Safety Study of Viaskin® Peanut Patch in Peanut-allergic Children 1 Through 3 Years of Age (COMFORT Toddlers)

DBV Technologies

Status and phase: Not yet enrolling; Phase 3

Conditions: Peanut Allergy; Allergy

Treatments: Combination Product: DBV712 250 mcg; Combination Product: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07003919

V712-308

Details and patient eligibility

About

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.

Full 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.

Enrollment: 480 estimated patients

Sex: All

Ages: 1 to 3 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

480 participants in 3 patient groups, including a placebo group

DBPC Treatment Period: DBV712 250 mcg

Experimental group

Description:

Participants will apply DBV712 250 mcg, epicutaneous system (or patch), daily for a period of 6 months.

Treatment:

Combination Product: DBV712 250 mcg

DBPC Treatment Period: Placebo

Placebo Comparator group

Description:

Participants will apply DBV712 matching placebo epicutaneous system (or patch), daily for a period of 6 months.

Treatment:

Combination Product: Placebo

Optional Open-Label Extension-Period: DBV712 250 mcg

Experimental group

Description:

The 6-month DBPC period will be followed by an optional open-label extension (OLE) period during which eligible participants will receive DBV712 250 mcg for a duration of 18 months (representing 24 months of active treatment for those participants initially randomized to DBV712 250 mcg and 18 months of active treatment for those participants that were initially randomized to placebo).

Treatment:

Combination Product: DBV712 250 mcg