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

Aimmune Therapeutics, Inc.506 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

506

Conditions

Peanut Allergy

Interventions

AR101BIOLOGICAL

AR101 powder provided in capsules

PlaceboBIOLOGICAL

Placebo powder provided in capsules

Eligibility

Sex: ALLMin age: 4 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (67)

Outcomes

Primary Outcomes

Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events

Frequency of Treatment Emergent Adverse Events, including Serious Adverse Events, during the overall study period. Treatment-emergent adverse events were defined as adverse events with onset after the first dose of study product.