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

ConditionsAllergyPeanut Allergy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-3
SponsorDBV Technologies

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • DBV712 250 mcg

    Combination product

    DBV712 250 mcg epicutaneous system.

  • Placebo

    Combination product

    DBV712 matching placebo epicutaneous system.

Treatment groups

480 Participants
are divided into 3 treatment groups
Group A: DBPC Treatment Period: DBV712 250 mcgExperimental treatment 1 intervention
Group B: DBPC Treatment Period: PlaceboPlacebo comparator 1 intervention
Group C: Optional Open-Label Extension-Period: DBV712 250 mcgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

DBPC Treatment Period: Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), and Serious Adverse Events (SAEs)

Time frame
Through DBPC Treatment Period, 6 months

Secondary outcomes

Other outcomes

1

Concentration of peanut-specific IgE (kUA/L) at baseline and month 6.

Time frame
Month 6
2

Concentration of peanut-specific IgG4 (mg/L) at baseline and month 6.

Time frame
Month 6
3

DBPC Treatment Period: Change from baseline in peanut Skin Prick Test (SPT) mean wheal diameters

Time frame
Month 6

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

DBV Technologies

Lead sponsor

Source ClinicalTrials.gov
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