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    Summary
    EudraCT Number:2021-002087-47
    Sponsor's Protocol Code Number:ARC001
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2021-12-07
    Trial results View 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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2021-002087-47
    A.3Full title of the trial
    Oral Desensitization to Peanut in Peanut-Allergic Children
    and Adults using Characterized Peanut Allergen (CPNA)
    Oral Immunotherapy (OIT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Peanut Allergy Study
    A.4.1Sponsor's protocol code numberARC001
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/222/2015
    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 Limited
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address10 Eastbourne Terrace
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW2 6LG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+442039232530
    B.5.6E-mailRegulatoryAffairs@aimmune.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Palforzia
    D.2.1.1.2Name of the Marketing Authorisation holderAimmune Therapeutics, Ireland Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 Oral powder in sachet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral powder in sachet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Peanut Allergy
    E.1.1.1Medical condition in easily understood language
    Allergy to peanuts or peanut-containing foods
    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
    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).
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    • To demonstrate the safety of Characterized Peanut Allergen as measured by incidence of adverse events and dosing symptoms.
    • To evaluate the immunological effects of peanut OIT therapy.
    • To determine the time course of tolerated up-dosing
    • To evaluate safety based on physician global assessment of disease
    activity
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age 4 through 26 years
    • Clinical history of allergy to peanuts or peanut-containing foods
    • Serum IgE to peanut of > 0.35 kUA/L [determined by UniCAPTM
    within the past 12 months] and/or a SPT to peanut > 3 mm
    compared to control
    • Experience dose-limiting symptoms at or before the 100 mg dose of
    peanut protein (measured as 200 mg of peanut flour) on screening
    DBPCFC conducted in accordance with PRACTALL (Practical
    Issues in Allergology, Joint United States/European Union
    Initiative) guidelines
    • Written informed consent from adult subjects
    • Written informed consent from parent/guardian for minor subjects
    • Written assent from minor subjects as appropriate (ie, above the age
    of 7 years)
    • Use of birth control by female subjects of child-bearing potential
    • Should not be residing in the same address as another subject in this
    study
    • Cannot have participated in a clinical trial 30 days prior to
    randomization
    E.4Principal exclusion criteria
    • History of cardiovascular disease
    • History of frequent or repeated, severe or life-threatening episodes of anaphylaxis or anaphylactic shock
    • History of other chronic disease (other than asthma, atopic
    dermatitis, or rhinitis) requiring therapy (e.g., heart disease,
    diabetes)
    • History of eosinophilic gastrointestinal disease
    • Current participation in any other interventional study
    • Subject is on ‘build-up phase” of immunotherapy to another
    allergen (i.e., has not reached maintenance dosing)
    • Severe asthma (2007 NHLBI Criteria Steps 5 or 6, see Appendix 2)
    • Mild or moderate (2007 NHLBI Criteria Steps 1-4) asthma, if
    uncontrolled as defined by any of the following:
     Forced expiratory volume in 1 second (FEV1) < 80% of
    predicted, or FEV1/FVC < 75%, with or without controller
    medications (only for age 6 or greater and able to do
    spirometry) or
    - Inhaled corticosteroid (ICS) dosing of > 500 mcg daily
    fluticasone (or equivalent ICSs based on National Heart,
    Lung, and Blood Institute [NHLBI] dosing chart) or
    - 1 hospitalization in the past year for asthma or
    - Emergency Room (ER) visit within 6 months
    • History of steroid medication use (via intravenous [IV],
    intramuscular [IM] or oral administration) in any of the following
    manners:
     daily oral steroid dosing for >1 month during the past year
    or
     burst or steroid course in the past 3 months or
     >2 burst oral steroid courses in the past year ≥1 week in
    duration
    • Inability to discontinue antihistamines 5 half-lives before the initial
    day of escalation, skin testing or DBPCFC
    • Lack of an available palatable vehicle food to which the subject is
    not allergic
    • Use of omalizumab within the past 6 months, or current use of other
    investigational forms of allergen immunotherapy (eg, oral or
    sublingual) or immunomodulator therapy (not including
    corticosteroids)
    • Use of beta-blockers (oral), angiotensin-converting enzyme (ACE)
    inhibitors, angiotensin-receptor blockers (ARB) or calcium channel
    blockers
    • Pregnancy or lactation
    • Having the same place of residence as another subject in the study
    • Participation in another clinical trial within 30 days prior to
    randomization
    E.5 End points
    E.5.1Primary end point(s)
    The primary clinical efficacy endpoint is 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
    E.5.1.1Timepoint(s) of evaluation of this end point
    After approximately 9 months of treatment
    E.5.2Secondary end point(s)
    • Change from baseline in tolerated dose of peanut protein at
    DBPCFC
    • Maximum dose achieved with no or mild symptoms at exit
    DBPCFC
    • Physician global assessment: Disease activity as measured on a 100 mm visual analogue scale (VAS)
    • Changes in peanut-specific IgE and IgG4, changes in skin prick test (SPT) mean wheal diameters
    • The safety of peanut OIT based on dosing symptoms and reported
    adverse events (AEs) including serious adverse events (SAEs)
    E.5.2.1Timepoint(s) of evaluation of this end point
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    Last assessment for the last subject in the study
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days0
    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: 50
    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: 35
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 5
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 50
    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
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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