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Keep this study
Lead
Aimmune Therapeutics, Inc.
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.
Age
4–26
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
