| City: |
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Willingboro |
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State:
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NJ |
| Zip Code: |
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08046 |
| Conditions: |
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Peanut Allergy |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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Inclusion Criteria:
- 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 >5kU/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 Criteria:
- 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. |
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| Study is available at: |
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CRI Worldwide
Willingboro, NJ 08046
United States
Primary Contact:
Howard A. Hassman, MD
Phone: 609-877-3181 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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