Safety of Epicutaneous Immunotherapy for the Treatment of Peanut Allergy

PHASE1CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

July 31, 2010

Primary Completion Date

February 29, 2012

Study Completion Date

February 29, 2012

Conditions
Peanut Allergy
Interventions
BIOLOGICAL

Whole peanut extract

Four different doses of whole peanut extract expressed as micrograms (mcg) of peanut proteins (20, 100, 250, 500 mcg) and two different dosing regimen (epicutaneous application for 24 hours every 24 hours and epicutaneous application for 48 hours every 48 hours) will be tested for determination of the maximum tolerated dose during a 2-week treatment period.

BIOLOGICAL

Placebo formulation

Matching placebo at two different dosing regimen (epicutaneous application for 24 hours every 24 hours and epicutaneous application for 48 hours every 48 hours) will be tested in parallel to the peanut proteins doses for determination of the maximum tolerated dose during a 2-week treatment period.

Trial Locations (5)

27710

Duke University Medical Center, Durham

72202

Arkansas Children's Hospital, Little Rock

80206

National Jewish Health, Denver

84058

Aspen Clinical Research, Orem

08046

CRI Worldwide, Willingboro

Sponsors

Lead Sponsor

All Listed Sponsors
lead

DBV Technologies

INDUSTRY

NCT01170286 - Safety of Epicutaneous Immunotherapy for the Treatment of Peanut Allergy | Biotech Hunter | Biotech Hunter