Safety Study of Viaskin Peanut to Treat Peanut Allergy

Trial ID or NCT#

NCT02916446

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Eligibility Criteria

Ages Eligible for Study: 4 Years to 11 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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).
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Investigator(s)

R. Sharon Chinthrajah
R. Sharon Chinthrajah
Allergist, Immunologist, Pulmonologist
Associate Professor of Medicine (Sean Parker Center for Allergy and Asthma Research - Clinic) and of Pediatrics

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Contact

Sharon Chinthrajah, MD
6505217237

View on ClinicalTrials.gov