Status:
COMPLETED
Safety of Epicutaneous Immunotherapy for the Treatment of Peanut Allergy
Lead Sponsor:
DBV Technologies
Conditions:
Peanut Allergy
Eligibility:
All Genders
6-50 years
Phase:
PHASE1
Brief 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...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01170286
Start Date
July 1 2010
End Date
February 1 2012
Last Update
March 23 2012
Active Locations (5)
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1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
2
National Jewish Health
Denver, Colorado, United States, 80206
3
CRI Worldwide
Willingboro, New Jersey, United States, 08046
4
Duke University Medical Center
Durham, North Carolina, United States, 27710