Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen OIT (ARC001)

Aimmune Therapeutics

Status and phase: Completed; Phase 2

Conditions: Peanut Allergy

Treatments: Biological: Placebo powder provided in capsules; Biological: AR101 powder provided in capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT01987817

ARC001

Details and patient eligibility

About

This is a multi-center, randomized, double-blind placebo controlled study of efficacy and safety of characterized peanut oral immunotherapy in peanut allergic individuals.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 4 to 26 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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56 participants in 2 patient groups, including a placebo group

AR101 powder provided in capsules

Experimental group

Description:

Study product provided as peanut protein in pull-apart capsules

Treatment:

Biological: AR101 powder provided in capsules

Placebo powder provided in capsules

Placebo Comparator group

Description:

Placebo formulation in pull-apart capsules containing only inactive ingredients

Treatment:

Biological: Placebo powder provided in capsules