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    Clinical Trial Results:
    Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen Oral Immunotherapy.

    Summary
    EudraCT number
    		 2021-002087-47
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    07 Jan 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Feb 2022
    First version publication date
    19 Feb 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ARC001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01987817
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aimmune Therapeutics Inc.
    Sponsor organisation address
    8000 Marina Blvd, Suite 300, Brisbane, United States, 94005
    Public contact
    Director of Regulatory Affairs, Aimmune Therapeutics Inc, +1 650-409-5164, RegulatoryAffairs@aimmune.com
    Scientific contact
    Director of Regulatory Affairs, Aimmune Therapeutics Inc, +1 650-409-5164, RegulatoryAffairs@aimmune.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001734-PIP01-14
    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
    18 Feb 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Jan 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Jan 2015
    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 Characterized Peanut Allergen through reduction in clinical reactivity to limited amounts of peanut allergen in peanut-allergic children and young adults (ages 4-26 years, inclusive)
    Protection of trial subjects
    Protocol and ICF were approved by IECs or IRBs and FDA in conformance with US code of Federal Regulations and ICH guidelines. Study was conducted per GCP and Declaration of Helsinki guidelines. Patients or parents /legal guardians of patients were educated on study and to notify sites of allergic symptoms occurring at home. Diary logs for completion at home by patients/families to measure IP compliance and alert sites of Adverse Events of Interest, including accidental exposure or Epi pen use.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Feb 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy, Ethical reason
    Long term follow-up duration
    		 23 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: 55
    Worldwide total number of subjects
    55
    EEA total number of subjects
    0
    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)
    41
    Adolescents (12-17 years)
    13
    Adults (18-64 years)
    1
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 67 subjects were initially enrolled. 11 subjects failed screening, resulting in 56 subjects being initially randomized and enrolled in the study. The randomized population comprised 29 subjects in the AR101 group and 27 subjects in the placebo group. The final intent-to-treat (ITT) population had one fewer subject in the placebo group (n=26).

    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
    		 AR101
    Arm description
    		 A peanut-derived oral immunotherapy drug.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AR101
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral powder
    Routes of administration
    Oral use
    Dosage and administration details
    Pull-apart capsules at 4 dosage strengths (0.5, 1, 10, 100 mg)

    Arm title
    		 Placebo
    Arm description
    		 Matching placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral powder
    Routes of administration
    Oral use
    Dosage and administration details
    Equivalent amount of placebo powder containing inactive ingredients.

    Number of subjects in period 1
    		AR101 Placebo
    Started
    29
    26
    Completed
    23
    26
    Not completed
    6
    0
         Physician decision
    1
    -
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    4
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AR101
    Reporting group description
    		 A peanut-derived oral immunotherapy drug.

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo

    Reporting group values
    		 AR101 Placebo Total
    Number of subjects
    		 29 26 55
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 20 21 41
        Adolescents (12-17 years)
    		 8 5 13
        Adults (18-64 years)
    		 1 0 1
    Age continuous
    Units: years
        median (full range (min-max))
    		 7 (4 to 21) 8 (4 to 14) -
    Gender categorical
    Units: Subjects
        Female
    		 9 10 19
        Male
    		 20 16 36
    Subject analysis sets

    Subject analysis set title
    AR101 intent-to-treat population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intent-to-treat population is defined as subjects who received at least 1 dose of randomized study treatment.

    Subject analysis set title
    Placebo intent-to-treat population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The final intent-to-treat (ITT) population consists of subjects who received at least 1 dose of randomized study treatment.

    Subject analysis sets values
    		 AR101 intent-to-treat population Placebo intent-to-treat population
    Number of subjects
    29
    26
    Age categorical
    Units: Subjects
        Children (2-11 years)
    20
    21
        Adolescents (12-17 years)
    8
    5
        Adults (18-64 years)
    1
    0
    Age continuous
    Units: years
        median (full range (min-max))
    7 (4 to 21)
    8 (4 to 14)
    Gender categorical
    Units: Subjects
        Female
    9
    10
        Male
    20
    16

    End points

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    End points reporting groups
    Reporting group title
    AR101
    Reporting group description
    		 A peanut-derived oral immunotherapy drug.

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo

    Subject analysis set title
    AR101 intent-to-treat population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intent-to-treat population is defined as subjects who received at least 1 dose of randomized study treatment.

    Subject analysis set title
    Placebo intent-to-treat population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The final intent-to-treat (ITT) population consists of subjects who received at least 1 dose of randomized study treatment.

    Primary: The Proportion of Subjects Who Tolerate at Least 300 mg (443 mg Cumulative) of Peanut Protein With no More Than Mild Symptoms at the Exit DBPCFC

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    End point title
    		 The Proportion of Subjects Who Tolerate at Least 300 mg (443 mg Cumulative) of Peanut Protein With no More Than Mild Symptoms at the Exit DBPCFC
    End point description
    The primary endpoint was the percentage of subjects who achieved desensitization, as determined by tolerating at least 300 mg (443 mg cumulative) of peanut protein at the Exit Double Blind Placebo Controlled Food Challenge (DBPCFC) with no more than mild symptoms (i.e., desensitization responders).
    End point type
    Primary
    End point timeframe
    6-9 months.
    End point values
    		 AR101 intent-to-treat population Placebo intent-to-treat population
    Number of subjects analysed
    29
    26
    Units: Number of subjects
    23
    5
    Statistical analysis title
    		 Treatment difference at 300 mg
    Statistical analysis description
    Fisher Exact test for the difference (AR101 - Placebo) in proportion of subjects who tolerated a single highest dose of at least 300 mg.
    Comparison groups
    Placebo intent-to-treat population v AR101 intent-to-treat population
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Fisher exact
    Parameter type
    		 Risk difference (RD)
    Point estimate
    60
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 35
         upper limit
    		 79

    Secondary: Change From Baseline in Maximum Tolerated Dose of Peanut Protein at the Exit DBPCFC

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    End point title
    		 Change From Baseline in Maximum Tolerated Dose of Peanut Protein at the Exit DBPCFC
    End point description
    The change in maximum tolerated dose of peanut protein from baseline (screening) to the Exit DBPCFC.
    End point type
    Secondary
    End point timeframe
    6-9 months.
    End point values
    		 AR101 intent-to-treat population Placebo intent-to-treat population
    Number of subjects analysed
    29
    26
    Units: milligram(s)
        least squares mean (confidence interval 95%)
    1.254 (0.984 to 1.523)
    0.341 (0.057 to 0.626)
    Statistical analysis title
    		 Change From Baseline in Maximum Tolerated Dose
    Statistical analysis description
    MTD for the baseline and Exit DBPCFC are transformed back to log10 scale before calculations. A value of 0.3 mg is substituted for subjects who could not tolerate the lowest DBPCFC dose before log10 transformation.
    Comparison groups
    AR101 intent-to-treat population v Placebo intent-to-treat population
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [1]
    Method
    		 ANCOVA
    Parameter type
    		 Treatment Difference
    Point estimate
    0.912
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5184
         upper limit
    		 1.3065
    Notes
    [1] - The p-value is based on the F-test for treatment effect adjusted for MTD from baseline (log10 mg). The p-value and confidence intervals are based on the normality assumption.

    Secondary: Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC

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    End point title
    		 Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC
    End point description
    The number of participants analyzed per outcome measure reflects the intent-to-treat (ITT) population (subjects who received at least 1 dose of randomized study treatment).
    End point type
    Secondary
    End point timeframe
    6-9 months
    End point values
    		 AR101 intent-to-treat population Placebo intent-to-treat population
    Number of subjects analysed
    29
    26
    Units: Number of subjects
        0.3 g
    0
    1
        3 mg
    2
    2
        10 mg
    3
    7
        30 mg
    1
    5
        100 mg
    0
    6
        300 mg
    5
    5
        600 mg
    18
    0
    No statistical analyses for this end point

    Secondary: Changes in Peanut-Specific IgE From Baseline to Exit DBPCFC

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    End point title
    		 Changes in Peanut-Specific IgE From Baseline to Exit DBPCFC
    End point description
    The number of participants analyzed per outcome measure reflects the intent-to-treat (ITT) population (subjects who received at least 1 dose of randomized study treatment). Relative change from baseline is calculated as the ratio of exit visit result to the baseline result, within treatment group.
    End point type
    Secondary
    End point timeframe
    6-9 months.
    End point values
    		 AR101 intent-to-treat population Placebo intent-to-treat population
    Number of subjects analysed
    29
    26
    Units: kUA/L
    geometric mean (confidence interval 95%)
        Baseline
    32.571 (18.626 to 56.957)
    53.839 (34.952 to 82.934)
        Exit
    36.889 (21.258 to 64.015)
    57.060 (37.186 to 87.557)
        Relative Change From Baseline
    1.231 (1.027 to 1.475)
    1.060 (1.001 to 1.112)
    No statistical analyses for this end point

    Secondary: Changes in Peanut-Specific IgG4 From Baseline to Exit DBPCFC

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    End point title
    		 Changes in Peanut-Specific IgG4 From Baseline to Exit DBPCFC
    End point description
    The number of participants analyzed per outcome measure reflects the intent-to-treat (ITT) population (subjects who received at least 1 dose of randomized study treatment) Relative change from baseline is calculated as the ratio of exit visit result to the baseline result, within treatment group.
    End point type
    Secondary
    End point timeframe
    6-9 months.
    End point values
    		 AR101 intent-to-treat population Placebo intent-to-treat population
    Number of subjects analysed
    29
    26
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Baseline
    0.734 (0.487 to 1.107)
    0.510 (0.344 to 0.757)
        Exit
    3.609 (2.074 to 6.281)
    0.540 (0.377 to 0.775)
        Relative Change From Baseline
    5.068 (3.640 to 7.055)
    1.066 (0.905 to 1.255)
    No statistical analyses for this end point

    Secondary: Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter Results From Baseline

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    End point title
    		 Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter Results From Baseline
    End point description
    The number of participants analyzed per outcome measure reflects the intent-to-treat (ITT) population (subjects who received at least 1 dose of randomized study treatment).
    End point type
    Secondary
    End point timeframe
    6-9 months.
    End point values
    		 AR101 intent-to-treat population Placebo intent-to-treat population
    Number of subjects analysed
    29
    26
    Units: millimeter(s)
    arithmetic mean (confidence interval 95%)
        Baseline
    14.1 (11.6 to 16.7)
    13.7 (11.4 to 16.0)
        Exit
    7.1 (5.7 to 8.6)
    11.8 (9.3 to 14.4)
        Change from Baseline
    -7.0 (-9.9 to -4.1)
    -1.8 (-4.8 to -1.1)
    No statistical analyses for this end point

    Secondary: Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC

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    End point title
    		 Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC
    End point description
    Maximum severity of symptoms that occurred at each challenge dose of peanut protein for all subjects during up-dosing DBPCFC.
    End point type
    Secondary
    End point timeframe
    Up to 36 weeks for up-dosing.
    End point values
    		 AR101 intent-to-treat population Placebo intent-to-treat population
    Number of subjects analysed
    21
    21
    Units: participants
        No symptoms at 3 mg
    11
    18
        Mild symptoms at 3 mg
    0
    3
        Moderate symptoms at 3 mg
    0
    0
        Severe symptoms at 3 mg
    0
    0
        Missing symptom at 3 mg
    10
    0
        No symptoms at 10 mg
    10
    21
        Mild symptoms at 10 mg
    1
    0
        Moderate symptoms at 10 mg
    0
    0
        Severe symptoms at 10 mg
    0
    0
        Missing symptom at 10 mg
    10
    0
        No symptoms at 30 mg
    10
    20
        Mild symptoms at 30 mg
    2
    1
        Moderate symptoms at 30 mg
    0
    0
        Severe symptoms at 30 mg
    0
    0
        Missing symptom at 30 mg
    9
    0
        No symptoms at 100 mg
    11
    18
        Mild symptoms at 100 mg
    1
    3
        Moderate symptoms at 100 mg
    0
    0
        Severe symptoms at 100 mg
    0
    0
        Missing symptom at 100 mg
    9
    0
        No symptoms at 300 mg
    7
    20
        Mild symptoms at 300 mg
    4
    1
        Moderate symptoms at 300 mg
    0
    0
        Severe symptoms at 300 mg
    0
    0
        Missing symptom at 300 mg
    10
    0
        No symptoms at 600 mg
    6
    12
        Mild symptoms at 600 mg
    6
    5
        Moderate symptoms at 600 mg
    0
    4
        Severe symptoms at 600 mg
    0
    0
        Missing symptom at 600 mg
    9
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC

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    End point title
    		 Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC
    End point description
    Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance).
    End point type
    Secondary
    End point timeframe
    Maximum severity of symptoms that occurred at each challenge dose of peanut protein for all subjects during maintenance DBPCFC.
    End point values
    		 AR101 intent-to-treat population Placebo intent-to-treat population
    Number of subjects analysed
    20
    20
    Units: participants
        No symptoms at 3 mg
    7
    9
        Mild symptoms at 3 mg
    0
    1
        Moderate symptoms at 3 mg
    0
    0
        Severe symptoms at 3 mg
    0
    0
        Missing symptom at 3 mg
    13
    10
        No symptoms at 10 mg
    6
    9
        Mild symptoms at 10 mg
    0
    0
        Moderate symptoms at 10 mg
    0
    0
        Severe symptoms at 10 mg
    0
    0
        Missing symptom at 10 mg
    14
    11
        No symptoms at 30 mg
    6
    9
        Mild symptoms at 30 mg
    0
    1
        Moderate symptoms at 30 mg
    0
    0
        Severe symptoms at 30 mg
    0
    0
        Missing symptom at 30 mg
    14
    10
        No symptoms at 100 mg
    6
    9
        Mild symptoms at 100 mg
    1
    0
        Moderate symptoms at 100 mg
    0
    0
        Severe symptoms at 100 mg
    0
    0
        Missing symptom at 100 mg
    13
    11
        No symptoms at 300 mg
    6
    8
        Mild symptoms at 300 mg
    0
    1
        Moderate symptoms at 300 mg
    0
    0
        Severe symptoms at 300 mg
    0
    0
        Missing symptom at 300 mg
    14
    11
        No symptoms at 600 mg
    7
    7
        Mild symptoms at 600 mg
    2
    3
        Moderate symptoms at 600 mg
    0
    1
        Severe symptoms at 600 mg
    0
    0
        Missing symptom at 600 mg
    11
    9
        No symptoms at 1000 mg
    5
    7
        Mild symptoms at 1000 mg
    7
    4
        Moderate symptoms at 1000 mg
    2
    2
        Severe symptoms at 1000 mg
    0
    1
        Missing symptom at 1000 mg
    6
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    6-9 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    AR101
    Reporting group description
    		 A peanut-derived oral immunotherapy drug

    Reporting group title
    Placebo
    Reporting group description
    		 Matching Placebo

    Serious adverse events
    		 AR101 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 26 (3.85%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 AR101 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    28 / 29 (96.55%)
    22 / 26 (84.62%)
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 29 (10.34%)
    3 / 26 (11.54%)
         occurrences all number
    3
    3
    Somnolence
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 26 (0.00%)
         occurrences all number
    2
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    5 / 29 (17.24%)
    4 / 26 (15.38%)
         occurrences all number
    5
    4
    Malaise
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    2
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 26 (0.00%)
         occurrences all number
    2
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    26 / 29 (89.66%)
    13 / 26 (50.00%)
         occurrences all number
    341
    68
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    4 / 29 (13.79%)
    2 / 26 (7.69%)
         occurrences all number
    8
    3
    Diarrhoea
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 26 (11.54%)
         occurrences all number
    1
    3
    Nausea
         subjects affected / exposed
    3 / 29 (10.34%)
    1 / 26 (3.85%)
         occurrences all number
    9
    1
    Abdominal pain
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 26 (3.85%)
         occurrences all number
    3
    1
    Abdominal pain upper
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 26 (7.69%)
         occurrences all number
    1
    4
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    2 / 29 (6.90%)
    3 / 26 (11.54%)
         occurrences all number
    2
    4
    Cough
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 26 (7.69%)
         occurrences all number
    2
    2
    Oropharyngeal pain
         subjects affected / exposed
    3 / 29 (10.34%)
    1 / 26 (3.85%)
         occurrences all number
    4
    1
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    3 / 29 (10.34%)
    2 / 26 (7.69%)
         occurrences all number
    3
    2
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 29 (6.90%)
    5 / 26 (19.23%)
         occurrences all number
    2
    9
    Viral infection
         subjects affected / exposed
    3 / 29 (10.34%)
    1 / 26 (3.85%)
         occurrences all number
    3
    1
    Pharyngitis streptococcal
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 26 (3.85%)
         occurrences all number
    2
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Dec 2013
    Protocol Amendment 1: Clarification of study design.
    06 Feb 2014
    Protocol Amendment 2: Changes in study procedures and various clarifications including dosage, primary efficacy endpoint and eligibility criteria.
    14 May 2014
    Protocol Amendment 3: Changes in study design and study procedures. the Exit DBPCFC was changed from up to 1000 mg (1443 mg cumulative) to up to 600 mg (1043 mg cumulative) peanut protein or placebo.

    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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