Title
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
Phase
Phase 2Lead Sponsor
Aimmune TherapeuticsStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Peanut AllergyIntervention/Treatment
ar101 ...Study Participants
56This 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 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
Study product provided as peanut protein in pull-apart capsules
Placebo formulation in pull-apart capsules containing only inactive ingredients
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
| Event Type | Organ System | Event Term | AR101 Powder Provided in Capsules | Placebo Powder Provided in Capsules |
|---|
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)
The change in maximum tolerated dose of peanut protein from baseline (screening) to the Exit Double-Blind, Placebo-Controlled Food Challenge
