A double-blind, placebo-controlled, randomized phase III trial to assess the safety and efficacy of Viaskin® Peanut in peanut-allergic young children 1-3 years of age (EPITOPE study)

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 400

Inclusion Criteria

1. Male or female from 1-3 years of age at Visit 1.
2. Physician-diagnosed peanut allergy or high suspicion of peanut allergy as assessed by the physician: child presenting signs, symptoms and a medical and/or a family history putting him/her at high risk of having a peanut allergy and/or history of presence of peanut-specific IgE and/or positive SPT.
3. Subject currently following a strict peanut-free diet.
4.Signed informed consent of parent(s)/guardian(s) of the children aged 1-3 years.
5. Peanut-specific immunoglobulin E (IgE) level (ImmunoCAP system) > 0.7 kU/L.
6. Positive peanut SPT with a largest wheal diameter = 6 mm.
7. Positive DBPCFC to peanut, with symptoms meeting the challenge stopping criteria at an Eliciting Dose (ED) =300 mg peanut protein.
8. Parents/guardians and subjects willing to comply with all study requirements during their participation in the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 400
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Peanut allergic subjects presenting a medical history of severe anaphylaxis to peanut will be excluded for this study. Severe anaphylaxis is defined by the Grade 3 of the Anaphylaxis Staging System (Appendix 4), including:
•Severe hypoxia, persistent hypotension or more than 20% drop in blood pressure, neurological compromise, or
•Cyanosis or SpO2 = 92% at any stage, confusion, cardiovascular collapse, loss of consciousness, bradychardia, cardiac arrest.
2. Severe reaction during the entry/screening DBPCFC, defined as any of the following:
•Need for intubation
•Hypotension persisting after epinephrine administration
•Need for three doses or more of systemic epinephrine.
3. Subject with reactions to the placebo formula during the screening DBPCFC (with reactions deemed to stopping the challenge).
4. Subjects who fail to complete the entry food challenge due to any reason including clear aversion to the food formula matrix,
5. Subject with any clinically significant abnormality identified at the time of screening such as major infantile infectious diseases (pox, measles) which in the judgment of the Investigator can preclude safe participation or strict compliance to the protocol procedures. Subjects can be considered for the study after recovery from these diseases.
6. Viral upper respiratory infection or gastroenteritis or any severe disease within 7 days of food challenge (challenge must be rescheduled at least after 7 days upon recovery).
7. Hypersensitivity to any of the Viaskin® patch components (except to peanut protein), including the adhesive film.
8. Hypersensitivity to any component of the food challenge formula (except to peanut protein) or a known history of apple allergy.
9. Inability to discontinue short-acting antihistamines or long-acting antihistamines for the minimum wash-out periods required (depending on half-lives and specified in APPENDIX 3) prior to the skin prick testing or the food challenges.
10. Diagnosis of asthma that fulfills any of the following criteria:
•Uncontrolled asthma (as per Global Initiative for Asthma [GINA] latest guidelines; see APPENDIX 8)
•Asthma requiring controller treatment step 3 or higher (as per GINA latest guidelines: either moderate [double low dose] of inhaled corticosteroid, or association of inhaled corticosteroid with leukotriene receptor antagonist [see APPENDIX 8]. Long acting beta agonists are not recommended below 5 years)
•History of 2 or more systemic corticoid courses within the 3 previous months prior to Visit 1 or 1 systemic corticoid course within the 4 weeks prior to Visit 1 for treating a diagnosed asthma.
•Prior intubation/mechanical ventilation for asthma within one year prior to Visit 1.
Asthmatic subjects with the following treatment options are eligible:
-No controller treatment (GINA Step 1),
-Controller treatment monotherapy (GINA Step 2):
o with daily or short-term course (intermittent) low dose inhaled corticosteroid,
o or with leukotriene receptor antagonist.
11. Presence of more than 3 episodes of wheezing in the past year (each lasting more than 10 consecutive days, apart from colds) or presence of respiratory symptoms (wheezing, cough, heavy breathing) between these episodes, and/or other respiratory symptoms suggesting either undiagnosed asthma or asthma not controlled by asthma treatment (as per GINA latest guidelines, see APPENDIX 8).
12. Generalized dermatologic disease (e.g. severe atopic dermatitis, uncontrolled generalized eczema, ichthyosis vu

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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