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.
Conditions
Peanut Allergy
Recruitment Status
Completed
Eligibility Criteria
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).
Intervention
Intervention Type
Intervention Name
Biological
Viaskin Peanut 250 mcg
Biological
Placebo
Phase
Phase 3
Gender
All
Min Age
4 Years
Max Age
11 Years
Download Date
February 3, 2021
Principal Investigator
N/A
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: