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Safety and Efficacy Study of ...

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

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-21

Study Completion Date

2029-10-31

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 double-blind, placebo-controlled (DBPC) Treatment Period.

Detailed Description

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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.

Conditions

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Allergy, Peanut

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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DBPC Treatment Period: DBV712 250 mcg

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).

Group Type EXPERIMENTAL

DBV712

Intervention Type DRUG

DBV712 250 mcg epicutaneous system.

DBPC Treatment Period: Placebo

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).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

DBV712 matching placebo epicutaneous system.

Open Label Extension Period: DBV712 250 mcg

Participants will apply DBV712 250 mcg, epicutaneous system (or patch), daily for a period of 2 additional years if they were randomized DBV712 250 mcg or for 3 years if they were randomized placebo. After 12 months of open-label treatment with DBV712 250 mcg, (i.e., at the end of Month 24), participants will undergo a peanut DBPCFC according to the following schedule: 3, 10, 30, 100, 300, 600, 1000, and 2000 mg (4043 mg cumulative dose). Participants who were randomized to placebo will also undergo an additional peanut DBPCFC after 24 months of open-label treatment with DBV712 250 mcg, (i.e., at the end of Month 36).

Group Type EXPERIMENTAL

DBV712

Intervention Type DRUG

DBV712 250 mcg epicutaneous system.

Interventions

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DBV712

DBV712 250 mcg epicutaneous system.

Intervention Type DRUG

Placebo

DBV712 matching placebo epicutaneous system.

Intervention Type OTHER

DBV712

DBV712 250 mcg epicutaneous system.

Intervention Type DRUG

Other Intervention Names

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ViaskinTM Peanut ViaskinTM Peanut

Eligibility Criteria

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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.

* 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.

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 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.

Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

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United States Australia Canada France Germany Ireland Netherlands Spain United Kingdom

Other Identifiers

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EU CTIS

Identifier Type: OTHER

Identifier Source: secondary_id

V712-306 (VITESSE)

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

DBPC Treatment Period: DBV712 250 mcg

DBV712

DBPC Treatment Period: Placebo

Placebo

Open Label Extension Period: DBV712 250 mcg

DBV712

Interventions

DBV712

Placebo

DBV712

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

DBV Technologies

Responsible Party

Locations

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