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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05741476
Registration number
NCT05741476
Ethics application status
Date submitted
14/02/2023
Date registered
23/02/2023
Date last updated
19/01/2024
Titles & IDs
Public title
Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age
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Scientific 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)
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Secondary ID [1]
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EU CTIS
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Secondary ID [2]
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V712-306 (VITESSE)
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Universal Trial Number (UTN)
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Trial acronym
VITESSE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Allergy, Peanut
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Condition category
Condition code
Inflammatory and Immune System
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Allergies
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - DBV712
Other interventions - Placebo
Experimental: 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).
Placebo Comparator: 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).
Treatment: Drugs: DBV712
DBV712 250 mcg epicutaneous system.
Other interventions: Placebo
DBV712 matching placebo epicutaneous system.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Treatment Responders in the DBV712 Group Compared to Placebo Group
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Assessment method [1]
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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.
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Timepoint [1]
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At Month 12
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Secondary outcome [1]
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Cumulative Reactive Dose (CRD) of Peanut Protein
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Assessment method [1]
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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).
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Timepoint [1]
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At Month 12
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Secondary outcome [2]
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Eliciting Dose (ED) of Peanut Protein
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Assessment method [2]
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Timepoint [2]
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At Month 12
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Secondary outcome [3]
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Percentage of Participants with an Eliciting Dose (ED) =600 mg and =1,000 mg Peanut Protein at Month 12
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Assessment method [3]
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Timepoint [3]
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At Month 12
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Secondary outcome [4]
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Number of Participants by Maximum Severity of Allergic Reaction During the Peanut Oral Food Challenge
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline up to Month 12
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Eligibility
Key inclusion criteria
Key
- 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.
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Minimum age
4
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Maximum age
7
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/03/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/03/2025
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Actual
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Sample size
Target
600
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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DBV Investigative Site - Adelaide
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DBV Investigative Site - Nedlands
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DBV Investigative Site - Richmond
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DBV Investigative Site - South Brisbane
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DBV Investigative Site - Westmead
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Recruitment postcode(s) [1]
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5006 - Adelaide
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6009 - Nedlands
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3052 - Parkville
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3121 - Richmond
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4101 - South Brisbane
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Recruitment postcode(s) [6]
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2145 - Westmead
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
DBV Technologies
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Address
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Ethics approval
Ethics application status
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Summary
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 treatment period.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05741476
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Contacts
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Contact person for public queries
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DBV Technologies
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Address
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Phone
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908-679-5200
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05741476
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