Peanut Allergy
Conditions
Brief summary
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.
Interventions
BIOLOGICALViaskin Peanut 250 mcg
BIOLOGICALPlacebo
Sponsors
DBV Technologies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Years to 11 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Through study completion, an average of 3 years |
Other
| Measure | Time frame |
|---|---|
| Change in peanut-specific Immunoglobulins E (IgE) | Baseline, month 3, 6, 9, 12, 18, 24, 30, 36, 42 |
| Change in peanut-specific Immunoglobulins G4 (IgG4) | Baseline, month 3, 6, 9, 12, 18, 24, 30, 36, 42 |
Countries
Canada, United States
Outcome results
None listed