Trial Search Results

Safety Study of Viaskin Peanut to Treat Peanut Allergy

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

DBV Technologies

Stanford Investigator(s):

Intervention(s):

  • Biological: Viaskin Peanut 250 mcg
  • Biological: Placebo

Phase:

Phase 3

Eligibility


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).

Ages Eligible for Study

4 Years - 11 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sharon Chinthrajah, MD
Recruiting