Peanut AllergyPhase 1NCT01170286
Safety of Epicutaneous Immunotherapy for the Treatment of Peanut Allergy
A Phase 1 study testing Whole peanut extract in people with Peanut Allergy, run by DBV Technologies at 5 sites in United States.
Trial summary
The purpose of this phase 1b study is to evaluate the safety and tolerability of repeated epicutaneous applications of peanut proteins using a patch delivery system (Viaskin device) in peanut allergic subjects. Read more about this study
- Who is it for?
- Ages 6 to 50 years
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- Whole peanut extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2010to Feb 2012
- Phase
- Phase 1
- 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 6 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or Female age 6 to 50 years at enrollment, any race, and any ethnicity.
- Physician-diagnosed peanut allergy or convincing history of peanut allergy regardless of the degree of the reaction. Subjects with history of severe anaphylaxis to peanuts (Grades 4 or 5 with dyspnea, cyanosis, hypoxia, hypotension, or neurological compromise) can be enrolled only after assessment of the safety of DBV712 Viaskin in subjects with historic non-severe anaphylaxis (Grade≤3).
- A peanut-specific IgE measured by ImmunoCAP >0.7 kU/L for all subjects and a positive skin prick test to peanut with a wheal diameter >8 mm for all non-severe subjects. A skin prick test to peanut for severe subjects will be performed only if deemed necessary by the investigator.
- Use of an effective method of contraception by females of childbearing potential and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study. Women who have had a hysterectomy or tubal ligation at least 6 months prior to the screening visit or who have been post-menopausal for at least 1 year prior to the screening visit are not considered to be of childbearing potential.
- Ability to perform spirometry maneuvers in accordance with the American Thoracic Society guidelines (1994).
- Able to understand the protocol and willing to comply with all study requirements during participation in the study.
- Provide signed informed consent and assent as appropriate.
Who cannot join
- Participation in a study using an investigational new drug in the last 30 days prior to the screening visit.
- Participation in any interventional study for the treatment of food allergy in the past 6 months prior to the screening visit.
- Pregnancy or lactation.
- Allergy or known hypersensitivity to the Viaskin patch or adhesives.
- Severe or poorly controlled atopic dermatitis or generalized eczema.
- FEV1 value <80% predicted or any clinical features of moderate or severe persistent asthma at baseline and treated by doses greater than high daily doses of inhaled corticosteroids (as defined in dosing tables from the 2007 NHLBI guidelines).
Show all 18Show fewer
- Use of steroid medications in the following manners: history of daily oral steroid dosing for >1 month during the past year, or burst oral steroid course in the past 6 months, or >1 burst oral steroid course in the past year, prior to the screening visit. Use of oral steroids as described above after the screening visit and before randomization will render the subject non eligible for randomization.
- Asthma requiring 1 or more hospitalization(s) in the past year or >1 emergency department visit in the past 6 months, prior to the screening visit. Occurrence of asthma in these conditions after the screening visit and before randomization will render the subject non eligible for randomization.
- Use of omalizumab or immunomodulatory or biologic therapy in the past year prior to the screening visit.
- Use of nontraditional forms of allergen immunotherapy (such as oral immunotherapy or sublingual immunotherapy) in the past year prior to the screening visit.
- Use of subcutaneous immunotherapy other than a stable maintenance dose for less than a year prior to the screening visit.
- Use of beta-blockers, angiotensin-converting enzyme inhibitors, or angiotensin-receptor blockers.
- Inability to discontinue antihistamines for at least 1 week to allow skin testing at the screening visit.
- History of alcohol or drug abuse.
- Uncontrolled hypertension.
- History of cardiovascular disease, arrhythmias, chronic lung disease, active eosinophilic gastrointestinal disease, malignancy, psychiatric illness, or any other medical or surgical conditions which, in the opinion of the investigator, place the subject at increased risk for participation in this study.
- Inability or unwillingness to sign informed consent or to provide assent (as appropriate).
- Inability to speak English, including caretakers of participants when the participant is a child.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
National Jewish Health
Denver, Colorado, 80206
Duke University Medical Center
Durham, North Carolina, 27710
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Aspen Clinical Research
Orem, Utah, 84058
CRI Worldwide
Willingboro, New Jersey, 08046
About this study
Official title: Epicutaneous Immunotherapy (EPIT) for Peanut Allergy: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Safety Study in Adult and Pediatric Subjects
The purpose of this phase 1b study is to evaluate the safety and tolerability of repeated epicutaneous applications of peanut proteins using a patch delivery system (Viaskin device) in peanut allergic subjects.
Read the detailed description
Peanut allergy is a common allergy in the United States, with a prevalence in the general population as high as 1%. So far, there is no approved treatment of peanut allergy. Peanut allergy management is based on strict peanut avoidance and injectable epinephrine after the allergic systemic reactions have started. Specific Immunotherapy methods currently available have shown some limitations in their use because of safety issues. Hence, there is an important unmet medical need for efficient and safe treatment of peanut allergy.
DBV Technologies has developed an epicutaneous delivery system, called Viaskin, a method based on delivering precise quantity of the allergen on the upper layers of the skin. Avoiding contact between the allergen and the bloodstream should confer to epicutaneous immunotherapy (EPIT) a higher level of safety as systemic reactions should be circumvented.
The aim of this phase 1b study is to evaluate the safety and tolerability of the epicutaneous immunotherapy method in subjects allergic to peanut. The trial will randomize 110 participants. Four doses of peanut proteins, 20 mcg, 100 mcg, 250 mcg and 500 mcg will be repeatedly delivered on the skin by dose escalation in consecutive cohorts of 5 subjects, starting with the lowest dose. In each cohort of 5, 4 subjects will receive peanut proteins and one will receive placebo in a blinded manner. For each dose, the peanut proteins will be applied on the skin either every day or every other day. The total duration of the treatment for each subject is 2 weeks. Firstly, adult subjects (18 to 50 years) with a history of non-severe anaphylaxis to peanut (Grade ≤3) will enroll and safety information be reviewed. If there are no major concerns, adolescent cohorts (12 to 17 years) with history of non-severe anaphylaxis to peanut will then enroll and safety again be reviewed. If there are no concerns, then child cohorts (6 to 11 years) with history of non-severe anaphylaxis to peanut will finally enroll.
Also, after the safety review of the treated adult non-severe cohorts is satisfactorily performed, adult subjects with a history of severe anaphylaxis to peanut (Grades 4 or 5) will enroll and dose escalation will undergo.
For the safety review, all the following parameters will be checked at each patient visit: physical examination, vital signs, skin examination, lab values, PEF values. FEV1, skin prick test to peanut and peanut-specific IgE values will also be determined at screening and end of treatment visits.
- Conditions
- Peanut Allergy
- Being tested
- Whole peanut extract, Placebo formulation
- Keywords
- Food allergy, Immediate hypersensitivity, Whole peanut extract, Allergenic product, Specific Immunotherapy, Epicutaneous Immunotherapy (EPIT), Safety
- Medical subject headings
- Peanut Hypersensitivity, Food Hypersensitivity, Hypersensitivity, Immediate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole peanut extractBiological
Also called DBV712 Viaskin
Four different doses of whole peanut extract expressed as micrograms (mcg) of peanut proteins (20, 100, 250, 500 mcg) and two different dosing regimen (epicutaneous application for 24 hours every 24 hours and epicutaneous application for 48 hours every 48 hours) will be tested for determination of the maximum tolerated dose during a 2-week treatment period.
Placebo formulationBiological
Also called Placebo Viaskin
Matching placebo at two different dosing regimen (epicutaneous application for 24 hours every 24 hours and epicutaneous application for 48 hours every 48 hours) will be tested in parallel to the peanut proteins doses for determination of the maximum tolerated dose during a 2-week treatment period.
| Study group | Role | What they receive |
|---|---|---|
| DBV712 Viaskin | Experimental | The experimental arm is composed of subjects treated with whole peanut extract on an epicutaneous delivery system (Viaskin patch) Receives: Biological: Whole peanut extract |
| Placebo Viaskin | Placebo comparator | The placebo arm is composed of subjects treated with a placebo formulation on an epicutaneous delivery system (Viaskin patch) Receives: Biological: Placebo formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety evaluation
The primary outcome measure is safety and the subjects will undergo the following procedures: physical examination including patch application site examination for evaluation of any skin reaction, vital signs, blood and urine collection for blood and urine analysis, ECG, Peak Expiratory Flow and spirometry (FEV1).
Adverse events, treatment-emergent adverse events, and serious adverse events will be classified according to severity, treatment relatedness, the system/organ class affected, and the countermeasures taken.
Measured: Safety evaluation to be performed at each visit during the 2-week treatment and at the follow-up visit one week after the end of treatment.
Secondary outcomes (1)
Systemic reactions evaluation and treatment; treatment adherence
Secondary outcomes:
- The proportion of subjects that experience systemic reactions such as urticaria, asthma and acute dyspnea, change in blood pressure, and digestive symptoms (vomiting, diarrhea) associated with experimental treatment versus placebo.
- The proportion of subjects requiring treatment for systemic reactions related to experimental treatment or placebo.
- Overall adherence to the study treatment
Measured: Safety evaluation to be performed at each visit during the 2-week treatment and at the follow-up visit one week after the end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionFeb 2012
- Study completionFeb 2012
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- DBV Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170286
- Sponsor's protocol ID
- PEP01.09
- Status last verified
- Mar 2012
- First submitted
- 24 Jul 2010
- Last updated
- 23 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jones SM, Agbotounou WK, Fleischer DM, Burks AW, Pesek RD, Harris MW, Martin L, Thebault C, Ruban C, Benhamou PH. Safety of epicutaneous immunotherapy for the treatment of peanut allergy: A phase 1 study using the Viaskin patch. J Allergy Clin Immunol. 2016 Apr;137(4):1258-1261.e10. doi: 10.1016/j.jaci.2016.01.008. Epub 2016 Feb 24. No abstract available.
PubMed 26920463
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epicutaneous Immunotherapy (EPIT) for Peanut Allergy: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Safety Study in Adult and Pediatric Subjects
- ClinicalTrials.gov ID
- NCT01170286
- Acronym / sponsor ID
- PEP01.09
- Conditions
- Peanut Allergy
- Keywords
- Food allergy, Immediate hypersensitivity, Whole peanut extract, Allergenic product, Specific Immunotherapy, Epicutaneous Immunotherapy (EPIT), Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- DBV TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 27 Jul 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.
The purpose of this phase 1b study is to evaluate the safety and tolerability of repeated epicutaneous applications of peanut proteins using a patch delivery system (Viaskin device) in peanut allergic subjects.
Detailed description
Peanut allergy is a common allergy in the United States, with a prevalence in the general population as high as 1%. So far, there is no approved treatment of peanut allergy. Peanut allergy management is based on strict peanut avoidance and injectable epinephrine after the allergic systemic reactions have started. Specific Immunotherapy methods currently available have shown some limitations in their use because of safety issues. Hence, there is an important unmet medical need for efficient and safe treatment of peanut allergy.
DBV Technologies has developed an epicutaneous delivery system, called Viaskin, a method based on delivering precise quantity of the allergen on the upper layers of the skin. Avoiding contact between the allergen and the bloodstream should confer to epicutaneous immunotherapy (EPIT) a higher level of safety as systemic reactions should be circumvented.
The aim of this phase 1b study is to evaluate the safety and tolerability of the epicutaneous immunotherapy method in subjects allergic to peanut. The trial will randomize 110 participants. Four doses of peanut proteins, 20 mcg, 100 mcg, 250 mcg and 500 mcg will be repeatedly delivered on the skin by dose escalation in consecutive cohorts of 5 subjects, starting with the lowest dose. In each cohort of 5, 4 subjects will receive peanut proteins and one will receive placebo in a blinded manner. For each dose, the peanut proteins will be applied on the skin either every day or every other day. The total duration of the treatment for each subject is 2 weeks. Firstly, adult subjects (18 to 50 years) with a history of non-severe anaphylaxis to peanut (Grade ≤3) will enroll and safety information be reviewed. If there are no major concerns, adolescent cohorts (12 to 17 years) with history of non-severe anaphylaxis to peanut will then enroll and safety again be reviewed. If there are no concerns, then child cohorts (6 to 11 years) with history of non-severe anaphylaxis to peanut will finally enroll.
Also, after the safety review of the treated adult non-severe cohorts is satisfactorily performed, adult subjects with a history of severe anaphylaxis to peanut (Grades 4 or 5) will enroll and dose escalation will undergo.
For the safety review, all the following parameters will be checked at each patient visit: physical examination, vital signs, skin examination, lab values, PEF values. FEV1, skin prick test to peanut and peanut-specific IgE values will also be determined at screening and end of treatment visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DBV712 Viaskin | Experimental | Biological: Whole peanut extractThe experimental arm is composed of subjects treated with whole peanut extract on an epicutaneous delivery system (Viaskin patch) |
| Placebo Viaskin | Placebo comparator | Biological: Placebo formulationThe placebo arm is composed of subjects treated with a placebo formulation on an epicutaneous delivery system (Viaskin patch) |
Who may qualify
- Ages
- 6 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Male or Female age 6 to 50 years at enrollment, any race, and any ethnicity.
- Physician-diagnosed peanut allergy or convincing history of peanut allergy regardless of the degree of the reaction. Subjects with history of severe anaphylaxis to peanuts (Grades 4 or 5 with dyspnea, cyanosis, hypoxia, hypotension, or neurological compromise) can be enrolled only after assessment of the safety of DBV712 Viaskin in subjects with historic non-severe anaphylaxis (Grade≤3).
- A peanut-specific IgE measured by ImmunoCAP >0.7 kU/L for all subjects and a positive skin prick test to peanut with a wheal diameter >8 mm for all non-severe subjects. A skin prick test to peanut for severe subjects will be performed only if deemed necessary by the investigator.
- Use of an effective method of contraception by females of childbearing potential and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study. Women who have had a hysterectomy or tubal ligation at least 6 months prior to the screening visit or who have been post-menopausal for at least 1 year prior to the screening visit are not considered to be of childbearing potential.
- Ability to perform spirometry maneuvers in accordance with the American Thoracic Society guidelines (1994).
Key exclusion criteria (18 listed)
- Participation in a study using an investigational new drug in the last 30 days prior to the screening visit.
- Participation in any interventional study for the treatment of food allergy in the past 6 months prior to the screening visit.
- Pregnancy or lactation.
- Allergy or known hypersensitivity to the Viaskin patch or adhesives.
- Severe or poorly controlled atopic dermatitis or 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 |
|---|---|---|
| Whole peanut extractAlso: DBV712 ViaskinFour different doses of whole peanut extract expressed as micrograms (mcg) of peanut proteins (20, 100, 250, 500 mcg) and two different dosing regimen (epicutaneous application for 24 hours every 24 hours and epicutaneous application for 48 hours every 48 hours) will be tested for determination of the maximum tolerated dose during a 2-week treatment period. | Biological | DBV712 Viaskin |
| Placebo formulationAlso: Placebo ViaskinMatching placebo at two different dosing regimen (epicutaneous application for 24 hours every 24 hours and epicutaneous application for 48 hours every 48 hours) will be tested in parallel to the peanut proteins doses for determination of the maximum tolerated dose during a 2-week treatment period. | Biological | Placebo Viaskin |
Primary outcome
Safety evaluation
Time frame: Safety evaluation to be performed at each visit during the 2-week treatment and at the follow-up visit one week after the end of treatment.
The primary outcome measure is safety and the subjects will undergo the following procedures: physical examination including patch application site examination for evaluation of any skin reaction, vital signs, blood and urine collection for blood and urine analysis, ECG, Peak Expiratory Flow and spirometry (FEV1). Adverse events, treatment-emergent adverse events, and serious adverse events will be classified according to severity, treatment relatedness, the system/organ class affected, and the countermeasures taken.
1 secondary outcome
Systemic reactions evaluation and treatment; treatment adherence
Time frame: Safety evaluation to be performed at each visit during the 2-week treatment and at the follow-up visit one week after the end of treatment.
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 23 Mar 2012.
- Derived from this study: PubMed 26920463Jones SM, Agbotounou WK, Fleischer DM, Burks AW, Pesek RD, Harris MW, Martin L, Thebault C, Ruban C, Benhamou PH. Safety of epicutaneous immunotherapy for the treatment of peanut allergy: A phase 1 study using the Viaskin patch. J Allergy Clin Immunol. 2016 Apr;137(4):1258-1261.e10. doi: 10.1016/j.jaci.2016.01.008. Epub 2016 Feb 24. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Whole peanut extract in people with Peanut Allergy, run by DBV Technologies at 5 sites in United States.
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 18 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 23 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety evaluation (time frame: Safety evaluation to be performed at each visit during the 2-week treatment and at the follow-up visit one week after the end of treatment.). 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 NCT01170286, 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 23 Mar 2012; AzTrials last refreshed its copy on 8 Nov 2026.