AR101 Health-Related Quality of Life Study in Peanut-Allergic Subjects
Research type
Research Study
Full title
Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adolescents: Real-World, Open-Label, Quality of Life Study
IRAS ID
248389
Contact name
George Du Toit
Contact email
Sponsor organisation
Aimmune Therapeutics, Inc.
Eudract number
2018-000326-58
Duration of Study in the UK
1 years, 10 months, 30 days
Research summary
Peanut allergy is a common and serious condition that is associated with severe reactions, including life-threatening anaphylaxis. The prevalence of peanut allergy has risen in the Western world, estimated to be approximately 2-3% in children. Current standard of care (SoC) is peanut avoidance, education on recognition and management of allergy symptoms and appropriate use of rescue medications (e.g. adrenaline auto-injectors).
Despite strict peanut avoidance, accidental exposure remains a major concern; allergic responses may be triggered by minute quantities of peanut protein. Accidental food allergen exposures are common, with 55% of peanut-allergic patients experiencing at least 1 allergic reaction over approximately 5 years.
Currently, no treatment is registered for desensitising patients to peanut allergens. Aimmune Therapeutics, Inc. is developing AR101 (characterised peanut protein allergen, CPNA) oral immunotherapy (OIT). AR101 is used to induce clinically meaningful desensitisation to peanut protein, defined as the absence of moderate or severe allergic reaction following ingestion of small, but potentially dangerous, amounts of peanut protein. It is hoped this desensitisation will be sufficient to protect a peanut-allergic patient in case of accidental exposure to peanut while maintaining a peanut-avoidant diet. Clinical studies indicate that patients receiving AR101 achieve a clinically relevant level of desensitisation to peanut.
This open-label, quality of life study will compare health-related quality of life of AR101 characterised oral desensitisation immunotherapy (CODIT™) in combination with SoC versus SoC alone in peanut-allergic patients aged 4-17 years.
Approximately 200 patients across 45 centres in Europe will be enrolled. The total duration of treatment (AR101+SoC or SoC alone) is approximately 18months. The focus of the study is the quality of life benefit for patients on AR101. After 12 months in the study all patients will be tested to define the level of peanut protein exposure that can be tolerated.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
18/WM/0240
Date of REC Opinion
28 Sep 2018
REC opinion
Further Information Favourable Opinion