Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen OIT

Study Overview
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Brief Summary
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This is a multi-center, randomized, double-blind placebo controlled study of efficacy and safety of characterized peanut oral immunotherapy in peanut allergic individuals.

Detailed Description
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This is a multicenter, randomized, double-blind placebo controlled study of efficacy and safety of characterized peanut OIT in peanut allergic individuals. All eligible subjects will receive an escalating dose of CPNA or placebo. Approximately 50 subjects will be randomized 1:1 to peanut OIT or placebo.

Official Title
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Phase 2 Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen Oral Immunotherapy

Conditions
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Peanut Allergy

Intervention / Treatment
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* Biological: AR101 powder provided in capsules
* Biological: Placebo powder provided in capsules


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Ages 4 through 26 years, inclusive Clinical history of allergy to peanuts or peanut-containing foods Serum IgE to peanut >0.35 kU/L (determined by UniCAP within the past 12 months) and/or a SPT to peanut >3 mm compared to control Experience dose-limiting symptoms at or before the 100mg dose of peanut protein (measured as 200 mg of peanut flour) on abbreviated screening OFC conducted via PRACTALL guidelines Use of birth control by females of child-bearing potential Key Exclusion Criteria: History of Cardiovascular disease History of frequent or repeated, severe or life-threatening episodes of anaphylactic shock History of other chronic disease History of eosinophilic gastrointestinal disease Severe asthma Mild or moderate asthma if uncontrolled Use of omalizumab within the past 6 months or current use of other non-traditional forms of allergen immunotherapy Use of beta-blockers(oral), angiotensin-converting enzyme (ACE) Pregnancy, lactation Having the same place of residence as another study subject Participation in an interventional clinical trial 30 days prior to randomization

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AR101 powder provided in capsules<br>Study product provided as peanut protein in pull-apart capsules | Biological: AR101 powder provided in capsules<br>* Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol<br>|
| Placebo Comparator: Placebo powder provided in capsules<br>Placebo formulation in pull-apart capsules containing only inactive ingredients | Biological: Placebo powder provided in capsules<br>* Study product formulated to contain only inactive ingredients for use as defined in the protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Subjects Who Tolerate at Least 300 mg (443 mg Cumulative) of Peanut Protein With no More Than Mild Symptoms at the Exit DBPCFC | 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) | 6-9 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Maximum Tolerated Dose of Peanut Protein at the Exit DBPCFC | The change in maximum tolerated dose of peanut protein from baseline (screening) to the Exit Double-Blind, Placebo-Controlled Food Challenge | 6-9 months | 
| Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC |  | 6-9 months | 
| Changes in Peanut-Specific IgE From Baseline to Exit DBPCFC |  | 6-9 months | 
| Changes in Peanut-Specific IgG4 From Baseline to Exit DBPCFC |  | 6-9 months | 
| Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter Results From Baseline |  | Baseline, 6-9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Characterized Peanut Allergen, Peanut, OIT, Oral Desensitization, Peanut Allergen, Allergy, Peanut Allergy, Peanut-Allergic Children, Children, Peanut-Allergic Adults