Clinical Trial Details

NCT ID: NCT03201003
Date Last Changed: September 28, 2017

Overview

Research Study Summary

A clinical trial to evaluate treatments using AR101 and Placebo for patients with Peanut Allergy

Research Study Title

AR101 Trial in Europe Measuring Oral Immunotherapy Success in Peanut Allergic Children (ARTEMIS)

Purpose

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

To Learn more

Recruitment Details

Phase
3
Gender
All
Age
4 to 17 Years
Overall Status
Recruiting
Lead Sponsor
Aimmune Therapeutics, Inc.
Duration
18 Months
Facility Type
N/A
Compensation

Eligibility

All ages 4 Years to 17 Years

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 at or before 444 mg cumulative peanut protein at the Screening DBPCFC

  • 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 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

Site Locations (5)

Country State City Zip Facility and Contact
Ireland Cork UCC Dept. of Paediatrics and Child, Cork University Hospital
United Kingdom London SE1 7EH Guy & St Thomas' Hospital, NHS Foundation Trust
United Kingdom London W2 1NY St. Mary's Hospital
United Kingdom Manchester M13 9WL Royal Manchester Children's Hospital
United Kingdom Southampton SO16 6YD University Hospitals Southampton Foundation NHS Trust

Contact

Kate McKeown
650-362-8705
E-mail:

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