Efficacy and safety of Viaskin Peanut in peanut-allergic childre

Phase 1

• Conditions: Peanut Allergy; MedDRA version: 19.0Level: LLTClassification code 10034202Term: Peanut allergySystem Organ Class: 100000004870; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2015-002461-37-DE
• Lead Sponsor: DBV Technologies

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-29
• Last Update Posted: 6 November 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

- Male or female children aged 4 through 11 years at Visit 1
- Physician-diagnosed peanut allergy or children with a well documented medical history of IgE-mediated reactions after ingestion of peanut and currently following a strict peanut-free diet.
Are the trial subjects under 18? yes
Number of subjects for this age range: 330
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- History of severe anaphylaxis to peanut with any of the following symptoms: hypotension, hypoxia, neurological compromise (collapse, loss of consciousness or incontinence)
- Severe reaction during the entry/screening DBPCFC (defined as need for intubation, hypotension persisting after epinephrine administration, and/or the need for =3 doses of epinephrine), or if they have an objective IgE-mediated reaction to the placebo formula during the entry/screening DBPCFC.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified