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

Phase 2

Completed

Interventions: Biological: Placebo powder provided in capsules
Biological: AR101 powder provided in capsules

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo powder provided in capsules	Placebo powder provided in capsules	Placebo formulation in pull-apart capsules containing only inactive ingredients
AR101 powder provided in capsules	AR101 powder provided in capsules	Study product provided as peanut protein in pull-apart capsules

Primary Outcome Measures

Name	Time	Method
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	6-9 Months	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)

Secondary Outcome Measures

Name	Time	Method
Changes in Peanut-Specific IgE From Baseline to Exit DBPCFC	6-9 months
Change From Baseline in Maximum Tolerated Dose of Peanut Protein at the Exit DBPCFC	6-9 months	The change in maximum tolerated dose of peanut protein from baseline (screening) to the Exit Double-Blind, Placebo-Controlled Food Challenge
Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at 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

Locations (8): University of North Carolina
🇺🇸
Chapel Hill, North Carolina, United States
Arkansas Children's Hospital
🇺🇸
Little Rock, Arkansas, United States
UC San Diego
🇺🇸
San Diego, California, United States
Boston Children's Hospital
🇺🇸
Boston, Massachusetts, United States
Mount Sinai Medical Center
🇺🇸
New York, New York, United States
Cincinnati Children's Hospital Medical Center
🇺🇸
Cincinnati, Ohio, United States
Children's Medical Center Dallas
🇺🇸
Dallas, Texas, United States
The Children's Hospital of Philadelphia
🇺🇸
Philadelphia, Pennsylvania, United States