AR101 TRIAL IN EUROPE MEASURING ORAL IMMUNOTHERAPY SUCCESS IN PEANUT ALLERGIC CHILDREN (ARTEMIS).

Phase 1

• Conditions: Peanut allergy.; MedDRA version: 20.0 Level: LLT Classification code 10013289 Term: Disorders involving the immune mechanism System Organ Class: 100000004870; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2016-005004-26-IT
• Lead Sponsor: AIMMUNE THERAPEUTICS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-14
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 160

Inclusion Criteria

• Age 4 through 17 years (inclusive)
• Clinical history of allergy to peanuts or peanut-containing foods
• Serum IgE to peanut = 0.35 kUA/L, inclusive (as determined by UniCAP™ within the past 12 months) and/or a peanut SPT wheal diameter = 3 mm compared to control
• Experience DLS at or before the 300 mg (444 mg cumulative) challenge dose of peanut protein (measured as 600 mg of peanut flour) on Screening DBPCFC conducted in accordance with PRACTALL (Practical Issues in Allergology, Joint United States/European Union Initiative) guidelines
• Written informed consent from subject or parent/guardian for all subjects
• Written assent from minor subjects as appropriate (eg, above the age of 7 years or the applicable age per local regulatory requirements)
• Use of effective birth control by female subjects of child-bearing potential
Are the trial subjects under 18? yes
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• History of hemodynamically significant 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 GI disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD),
symptoms of dysphagia (eg, difficulty swallowing, food getting stuck”), or recurrent GI symptoms of undiagnosed etiology
• Current participation in any other interventional study and/or participation in another interventional clinical study within 30 days or 5 half-lives of the IP,
whichever is longer, prior to randomization
• Participation in, and having received active treatment in, any previous clinical study of AR101 CODIT™
• Participation in any peanut immunotherapy clinical study (including oral, sublingual, or epicutaneous) within 6 months prior to Screening
• Subject is in build-up phase” of immunotherapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified