Current Environment:

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

Minimum Age

4 Years

Maximum 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: