safety and efficacy study of viaskin peanut in peanut-allergic children 4-7 years of age

Conditions: Allergy, Peanut

Summary: the primary purpose of this study is to assess the efficacy and safety of daily dbv712 250 micrograms (mcg) to induce desensitization to peanut in peanut-allergic children 4-7 years of age over a 12-month double-blind, placebo-controlled (dbpc) treatment period.

this study is consisting of a 4-week screening period, 12-month dbpc treatment period and an open-label extension of either 24 or 36-months duration so that each participant may have the opportunity to receive dbv712 for a total duration of 36 months. following 36 months of treatment with dbv712 250 mcg, sustained unresponsiveness (su) will be evaluated by subsequent open food challenge(s) \[fc(s)\] at 2-, 4-, and 6-months off treatment. maximum participant participation will be either approximately 44 or 56 months, depending on the participant's randomized treatment assignment. during the 4-week screening period, participants are required to meet 2 sequential screening parameters to determine eligibility prior to randomization: * assessment of peanut skin prick test (spt) and serum peanut immunoglobulin-e (ige) * peanut double-blind placebo-controlled food challenge (dbpcfc) to confirm peanut allergy and establish an entry peanut eliciting dose (ed). participants with a peanut protein ed less than or equal to (≤) 100 milligram (mg) will be eligible for randomization. the starting dose of the eligibility peanut dbpcfc will be 1 mg peanut protein and will escalate up to a highest single dose of 100 mg peanut protein (cumulative 144 mg) via the following schedule: 1, 3, 10, 30, 100 mg. participants who react, with an eliciting dose (ed) (with dose-limiting symptoms) at or below the dose of 100 mg peanut protein will be considered eligible. randomization of eligible participants will occur in a 2:1 ratio to dbv712 250 mcg (active treatment) or placebo, respectively.

Eligibility criteria:
key inclusion criteria: * aged 4 through 7 years at visit 1 (screening). * physician-diagnosed peanut allergy or children with a well-documented medical history of ige-mediated reactions after ingestion of peanut and currently following a strict peanut-free diet. * peanut-specific ige of \>0.7 kilo allergy unit per liter (kua/l) and a positive peanut spt with the largest wheal diameter of ≥6 millimeter (mm) at visit 1. * an ed of ≤100 mg peanut protein at screening dbpcfc. participants may enter the open-label extension period if they meet all of the following inclusion criteria: * signed icf by the participant's parent(s)/caregiver(s). this consent should be signed after completion of the procedures in the randomized, dbpc treatment period, and before any procedure in open-label extension period begins. * participants who perform the peanut dbpcfc at the end of month 12 and have ≥80% compliance with investigational medicinal product (imp). * parent(s)/caregiver(s) and participants willing to comply with all study requirements during the participant's participation in the study. key exclusion criteria: * severe generalized dermatologic disease involving the application area (interscapular region) * uncontrolled persistent asthma. * past or current immunotherapy for peanut allergy, including oral immunotherapy (oit). * current immunotherapy for any allergen (including food allergy, allergic rhinitis and/or insect allergy), or treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to visit 1. participants may not enter the open-label extension period if they meet any of the following exclusion criteria: * participants who develop a severe anaphylactic reaction during the dbpcfc at the end of month 12 with the event requiring tracheal intubation or leading to a cardiac arrest and/or to coma. participants with other reported cases of severe anaphylaxis will be considered eligible to participate in the open-label extension period, at the judgement of the investigator. * any clinically significant disease which in the judgment of the investigator may preclude safe participation or strict compliance with the protocol procedures.

Keywords: peanut hypersensitivity epicutaneous immunotherapy (epit) epicutaneous immunotherapy viaskin nut and peanut hypersensitivity food hypersensitivity peanut allergy food allergy nut and peanut allergy