POSEIDON
Research type
Research Study
Full title
Peanut Oral Immunotherapy Study of Early Intervention for Desensitization (POSEIDON)
IRAS ID
261131
Contact name
Vibha Sharma
Contact email
Sponsor organisation
Aimmune Therapeutics, Inc.
Eudract number
2018-001749-15
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
15463, Investigational New Drug (IND) number:
Duration of Study in the UK
2 years, 4 months, 30 days
Research summary
Summary of Research
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 as approximately 2-3% in children. Current standard of care is peanut avoidance, education on recognition and management of allergy symptoms and 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 5years.
Currently, there is no treatment for desensitising patients to peanut allergens. Therefore, a significant unmet medical need remains for an effective treatment for peanut allergy.
Although allergic reactions can be dangerous at any age, young children are particularly vulnerable because they may not be able to understand or communicate what they are feeling when experiencing an allergic reaction. Initiation of peanut allergen exposure using oral immunotherapy (OIT) in early life may have unique benefits for children at high risk of developing a peanut allergy.
Aimmune Therapeutics, Inc. is developing AR101 (characterised peanut protein allergen, CPNA) OIT. AR101 is used to induce clinically meaningful desensitisation to peanut protein, defined as no more than mild symptoms following ingestion of small but potentially dangerous amounts of peanut protein. It is expected this desensitisation will be sufficient to protect peanut-allergic patients in case of accidental exposure to peanut while maintaining peanut-avoidance. Clinical studies indicate that patients receiving AR101 achieve clinically relevant desensitisation to peanut.
This double-blind, placebo-controlled study will determine the efficacy and safety of AR101 characterised oral desensitisation immunotherapy (CODIT™) compared with placebo in peanut-allergic children aged 1 to <4years.
Approximately 105 patients in North America and Europe will be enrolled. The total duration of treatment is approximately 12 months for each participant.
Summary of Results
At the end of this study, more toddlers (68.4%) treated with AR101 could tolerate at least 1,000 mg of peanut protein (roughly 3-4 peanuts depending on the size of the peanuts), with no more than mild symptoms, compared to those treated with placebo (4.2%).
There were no serious side effects that made patients stop the study and no deaths.
However, 6.1% of toddlers treated with AR101 discontinued participation in the study because of side effects(most often due to gastrointestinal symptoms such as abdominal pain, vomiting, and/or diarrhoea), compared to none in the placebo group. Allergic reactions due to treatment and involving several organs occurred in 2% of toddlers on AR101 and 0% on placebo, though none of these reactions resulted in discontinuation of AR101.
The most common side effects related to the treatment included skin symptoms (hives, redness, itchiness) and gastrointestinal symptoms (abdominal pain, vomiting, diarrhoea).REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
19/YH/0097
Date of REC Opinion
21 May 2019
REC opinion
Further Information Favourable Opinion