PEANUT ALLERGY STUDY IN CHILDREN AND ADULTS
Research type
Research Study
Full title
PEANUT ALLERGY ORAL IMMUNOTHERAPY STUDY OF AR101 FOR DESENSITIZATION IN CHILDREN AND ADULTS (PALISADE)
IRAS ID
193839
Contact name
George Du Toit
Contact email
Sponsor organisation
Aimmune Therapeutics Inc.
Eudract number
2015-004257-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 7 months, 0 days
Research summary
This clinical trial aims to investigate whether the study drug, called AR101, is effective in reducing reactivity to peanut allergen in peanut-allergic children, adolescents and adults. This study will collect information about the effectiveness and safety of AR101 as an immunotherapy product for peanut-allergic children and adults.
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 500 participants in this study. Participants will be randomized 3:1 to peanut oral immunotherapy versus placebo. At least 80% of the participants randomized will be children.The study is being carried out at multiple sites around the world.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
16/LO/0361
Date of REC Opinion
13 Apr 2016
REC opinion
Further Information Favourable Opinion