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    Clinical Trial Results:
    Peanut Oral Immunotherapy Study of Early Intervention for Desensitization (POSEIDON)

    Summary
    EudraCT number
    		 2018-001749-15
    Trial protocol
    		 GB   IE   FR   DE  
    Global end of trial date
    05 Jul 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Feb 2023
    First version publication date
    26 Feb 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ARC005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03736447
    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
    14 Dec 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Jul 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Jul 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to determine the efficacy and safety of Characterized Peanut Allergen (AR101) through reduction in clinical reactivity to limited amounts of peanut allergen in peanut‑allergic children aged 1 to < 4 years.
    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 epinephrine pen use.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Nov 2018
    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
    United States: 84
    Country: Number of subjects enrolled
    United Kingdom: 41
    Country: Number of subjects enrolled
    Germany: 14
    Country: Number of subjects enrolled
    France: 7
    Worldwide total number of subjects
    146
    EEA total number of subjects
    21
    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)
    49
    Children (2-11 years)
    97
    Adolescents (12-17 years)
    0
    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
    		 -

    Pre-assignment
    Screening details
    		 289 subjects were screened and 146 were initially randomized and enrolled in the study. The randomized population consisted of 98 subjects in the AR101 group and 48 subjects in the placebo group. The final intent-to-treat (ITT) population had 146 subjects.

    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 containing 0.5, 1, 10 or 100 mg peanut protein Sachets containing 300 mg peanut protein

    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 in pull-apart capsules and sachets.

    Number of subjects in period 1
    		AR101 Placebo
    Started
    98
    48
    Completed
    83
    45
    Not completed
    15
    3
         Continued commitment to study treatment
    3
    -
         Physician decision
    1
    -
         Consent withdrawn by subject
    5
    1
         Adverse event, non-fatal
    5
    1
         Taste aversion to study product
    -
    1
         Lost to follow-up
    1
    -

    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
    		 98 48 146
    Age categorical
    Units: Subjects
        1-<2 years
    		 33 16 49
        2-<3 years
    		 35 15 50
        3-<4 years
    		 30 17 47
    Gender categorical
    Units: Subjects
        Female
    		 41 20 61
        Male
    		 57 28 85

    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

    Primary: Percentage of Subjects Who Tolerated a Single Highest Dose of at Least 1000 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC)

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    End point title
    		 Percentage of Subjects Who Tolerated a Single Highest Dose of at Least 1000 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC)
    End point description
    The percentage of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild allergy symptoms during the exit double-blind placebo-controlled food challenge (DBPCFC).
    End point type
    Primary
    End point timeframe
    12 months
    End point values
    		 AR101 Placebo
    Number of subjects analysed
    98
    48
    Units: percentage of subjects
        number (confidence interval 95%)
    68.4 (58.2 to 77.4)
    4.2 (0.5 to 14.3)
    Statistical analysis title
    		 % of subjects who tolerated 1000 mg in DBPCFC
    Comparison groups
    AR101 v Placebo
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Farrington-Manning test
    Parameter type
    		 Risk difference (RD)
    Point estimate
    64.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 47
         upper limit
    		 81.4

    Secondary: Percentage of Subjects Who Tolerated a Single Highest Dose of at Least 600 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC)

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    End point title
    		 Percentage of Subjects Who Tolerated a Single Highest Dose of at Least 600 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC)
    End point description
    The percentage of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild allergy symptoms during the exit double-blind placebo-controlled food challenge (DBPCFC).
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 AR101 Placebo
    Number of subjects analysed
    98
    48
    Units: percentage of subjects
        number (confidence interval 95%)
    73.5 (63.6 to 81.9)
    6.3 (1.3 to 17.2)
    Statistical analysis title
    		 % of subjects who tolerated 600 mg in DBPCFC
    Comparison groups
    AR101 v Placebo
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Farrington-Manning test
    Parameter type
    		 Risk difference (RD)
    Point estimate
    67.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 50
         upper limit
    		 84.5

    Secondary: Percentage of Subjects Who Tolerated a Single Highest Dose of at Least 300 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC)

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    End point title
    		 Percentage of Subjects Who Tolerated a Single Highest Dose of at Least 300 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC)
    End point description
    The percentage of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild allergy symptoms during the exit double-blind placebo-controlled food challenge (DBPCFC).
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 AR101 Placebo
    Number of subjects analysed
    98
    48
    Units: percentage of subjects
        number (confidence interval 95%)
    79.6 (70.3 to 87.1)
    22.9 (12.0 to 37.3)
    Statistical analysis title
    		 % of subjects who tolerated 300 mg in DBPCFC
    Comparison groups
    AR101 v Placebo
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Farrington-Manning test
    Parameter type
    		 Risk difference (RD)
    Point estimate
    56.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 39.8
         upper limit
    		 73.5

    Secondary: Maximum Severity of Symptoms in Participants at Any Challenge Dose During the Exit Double-blind Placebo Controlled Food Challenge (DBPCFC)

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    End point title
    		 Maximum Severity of Symptoms in Participants at Any Challenge Dose During the Exit Double-blind Placebo Controlled Food Challenge (DBPCFC)
    End point description
    The maximum severity of symptoms that occurred at any challenge dose of peanut protein during the exit DBPCFC.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 AR101 Placebo
    Number of subjects analysed
    98
    48
    Units: Participants
        None
    50
    2
        Mild
    29
    23
        Moderate
    17
    21
        Severe
    2
    2
        Life-threatening or fatal
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    AR101
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 AR101 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 98 (7.14%)
    2 / 48 (4.17%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Carbon monoxide poisoning
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Enterovirus infection
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status asthmaticus
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 48 (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: 5%
    Non-serious adverse events
    		 AR101 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    96 / 98 (97.96%)
    47 / 48 (97.92%)
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    7 / 98 (7.14%)
    2 / 48 (4.17%)
         occurrences all number
    7
    2
    Contusion
         subjects affected / exposed
    5 / 98 (5.10%)
    0 / 48 (0.00%)
         occurrences all number
    5
    0
    Head injury
         subjects affected / exposed
    6 / 98 (6.12%)
    1 / 48 (2.08%)
         occurrences all number
    6
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 98 (10.20%)
    1 / 48 (2.08%)
         occurrences all number
    10
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    50 / 98 (51.02%)
    20 / 48 (41.67%)
         occurrences all number
    50
    20
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    5 / 98 (5.10%)
    3 / 48 (6.25%)
         occurrences all number
    5
    3
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    8 / 98 (8.16%)
    4 / 48 (8.33%)
         occurrences all number
    8
    4
    Seasonal allergy
         subjects affected / exposed
    4 / 98 (4.08%)
    4 / 48 (8.33%)
         occurrences all number
    4
    4
    Eye disorders
    Eye pruritus
         subjects affected / exposed
    9 / 98 (9.18%)
    5 / 48 (10.42%)
         occurrences all number
    9
    5
    Eye swelling
         subjects affected / exposed
    9 / 98 (9.18%)
    3 / 48 (6.25%)
         occurrences all number
    9
    3
    Ocular hyperaemia
         subjects affected / exposed
    6 / 98 (6.12%)
    2 / 48 (4.17%)
         occurrences all number
    6
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    23 / 98 (23.47%)
    6 / 48 (12.50%)
         occurrences all number
    23
    6
    Abdominal pain upper
         subjects affected / exposed
    14 / 98 (14.29%)
    4 / 48 (8.33%)
         occurrences all number
    14
    4
    Constipation
         subjects affected / exposed
    11 / 98 (11.22%)
    5 / 48 (10.42%)
         occurrences all number
    11
    5
    Diarrhoea
         subjects affected / exposed
    34 / 98 (34.69%)
    13 / 48 (27.08%)
         occurrences all number
    34
    13
    Flatulence
         subjects affected / exposed
    5 / 98 (5.10%)
    0 / 48 (0.00%)
         occurrences all number
    5
    0
    Lip swelling
         subjects affected / exposed
    5 / 98 (5.10%)
    0 / 48 (0.00%)
         occurrences all number
    5
    0
    Nausea
         subjects affected / exposed
    5 / 98 (5.10%)
    2 / 48 (4.17%)
         occurrences all number
    5
    2
    Oral pruritus
         subjects affected / exposed
    10 / 98 (10.20%)
    2 / 48 (4.17%)
         occurrences all number
    10
    2
    Teething
         subjects affected / exposed
    10 / 98 (10.20%)
    7 / 48 (14.58%)
         occurrences all number
    10
    7
    Vomiting
         subjects affected / exposed
    52 / 98 (53.06%)
    15 / 48 (31.25%)
         occurrences all number
    52
    15
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    11 / 98 (11.22%)
    7 / 48 (14.58%)
         occurrences all number
    11
    7
    Cough
         subjects affected / exposed
    52 / 98 (53.06%)
    21 / 48 (43.75%)
         occurrences all number
    52
    21
    Dysphonia
         subjects affected / exposed
    5 / 98 (5.10%)
    1 / 48 (2.08%)
         occurrences all number
    5
    1
    Nasal congestion
         subjects affected / exposed
    14 / 98 (14.29%)
    5 / 48 (10.42%)
         occurrences all number
    14
    5
    Rhinitis allergic
         subjects affected / exposed
    5 / 98 (5.10%)
    1 / 48 (2.08%)
         occurrences all number
    5
    1
    Rhinorrhoea
         subjects affected / exposed
    42 / 98 (42.86%)
    15 / 48 (31.25%)
         occurrences all number
    42
    15
    Sneezing
         subjects affected / exposed
    23 / 98 (23.47%)
    9 / 48 (18.75%)
         occurrences all number
    23
    9
    Throat irritation
         subjects affected / exposed
    8 / 98 (8.16%)
    2 / 48 (4.17%)
         occurrences all number
    8
    2
    Wheezing
         subjects affected / exposed
    14 / 98 (14.29%)
    4 / 48 (8.33%)
         occurrences all number
    14
    4
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    6 / 98 (6.12%)
    5 / 48 (10.42%)
         occurrences all number
    6
    5
    Dry skin
         subjects affected / exposed
    8 / 98 (8.16%)
    2 / 48 (4.17%)
         occurrences all number
    8
    2
    Eczema
         subjects affected / exposed
    24 / 98 (24.49%)
    12 / 48 (25.00%)
         occurrences all number
    24
    12
    Erythema
         subjects affected / exposed
    34 / 98 (34.69%)
    17 / 48 (35.42%)
         occurrences all number
    34
    17
    Perioral dermatitis
         subjects affected / exposed
    17 / 98 (17.35%)
    4 / 48 (8.33%)
         occurrences all number
    17
    4
    Pruritus
         subjects affected / exposed
    27 / 98 (27.55%)
    15 / 48 (31.25%)
         occurrences all number
    27
    15
    Rash
         subjects affected / exposed
    23 / 98 (23.47%)
    11 / 48 (22.92%)
         occurrences all number
    23
    11
    Rash erythematous
         subjects affected / exposed
    8 / 98 (8.16%)
    3 / 48 (6.25%)
         occurrences all number
    8
    3
    Swelling face
         subjects affected / exposed
    5 / 98 (5.10%)
    1 / 48 (2.08%)
         occurrences all number
    5
    1
    Urticaria
         subjects affected / exposed
    51 / 98 (52.04%)
    24 / 48 (50.00%)
         occurrences all number
    51
    24
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    6 / 98 (6.12%)
    1 / 48 (2.08%)
         occurrences all number
    6
    1
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    6 / 98 (6.12%)
    5 / 48 (10.42%)
         occurrences all number
    6
    5
    Coronavirus infection
         subjects affected / exposed
    6 / 98 (6.12%)
    6 / 48 (12.50%)
         occurrences all number
    6
    6
    Ear infection
         subjects affected / exposed
    11 / 98 (11.22%)
    2 / 48 (4.17%)
         occurrences all number
    11
    2
    Gastroenteritis
         subjects affected / exposed
    10 / 98 (10.20%)
    6 / 48 (12.50%)
         occurrences all number
    10
    6
    Gastroenteritis viral
         subjects affected / exposed
    8 / 98 (8.16%)
    1 / 48 (2.08%)
         occurrences all number
    8
    1
    Hand-foot-and-mouth disease
         subjects affected / exposed
    5 / 98 (5.10%)
    2 / 48 (4.17%)
         occurrences all number
    5
    2
    Influenza
         subjects affected / exposed
    5 / 98 (5.10%)
    0 / 48 (0.00%)
         occurrences all number
    5
    0
    Lower respiratory tract infection
         subjects affected / exposed
    5 / 98 (5.10%)
    0 / 48 (0.00%)
         occurrences all number
    5
    0
    Nasopharyngitis
         subjects affected / exposed
    28 / 98 (28.57%)
    13 / 48 (27.08%)
         occurrences all number
    28
    13
    Rhinitis
         subjects affected / exposed
    20 / 98 (20.41%)
    8 / 48 (16.67%)
         occurrences all number
    20
    8
    Upper respiratory tract infection
         subjects affected / exposed
    35 / 98 (35.71%)
    13 / 48 (27.08%)
         occurrences all number
    35
    13
    Urinary tract infection
         subjects affected / exposed
    5 / 98 (5.10%)
    0 / 48 (0.00%)
         occurrences all number
    5
    0
    Viral infection
         subjects affected / exposed
    9 / 98 (9.18%)
    5 / 48 (10.42%)
         occurrences all number
    9
    5
    Viral upper respiratory tract infection
         subjects affected / exposed
    9 / 98 (9.18%)
    5 / 48 (10.42%)
         occurrences all number
    9
    5
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    5 / 98 (5.10%)
    0 / 48 (0.00%)
         occurrences all number
    5
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Jun 2019
    Amendment 1.0
    02 Mar 2020
    Amendment 2.0
    29 May 2020
    Amendment 3.0
    17 Mar 2021
    Amendment 4.0

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    18 Mar 2020
    On the 11 March 2020 the World Health Organization (WHO) declared COVID-19 a global pandemic. On the 18 March 2020, Aimmune notified the sites globally of a halt to screening, enrolment and exit visits. A protocol amendment was submitted on the 29 March 2020 to include an emergency situations appendix. Temporary halt notifications were sent to some countries. It was agreed that prior to sites re‐starting these specified study procedures, and following the lifting of emergency restrictions, several points needed to be considered to ensure sites are ready to recommence these procedures again on‐site: 1. Required Aimmune resources, clinical supplies and related vendor processes are in place and fully functional to restart specified procedures as per protocol. 2. Site can restart in‐clinic visit procedures/assessments (e.g., screening, up‐dosing, maintenance) as per protocol for all subjects. 3. Site can accommodate and recommence CRA on‐site monitoring visits. 4. Site has adequate resources and clinical supplies in place to conduct the required procedures per protocol, including data entry and query resolution. Upon completion of Study Procedure Restart Checklist forms, sites were then able to recommence their study activities. The last site restarted activities on the 13 February 2021.
    13 Feb 2021

    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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