) 31.9 ( 8.53 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 8 9 3 2 22
        Male
    		 26 8 5 6 45
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    		 0 1 0 0 1
        White
    		 34 16 8 8 66

    End points

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    End points reporting groups
    Reporting group title
    CMK389 10mg/kg i.v.
    Reporting group description
    		 CMK389 10 mg/kg monthly i.v. dose

    Reporting group title
    CMK389 300mg s.c.
    Reporting group description
    		 CMK389 300mg monthly s.c. dose

    Reporting group title
    Placebo i.v.
    Reporting group description
    		 Placebo monthly i.v. dose

    Reporting group title
    Placebo s.c.
    Reporting group description
    		 Placebo monthly s.c. dose

    Primary: Number of participants with Investigator Global assessment (IGA) response

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    End point title
    		 Number of participants with Investigator Global assessment (IGA) response [1]
    End point description
    The Investigator Global assessment (IGA) scale used was vIGA-AD^TM (Validated Investigator Global Assessment scale for Atopic Dermatitis). The IGA rating scale was used to determine the severity of atopic dermatitis and clinical response to treatment. It reflected a participant’s overall disease severity for the whole body based on a 5-point scale. The 5-point scale included: clear, almost clear, mild, moderate, and severe disease. IGA response is defined as clear or almost clear and at least a 2 point-reduction from baseline at week 16.
    End point type
    Primary
    End point timeframe
    Baseline, Week 16
    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 analyzed descriptively
    End point values
    		 CMK389 10mg/kg i.v. CMK389 300mg s.c. Placebo i.v. Placebo s.c.
    Number of subjects analysed
    34
    17
    8
    8
    Units: participants
    5
    2
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with treatment emergent adverse events (AEs) and serious adverse events (SAEs)

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    End point title
    		 Number of participants with treatment emergent adverse events (AEs) and serious adverse events (SAEs)
    End point description
    Number of participants with treatment emergent AEs (any AE regardless of seriousness), AEs led to study treatment discontinuation, SAEs and SAEs led to study treatment discontinuation.
    End point type
    Secondary
    End point timeframe
    AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
    End point values
    		 CMK389 10mg/kg i.v. CMK389 300mg s.c. Placebo i.v. Placebo s.c.
    Number of subjects analysed
    34
    17
    8
    8
    Units: participants
        Adverse Events
    25
    11
    5
    8
        Serious Adverse Events
    1
    1
    0
    0
        AEs leading to discontinuation of study treatment
    0
    0
    0
    0
        SAEs leading to discontinuation of study treatment
    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
    AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Pooled Placebo
    Reporting group description
    		 Pooled Placebo

    Reporting group title
    Total
    Reporting group description
    		 Total

    Reporting group title
    Placebo i.v.
    Reporting group description
    		 Placebo i.v.

    Reporting group title
    Placebo s.c.
    Reporting group description
    		 Placebo s.c.

    Reporting group title
    CMK389 10 mg/kg i.v.
    Reporting group description
    		 CMK389 10 mg/kg i.v.

    Reporting group title
    CMK389 300 mg s.c.
    Reporting group description
    		 CMK389 300 mg s.c.

    Serious adverse events
    		 Pooled Placebo Total Placebo i.v. Placebo s.c. CMK389 10 mg/kg i.v. CMK389 300 mg s.c.
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 67 (2.99%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 34 (2.94%)
    1 / 17 (5.88%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Reproductive system and breast disorders
    Heavy menstrual bleeding
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 67 (1.49%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 67 (1.49%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pooled Placebo Total Placebo i.v. Placebo s.c. CMK389 10 mg/kg i.v. CMK389 300 mg s.c.
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 16 (81.25%)
    44 / 67 (65.67%)
    5 / 8 (62.50%)
    8 / 8 (100.00%)
    20 / 34 (58.82%)
    11 / 17 (64.71%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine leiomyoma
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 67 (1.49%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 67 (2.99%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 34 (0.00%)
    2 / 17 (11.76%)
         occurrences all number
    0
    2
    0
    0
    0
    2
    General disorders and administration site conditions
    Injection site reaction
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 67 (1.49%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    3
    0
    0
    0
    3
    Fatigue
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 67 (1.49%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    Reproductive system and breast disorders
    Menstruation irregular
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 67 (1.49%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 67 (1.49%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Dysphonia
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 67 (1.49%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Rhinitis allergic
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 67 (1.49%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 67 (2.99%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    2 / 34 (5.88%)
    0 / 17 (0.00%)
         occurrences all number
    0
    2
    0
    0
    2
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 16 (6.25%)
    3 / 67 (4.48%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    2 / 34 (5.88%)
    0 / 17 (0.00%)
         occurrences all number
    0
    3
    0
    1
    2
    0
    Blood creatine increased
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 67 (1.49%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 67 (2.99%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    2 / 34 (5.88%)
    0 / 17 (0.00%)
         occurrences all number
    0
    2
    0
    0
    2
    0
    Blood ketone body increased
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 67 (1.49%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Urine analysis abnormal
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 67 (1.49%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    Urinary sediment present
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 67 (1.49%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    Lymphocyte count decreased
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 67 (1.49%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Glucose urine
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 67 (1.49%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Cardiac disorders
    Sinus bradycardia
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 67 (1.49%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 67 (1.49%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Headache
         subjects affected / exposed
    1 / 16 (6.25%)
    5 / 67 (7.46%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    3 / 34 (8.82%)
    1 / 17 (5.88%)
         occurrences all number
    0
    8
    2
    0
    5
    1
    Migraine
         subjects affected / exposed
    2 / 16 (12.50%)
    2 / 67 (2.99%)
    2 / 8 (25.00%)
    0 / 8 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    3
    3
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 67 (1.49%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 67 (1.49%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Eye disorders
    Visual impairment
         subjects affected / exposed
    1 / 16 (6.25%)
    2 / 67 (2.99%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    2
    1
    0
    0
    1
    Eyelid oedema
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 67 (1.49%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 67 (1.49%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 16 (0.00%)
    5 / 67 (7.46%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    3 / 34 (8.82%)
    2 / 17 (11.76%)
         occurrences all number
    0
    7
    0
    0
    5
    2
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 67 (1.49%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Dermatitis atopic
         subjects affected / exposed
    4 / 16 (25.00%)
    8 / 67 (11.94%)
    0 / 8 (0.00%)
    4 / 8 (50.00%)
    2 / 34 (5.88%)
    2 / 17 (11.76%)
         occurrences all number
    0
    8
    0
    4
    2
    2
    Renal and urinary disorders
    Hypertonic bladder
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 67 (1.49%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Bursitis
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 67 (1.49%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Arthralgia
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 67 (2.99%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    2 / 34 (5.88%)
    0 / 17 (0.00%)
         occurrences all number
    0
    2
    0
    0
    2
    0
    Muscle tightness
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 67 (1.49%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Infections and infestations
    Asymptomatic bacteriuria
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 67 (1.49%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 67 (2.99%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 34 (2.94%)
    1 / 17 (5.88%)
         occurrences all number
    0
    2
    0
    0
    1
    1
    Rhinitis
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 67 (2.99%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 34 (2.94%)
    1 / 17 (5.88%)
         occurrences all number
    0
    2
    0
    0
    1
    1
    Otitis externa
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 67 (1.49%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 16 (12.50%)
    13 / 67 (19.40%)
    1 / 8 (12.50%)
    1 / 8 (12.50%)
    7 / 34 (20.59%)
    4 / 17 (23.53%)
         occurrences all number
    0
    13
    1
    1
    7
    4
    COVID-19
         subjects affected / exposed
    4 / 16 (25.00%)
    19 / 67 (28.36%)
    3 / 8 (37.50%)
    1 / 8 (12.50%)
    10 / 34 (29.41%)
    5 / 17 (29.41%)
         occurrences all number
    0
    21
    3
    1
    10
    7
    Bacteriuria
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 67 (1.49%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    Metabolism and nutrition disorders
    Hyperlipidaemia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 67 (1.49%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 67 (1.49%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    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
    03 Mar 2021
    The main purpose of this amendment is to address requests from Health Authorities (HA) and Ethics Committees (EC) received during review of the clinical trial application, which includes the creation of an independent Data Monitoring Committee (DMC) for this proof of concept study.
    04 Mar 2022
    The main purpose of this amendment is to address Health Authority (HA) request and to update and clarify language in selected sections of the protocol. In accordance with the HA request and to avoid ambiguity, a sentence in the rescue medication section stating that investigator should consult with sponsor’s medical lead before study drug discontinuation has been deleted. Furthermore, in order to resolve previously detected issues in the protocol, the content of several sections have been updated with clarifications.

    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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