Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age (EPITOPE)

DBV Technologies

Status and phase: Active, not recruiting; Phase 3

Conditions: Peanut Allergy

Treatments: Biological: Placebo; Biological: Viaskin Peanut 100 mcg; Biological: Viaskin Peanut 250 mcg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03211247

EPITOPE

Details and patient eligibility

About

The study aims to assess the safety and efficacy of Viaskin Peanut to induce desensitization to peanut in peanut-allergic children 1 to 3 years of age after a 12-month treatment by EPicutaneous ImmunoTherapy (EPIT).

Enrollment: 414 patients

Sex: All

Ages: 1 to 3 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Male or female from 1-3 years of age;
• Physician-diagnosed peanut allergy;
• Peanut-specific IgE level > 0.7 kU/L;
• Positive peanut SPT with a largest wheal diameter ≥ 6 mm;
• Positive DBPCFC at ≤ 300 mg peanut protein;

Key Exclusion Criteria:

• Uncontrolled asthma;
• History of severe anaphylaxis to peanut;
• Prior immunotherapy to any food or other immunotherapy;
• Generalized severe dermatologic disease;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

414 participants in 3 patient groups, including a placebo group

Viaskin Peanut 250 mcg

Experimental group

Treatment:

Biological: Viaskin Peanut 250 mcg

Viaskin Peanut 100 mcg

Experimental group

Treatment:

Biological: Viaskin Peanut 100 mcg

Placebo

Placebo Comparator group

Treatment:

Biological: Placebo