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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05741476




Registration number
NCT05741476
Ethics application status
Date submitted
14/02/2023
Date registered
23/02/2023
Date last updated
23/09/2024

Titles & IDs
Public title
Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age
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)
Secondary ID [1] 0 0
EU CTIS
Secondary ID [2] 0 0
V712-306 (VITESSE)
Universal Trial Number (UTN)
Trial acronym
VITESSE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergy, Peanut 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DBV712
Other interventions - Placebo
Treatment: Drugs - DBV712

Experimental: 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).

Placebo comparator: 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).

Experimental: 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).


Treatment: Drugs: DBV712
DBV712 250 mcg epicutaneous system.

Other interventions: Placebo
DBV712 matching placebo epicutaneous system.

Treatment: Drugs: DBV712
DBV712 250 mcg epicutaneous system.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
DBPC Treatment Period: Percentage of Treatment Responders in the DBV712 250 mcg Group Compared to Placebo Group
Timepoint [1] 0 0
At Month 12
Secondary outcome [1] 0 0
DBPC Treatment Period: Cumulative Reactive Dose (CRD) of Peanut Protein
Timepoint [1] 0 0
At Month 12
Secondary outcome [2] 0 0
DBPC Treatment Period: Eliciting Dose (ED) of Peanut Protein
Timepoint [2] 0 0
At Month 12
Secondary outcome [3] 0 0
DBPC Treatment Period: Percentage of Participants with an Eliciting Dose (ED) =600 mg and =1,000 mg Peanut Protein at Month 12
Timepoint [3] 0 0
At Month 12
Secondary outcome [4] 0 0
DBPC Treatment Period: Number of Participants by Maximum Severity of Allergic Reaction During the Peanut Oral Food Challenge
Timepoint [4] 0 0
Baseline up to Month 12

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.

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
Minimum age
4 Years
Maximum age
7 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2029
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
DBV Investigative Site - Adelaide
Recruitment hospital [2] 0 0
DBV Investigative Site - Nedlands
Recruitment hospital [3] 0 0
DBV Investigative Site - Parkville
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DBV Investigative Site - Richmond
Recruitment hospital [5] 0 0
DBV Investigative Site - South Brisbane
Recruitment hospital [6] 0 0
DBV Investigative Site - Westmead
Recruitment postcode(s) [1] 0 0
5006 - Adelaide
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment postcode(s) [3] 0 0
3052 - Parkville
Recruitment postcode(s) [4] 0 0
3121 - Richmond
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
2145 - Westmead
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
DBV Technologies
Address
Country

Ethics approval
Ethics application status

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 double-blind, placebo-controlled (DBPC) Treatment Period.
Trial website
https://clinicaltrials.gov/study/NCT05741476
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
DBV Technologies
Address 0 0
Country 0 0
Phone 0 0
908-679-5200
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05741476