A Phase 2 interventional study of Epicutaneous Immunotherapy and placebo of peanut in Peanut Allergy, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2, Interventional, and Treatment
This study aims at showing that Epicutaneous Immunotherapy with peanut proteins is safe and efficacious for desensitizing children with peanut allergy.
Peanut allergy is a common allergy in the United Sates, with prevalence in the general population as high as 1%. Peanut allergy starts in childhood, its prevalence in children has doubled in the past 5 years, and barely 20% of the allergic children will outgrow this allergy So far, the only treatments available for peanut allergy are avoidance of peanut and injectable epinephrine after the allergic systemic reactions have started. Immunotherapy methods currently available have shown some limitations in their use because of important safety issues. Hence, there is an important unmet medical need for efficient and safe treatment of peanut allergy.
DBV Technologies, is a French biotech company which has developed an Epicutaneous Delivery System, called Viaskin®, a method based on delivering precise quantity of allergens on the upper layers of the skin, i.e. on the epidermis and without any passage in the vascularised dermis. Avoiding contact between the allergens and the bloodstream should confer to epicutaneous immunotherapy (EPIT) a high level of safety as systemic reactions are circumvented.
The goal of this pilot study is to demonstrate that epicutaneous immunotherapy (EPIT) with Viaskin® is safe and efficacious for the desensitization of peanut-allergic children, i.e. increasing the quantity of peanut proteins they can consume symptom-free.
Fifty-two (52) children from 5 to 17 years of age with a confirmed peanut allergy during a baseline double blind placebo-controlled food challenge (DBPCFC) (reacting to a capped value below 250 mg of peanut proteins) will be randomized 1 to 1 and treated either with DBV712, the Viaskin® disk loaded with 100 mcg peanut proteins (active treatment), or with placebo, the Viaskin® disk loaded with a placebo formulation devoid of peanut. Each child will receive one application of one Viaskin® on the skin every day repeatedly for 6 months in a blinded manner, followed by a 12-month open treatment with DBV712 for all of them; placebo children will all cross-over after the first 6 months of treatment to also receive the active treatment.
A DBPCFC to peanut will then be conducted after every 6 months of treatment to assess the efficacy of the treatment. Safety will be assessed during the whole study period.
Skin testing, peanut-specific IgE and IgG4 will occur at selected visits
166 studies on the registry are indexed under Peanut Hypersensitivity; 27 are open to participants now.
This study's enrollment of 60 is above the median of 50 across 127 interventional studies indexed under Peanut Hypersensitivity.
Browse Peanut Hypersensitivity studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
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Exclusion criteria :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
100 mcg DBV712 administered epicutaneously every 24 hours.
Biological: Epicutaneous Immunotherapy
Placebo will be administered epicutaneously every 24 hours
Biological: placebo of peanut
100 mcg peanut proteins (active arm) applied on the skin every 24 hrs for 6 months blinded, followed by 12 months open treatment for all patients in the active arm
placebo applied on the skin every 24 hrs for 6 months blinded, followed by 12 months open treatment for all patients in the active arm
Proportion of patients able to consume >1000 mg of peanut proteins symptom-free
Proportion of patients able to consume \>1000 mg of peanut proteins symptom-free during the double blind placebo-controlled food challenges (DBPCFC) to peanut at 6 months, or who have a 10-fold increase in the quantity of peanut proteins consumed as compared to baseline value
Time frame: 6 months
Description of the level of Ig
* Level of Peanut-specific IgE at 3 months and 6 months in both groups of treatment. * Level of Peanut-specific IgG4 at 3 months and 6 months in both groups of treatment. * Evolution of peanut-specific IgE between Day-21 and 12 months and between Day-21 and 18 months for each subject in both groups. * Evolution of Peanut-specific IgG4 between Day-21 and 12 months and between Day-21 and 18 months for each subject in both groups.
Time frame: 6 months
Proportion of patients able to consume >1000 mg of peanut proteins symptom-free
-Proportion of patients able to consume \>1000 mg of peanut proteins symptom-free during the double blind placebo-controlled food challenges (DBPCFC) to peanut at 12 months
Time frame: 12 months
Proportion of patients able to consume >1000 mg of peanut proteins symptom-free
-Proportion of patients able to consume \>1000 mg of peanut proteins symptom-free during the double blind placebo-controlled food challenges (DBPCFC) to peanut at 18 months
Time frame: 18 months
diameter and safety
* Diameter of the wheal of the Skin Prick tests to peanut at month 3 and month 6 in both groups * Diameter of the wheal of the Skin Prick tests to peanut at 12 and 18 months for each subject in both groups * Safety and tolerability of the epicutaneous administration of peanut proteins to peanut allergic children at 6, 12 and 18 months
Time frame: 3, 6, 12 and 18 months
The record gives a start of Aug 2010, a primary completion of Feb 2015 and a completion of Apr 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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