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)

Sayantani Sindher
Allergist, Immunologist
Clinical Associate Professor, Medicine Clinical Associate Professor, Pediatrics - Allergy and Clinical Immunology
R. Sharon Chinthrajah
R. Sharon Chinthrajah
Allergist, Immunologist, Pulmonologist
Associate Professor of Medicine (Sean Parker Center) and of Pediatrics (Allergy and Clinical Immunology)

Contact us to find out if this trial is right for you.

Contact

Sharon Chinthrajah, MD
6505217237

View on ClinicalTrials.gov