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    Summary
    EudraCT Number:2017-001334-26
    Sponsor's Protocol Code Number:ARC008
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-12-01
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2017-001334-26
    A.3Full title of the trial
    A MULTICENTER, OPEN-LABEL, LONG-TERM SAFETY STUDY OF AR101 CHARACTERIZED ORAL DESENSITIZATION IMMUNOTHERAPY IN SUBJECTS WHO PARTICIPATED IN A PRIOR AR101 STUDY
    ESTUDIO MULTICÉNTRICO, ABIERTO, DE SEGURIDAD A LARGO PLAZO DE LA INMUNOTERAPIA CARACTERIZADA POR LA DESENSIBILIZACIÓN ORAL DE AR101 EN LOS SUJETOS QUE PARTICIPARON EN UN ESTUDIO ANTERIOR SOBRE AR101
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PEANUT ALLERGY STUDY
    ESTUDIO DE ALERGIA A LOS CACAHUETES
    A.3.2Name or abbreviated title of the trial where available
    Long-term Safety Study of AR101 CODIT™
    Estudio de seguridad a largo plazo del AR101 CODIT™
    A.4.1Sponsor's protocol code numberARC008
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAimmune Therapeutics, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAimmune Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAimmune Therapeutics UK Ltd
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address344-354 Gray's Inn Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeWC1X 8BP
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44208629 0240
    B.5.6E-mailgroberts@aimmune.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAR101
    D.3.4Pharmaceutical form Pouch
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot Available
    D.3.9.2Current sponsor codeAR101
    D.3.9.3Other descriptive nameCharacterised Peanut Allergen
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAR101
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot Available
    D.3.9.2Current sponsor codeAR101
    D.3.9.3Other descriptive nameCharacterised Peanut Allergen
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAR101
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot Available
    D.3.9.2Current sponsor codeAR101
    D.3.9.3Other descriptive nameCharacterised Peanut Allergen
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAR101
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot Available
    D.3.9.2Current sponsor codeAR101
    D.3.9.3Other descriptive nameCharacterised Peanut Allergen
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 5
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAR101
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot Available
    D.3.9.2Current sponsor codeAR101
    D.3.9.3Other descriptive nameCharacterised Peanut Allergen
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 6
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAR101
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot Available
    D.3.9.2Current sponsor codeAR101
    D.3.9.3Other descriptive nameCharacterised Peanut Allergen
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Peanut Allergy
    Alergia a los cacahuetes
    E.1.1.1Medical condition in easily understood language
    Allergy to peanuts or peanut-containing foods
    Alergia a los cacahuetes o a los alimentos que contengan cacahuetes
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To describe the long-term safety and tolerability of AR101 using a CODIT™ regimen administered to peanut-allergic children and adults
    Describir la seguridad a largo plazo y la tolerabilidad del AR101 empleando una pauta de CODIT™ administrado a niños y adultos alérgicos al cacahuete.
    E.2.2Secondary objectives of the trial
    - To assess the level of desensitization achievable through extended maintenance of AR101
    - To characterize the interaction of AR101 and asthma control or nasal allergy symptoms in subjects with a history of asthma and/or allergic rhinitis
    - To evaluate subjects' QoL and treatment satisfaction during AR101 treatment on daily and nondaily treatment regimens
    - To evaluate parent/guardian QoL during the child's treatment with AR101
    - To evaluate the long-term immunologic effects of AR101 on immune parameters
    - To characterize the effect of AR101 on basophil activation
    - Evaluar el nivel de desensibilización alcanzable mediante la administración de dosis de AR101 durante un periodo de mantenimiento ampliado.
    - Caracterizar la interacción del AR101 y del control del asma o de los síntomas de alergia nasal en sujetos con historial de asma y/o rinitis alérgica
    - Evaluar la calidad de vida (CdV) de los sujetos y la satisfacción con el tratamiento durante el tratamiento con AR101 en pautas de tratamiento a diario y no a diario
    - Evaluar la CdV del progenitor/tutor durante el tratamiento del niño con AR101
    - Evaluar los efectos inmunológicos a largo plazo del tratamiento con AR101 sobre los parámetros inmunitarios
    - Caracterizar el efecto del AR101 sobre la activación de basófilos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all the following criteria to be eligible:
    1. Prior participation in one of the following Aimmune AR101 clinical studies: ARC002, ARC004, ARC007, ARC010, ARC011, or any future clinical study that identifies ARC008 as a follow-on study option in the protocol
    2. Written informed consent from the subject or parent/guardian in accordance with local Institutional Review Board (IRB)/Ethics Committee (EC) guidelines
    3. Written assent from the subject as required by local IRB/EC guidelines
    4. Use of effective birth control by sexually active females of childbearing potential
    Los sujetos deben cumplir todos los siguientes criterios para ser aptos de participar en el estudio:
    1. Participación previa en uno de los siguientes estudios clínicos del AR101 de Aimmune: ARC002, ARC004, ARC007, ARC010, ARC011, o cualquier futuro estudio clínico que identifique el ARC008 como una posible opción de estudio de seguimiento en el protocolo
    2. El sujeto o su progenitor/tutor debe haber dado su consentimiento informado por escrito de conformidad con las directrices del comité de ética de investigación clínica (Institutional Review Board, IRB)/comité de ética (CE) local
    3. Debe contarse con el asentimiento por escrito por parte del sujeto, según lo requieran las directrices del IRB/CE local
    4. Uso de un método anticonceptivo eficaz por parte de mujeres sexualmente activas en edad fértil
    E.4Principal exclusion criteria
    Subjects who meet any of the following criteria are not eligible:
    1. Did not complete a minimum of 3 months of AR101 Maintenance in the parent study if subject was assigned to AR101 in that study.
    2. For subjects treated with AR101 in the parent study requiring a food challenge, failure to successfully consume at least the 300 mg single dose (443 mg cumulative) of peanut protein at parent study's exit food challenge
    3. History of chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) that is, or is at significant risk of, becoming unstable or requiring a change in chronic therapeutic regimen, including autoimmune diseases and malignancies
    4. Subjects with a history of alcohol, illicit or recreational drug or prescribed medication abuse
    5. Developed a clinically significant change in health status during the parent study that, in the opinion of the investigator, would make the subject unsuitable for participation in this study
    6. Taking a prohibited medication, as listed in Section 5.9.5 of the trial protocol
    7. Currently participating in any other interventional clinical study other than the Aimmune parent study
    8. Participation in any peanut immunotherapy clinical study, other than Aimmune-sponsored AR101 studies (including oral, sublingual, or epicutaneous), within 5 years prior to Screening, except for Aimmune Studies ARC002, ARC004, ARC007, ARC010 and ARC011
    9. Subject is living in the same household or is a dependent of sponsor employees and/or site staff involved in conducting this study, except for subjects originating from Aimmune Studies ARC002, ARC004, ARC007, ARC010 and ARC011
    10. Except for subjects from ARC002, subjects currently receiving, or having received in the last 5 years, any type of non-peanut allergen immunotherapy (including subcutaneous, sublingual, oral or other)
    11. Hypersensitivity to epinephrine or hypersensitivity to any of the excipients in the investigational product (IP)
    12. Pregnant or breastfeeding
    13. Inability to withhold antihistamines for 5 half-lives prior to initial day of escalation or visits at which a skin prick test (SPT) or open-label food challenge (OLFC) is conducted
    14. Discontinued early from the parent study for any safety reason (other than a subject from study ARC004 who has experienced a lack of tolerance for a nondaily dosing regimen)
    15. Any other condition that, in the opinion of the investigator, precludes participation for reasons of safety
    16. Subjects unable to follow the protocol requirements
    Los sujetos que cumplan alguno de los criterios siguientes no son aptos para participar en el estudio:
    1. No hayan completado un mínimo de 3 meses de mantenimiento con AR101 en el estudio principal, si al sujeto se le asignó el AR101 en dicho estudio
    2. Para los sujetos tratados con AR101 en el estudio principal que requirieran una prueba de estimulación alimentaria, no haber asimilado correctamente, al menos, la dosis única de 300 mg (dosis acumulativa de 443 mg) de proteína de cacahuete en la prueba de estimulación alimentaria de salida del estudio principal
    3. Antecedentes de enfermedad crónica (distinta del asma, la dermatitis atópica o la rinitis alérgica) que se esté padeciendo o que presente un riesgo significativo de padecerse, que se vuelva inestable, o que requiera un cambio en la pauta terapéutica crónica, incluyendo enfermedades autoinmunes y neoplasias malignas
    4. Sujetos con un historial de alcoholismo, abuso de drogas ilegales o recreativas o de medicación prescrita
    5. Sujetos que hayan desarrollado un cambio de importancia clínica en su estado de salud durante el estudio principal que, en opinión del investigador, haría que fueran no aptos para su participación en este estudio
    6. Sujetos que estén tomando medicamentos prohibidos, tal y como se indican en la sección 5.9.5 del protocolo del ensayo
    7. Sujetos que estén participando actualmente en cualquier otro estudio clínico de intervención distinto del estudio principal de Aimmune
    8. Sujetos que hayan participado en cualquier estudio clínico de inmunoterapia distinto a los estudios promovidos por Aimmune del AR101 (incluyendo orales, sublinguales o epicutáneos) en los 5 años anteriores a la selección, excepto en los estudios de Aimmune ARC002, ARC004, ARC007, ARC010 y ARC011
    9. Sujetos que vivan en la misma casa de empleados del promotor o que dependan de ellos y/o de personal del centro implicado en la realización de este estudio, excepto los sujetos que procedan de los estudios de Aimmune ARC002,, ARC004, ARC007, ARC010 y ARC011
    10. Excepto los sujetos procedentes del ARC002, los sujetos que estén recibiendo actualmente, o que hayan recibido en los últimos 5 años, cualquier tipo de inmunoterapia a alérgenos distintos al cacahuete (incluyendo subcutánea, sublingual, oral u otras)
    11. Hipersensibilidad a la epinefrina o a cualquiera de los excipientes presentes en el producto en investigación (PEI)
    12. Mujeres embarazadas o que estén dando el pecho
    13. Incapacidad para soportar antihistamínicos durante 5 semividas antes del día inicial del aumento de la dosis o de las visitas en las que se lleve a cabo una SPT o una OLFC
    14. Sujetos que interrumpieran de forma anticipada su participación en el estudio principal por cualquier motivo de seguridad (distintos a sujetos del estudio ARC004 que hayan experimentado intolerancia para una pauta posológica no a diario)
    15. Cualquier otra afección que, en opinión del investigador, impida la participación por motivos de seguridad
    16. Sujetos incapaces de seguir los requisitos del protocolo
    E.5 End points
    E.5.1Primary end point(s)
    - Frequency of Adverse Events
    - Frequency of premature discontinuation of AR101 dosing due to Adverse Events
    - Frequency of premature discontinuation of dosing due to chronic/recurrent GI Adverse Events
    - Frequency of Adverse Events that lead to a change in treatment regimen´
    - Frequency of Adverse Events that lead to early withdrawal
    - Frequency of anaphylaxis (as defined in Section 8.1.4.1 of the trial protocol)
    - Frequency of use of epinephrine as a rescue medication
    - Frequency of accidental ingestion of peanut and other allergenic foods
    - Frequency of Adverse Events following accidental exposure to peanut and other allergenic foods
    - Frequency of eosinophilic esophagitis (EoE)
    - Frecuencia de Reacciones Adversas (AA)
    - Frecuencia de la interrupción prematura de la administración de dosis de AR101 por AA
    - Frecuencia de la interrupción prematura de la administración de dosis por AA GI crónicos/recurrentes
    - Frecuencia de AA que provoquen un cambio en la pauta de tratamiento
    - Frecuencia de AA que provoquen la retirada prematura
    - Frecuencia de anafilaxia (tal y como se define en la sección 8.1.4.1 del protocolo del ensayo)
    - Frecuencia de uso de epinefrina como medicamento de rescate
    - Frecuencia de ingestión accidental de cacahuetes y otros alimentos alergénicos
    - Frecuencia de AA tras la exposición accidental a los cacahuetes y otros alimentos alergénicos
    - Frecuencia de esofagitis eosinofílica (EE)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Interim data analyses may be performed as needed to summarize safety data
    Pueden realizarse análisis de datos provisionales según sea necesario para resumir los datos de seguridad
    E.5.2Secondary end point(s)
    Objective: To assess the level of desensitization achievable through extended maintenance dosing of AR101
    - Proportion of subjects tolerating each challenge dose in the open-label food challenge (OLFC)
    - Proportion of subjects who tolerate the oral real-world peanut challenge (RWPC)
    - The maximum tolerated challenge dose at each OLFC
    - Change in tolerated dose of peanut protein
    - Maximum severity of symptoms in each OLFC
    - Maximum severity of symptoms in each RWPC
    - Frequency of use of epinephrine as a rescue medication during the OLFCs
    - Frequency of use of epinephrine as a rescue medication during the RWPCs
    - Change in peanut skin prick test (SPT) mean wheal diameter

    Objective: To characterize the interaction of AR101 and asthma control or nasal allergy symptoms in subjects with a history of asthma and/or allergic rhinitis
    - Change in peak expiratory flow rate (PEFR)
    - Change in Childhood Asthma Control Test (C-ACT) and Asthma Control Test (ACT) score
    - Change in Total Nasal Symptom Score (TNSS)

    Objective: To evaluate subjects’ QoL and treatment satisfaction during AR101 treatment on daily and nondaily treatment regimens
    - Changes in food allergy QoL scores as measured by Food Allergy Quality of Life questionnaire (FAQLQ), and the Food Allergy Independent Measure (FAIM) questionnaire

    Objective: To evaluate parent/guardian QoL during the child’s treatment with AR101
    - Change in Food Allergy Quality of Life – Parental Burden (FAQL-PB) questionnaire score

    Objective: To evaluate the long-term immunologic effects of AR101 on immune parameters
    - Change in peanut-specific and peanut component-specific serum immunoglobulin G subclass 4 (IgG4)
    - Change in peanut-specific and peanut component-specific serum immunoglobulin E (IgE)

    Objective: To characterize the effect of AR101 on basophil activation
    - Change in percent activated basophils
    Objetivo: Evaluar el nivel de desensibilización alcanzable mediante la administración de dosis de AR101 durante un periodo de mantenimiento ampliado
    - Proporción de sujetos tolerantes a cada dosis de estimulación en la prueba abierta de estimulación alimentaria (Open-Label Food Challenge, OLFC)
    - Proporción de sujetos tolerantes a la prueba de estimulación alimentaria oral con cacahuetes en el mundo real (Oral Real-World Peanut Challenge, RWPC)
    - Dosis máxima de estimulación tolerada en cada OLFC
    - Cambio en la dosis tolerada de proteína de cacahuete
    - Gravedad máxima de los síntomas en cada OLFC
    - Gravedad máxima de los síntomas en cada RWPC
    - Frecuencia de uso de epinefrina como medicamento de rescate durante las OLFC
    - Frecuencia de uso de epinefrina como medicamento de rescate durante las RWPC
    - Cambio en el diámetro medios de la pápula en la prueba de punción cutánea (Skin Prick Test, SPT) para los alérgenos del cacahuete

    Objetivo: Caracterizar la interacción del AR101 y del control del asma o de los síntomas de alergia nasal en sujetos con historial de asma y/o rinitis alérgica
    - Cambio en la tasa de flujo espiratorio máxima (Peak expiratory flow rate, PEFR)
    - Cambio en la puntuación de la prueba de control del asma en niños (Childhood Asthma Control Test, C ACT) y en la prueba de control del asma (Asthma Control Test, ACT)
    - Cambio en la puntuación total de síntomas nasales (Total Nasal Symptom Score, TNSS)

    Objetivo: Evaluar la calidad de vida (CdV) de los sujetos y la satisfacción con el tratamiento durante el tratamiento con AR101 en pautas de tratamiento a diario y no a diario
    - Cambios en las puntuaciones de la CdV con alergias alimentarias según la evaluación realizada mediante el cuestionario de la calidad de vida relacionado con la alergia alimentaria (Food Allergy Quality of Life questionnaire, FAQLQ) y el cuestionario de medida independiente de la alergia alimentaria (Food Allergy Independent Measure, FAIM).

    Objetivo: Evaluar la CdV del progenitor/tutor durante el tratamiento del niño con AR101
    - Cambio en la puntuación del cuestionario de la calidad de vida relacionada con la alergia alimentaria - carga parental (Food Allergy Quality of Life - Parental Burden, FAQL-PB)

    Objetivo: Evaluar los efectos inmunológicos a largo plazo del tratamiento con AR101 sobre los parámetros inmunitarios
    - Cambio en la inmunoglobulina sérica G, subclase 4 (IgG4) específica del cacahuete y específica de los componentes del cacahuete
    - Cambio en la inmunoglobulina sérica E (IgE) específica del cacahuete y específica de los componentes del cacahuete

    Objetivo: Caracterizar el efecto del AR101 sobre la activación de basófilos
    - Cambio en el porcentaje de basófilos activados
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    NA
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Denmark
    France
    Germany
    Ireland
    Italy
    Netherlands
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 1060
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 700
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 360
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state44
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 1100
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Ninguno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-02-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-04-18
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