Efficacy and Safety of Viaskin Peanut in Children With Immunoglobulin E (IgE)-Mediated Peanut All… (NCT02636699) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Viaskin Peanut in Children With Immunoglobulin E (IgE)-Mediated Peanut Allergy
United States500 participantsStarted 2015-12
Plain-language summary
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).
Who can participate
Age range4 Years – 11 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female children aged 4 through 11 years;
✓. 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;
✓. Positive peanut skin prick test (SPT) with a largest wheal diameter:
✓. Positive DBPCFC at ≤300 mg peanut protein.
Exclusion criteria
✕. History of severe anaphylaxis to peanut with any of the following symptoms: hypotension, hypoxia, neurological compromise (collapse, loss of consciousness or incontinence);
✕. Generalized dermatologic disease
✕. Diagnosis of mast cell disorders, including mastocytosis or uricaria pigmentosa as well as hereditary or idiopathic angioedema;
✕. Diagnosis of asthma that fulfills any of the following criteria:
✕. 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;
What they're measuring
1
Difference in Percentages of Treatment Responders at Month 12; Analyzed in the Overall Population
✕. 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;
✕. Prior or concomitant history of any immunotherapy to any food;