Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age
a study on Peanut Allergy Immunotherapy
Summary
- Eligibility
- for people ages 4-7 (full criteria)
- Location
- at Los Angeles, California and other locations
- Dates
- study startedcompletion around
Description
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.
Official Title
A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of Epicutaneous Immunotherapy With DBV712 250 μg in 4-7-year-old Children With Peanut Allergy (VITESSE)
Details
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.
Keywords
Allergy, Peanut, Peanut Hypersensitivity, Epicutaneous Immunotherapy (EPIT), Epicutaneous, Immunotherapy, Viaskin, Nut and Peanut Hypersensitivity, Food Hypersensitivity, Peanut Allergy, Food Allergy, Nut and Peanut Allergy, Hypersensitivity, DBV712
Eligibility
You can join if…
Open to people ages 4-7
- 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.
You CAN'T join if...
- 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.
Locations
- DBV Investigative Site
accepting new patients
Los Angeles California 90095 United States - DBV Investigative Site
accepting new patients
Los Angeles California 90027 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- DBV Technologies
- Links
- Sign up for this study
- ID
- NCT05741476
- Phase
- Phase 3 research study
- Study Type
- Interventional
- Participants
- Expecting 600 study participants
- Last Updated
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