Safety Study of Viaskin Peanut to Treat Peanut Allergy



Status:Active, not recruiting
Conditions:Allergy, Allergy, Neurology
Therapuetic Areas:Neurology, Otolaryngology
Healthy:No
Age Range:4 - 11
Updated:2/23/2019
Start Date:October 2016
End Date:September 2020

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Trial Summary
Trial Overview
Inclusion Criteria

This study evaluates the safety of Viaskin Peanut 250 mcg in the treatment of peanut allergy
in children from 4 to 11 years of age. Subjects will receive either Viaskin Peanut 250 mcg or
a placebo for a period of 6 months, after which all subjects will be receiving the active
treatment up to a period of 3 years under active treatment.


Inclusion Criteria:

- Physician-diagnosed peanut allergy;

- A peanut Skin Prick Test (SPT) with a wheal largest diameter ≥8 mm;

- A specific-peanut Immunoglobulin E (IgE) ≥14 kU/L;

- Subjects following a strict peanut-free diet.

Exclusion Criteria:

- Generalized dermatologic disease

- Spirometry forced expiratory volume in 1 second (FEV1) <80% of the predicted value, or
peak expiratory flow (PEF) <80% of predicted value;

- Receiving β-blocking agents, angiotensin-converting enzyme inhibitors,
angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant
therapy; anti-tumor necrosis factor drugs or anti-IgE drugs (such as omalizumab) or
any biologic immunomodulatory therapy;

- Prior or concomitant history of any immunotherapy to any food allergy (for example
EPIT, OIT, SLIT, or specific oral tolerance induction).
We found this trial at
27
sites
Stanford University School of Medicine
291 Campus Dr
Stanford, California 94305
(650) 725-3900
Principal Investigator: Sharon Chinthrajah, MD
Stanford University School of Medicine Vast in both its physical scale and its impact on...
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Massachusetts General Hospital
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Wayne Shreffler, MD
Phone: 617-726-6147
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Boston, MA
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Children's Mercy Hospital
2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Principal Investigator: Paul Dowling, MD
Phone: 816-960-8885
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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Kansas City, MO
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Mount Sinai Hospital
1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Principal Investigator: Anna Nowak-Wegrzyn, MD
Phone: 212-241-5548
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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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...
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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...
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Aurora, CO
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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...
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Baltimore, MD
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The Asthma & Allergy Center, PC
Bellevue, Nebraska 68123
Principal Investigator: Linda Ford, MD
Phone: 402-592-2055
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Bellevue, NE
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Boston Children's Hospital
300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: Lynda Schneider, MD
Phone: 617-355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Boston, MA
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University of North Carolina Chapell Hill
Chapel Hill, North Carolina 27599
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Chapel Hill, NC
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National Allergy and Asthma Research, LLC
Charleston, South Carolina 29407
Principal Investigator: Ned Rupp, MD
Phone: 843-797-8162
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Charleston, SC
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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
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Children's Medical Center of Dallas
1935 Medical District Dr
Dallas, Texas 75235
(214) 456-7000
Principal Investigator: Drew Bird, MD
Phone: 214-456-5142
Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
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Dallas, TX
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National Jewish Health
1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
Principal Investigator: Bruce Lanser, MD
Phone: 303-398-1379
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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Baylor College of Medicine/Texas Children's Hospital
Houston, Texas
Principal Investigator: Davis Carla, MD
Phone: 832-824-1319
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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...
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Little Rock, AR
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Atlanta Allergy & Asthma Clinic, PA
Marietta, Georgia 30060
Principal Investigator: Stanley Fineman, MD
Phone: 770-427-1471
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Marietta, GA
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Allergy and Asthma Associates of Southern California
Mission Viejo, California 92691
Principal Investigator: William Berger, MD
Phone: 949-364-2900
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Mission Viejo, CA
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Sneeze, Wheeze and Itch Associates,Clinical Research
Normal, Illinois 62704
Principal Investigator: Dareen Siri, MD
Phone: 309-452-0995
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Normal, IL
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Children's Hospital of Pittsburgh
3414 Fifth Avenue
Pittsburgh, Pennsylvania 15213
Principal Investigator: Todd Green, MD
Phone: 412-692-8296
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Pittsburgh, PA
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Clinical Research Institute Inc
Plymouth, Minnesota 55441
Principal Investigator: Allan Stillerman, MD
Phone: 763-744-1140
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Plymouth, MN
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Palos Verdes Medical Group
Rolling Hills Estates, California 90274
Principal Investigator: Lawrence Sher, MD
Phone: 310-265-1623
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Sylvana Research
San Antonio, Texas
Principal Investigator: Paul Ratner, MD
Phone: 210-614-6673
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STAAMP Research
San Antonio, Texas 78251
Principal Investigator: Erika Gonzales-Reyes, MD
Phone: 210-573-2451
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Sarasota Clinical Research
Sarasota, Florida 34233
Principal Investigator: Hugh Windom, MD
Phone: 941-927-4888
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ASTHMA, Inc. Clinical Research
Seattle, Washington 98115
Principal Investigator: Stephen Tilles, MD
Phone: 206-525-5520
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Children's and Women's Health Centre of Brisith Columbia
Vancouver, British Columbia
Principal Investigator: Chan Edmond, MD
Phone: 604-875-2118
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