Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age

Study Overview
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Brief Summary
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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 treatment period.

Detailed Description
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The overall maximum study duration for each participant will be approximately 58 weeks: Screening Period of 4-weeks, Treatment Period of 12-months and Follow-up Period of 2-weeks. 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.

Official Title
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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)

Conditions
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Allergy, Peanut

Intervention / Treatment
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* Drug: DBV712
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DBV712 250 mcg<br>Participants will apply DBV712 250 mcg, epicutaneous system (or patch), daily for a period of 12 months. At Month 12, a post-treatment peanut DBPCFC will be performed, with a starting dose of 3 mg peanut protein with escalation to the highest dose of 1,000 mg peanut protein according to the following schedule: 3, 10, 30, 100, 300, 600, and 1,000 mg (2,043 mg cumulative dose). | Drug: DBV712<br>* DBV712 250 mcg epicutaneous system.<br>* Other names: ViaskinTM Peanut;|
| Placebo Comparator: Placebo<br>Participants will apply DBV712 matching placebo epicutaneous system (or patch), daily for a period of 12 months. At Month 12, a post-treatment peanut DBPCFC will be performed, with a starting dose of 3 mg peanut protein with escalation to the highest dose of 1,000 mg peanut protein according to the following schedule: 3, 10, 30, 100, 300, 600, and 1,000 mg (2,043 mg cumulative dose). | Other: Placebo<br>* DBV712 matching placebo epicutaneous system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Treatment Responders in the DBV712 Group Compared to Placebo Group | A participant is defined as a treatment responder if: The initial ED was ≤30 mg peanut protein and the ED is ≥ 300 mg peanut protein at the post-treatment DBPCFC at Month 12; OR the initial ED was > 30 mg peanut protein and the ED is ≥600 mg peanut protein at the post-treatment DBPCFC at Month 12. Percentage of treatment responders in the DBV712 group compared to the placebo group after 12 months of treatment in the target population will be reported. | At Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Reactive Dose (CRD) of Peanut Protein | The Peanut Protein CRD is defined as the sum of all peanut protein doses taken by the subject during the DBPCFC (including the ED and any partial dose given before the reaction). | At Month 12 | 
| Eliciting Dose (ED) of Peanut Protein |  | At Month 12 | 
| Percentage of Participants with an Eliciting Dose (ED) ≥600 mg and ≥1,000 mg Peanut Protein at Month 12 |  | At Month 12 | 
| Number of Participants by Maximum Severity of Allergic Reaction During the Peanut Oral Food Challenge | The maximum severity of allergic reaction will be assessed according to Consortium of Food Allergy Research (CoFAR) Grading Scale Version 3.0. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. | Baseline up to Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peanut Hypersensitivity, Epicutaneous Immunotherapy (EPIT), Epicutaneous, Immunotherapy, Viaskin, Nut and Peanut Hypersensitivity, Food Hypersensitivity, Peanut Allergy, Food Allergy, Nut and Peanut Allergy