Safety Study of Viaskin Peanut to Treat Peanut Allergy

Completed · Phase 3 · Has a placebo group

Conditions studied: Peanut Allergy

In brief

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.

Key facts

Study ID

NCT02916446

Run by

DBV Technologies

People needed

393

Starts

2016-10-01

Expected to finish

2020-10-07

Last updated by the study team

2021-02-03

Who can join

Age: 4 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Allergy & Asthma Associates of Southern California — Mission Viejo, California, United States
• Palos Verdes Medical Group — Rolling Hills Estates, California, United States
• Stanford University School of Medicine — Stanford, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• National Jewish Health — Denver, Colorado, United States
• Sarasota Clinical Research — Sarasota, Florida, United States
• Atlanta Allergy & Asthma Clinic — Marietta, Georgia, United States
• Ann & Robert H. Lurie Children's Hospital of CHicago — Chicago, Illinois, United States
• Sneeze, Wheeze and Itch Associates,Clinical Research — Normal, Illinois, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Boston Childrens' Hospital — Boston, Massachusetts, United States
• Clinical Research Institute — Plymouth, Minnesota, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• The Asthma and Allergy Center — Bellevue, Nebraska, United States
• Mount Sinai Medical Center — New York, New York, United States
• The University of North Carolina - Chapell Hill — Chapel Hill, North Carolina, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• National Allergy and Asthma Research — Charleston, South Carolina, United States
• Children's Medical Center of Dallas — Dallas, Texas, United States
• Baylor College of Medicine - Texas Children's Hospital — Houston, Texas, United States
• Sylvana Research — San Antonio, Texas, United States
• STAAMP Research — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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