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

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

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.

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