Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)

Aimmune Therapeutics

Status and phase: Completed; Phase 3

Conditions: Peanut Allergy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02635776

ARC003

Details and patient eligibility

About

The purpose of this study is to demonstrate the efficacy and safety of AR101 through reduction in clinical reactivity to peanut allergen in peanut-allergic children and adults.

Full description

This is an international, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of AR101 in a characterized desensitization oral immunotherapy regimen in peanut-allergic individuals.

Enrollment: 555 patients

Sex: All

Ages: 4 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Age 4 through 55 years
• Clinical history of allergy to peanuts or peanut-containing foods
• Serum immunoglobulin E (IgE) to peanut ≥0.35 kUA/L (kilos of allergen-specific units per liter, determined by UniCAP™* within the past 12 months) and/or a skin prick test (SPT) to peanut ≥3 mm compared to control
• Experience dose-limiting symptoms at or before the 100 mg challenge dose of peanut protein (measured as 200 mg of peanut flour) on Screening DBPCFC conducted in accordance with PRACTALL** guidelines
• Not be residing at the same address as another subject in this or any peanut OIT study

UniCAP™*: a laboratory system for routine diagnostic testing of allergy and tool for basic studies on allergens and antibodies

PRACTALL**: PRACTical issues in ALLergology Joint United States/European Union Initiative

Key Exclusion Criteria:

• History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
• History of severe or life-threatening episode of anaphylaxis or anaphylactic shock within 60 days of Screening DBPCFC
• History of chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) that is, or is at significant risk of becoming, unstable or requiring a change in chronic therapeutic regimen
• History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD), symptoms of dysphagia or recurrent gastrointestinal symptoms of undiagnosed etiology
• History of severe asthma (NHLBI criteria steps 5 or 6), or mild to moderate asthma (2007 NHLBI criteria steps 1-4) that is uncontrolled or difficult to control
• History of steroid medication use
• History of a mast cell disorder, including mastocytosis, urticarial pigmentosa, and hereditary or idiopathic angioedema
• Developing dose-limiting symptoms in reaction to the placebo part of the Screening DBPCFC
• Having the same place of residence as another subject in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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555 participants in 2 patient groups, including a placebo group

AR101 powder provided in capsules & sachets

Experimental group

Description:

Study product provided as peanut protein in pull-apart capsules or sachets

Treatment:

Biological: AR101 powder provided in capsules & sachets

Placebo powder provided in capsules & sachets

Placebo Comparator group

Description:

Placebo formulation in pull-apart capsules or sachets containing only inactive ingredients

Treatment:

Biological: Placebo powder provided in capsules & sachets