Peanut AllergyPhase 2ARACHILDNCT01197053
Epicutaneous Immunotherapy in Peanut Allergy in Children
A Phase 2 study testing Epicutaneous Immunotherapy in people with Peanut Allergy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This study aims at showing that Epicutaneous Immunotherapy with peanut proteins is safe and efficacious for desensitizing children with peanut allergy. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- Epicutaneous Immunotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2010to Apr 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or Female between 5 and 17 years of age at enrollment
- An efficient contraceptive method for girls with childbearing potential. Acceptable methods include sexual abstinence, oral, injectable contraceptive methods, intra uterine device.
- Negative pregnancy test for girls with childbearing potential.
- Child with a documented allergy to peanut, i.e. with peanut-specific IgE (>5KU/L, ImmunoCAP method) and/or a positive skin prick test to peanut (wheal diameter ≥ 8mm).
- Child able to consume a cumulated quantity of peanut proteins <250 mg during the baseline DBPCFC.
- Child and his/her legal representative(s) who provide a signed consent form and assent form.
- Child and his/her legal representative(s) whose family and social conditions allow them to understand the protocol and agree to comply in the long term with all study requirements.
Who cannot join
- Child considered too severely allergic to peanut: with a history of severe anaphylaxis to peanut (with hypotension, loss of consciousness, severe bradycardia, respiratory or cardiac arrest requiring an admission to emergency rooms).
- Child with peanut-specific IgE<5 KU/L and whose skin prick test to peanut gave a wheal diameter <8mm).
- Child participating or having participated in a therapeutic study in the last 3 months
- Pregnancy or Breastfeeding
- Child with a generalized eczema
- Child with an immune deficiency
Show all 16Show fewer
- Diabetic child
- Child allergic to chocolate
- Child or legal representative(s) who did not sign their consent or assent
- Child with no baseline DBPCFC
- Child having reacted to placebo during the baseline DBPCFC
- Child able to consume > 250 mg of cumulated peanut proteins during the baseline DBPCFC
- Child with a respiratory deficiency or with an uncontrolled asthma.
- Child who could not discontinue oral or I.V. antihistamines or oral or I.V. corticosteroids at least the week prior to Visit 1.
- Child with important skin lesions precluding the application of the disks.
- Child not affiliated to social security.
Trial locations and contacts
1 site in 1 country.
About this study
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
This study aims at showing that Epicutaneous Immunotherapy with peanut proteins is safe and efficacious for desensitizing children with peanut allergy.
Read the detailed description
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
- Conditions
- Peanut Allergy
- Being tested
- Epicutaneous Immunotherapy, placebo of peanut
- Keywords
- Peanut Allergy, Food Allergy, Epicutaneous Immunotherapy (EPIT), Food Challenge
- Medical subject headings
- Peanut Hypersensitivity, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epicutaneous ImmunotherapyBiological
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 of peanutBiological
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
| Study group | Role | What they receive |
|---|---|---|
| 100 mcg DBV712 (active) | Experimental | 100 mcg DBV712 administered epicutaneously every 24 hours. Receives: Biological: Epicutaneous Immunotherapy |
| Placebo | Placebo comparator | Placebo will be administered epicutaneously every 24 hours Receives: Biological: placebo of peanut |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (4)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 3, 6, 12 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionFeb 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- DBV Technologies, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Christophe Dupont, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197053
- Sponsor's protocol ID
- P091102
- Other IDs
- 2010-019541-26, A100293-36
- Acronym
- ARACHILD
- Status last verified
- Aug 2026
- First submitted
- 7 Sep 2010
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Christophe Dupont, Thierry Bourrier, Frederic de Blay, Lydie Guénard-Bilbault, Christine Sauvage, Marie-Odile Cousin, Gisèle Kanny, Sophie Jarlot, Chantal Karila,Peanut Epicutaneous Immunotherapy (EPIT) In Peanut-Allergic Children: 18 Months Treatment In The Arachild Study,Journal of Allergy and Clinical Immunology
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01197053
- Acronym / sponsor ID
- ARACHILD / P091102
- Conditions
- Peanut Allergy
- Keywords
- Peanut Allergy, Food Allergy, Epicutaneous Immunotherapy (EPIT), Food Challenge
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- DBV Technologies, URC-CIC Paris Descartes Necker Cochin
- Study start
- Aug 2010
- Primary completion
- Feb 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 9 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims at showing that Epicutaneous Immunotherapy with peanut proteins is safe and efficacious for desensitizing children with peanut allergy.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 100 mcg DBV712 (active) | Experimental | Biological: Epicutaneous Immunotherapy100 mcg DBV712 administered epicutaneously every 24 hours. |
| Placebo | Placebo comparator | Biological: placebo of peanutPlacebo will be administered epicutaneously every 24 hours |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Male or Female between 5 and 17 years of age at enrollment
- An efficient contraceptive method for girls with childbearing potential. Acceptable methods include sexual abstinence, oral, injectable contraceptive methods, intra uterine device.
- Negative pregnancy test for girls with childbearing potential.
- Child with a documented allergy to peanut, i.e. with peanut-specific IgE (>5KU/L, ImmunoCAP method) and/or a positive skin prick test to peanut (wheal diameter ≥ 8mm).
- Child able to consume a cumulated quantity of peanut proteins <250 mg during the baseline DBPCFC.
Key exclusion criteria (16 listed)
- Child considered too severely allergic to peanut: with a history of severe anaphylaxis to peanut (with hypotension, loss of consciousness, severe bradycardia, respiratory or cardiac arrest requiring an admission to emergency rooms).
- Child with peanut-specific IgE<5 KU/L and whose skin prick test to peanut gave a wheal diameter <8mm).
- Child participating or having participated in a therapeutic study in the last 3 months
- Pregnancy or Breastfeeding
- Child with a generalized eczema
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epicutaneous Immunotherapy100 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 | Biological | 100 mcg DBV712 (active) |
| placebo of peanutplacebo applied on the skin every 24 hrs for 6 months blinded, followed by 12 months open treatment for all patients in the active arm | Biological | Placebo |
Primary outcome
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
4 secondary outcomes
Description of the level of Ig
Time frame: 6 months
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
Time frame: 18 months
diameter and safety
Time frame: 3, 6, 12 and 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Results publicationChristophe Dupont, Thierry Bourrier, Frederic de Blay, Lydie Guénard-Bilbault, Christine Sauvage, Marie-Odile Cousin, Gisèle Kanny, Sophie Jarlot, Chantal Karila,Peanut Epicutaneous Immunotherapy (EPIT) In Peanut-Allergic Children: 18 Months Treatment In The Arachild Study,Journal of Allergy and Clinical Immunology
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe Dupont, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epicutaneous Immunotherapy in people with Peanut Allergy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients able to consume >1000 mg of peanut proteins symptom-free (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01197053, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.