Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children (RAMSES)

Aimmune Therapeutics

Status and phase: Completed; Phase 3

Conditions: Peanut Allergy

Treatments: Biological: AR101; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03126227

ARC007

Details and patient eligibility

About

This is a multicenter, randomized, double-blind, placebo-controlled safety study of AR101 using the characterized oral desensitization immunotherapy (CODIT™) regimen in peanut-allergic children.

Full description

The primary objective is to assess the safety and tolerability of AR101 when used in a CODIT™ regimen for approximately 6 months in peanut-allergic children children aged 4 to 17 years, inclusive.

Enrollment: 506 patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Ages 4 to 17 years, inclusive
• History of physician-diagnosed peanut allergy that includes allergic signs and symptoms within two hours of known oral exposure to peanut
• Mean peanut wheal diameter on SPT of at least 8mm and elevated psIgE of at least 14 kUA/L at screening
• Written informed consent from the subject's parent/guardian
• Written assent from the subject as appropriate (per local regulatory requirements)
• Use of effective birth control by sexually active female subjects of childbearing potential

Key Exclusion Criteria:

• Subjects in whom the clinical diagnosis of peanut allergy is uncertain
• Severe or uncontrolled asthma
• 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
• 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 a mast cell disorder, including mastocytosis, urticaria pigmentosa, chronic idiopathic or chronic physical urticaria beyond simple dermatographism (e.g., cold urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema
• Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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506 participants in 2 patient groups, including a placebo group

AR101 Powder Provided in Capsules

Active Comparator group

Description:

Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol

Treatment:

Biological: AR101

Placebo powder

Placebo Comparator group

Description:

Placebo formulation in pull-apart capsules containing only excipients color-matched to AR101 study product.

Treatment:

Biological: Placebo