Safety of Epicutaneous Immunotherapy for the Treatment of Peanut Allergy

NCT ID: NCT01170286

Last Updated: 2012-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-02-29

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 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.

Conditions

Peanut Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

DBV712 Viaskin

The experimental arm is composed of subjects treated with whole peanut extract on an epicutaneous delivery system (Viaskin patch)

Group Type: EXPERIMENTAL

Whole peanut extract

Intervention Type: BIOLOGICAL

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 Viaskin

The placebo arm is composed of subjects treated with a placebo formulation on an epicutaneous delivery system (Viaskin patch)

Group Type: PLACEBO_COMPARATOR

Placebo formulation

Intervention Type: BIOLOGICAL

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.

Interventions

Whole peanut extract

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.

Intervention Type: BIOLOGICAL

Placebo formulation

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

DBV712 Viaskin; Placebo Viaskin

Eligibility Criteria

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 >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 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DBV Technologies

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Arkansas Children's Hospital

Little Rock, Arkansas, United States

National Jewish Health

Denver, Colorado, United States

CRI Worldwide

Willingboro, New Jersey, United States

Duke University Medical Center

Durham, North Carolina, United States

Aspen Clinical Research

Orem, Utah, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26920463 (View on PubMed)

Other Identifiers

PEP01.09

Identifier Type: -

Identifier Source: org_study_id