A double-blind, placebo-controlled, randomized trial to study the Viaskin® Peanut’s Efficacy and Safety for treating peanut allergy in children and adults.

• Conditions: Treatment of peanut allergy in adults and children age 6 years and older with documented hypersensitivity to peanut. The induction of clinical desensitization to peanut in patients allergic to peanut should reduce the risk of anaphylaxis in case of accidental exposure to small amounts of peanut proteins.; MedDRA version: 14.1Level: LLTClassification code 10034202Term: Peanut allergySystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2011-002550-32-PL
• Lead Sponsor: DBV Technologies

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-23
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

1. Peanut-allergic subjects between 6 and 55 years of age, with a well-documented medical history of systemic reactions after ingestion of peanut and currently following a strict peanut-free diet.
2. Peanut-specific immunoglobulin E (IgE) level (Phadia CAP-system) > 0.7 kU/L AND a positive peanut SPT with a largest wheal diameter = 8 mm.
3. Positive DBPCFC at = 300 mg of peanut proteins: the eliciting dose of peanut proteins during the DBPCFC is capped at 300 mg, i.e. subjects must react to peanut before reaching or at the dose of 300 mg peanut proteins.
4. Negative pregnancy test for women of childbearing potential. Females of childbearing age must use effective methods of contraception to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of participation in the study. Sexual abstinence will be accepted as an effective method of contraception for girls below 15 years of age.
5. Ability to perform spirometry maneuvers in accordance with the American Thoracic Society guidelines (2005) for subjects 9 years of age and above. Subjects below 9 years of age can perform peak expiratory flow (PEF) instead.
6. Subjects and/or parents/guardians willing to comply with all study requirements during their participation in the study.
7. Signed informed consent from adult subjects or parent(s)/guardian(s) of children < 18 years + children’s assent (for children > 7 years or as per country specific regulations).

Are the trial subjects under 18? yes
Number of subjects for this age range: 180
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subjects with a history of severe anaphylaxis to peanut with the following symptoms:
hypotension, hypoxia, neurological compromise (collapse, loss of consciousness or
incontinence), (See Appendix 2: Anaphylaxis Staging System).
2. Pregnancy or lactation.
3. Forced expiratory volume in one second (FEV1) < 80% of the predicted value at screening
(Visit 1) for subjects 9 years of age and above. PEF < 80% of predicted for subjects below
9 years.
4. Subject who did not react at or below the dose of 300 mg of peanut proteins during the
DBPCFC at screening.
5. Subjects allergic to chocolate or who do not consume chocolate.
6. Known allergy or known hypersensitivity to excipients either of the Viaksin or of the food
challenge formulas.
7. Subjects reacting objectively to the placebo formula.
8. Severe reaction during the screening food challenge defined as need for intubation,
hypotension persisting after epinephrine administration, or the need for more than two doses of
epinephrine.
9. Subjects with symptomatic allergy to pollens whose symptoms during the corresponding
pollen season might interfere with the recording of symptoms during the DBPCFC, if the
DBPCFC is conducted during the pollen season. The Investigator will have to ensure that the
period for conducting the DBPCFC for such a subject will be outside of the pollen season.
10. Inability to discontinue short-acting antihistamines for three days or long-acting antihistamines
for five to seven days (depending on half-life) prior to skin prick testing or food challenges.
11. Subjects treated with systemic long-acting corticosteroids (depot corticosteroids) within
12 weeks prior to Visit 1 and/or systemic short-acting corticosteroid within 4 weeks prior to
Visit 1 or any systemic corticosteroid at screening.
12. Subject with asthma conditions defined as follows:
a. uncontrolled persistent asthma by National Asthma Education and Prevention Program
Asthma guidelines (2007) or by Global Initiative for Asthma (2011) or being treated with
combination therapy of medium dose inhaled corticosteroid with a long acting inhaled ß2-
agonists (See Appendix 5: Dosages of inhaled corticosteroids);
b. at least two systemic corticosteroid courses for asthma in the past year or one oral
corticosteroid course for asthma in the past three months;
c. prior intubation for asthma in the past two years.
13. Subjects on ß-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor
blockers, calcium channel blockers or tricyclic antidepressant therapy.
14. Subjects who had a viral upper respiratory infection or gastroenteritis within seven days of
food challenge (challenge must be rescheduled).
15. Subjects undergoing any type of immunotherapy to any food (oral immunotherapy, sublingual
immunotherapy, specific oral tolerance induction) within one year prior to Visit 1.
16. Subjects presently on aeroallergen immunotherapy and unwilling or unable to discontinue.
17. Subjects currently treated with anti-tumor necrosis factor drugs or anti-IgE drugs (such as
omalizumab) or any biologic immunomodulatory therapy within one year prior to Visit 1.
18. Allergy or known history of reaction to Tegaderm®.
19. Subjects suffering from generalized dermatologic diseases (e.g. severe atopic dermatitis,
uncontrolled generalized eczema, keratosis pilaris, ichthyosis vulgaris) with no intact skin
zones to apply the Viaskins.
20. Subjects (or parents of subjects) wi

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the efficacy of several doses of Viaskin® Peanut to significantly desensitize peanut-allergic subjects to peanut after 12 months of Specific Immunotherapy by the cutaneous/epicutaneous route (i.e. Epicutaneous Immunotherapy or EPIT). ;Secondary Objective: To evaluate the safety of a long-term EPIT with Viaskin® Peanut.;Primary end point(s): Percentage of treatment responders for each active treatment compared to placebo. A treatment responder is defined as a subject with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPC peanut challenge after 12 months of treatment or a subject with a = 10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose.;Timepoint(s) of evaluation of this end point: at the 12-month time point (end of the study)