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

DBV Technologies

Status and phase: Completed; Phase 3

Conditions: Peanut Allergy

Treatments: Biological: Part A Viaskin Peanut 250 mcg; Biological: Part A Placebo; Biological: Part B Viaskin Peanut 250 mcg; Biological: Part B Placebo; Biological: Part A Viaskin Peanut 100 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).

Full description

The study comprised of two parts:

• In part A, subjects were randomized to receive either Viaskin Peanut 250 mcg, or Viaskin Peanut 100 mcg or the placebo in a 2:1 ratio, for 12 months. After 3 months of treatment, a data safety monitoring board had to determine the active dose to be applyed during the part B
• In Part B, subjects were randomized to receive either Viaskin Peanut 250 mcg or the placebo in a 2:1 ratio, for 12 months

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: Quadruple Blind

---

414 participants in 5 patient groups, including a placebo group

Part A Viaskin Peanut 250 mcg

Experimental group

Treatment:

Biological: Part A Viaskin Peanut 250 mcg

Part A Viaskin Peanut 100 mcg

Experimental group

Treatment:

Biological: Part A Viaskin Peanut 100 mcg

Part A Placebo

Placebo Comparator group

Treatment:

Biological: Part A Placebo

Part B Viaskin Peanut 250 mcg

Experimental group

Treatment:

Biological: Part B Viaskin Peanut 250 mcg

Part B Placebo

Placebo Comparator group

Treatment:

Biological: Part B Placebo