Clinical trial NCT05741476: Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Allergy, Peanut
Keywords: Peanut Hypersensitivity
Epicutaneous Immunotherapy (EPIT)
Epicutaneous
Immunotherapy
Viaskin
Nut and Peanut Hypersensitivity
Food Hypersensitivity
Peanut Allergy
Food Allergy
Nut and Peanut Allergy
Lead sponsor: DBV Technologies
Sponsor class: INDUSTRY
First posted: 2023-02-23
Enrollment: 600
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Primary outcomes:
measure: DBPC Treatment Period: Percentage of Treatment Responders in the DBV712 250 mcg Group Compared to Placebo Group
timeFrame: At Month 12
Secondary outcomes:
measure: DBPC Treatment Period: Cumulative Reactive Dose (CRD) of Peanut Protein
timeFrame: At Month 12
measure: DBPC Treatment Period: Eliciting Dose (ED) of Peanut Protein
timeFrame: At Month 12
measure: DBPC Treatment Period: Percentage of Participants with an Eliciting Dose (ED) ≥600 mg and ≥1,000 mg Peanut Protein at Month 12
timeFrame: At Month 12
measure: DBPC Treatment Period: Number of Participants by Maximum Severity of Allergic Reaction During the Peanut Oral Food Challenge
timeFrame: Baseline up to Month 12
Other outcomes:
measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESI)
timeFrame: Screening up to 56 months.
measure: Number of Participants With Systemic Allergic Reactions
timeFrame: Screening up to 56 months.
measure: Total Score for Scoring Atopic Dermatitis (SCORAD)
timeFrame: Screening up to 56 months.
Locations:
city: Birmingham
country: United States
facility: DBV Investigative Site
state: Alabama
city: Tucson
country: United States
facility: DBV Investigative Site
state: Arizona
city: Little Rock
country: United States
facility: DBV Investigative Site
state: Arkansas
city: Los Angeles
country: United States
facility: DBV Investigative Site
state: California
city: Los Angeles
country: United States
facility: DBV Investigative Site
state: California
city: Mission Viejo
country: United States
facility: DBV Investigative site
state: California
city: San Diego
country: United States
facility: DBV Investigative Site
state: California
city: San Francisco
country: United States
facility: DBV Investigative Site
state: California
city: San Jose
country: United States
facility: DBV Investigative Site
state: California
city: Aurora
country: United States
facility: DBV Investigative Site
state: Colorado
city: Colorado Springs
country: United States
facility: DBV Investigative Site
state: Colorado
city: Washington
country: United States
facility: DBV Investigative Site
state: District of Columbia
city: Hollywood
country: United States
facility: DBV Investigative Site
state: Florida
city: Miami
country: United States
facility: DBV Investigative Site
state: Florida
city: Saint Petersburg
country: United States
facility: DBV Investigative Site
state: Florida
city: Tampa
country: United States
facility: DBV Investigative Site
state: Florida
city: Atlanta
country: United States
facility: DBV Investigative site
state: Georgia
city: Marietta
country: United States
facility: DBV Investigative Site
state: Georgia
city: Chicago
country: United States
facility: DBV Investigative Site
state: Illinois
city: Normal
country: United States
facility: DBV Investigative Site
state: Illinois
city: Indianapolis
country: United States
facility: DBV Investigative Site
state: Indiana
city: Louisville
country: United States
facility: DBV Investigative Site
state: Kentucky
city: Baltimore
country: United States
facility: DBV Investigative Site
state: Maryland
city: Chevy Chase
country: United States
facility: DBV Investigative Site
state: Maryland
city: Boston
country: United States
facility: DBV Investigative Site
state: Massachusetts
city: Boston
country: United States
facility: DBV Investigative Site
state: Massachusetts
city: Taunton
country: United States
facility: DBV Investigative Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: DBV Investigative Site
state: Michigan
city: Ypsilanti
country: United States
facility: DBV Investigative Site
state: Michigan
city: Maplewood
country: United States
facility: DBV Investigative Site
state: Minnesota
city: Kansas City
country: United States
facility: DBV Investigative Site
state: Missouri
city: Great Neck
country: United States
facility: DBV Investigative Site
state: New York
city: New York
country: United States
facility: DBV Investigative Site
state: New York
city: New York
country: United States
facility: DBV Investigative Site
state: New York
city: Rochester
country: United States
facility: DBV Investigative Site
state: New York
city: Chapel Hill
country: United States
facility: DBV Investigative Site
state: North Carolina
city: Cincinnati
country: United States
facility: DBV Investigative Site
state: Ohio
city: Cleveland
country: United States
facility: DBV Investigative Site
state: Ohio
city: Cleveland
country: United States
facility: DBV Investigative Site
state: Ohio
city: Columbus
country: United States
facility: DBV Investigative Site
state: Ohio
city: Philadelphia
country: United States
facility: DBV Investigative Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: DBV Investigative Site
state: Pennsylvania
city: Memphis
country: United States
facility: DBV Investigative Site
state: Tennessee
city: Nashville
country: United States
facility: DBV Investigative Site
state: Tennessee
city: Austin
country: United States
facility: DBV Investigative Site
state: Texas
city: Dallas
country: United States
facility: DBV Investigative Site
state: Texas
city: Houston
country: United States
facility: DBV Investigative Site
state: Texas
city: Seattle
country: United States
facility: DBV Investigative Site
state: Washington
city: Seattle
country: United States
facility: DBV Investigative Site
state: Washington
city: Milwaukee
country: United States
facility: DBV Investigative Site
state: Wisconsin
city: Adelaide
country: Australia
facility: DBV Investigative Site
city: Nedlands
country: Australia
facility: DBV Investigative Site
city: Parkville
country: Australia
facility: DBV Investigative Site
city: Richmond
country: Australia
facility: DBV Investigative Site
city: South Brisbane
country: Australia
facility: DBV Investigative Site
city: Westmead
country: Australia
facility: DBV Investigative Site
city: Vancouver
country: Canada
facility: DBV Investigative Site
state: British Columbia
city: Winnipeg
country: Canada
facility: DBV Investigative Site
state: Manitoba
city: Burlington
country: Canada
facility: DBV Investigative Site
state: Ontario
city: North York
country: Canada
facility: DBV Investigative Site
state: Ontario
city: Ottawa
country: Canada
facility: DBV Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: DBV Investigative Site
state: Ontario
city: Montréal
country: Canada
facility: DBV Investigative Site
state: Quebec
city: Montréal
country: Canada
facility: DBV Investigative Site
state: Quebec
city: Québec
country: Canada
facility: DBV Investigative Site
state: Quebec
city: Hamilton
country: Canada
facility: DBV Investigative Site
city: Angers
country: France
facility: DBV Investigative Site
city: Brest
country: France
facility: DBV Investigative Site
city: Bron
country: France
facility: DBV Investigative Site
city: Nice
country: France
facility: DBV Investigative Site
city: Strasbourg
country: France
facility: DBV Investigative Site
city: Vandœuvre-lès-Nancy
country: France
facility: DBV Investigative Site
city: Düsseldorf
country: Germany
facility: DBV Investigative Site
city: Frankfurt
country: Germany
facility: DBV Investigative Site
city: Ulm
country: Germany
facility: DBV Investigative Site
city: Cork
country: Ireland
facility: DBV Investigative Site
city: Dublin
country: Ireland
facility: DBV Investigative Site
city: Rotterdam
country: Netherlands
facility: DBV Investigative Site
city: Utrecht
country: Netherlands
facility: DBV Investigative Site
city: Madrid
country: Spain
facility: DBV Investigative Site
city: Madrid
country: Spain
facility: DBV Investigative Site
city: Málaga
country: Spain
facility: DBV Investigative Site
city: London
country: United Kingdom
facility: DBV Investigative Site
city: London
country: United Kingdom
facility: DBV Investigative Site
city: Manchester
country: United Kingdom
facility: DBV Investigative Site
city: Sheffield
country: United Kingdom
facility: DBV Investigative Site
city: Southampton
country: United Kingdom
facility: DBV Investigative Site
Study officials:
References: