Follow-up of the PEPITES Study to Evaluate Long-term Efficacy and Safety of Viaskin Peanut in Children (PEOPLE)

DBV Technologies

Status and phase: Unknown; Phase 3

Conditions: Peanut Allergy

Treatments: Drug: Viaskin Peanut 250µg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03013517

PEOPLE

Details and patient eligibility

About

This is an open-label, follow-up study for subjects who completed the PEPITES study. Subjects will be offered enrollment in this follow-up study to receive Viaskin Peanut 250 μg for 2 additional years if previously on active treatment in the PEPITES study, or for 3 years if previously on placebo in the PEPITES study.

Enrollment: 300 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who completed the PEPITES study.

Exclusion criteria

• Generalized dermatologic disease (for example, active atopic dermatitis, uncontrolled generalized active eczema, ichthyosis vulgaris) extending widely on the skin and especially on the back or arms with no intact zones to apply the Viaskin patches.
• Diagnosis of asthma that evolved to severe, unstable or uncontrolled asthma.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

300 participants in 1 patient group

Viaskin Peanut 250µg

Experimental group

Treatment:

Drug: Viaskin Peanut 250µg