Brief Summary
The primary objective of this study is to assess the 6-month safety of DBV712 250 micrograms (mcg) in subjects 1 through 3 years of age with peanut allergy.
Brief Title
Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers)
Detailed Description
This is a Phase 3 randomized double-blind, placebo-controlled (DBPC) study of 6-months duration to assess the safety of DBV712 250 mcg in subjects 1 through 3 years of age with peanut allergy. Participants who complete the 6-month DBPC period will be eligible to enter an optional 18-month open-label extension (OLE).
The overall maximum study duration for each participant will be approximately 112 weeks: Screening Period of 6-weeks, DBPC Treatment Period of 26-weeks, Open-label Period of 78-weeks and Follow-up Period of 2-weeks.
For participation eligibility, please refer to eligibility criteria section.
Randomization of eligible participants will occur in a 3:1 ratio to DBV712 250 mcg (active treatment) or placebo, respectively.
The overall maximum study duration for each participant will be approximately 112 weeks: Screening Period of 6-weeks, DBPC Treatment Period of 26-weeks, Open-label Period of 78-weeks and Follow-up Period of 2-weeks.
For participation eligibility, please refer to eligibility criteria section.
Randomization of eligible participants will occur in a 3:1 ratio to DBV712 250 mcg (active treatment) or placebo, respectively.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
908-679-5200
Central Contact Email
clinicaltrials@dbv-technologies.com
Central Contact Role
Contact
Central Contact Phone
908-679-5200
Completion Date
Completion Date Type
Estimated
Conditions
Allergy
Peanut Allergy
Eligibility Criteria
Key Inclusion Criteria:
* Aged 1 through 3 years at Visit 1 (screening).
* Physician-diagnosed peanut allergy and following a strict peanut-free diet
* Peanut-specific IgE \> 0.7 kUA/L.
* A positive peanut SPT with the largest wheal diameter of ≥ 6 mm at Visit 1 (screening).
* An ED ≤ 300 mg peanut protein at screening double-blind placebo-controlled food challenge (DBPCFC).
Key Exclusion Criteria:
* Peanut allergic subjects presenting a medical history of severe anaphylaxis to peanut.
* Severe generalized dermatologic disease involving the proposed treatment application area (interscapular region).
* Current immunotherapy for any allergen (including food allergy, allergic rhinitis and/or insect allergy).
* History of any immunotherapy for peanut allergy, including Epicutaneous immunotherapy (EPIT), oral immunotherapy (OIT), sublingual immunotherapy (SLIT).
* Treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to Visit 1.
* Uncontrolled persistent asthma.
* Aged 1 through 3 years at Visit 1 (screening).
* Physician-diagnosed peanut allergy and following a strict peanut-free diet
* Peanut-specific IgE \> 0.7 kUA/L.
* A positive peanut SPT with the largest wheal diameter of ≥ 6 mm at Visit 1 (screening).
* An ED ≤ 300 mg peanut protein at screening double-blind placebo-controlled food challenge (DBPCFC).
Key Exclusion Criteria:
* Peanut allergic subjects presenting a medical history of severe anaphylaxis to peanut.
* Severe generalized dermatologic disease involving the proposed treatment application area (interscapular region).
* Current immunotherapy for any allergen (including food allergy, allergic rhinitis and/or insect allergy).
* History of any immunotherapy for peanut allergy, including Epicutaneous immunotherapy (EPIT), oral immunotherapy (OIT), sublingual immunotherapy (SLIT).
* Treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to Visit 1.
* Uncontrolled persistent asthma.
Inclusion Criteria
Inclusion Criteria:
* Aged 1 through 3 years at Visit 1 (screening).
* Physician-diagnosed peanut allergy and following a strict peanut-free diet
* Peanut-specific IgE \> 0.7 kUA/L.
* A positive peanut SPT with the largest wheal diameter of ≥ 6 mm at Visit 1 (screening).
* An ED ≤ 300 mg peanut protein at screening double-blind placebo-controlled food challenge (DBPCFC).
* Aged 1 through 3 years at Visit 1 (screening).
* Physician-diagnosed peanut allergy and following a strict peanut-free diet
* Peanut-specific IgE \> 0.7 kUA/L.
* A positive peanut SPT with the largest wheal diameter of ≥ 6 mm at Visit 1 (screening).
* An ED ≤ 300 mg peanut protein at screening double-blind placebo-controlled food challenge (DBPCFC).
Gender
All
Gender Based
false
Keywords
Peanut hypersensitivity
Epicutaneous Immunotherapy (EPIT)
Epicutaneous
Immunotherapy
Viaskin
Nut and Peanut Hypersensitivity
Food Hypersensitivity
Peanut Allergy
Food Allergy
Nut and Peanut Allergy
Safety Study
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
3 Years
Minimum Age
1 Year
NCT Id
NCT07003919
Org Class
Industry
Org Full Name
DBV Technologies
Org Study Id
V712-308
Overall Status
Recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Phase 3, Double-Blind, Placebo-Controlled, Randomized Study to Assess the Safety of Epicutaneous Immunotherapy With DBV712 250 mcg in 1-through 3-year-old Children With Peanut Allergy
Primary Outcomes
Outcome Measure
DBPC Treatment Period: Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), and Serious Adverse Events (SAEs)
Outcome Time Frame
Through DBPC Treatment Period, 6 months
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
3
Minimum Age Number (converted to Years and rounded down)
1
Investigators
Investigator Type
Principal Investigator
Investigator Name
Punita Ponda
Investigator Email
punponda@montefiore.org
Investigator Sponsor Organization
External
Study Department
Pediatrics
Study Division
Pediatrics Allergy & Immunology
Categories Mesh Debug
Lung --- HYPERSENSITIVITY
Infectious Disease --- IMMUNE SYSTEM DISEASES
Lung --- IMMUNE SYSTEM DISEASES
Lung --- HYPERSENSITIVITY, IMMEDIATE
MeSH Terms
HYPERSENSITIVITY
PEANUT HYPERSENSITIVITY
NUT AND PEANUT HYPERSENSITIVITY
FOOD HYPERSENSITIVITY
IMMUNE SYSTEM DISEASES
HYPERSENSITIVITY, IMMEDIATE