Efficacy and Safety of Viaskin Milk in Children With IgE-Mediated Cow's Milk Allergy

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

198

Participants

Timeline

Start Date

November 30, 2014

Primary Completion Date

December 14, 2017

Study Completion Date

December 22, 2020

Conditions
Food Allergy
Interventions
BIOLOGICAL

Viaskin Milk 150 mcg

Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 150 mcg cow's milk proteins.

BIOLOGICAL

Viaskin Milk 300 mcg

Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 300 mcg cow's milk proteins.

BIOLOGICAL

Viaskin Milk 500 mcg

Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins.

BIOLOGICAL

Viaskin Placebo

Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation.

Trial Locations (17)

10029

Mount Sinai Medical Center, New York

15224

Children's Hospital of Pittsburgh, Pittsburgh

19104

Children's Hospital of Philadelphia, Philadelphia

21287

Johns Hopkins Hospital, Baltimore

60611

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

72202

Arkansas Children's Hospital, Little Rock

75235

Children's Medical Center of Dallas, Dallas

80045

Children's Hospital Colorado, Aurora

92123

Rady Children's Hospital, San Diego

94305

Stanford University School of Medicine, Stanford

98115

ASTHMA, Inc., Seattle

02114

Massachusetts General Hospital, Boston

L5A 3V4

Cheema Research Inc., Mississauga

K1G6C6

Ottawa Allergy Research Corporation, Ottawa

M4V 1R2

Gordon Sussman Clinical Research Inc., Toronto

H3T 1C4

Centre Hospitalier Universitaire Sainte Justine, Montreal

G1V 4W2

Clinique Spécialisée en allergie de la Capitale, Québec

Sponsors

Lead Sponsor

All Listed Sponsors
lead

DBV Technologies

INDUSTRY

NCT02223182 - Efficacy and Safety of Viaskin Milk in Children With IgE-Mediated Cow's Milk Allergy | Biotech Hunter | Biotech Hunter