Epicutaneous Immunotherapy in Peanut Allergy in Children (ARACHILD)
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|ClinicalTrials.gov Identifier: NCT01197053|
Recruitment Status : Completed
First Posted : September 9, 2010
Last Update Posted : October 20, 2015
|Condition or disease||Intervention/treatment||Phase|
|Peanut Allergy||Biological: Epicutaneous Immunotherapy Biological: placebo of peanut||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||ARACHILD: A Multicentric, Double Blind Placebo-controlled Pilot Protocol to Study the Efficacy and Safety of an Epicutaneous Immunotherapy in Children Allergic to Peanut|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||April 2015|
Experimental: 100 mcg DBV712 (active)
100 mcg DBV712 administered epicutaneously every 24 hours.
Biological: Epicutaneous Immunotherapy
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 Comparator: Placebo
Placebo will be administered epicutaneously every 24 hours
Biological: placebo of peanut
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 [ Time Frame: 6 months ]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
- Description of the level of Ig [ Time Frame: 6 months ]
- 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.
- Proportion of patients able to consume >1000 mg of peanut proteins symptom-free [ Time Frame: 12 months ]-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
- Proportion of patients able to consume >1000 mg of peanut proteins symptom-free [ Time Frame: 18 months ]-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
- diameter and safety [ Time Frame: 3, 6, 12 and 18 months ]
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01197053
|Paris, France, 75015|
|Principal Investigator:||Christophe Dupont, MD, PhD||Assistance Publique - Hôpitaux de Paris|