Clinical trial NCT07003919: Safety Study of Viaskin® Peanut Patch in Peanut-allergic Children 1 Through 3 Years of Age (COMFORT Toddlers)
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Allergy
Peanut Allergy
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
Lead sponsor: DBV Technologies
Sponsor class: INDUSTRY
First posted: 2025-06-04
Enrollment: 480
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: DBPC Treatment Period: Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), and Serious Adverse Events (SAEs)
timeFrame: Through DBPC Treatment Period, 6 months
Secondary outcomes:
Other outcomes:
measure: Concentration of peanut-specific IgE (kUA/L) at baseline and month 6.
timeFrame: Month 6
measure: Concentration of peanut-specific IgG4 (mg/L) at baseline and month 6.
timeFrame: Month 6
measure: DBPC Treatment Period: Change from baseline in peanut Skin Prick Test (SPT) mean wheal diameters
timeFrame: Month 6
Locations:
Study officials:
References: