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    Clinical Trial Results:
    A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT)

    Summary
    EudraCT number
    		 2020-004011-28
    Trial protocol
    		 FR   PL   NL   BE   DE   IT  
    Global end of trial date
    10 Nov 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Jun 2023
    First version publication date
    18 Jun 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    A4250-012
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04674761
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Albireo AB
    Sponsor organisation address
    Arvid Wallgrens backe 20, Göteborg, Sweden, 413 46
    Public contact
    Medical Director, Albireo Pharma, Inc., medinfo@albireopharma.com
    Scientific contact
    Medical Director, Albireo Pharma, Inc., medinfo@albireopharma.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-002054-PIP03-20
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Sep 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Sep 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Nov 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to demonstrate the efficacy of repeated daily doses of 120 μg/kg/day odevixibat in relieving pruritus in patients with ALGS.
    Protection of trial subjects
    Safety was evaluated throughout the study, including monitoring for AEs and concomitant medications, physical examinations, vital signs, laboratory tests (including chemistry, haematology, urinalysis, vitamins A and E, 25-hydroxy vitamin D, and INR), and liver ultrasound/ elastography (where available). A Data and Safety Monitoring Board (DSMB) comprised of independent clinical and statistical experts was established to periodically review accumulating study data, including AEs and laboratory data. Cases of suspected drug-induced liver injury (DILI) or other protocol-defined liver-related AEs underwent blinded review and adjudication of aetiology by an independent Hepatic Safety Adjudication Committee (HSAC) comprised of 3 hepatologists with experience assessing events of potential hepatotoxicity.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Dec 2020
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 17 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 11
    Country: Number of subjects enrolled
    Malaysia: 3
    Country: Number of subjects enrolled
    Turkey: 1
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    Netherlands: 6
    Country: Number of subjects enrolled
    Poland: 10
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Germany: 8
    Country: Number of subjects enrolled
    Italy: 6
    Worldwide total number of subjects
    52
    EEA total number of subjects
    36
    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)
    8
    Children (2-11 years)
    39
    Adolescents (12-17 years)
    5
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment took place between 16 December 2020 to 28 March 2022. Patients were recruited at hospitals or medical specialty centers. Patients were recruited in all countries except Canada, Israel, and New Zealand.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 52
    Intermediate milestone: Number of subjects
    Subjects Randomised: 52
    Number of subjects completed
    		 52

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Odevixibat
    Arm description
    		 Odevixibat 120 µg/kg/day
    Arm type
    		 Experimental

    Investigational medicinal product name
    Odevixibat
    Investigational medicinal product code
    A4250
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    120 μg/kg/day was orally administered once daily in the morning for 24 weeks. For young children or in case of difficulties swallowing the capsules, capsules could be opened and the content sprinkled on soft foods.

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo was orally administered once daily in the morning for 24 weeks. For young children or in case of difficulties swallowing the capsules, capsules could be opened and the content sprinkled on soft foods.

    Number of subjects in period 1
    		Odevixibat Placebo
    Started
    35
    17
    Received Treatment
    35
    17
    Completed
    35
    17

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Odevixibat
    Reporting group description
    		 Odevixibat 120 µg/kg/day

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group values
    		 Odevixibat Placebo Total
    Number of subjects
    		 35 17 52
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 3 5 8
        Children (2-11 years)
    		 28 11 39
        Adolescents (12-17 years)
    		 4 1 5
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 6.73 ( 3.780 ) 5.40 ( 4.411 ) -
    Gender categorical
    Units: Subjects
        Female
    		 14 11 25
        Male
    		 21 6 27
    Genetic Mutation
    Units: Subjects
        JAG1
    		 32 16 48
        NOTCH2
    		 3 1 4
    Age category 1
    Units: Subjects
        < 10 years
    		 29 13 42
        > = 10 years and < 18 years
    		 6 4 10

    End points

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    End points reporting groups
    Reporting group title
    Odevixibat
    Reporting group description
    		 Odevixibat 120 µg/kg/day

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Primary: Change from baseline in average AM and PM scratching score to month 6 (weeks 21 to 24)

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    End point title
    		 Change from baseline in average AM and PM scratching score to month 6 (weeks 21 to 24)
    End point description
    The post treatment monthly (28-day) average AM and PM scratching score was calculated by averaging 4 weekly average AM and PM scores within the 4-week interval. Monthly score could be calculated only if at least 3 of 4 weekly scores were available within the 4-week interval. The weekly average AM and PM score was calculated by averaging of the average of AM score and the average of PM in a week only if at least 7 of 14 AM or PM assessments were collected. The baseline average AM and PM score was calculated by averaging the two-baseline weekly average AM and PM scores in the 14 days preceding start of treatment. Baseline values could be calculated only if both weeks could be calculated. Change from baseline was calculated as the monthly score minus the baseline score.
    End point type
    Primary
    End point timeframe
    Month 6 (weeks 21 to 24)
    End point values
    		 Odevixibat Placebo
    Number of subjects analysed
    35
    17
    Units: score
        least squares mean (standard error)
    -1.69 ( 0.174 )
    -0.8 ( 0.233 )
    Statistical analysis title
    		 Change in AM and PM scratching score
    Comparison groups
    Odevixibat v Placebo
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.0012
    Method
    		 MMRM
    Parameter type
    		 LS mean difference
    Point estimate
    -0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.44
         upper limit
    		 -0.33
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.277
    Notes
    [1] - The analysis is based on a mixed model for repeated measures (MMRM) using a restricted maximum likelihood (REML) with baseline score as a covariate, and baseline age stratification, baseline direct bilirubin, treatment group, time (in months), and treatment-by-time interaction as fixed effects. One-sided p-value was reported.

    Secondary: Key Secondary Endpoint: Change in Serum Bile Acids from Baseline to the Average of Weeks 20 and 24 (μmol/L)

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    End point title
    		 Key Secondary Endpoint: Change in Serum Bile Acids from Baseline to the Average of Weeks 20 and 24 (μmol/L)
    End point description
    Baseline was calculated as the average of the last 2 values prior to the first dose and the average of week 20 and week 24 was calculated as the average of values at week 20 and week 24. Change from baseline was calculated as serum bile acid value at post baseline minus the baseline value.
    End point type
    Secondary
    End point timeframe
    Average of Week 20 and Week 24
    End point values
    		 Odevixibat Placebo
    Number of subjects analysed
    35
    17
    Units: Result
        least squares mean (standard error)
    -90.35 ( 21.336 )
    22.39 ( 28.463 )
    Statistical analysis title
    		 Change in serum bile acid level (μmol/L)
    Comparison groups
    Placebo v Odevixibat
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.0006
    Method
    		 MMRM
    Parameter type
    		 LS mean difference
    Point estimate
    -112.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -178.78
         upper limit
    		 -46.69
    Variability estimate
    Standard error of the mean
    Dispersion value
    32.864
    Notes
    [2] - The analysis is based on a mixed model for repeated measures (MMRM) using a restricted maximum likelihood (REML) with baseline serum bile acid (sBA) concentration data as a covariate, and baseline age stratification, treatment group, visits (Weeks 4, 8, 12, 16, 20, 24), and treatment-by-visit interaction as fixed effects. The comparison of treatment difference in change from baseline to the average of Week 20 and Week 24 is estimated and tested using contrast. One-sided p-value was reported.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The safety reporting period for adverse events is from the first dose of study drug through the last planned study visit or 28 calendar days after the last dose of the study drug, whichever occurs later.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Odevixibat
    Reporting group description
    		 Odevixibat 120 µg/kg/day

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Serious adverse events
    		 Odevixibat Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 35 (14.29%)
    2 / 17 (11.76%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    International normalised ratio increased
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Cerumen impaction
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Adenoidal hypertrophy
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Otitis media chronic
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinovirus infection
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Odevixibat Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 35 (74.29%)
    12 / 17 (70.59%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 17 (0.00%)
         occurrences all number
    3
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 17 (0.00%)
         occurrences all number
    2
    0
    Fatigue
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    8 / 35 (22.86%)
    4 / 17 (23.53%)
         occurrences all number
    8
    7
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Seasonal allergy
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Cough
         subjects affected / exposed
    3 / 35 (8.57%)
    1 / 17 (5.88%)
         occurrences all number
    4
    1
    Epistaxis
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 17 (11.76%)
         occurrences all number
    0
    2
    Nasal turbinate hypertrophy
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Pharyngeal inflammation
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Rhinitis allergic
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences all number
    2
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 17 (5.88%)
         occurrences all number
    1
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Blood pressure diastolic increased
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Blood triglycerides increased
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 17 (5.88%)
         occurrences all number
    1
    1
    International normalised ratio increased
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 17 (11.76%)
         occurrences all number
    0
    2
    Platelet count decreased
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Vitamin A decreased
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Vitamin E decreased
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Weight decreased
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 17 (0.00%)
         occurrences all number
    2
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Ligament sprain
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Vaccination complication
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Nervous system disorders
    Bell's palsy
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia macrocytic
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Coagulopathy
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Lymphadenopathy
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Cataract cortical
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 35 (11.43%)
    1 / 17 (5.88%)
         occurrences all number
    4
    1
    Abdominal pain upper
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences all number
    2
    0
    Aphthous ulcer
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    10 / 35 (28.57%)
    1 / 17 (5.88%)
         occurrences all number
    11
    1
    Faeces discoloured
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Faeces soft
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Frequent bowel movements
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 17 (5.88%)
         occurrences all number
    2
    1
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Skin lesion
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Urticaria
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 17 (0.00%)
         occurrences all number
    4
    0
    COVID-19
         subjects affected / exposed
    5 / 35 (14.29%)
    4 / 17 (23.53%)
         occurrences all number
    5
    4
    Conjunctivitis
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 17 (0.00%)
         occurrences all number
    3
    0
    Gastroenteritis
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 17 (0.00%)
         occurrences all number
    2
    0
    Influenza
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 17 (5.88%)
         occurrences all number
    4
    1
    Otitis externa
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Otitis media
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Pharyngitis
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    3 / 35 (8.57%)
    1 / 17 (5.88%)
         occurrences all number
    3
    1
    Subcutaneous abscess
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Tonsillitis
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 35 (8.57%)
    2 / 17 (11.76%)
         occurrences all number
    3
    2
    Viral infection
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 17 (5.88%)
         occurrences all number
    1
    1
    Viral rash
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Hypophagia
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Vitamin D deficiency
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 17 (5.88%)
         occurrences all number
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Aug 2020
    Amendment 1. Global amendment to add EudraCT number, redefine adverse event reporting period, and additional minor clarifications. Original protocol under which patients were first enrolled

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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