This is a multi-center, randomized, double-blind placebo controlled study of efficacy and safety of characterized peanut oral immunotherapy in peanut allergic individuals.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
56
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
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
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)
Time frame: 6-9 Months
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
Time frame: 6-9 months
Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC
Time frame: 6-9 months
Changes in Peanut-Specific IgE From Baseline to Exit DBPCFC
Time frame: 6-9 months
Changes in Peanut-Specific IgG4 From Baseline to Exit DBPCFC
Time frame: 6-9 months
Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter Results From Baseline
Time frame: Baseline, 6-9 months
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University of North Carolina
Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Medical Center Dallas
Dallas, Texas, United States