The EPITOPE Study
Research type
Research Study
Full title
A double-blind, placebo-controlled, randomized phase III trial to assess the safety and efficacy of Viaskin® Peanut in peanut-allergic young children 1-3 years of age (EPITOPE study)
IRAS ID
258058
Contact name
Paul Turner
Contact email
Sponsor organisation
DBV TECHNOLOGIES S.A.
Eudract number
2016-003679-23
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
14366, IND
Duration of Study in the UK
1 years, 4 months, 17 days
Research summary
Summary of Research
Peanut allergy is the most common cause of death from food allergies. It is estimated that around 1 in 30 children in the UK are allergic to peanuts or tree nuts. Peanut allergy might resolve in about 20% of patients but may recur making this allergy a life-long affliction. The reactions after exposure to peanuts affect(s) different parts of the body, such as the skin, lungs, intestines, heart and nervous system. The only treatment for severe allergic reactions is an injection of adrenaline administered in the thigh. There are no recommended medications for prevention of allergic reactions. The only way to prevent it is a strict peanut avoidance.
Viaskin® Peanut is a medication administered using a patch, containing a dry extract of peanut proteins, applied on the skin. It is designed to desensitise a peanut-allergic person by repeated exposures to very low amounts of peanut. The objective is to prevent/minimise the severity of the allergic reaction(s) if peanuts are eaten accidentally.
The study is being conducted in two parts, approximately 400 children will take part globally. In Part A patient enrolment has been completed. The safety of Viaskin® Peanut was assessed and the highest safe dose (Viaskin® Peanut 250 µg) was selected for use in Part B. Part B will be conducted in the UK to evaluate the efficacy and safety of Viaskin® Peanut 250 µg administered for 12 months in young children aged between 1 and 3 years with peanut allergy.
The study will be conducted at 20-40 sites globally, with Investigators experienced in the management of peanut allergy and anaphylaxis. The maximum study duration for each participant is approximately 60 weeks. Most of the assessments performed in the study are routine tests performed in peanut allergic children. Some tests may be done more frequently than standard practice.
Summary of Results
This will be made available on https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agba4yu73OCS9U-2BkKS40W1kfbzSmdWCVTTDSfM-2Bp8ODc89gHBB_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YLtK0gYRmJHtF6xXtiqLT4D4SPMu7BByip3ozMV260VLw3IF-2FJ8aRDfBlLZO5A5v7mdlZWzXfGhhvdvwyu4eyx-2BfSwsNTjk-2Fp32GD0QC9SLkOBLIxGTMsrMizVDAO7T9EfrDyrnTnHUYDHLXKI6NRnwjosWf74KCSwiHp6yOGHCFQ-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7Cdd7050c54df6457b20c208daf3ebaec3%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638090490813195949%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=HTxHe8rbt7%2BZDfc3jJGpdrnaPUIB2G1EQbxDcD78wbE%3D&reserved=0 by 31-Mar-2023.
REC name
London - Hampstead Research Ethics Committee
REC reference
19/LO/0150
Date of REC Opinion
8 Mar 2019
REC opinion
Further Information Favourable Opinion