Follow-up of the EPITOPE Study to Evaluate Long-term Efficacy and Safety of DBV712 in Young Children

Conditions

Peanut Allergy

Keywords

EPIT, Epicutaneous, Immunotherapy, Viaskin

Brief summary

Open-label, follow-up study for subjects who completed the EPITOPE study.

Greenhawt M, Albright D, Anvari S, Arends N, Arkwright PD, Bégin P, Blümchen K, Brown-Whitehorn T, Cassell H, Chan ES, Ciaccio CE, Deschildre A, Divaret-Chauveau A, Dorris S, Dorsey M, Du Toit G, Eiwegger T, Erlewyn-Lajeunesse M, Fleischer DM, Ford LS, Garcia-Lloret M, O'B Hourihane J, Jay N, Jones SM, Kim EH, Kloepfer K, Leonard S, Lezmi G, Lieberman J, Lomas J, Makhija M, O'Sullivan M, Parrish C, Peake J, Perrett KP, Petroni D, Pongracic JA, Quinn P, Robison RG, Sanders G, Schneider L, Sharma H, Sindher SB, Trujillo J, Turner PJ, Tuttle K, Upton J, Varshney P, Vickery BP, Vogelberg C, Wainstein B, Wang J, Wood R, Bee KJ, Campbell DE, Green TD, Rouissi R, Bahnson HT, Bois T, Sampson HA, Burks AW.

2025-02-146 citations

10.1016/j.jaip.2025.02.004

Interventions

BIOLOGICALDBV712 250 mcg

DBV712 250 mcg, once daily

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 5 Years

Healthy volunteers

No

Inclusion criteria

* completion of the EPITOPE study

Exclusion criteria

* Generalized dermatologic disease (for example, active atopic dermatitis, uncontrolled generalized active eczema, ichthyosis vulgaris) extending widely on the skin and especially on the back or arms with no intact zones to apply the Viaskin patches. * Diagnosis of asthma that evolved to severe, unstable or uncontrolled asthma

Design outcomes

Primary

Measure	Time frame
Proportion of subjects reaching an ED ≥1000 mg	12 months

Secondary

Measure	Time frame
Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)	Throughout the study during 36 months

Countries

United States

Outcome results

None listed