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 |
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.
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).
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