This trial is active, not recruiting.

Condition peanut allergy
Treatments viaskin peanut 250mcg, placebo
Phase phase 3
Sponsor DBV Technologies
Start date December 2015
End date August 2017
Trial size 356 participants
Trial identifier NCT02636699, PEPITES


The PEPITES study evaluates the efficacy and safety of Viaskin Peanut 250 µg peanut protein to induce desensitization to peanut in peanut-allergic children 4 through 11 years of age after a 12-month treatment by epicutaneous immunotherapy (EPIT).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
viaskin peanut 250mcg DBV712
Peanut extract cutaneous patch
(Placebo Comparator)
Cutaneous patch containing an inactive deposit manufactured to mimic peanut extract

Primary Outcomes

Percentage of treatment responders in the overall population
time frame: Month 12

Secondary Outcomes

Percentage of treatment responders in each of the 2 screening ED strata
time frame: Month 12
Change from baseline of mean and median cumulative reactive dose of peanut protein
time frame: Baseline and Month 12
Change from baseline of mean and median eliciting dose of peanut protein
time frame: Baseline and Month 12

Eligibility Criteria

Male or female participants from 4 years up to 11 years old.

Main Inclusion Criteria: 1. Male or female children aged 4 through 11 years; 2. Physician-diagnosis of peanut allergy or children with a well documented medical history of IgE-mediated symptoms after ingestion of peanut and currently following a strict peanut-free diet, but without a physician diagnosis; 3. Peanut-specific IgE level (ImmunoCAP system) >0.7 kU/L; 4. Positive peanut skin prick test (SPT) with a largest wheal diameter: - ≥6 mm for children 4 through 5 years of age at Visit 1, - ≥8 mm for children 6 years and above at Visit 1; 5. Positive DBPCFC at ≤300 mg peanut protein. Main Exclusion Criteria: 1. History of severe anaphylaxis to peanut with any of the following symptoms: hypotension, hypoxia, neurological compromise (collapse, loss of consciousness or incontinence); 2. Generalized dermatologic disease 3. Diagnosis of mast cell disorders, including mastocytosis or uricaria pigmentosa as well as hereditary or idiopathic angioedema; 4. Diagnosis of asthma that fulfills any of the following criteria: - Uncontrolled persistent asthma as defined by National Asthma Education and Prevention Program Asthma guidelines 2007 or by Global Initiative for Asthma guidelines 2015, - Asthma treated with either a high daily high dose of inhaled corticosteroid or with a combination therapy of a medium or high daily dose of inhaled corticosteroid with a long acting inhaled β2 agonist or with a combination therapy of a high daily dose of inhaled corticosteroid with a long acting inhaled β2 agonist. Asthmatic subjects treated with a medium daily dose of inhaled corticosteroids are eligible. Intermittent asthmatic subjects who require intermittent use of inhaled corticosteroids for rescue are also eligible, - Two or more systemic corticosteroid courses for asthma in the past year or 1 oral corticosteroid course for asthma within 3 months prior to Visit 1, or during screening period, - Prior intubation/mechanical ventilation for asthma within 1 year prior to Visit 1, or during screening; 5. Receiving β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy; 6. Received anti-tumor necrosis factor drugs or anti-IgE drugs (such as omalizumab) or any biologic immunomodulatory therapy within 1 year prior to Visit 1, during screening period or during study participation; 7. Use of systemic long-acting corticosteroids within 12 weeks prior to Visit 1 and/or use of systemic short-acting corticosteroids within 4 weeks prior to Visit 1 or during screening; 8. Prior or concomitant history of any immunotherapy to any food; 9. Receiving or planning to receive any aeroallergen immunotherapy during their participation in the study. Aeroallergen immunotherapy must be discontinued at the time of Visit 1; 10. Any disorder in which epinephrine is contraindicated such as coronary artery disease, uncontrolled hypertension, or serious ventricular arrhythmias.

Additional Information

Official title A Double-blind, Placebo-controlled, Randomized Phase 3 Pivotal Trial to Assess the Efficacy and Safety of Peanut Epicutaneous Immunotherapy With Viaskin Peanut in Peanut-allergic Children
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by DBV Technologies.