Safety Study of Viaskin Peanut to Treat Peanut Allergy (REALISE)

DBV Technologies

Status and phase

Completed

Phase 3

Conditions

Peanut Allergy

Treatments

Biological: Viaskin Peanut 250 mcg

Biological: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02916446

REALISE

Details and patient eligibility

About

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.

Enrollment

393 patients

Sex

All

Ages

4 to 11 years old

Volunteers

No Healthy Volunteers

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).