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

Status:	Recruiting
Conditions:	Allergy, Allergy
Therapuetic Areas:	Otolaryngology
Healthy:	No
Age Range:	1 - 3
Updated:	3/2/2019
Start Date:	July 31, 2017
End Date:	May 30, 2020

A Double-blind, Placebo-controlled, Randomized Phase III Trial to Assess the Safety and Efficacy of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age.

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).

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;

We found this trial at

sites

Baylor College of Medicine/Texas Children's Hospital

Houston, Texas

Principal Investigator: Sara Anvari, MD

Phone: 832-825-4668

from

Houston, TX

Emory University

201 Dowman Dr
Atlanta, Georgia 30303

(404) 727-6123

Principal Investigator: Brian VICKERY, MD

Phone: 404-727-8536

Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...

from

Atlanta, GA

Cleveland Clinic

9500 Euclid Avenue
Cleveland, Ohio 44106

216.444.2200

Principal Investigator: Leigh Ann KERNS, MD

Phone: 216-444-6340

Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...

from

Cleveland, OH

Mount Sinai Hospital

1 Gustave L Levy Pl # 271
New York, New York 10029

(212) 241-6500

Principal Investigator: Julie Wang, MD

Phone: 212-241-5548

Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...

from

New York, NY

Children's Hospital of Philadelphia

South 34th Street
Philadelphia, Pennsylvania 19104

215-590-1000

Principal Investigator: Terri Brown-Whitehorn, MD

Phone: 215-590-2549

Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...

from

Philadelphia, PA

University of Rochester

60 Crittenden Blvd # 70
Rochester, New York 14642

(585) 275-2121

Principal Investigator: Jeanne Lomas, MD

Phone: 716-604-6928

University of Rochester The University of Rochester is one of the country's top-tier research universities....

from

Rochester, NY

Stanford University School of Medicine

291 Campus Dr
Stanford, California 94305

(650) 725-3900

Principal Investigator: Sayantani Sindher, MD

Phone: 650-724-0293

Stanford University School of Medicine Vast in both its physical scale and its impact on...

from

Stanford, CA

University of Michigan Health System

1500 E Medical Center Dr
Ann Arbor, Michigan 48109

(734) 936-4000

Principal Investigator: Georgiana M Sanders, MD

Phone: 734-936-5634

University of Michigan Health System The University of Michigan is home to one of the...

from

Ann Arbor, MI

Children's Hospital Colorado

13123 E 16th Ave
Aurora, Colorado 80045

(720) 777-1234

Principal Investigator: David M. Fleischer, MD

Phone: 720-777-2575

Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...

from

Aurora, CO

Dell Children's Medical center

Austin, Texas 78723

Principal Investigator: Pooja VARSHNEY, MD

Phone: 512-628-1870

from

Austin, TX

Johns Hopkins Hospital

1800 Orleans St.
Baltimore, Maryland 21287

410-955-5000

Principal Investigator: Robert Wood, MD

Phone: 410-955-5883

Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...

from

Baltimore, MD

Boston Children's Hospital

300 Longwood Ave
Boston, Massachusetts 02115

(617) 355-6000

Principal Investigator: Lynda Schneider, MD

Phone: 617-355-6180

Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....

from

Boston, MA

University of North Carolina Chapell Hill

Chapel Hill, North Carolina 27599

Principal Investigator: Edwin Kim, MD

Phone: 919-843-9087

from

Chapel Hill, NC

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

225 E Chicago Ave
Chicago, Illinois 60611

(312) 227-4000

Principal Investigator: Jacqueline Pongracic, MD

Phone: 312-227-6474

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

from

Chicago, IL

The Universal of Chicago Medical Center

Chicago, Illinois 60637

Principal Investigator: Christina Ciaccio, MD

Phone: 773-834-4010

from

Chicago, IL

Children's Medical Center of Dallas

1935 Medical District Dr
Dallas, Texas 75235

(214) 456-7000

Principal Investigator: Christopher Parrish, MD

Phone: 214-456-5730

Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...

from

Dallas, TX

Riley Hospital for Children, Indiana University

Indianapolis, Indiana 46202

Principal Investigator: Kirsten KLOEPFER, MD

Phone: 317-278-7860

from

Indianapolis, IN

Arkansas Children's Hospital

1 Children's Way
Little Rock, Arkansas 72202

(501) 364-1100

Principal Investigator: Stacie M. Jones, MD

Phone: 501-364-1060

Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...

from

Little Rock, AR

University of California School of Medicine

Los Angeles, California 10833

Principal Investigator: Maria Garcia-Lloret, MD

Phone: 310-825-6481

from

Los Angeles, CA

Le Bonheur Children's Hospital

Memphis, Tennessee 38103

Principal Investigator: Jay LIEBERMAN, MD

Phone: 901-287-7337

from

Memphis, TN

Children's Hospital of Pittsburgh

3414 Fifth Avenue
Pittsburgh, Pennsylvania 15213

Principal Investigator: Deborah Albright, MD

Phone: 412-692-8296

from

Pittsburgh, PA

University of California, Rady Childrens Hospital

San Diego, California 92123

Principal Investigator: Stephanie Leonard, MD

Phone: 858-966-5961

from

San Diego, CA

University of California at San Francisco

San Francisco, California 94143

Principal Investigator: Morna DORSEY, MD

Phone: 415-476-3086

from

San Francisco, CA

ASTHMA, Inc.

Seattle, Washington 98105

Principal Investigator: Daniel Petroni, MD

Phone: 206-525-5520

from

Seattle, WA

University of Arizona Health Science

Tucson, Arizona 85719

Principal Investigator: Heather Cassell, MD

Phone: 520-626-7780

from

Tucson, AZ

British Columbia Children's Hospital

Vancouver, British Columbia

Principal Investigator: Chan Edmond, MD

Phone: 1 604 875 2628

from

Vancouver,

Children's National Health System

Washington, District of Columbia 20010

Principal Investigator: Hemant Sharma, MD

Phone: 202-476-6080

from

Washington,

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

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A Double-blind, Placebo-controlled, Randomized Phase III Trial to Assess the Safety and Efficacy of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age.

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