ARTEMIS Peanut Allergy In Children

Aimmune Therapeutics

Status and phase: Completed; Phase 3

Conditions: Peanut Allergy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03201003

ARC010

Details and patient eligibility

About

The purpose of this study is to demonstrate the efficacy and safety of AR101 through oral immunotherapy (OIT) in peanut-allergic children.

Full description

This is a European, multicenter, double-blind, randomized, placebo-controlled 2-arm study of the efficacy and safety of AR101 in peanut-allergic children.

Enrollment: 175 patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Age 4 to 17 years, inclusive
• Clinical history of allergy to peanuts
• Serum SPT ≥ 3 mm greater than control and/or psIgE ≥ 0.35 kUa/L
• Dose limiting symptoms after consuming a single dose of peanut protein ≤ 300 mg
• 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:

• History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
• 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 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: Quadruple Blind

---

175 participants in 2 patient groups, including a placebo group

AR101

Active Comparator group

Description:

AR101 powder provided in capsules \& sachets

Treatment:

Biological: AR101 powder provided in capsules & sachets

Placebo

Placebo Comparator group

Description:

Placebo powder provided in capsules \& sachets

Treatment:

Other: Placebo powder provided in capsules & sachets