Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)
Condition: Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Intervention: AR101 powder provided in capsules & sachets; Placebo powder provided in capsules & sachets
Intervention description: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol; Study product formulated to contain only inactive ingredients for use as defined in the protocol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 555.0
Sex: All
Minimum age: 4 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: AR101 (Characterized Peanut Allergen); Characterized Peanut Allergen; CPNA (Characterized Peanut Allergen); OIT (oral immunotherapy); Oral Immunotherapy; Peanut Allergy; Allergy; Peanut-Allergic Children; Peanut-Allergic Adults; Desensitization

Summary:

      The purpose of this study is to demonstrate the efficacy and safety of AR101 through
      reduction in clinical reactivity to peanut allergen in peanut-allergic children and adults.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Age 4 through 55 years

          -  Clinical history of allergy to peanuts or peanut-containing foods

          -  Serum immunoglobulin E (IgE) to peanut ≥0.35 kUA/L (kilos of allergen-specific units
             per liter, determined by UniCAP™* within the past 12 months) and/or a skin prick test
             (SPT) to peanut ≥3 mm compared to control

          -  Experience dose-limiting symptoms at or before the 100 mg challenge dose of peanut
             protein (measured as 200 mg of peanut flour) on Screening DBPCFC conducted in
             accordance with PRACTALL** guidelines

          -  Not be residing at the same address as another subject in this or any peanut OIT study

        UniCAP™*: a laboratory system for routine diagnostic testing of allergy and tool for basic
        studies on allergens and antibodies

        PRACTALL**: PRACTical issues in ALLergology Joint United States/European Union Initiative

        Key Exclusion Criteria:

          -  History of cardiovascular disease, including uncontrolled or inadequately controlled
             hypertension

          -  History of severe or life-threatening episode of anaphylaxis or anaphylactic shock
             within 60 days of Screening DBPCFC

          -  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

          -  History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal
             disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD),
             symptoms of dysphagia or recurrent gastrointestinal symptoms of undiagnosed etiology

          -  History of severe asthma (NHLBI criteria steps 5 or 6), or mild to moderate asthma
             (2007 NHLBI criteria steps 1-4) that is uncontrolled or difficult to control

          -  History of steroid medication use

          -  History of a mast cell disorder, including mastocytosis, urticarial pigmentosa, and
             hereditary or idiopathic angioedema

          -  Developing dose-limiting symptoms in reaction to the placebo part of the Screening
             DBPCFC

          -  Having the same place of residence as another subject in the study