PEANUT ALLERGY STUDY IN CHILDREN
Research type
Research Study
Full title
AR101 TRIAL IN EUROPE MEASURING ORAL IMMUNOTHERAPY SUCCESS IN PEANUT ALLERGIC CHILDREN (ARTEMIS)
IRAS ID
224090
Contact name
George Du Toit
Contact email
Sponsor organisation
Aimmune Therapeutics, Inc.
Eudract number
2016-005004-26
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
This clinical trial aims to investigate and collect further information about whether the study drug, called AR101, is effective in reducing reactivity to peanut allergen in peanut-allergic children and adolescents - the age group most likely to be at a greater risk from accidental exposure.
Peanut allergy is a common and serious condition that often affects children and is commonly associated with severe reactions, including anaphylaxis, which is a severe and potentially life-threatening allergic reaction. Peanut allergy, unlike many other types of food allergy, is usually life-long, with approximately 80% of patients remaining peanut-allergic in adulthood.
The current standard of care in the management of food (and hence peanut) allergy is avoiding the allergenic food and teaching parents and patients how to manage allergic reactions, when they occur. Unfortunately, accidental ingestions remain common. Furthermore, avoiding the allergenic food can be complicated due to difficulty interpreting food labels and unknown ingredients in commercially prepared foods. Despite efforts at strict peanut avoidance, accidental exposure continues to be a major concern in peanut allergy, especially since allergic responses can be triggered after ingestion of trace amounts of peanut protein.
The study will consist of a Screening Phase, which includes an Entry Food Challenge, and a Treatment Phase, which includes an Initial Escalation Period, an Up-dosing Period, a Maintenance Period, and an Exit Food Challenge.
There will be approximately 160 participants in this study. Participants will be randomized 3:1 to peanut oral immunotherapy versus placebo. The study is being
carried out at multiple sites across Europe.REC name
South Central - Oxford B Research Ethics Committee
REC reference
17/SC/0122
Date of REC Opinion
18 Apr 2017
REC opinion
Further Information Favourable Opinion