drugset / Trial / NCT03859700
Follow-up of the EPITOPE Study to Evaluate Long-term Efficacy and Safety of DBV712 in Young Children
NaSingle-groupOpen-labelTreatment
Summary
Open-label, follow-up study for subjects who completed the EPITOPE study.
Timeline
- Start
- 2018-12-06
- Primary completion
- 2025-05-13
- Completion
- 2025-05-13
Publications
- Greenhawt M, Albright D, Anvari S, Arends N, Arkwright PD, Begin P, Blumchen 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. Efficacy and Safety of Epicutaneous Immunotherapy in Peanut-Allergic Toddlers: Open-Label Extension to EPITOPE. J Allergy Clin Immunol Pract. 2025 May;13(5):1176-1187.e7. doi: 10.1016/j.jaip.2025.02.004. Epub 2025 Feb 14.
- Greenhawt M, Sindher SB, Wang J, O'Sullivan M, du Toit G, Kim EH, Albright D, Anvari S, Arends N, Arkwright PD, Begin P, Blumchen K, Bourrier T, Brown-Whitehorn T, Cassell H, Chan ES, Ciaccio CE, Deschildre A, Divaret-Chauveau A, Dorris SL, Dorsey MJ, Eiwegger T, Erlewyn-Lajeunesse M, Fleischer DM, Ford LS, Garcia-Lloret M, Giovannini-Chami L, Hourihane JO, Jay N, Jones SM, Kerns LA, Kloepfer KM, Leonard S, Lezmi G, Lieberman JA, Lomas J, Makhija M, Parrish C, Peake J, Perrett KP, Petroni D, Pfutzner W, Pongracic JA, Quinn P, Robison RG, Sanders G, Schneider L, Sharma HP, Trujillo J, Turner PJ, Tuttle K, Upton JE, Varshney P, Vickery BP, Vogelberg C, Wainstein B, Wood RA, Bee KJ, Campbell DE, Green TD, Rouissi R, Peillon A, Bahnson HT, Bois T, Sampson HA, Burks AW. Phase 3 Trial of Epicutaneous Immunotherapy in Toddlers with Peanut Allergy. N Engl J Med. 2023 May 11;388(19):1755-1766. doi: 10.1056/NEJMoa2212895.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DEFATTED POWDER OF ARACHIS HYPOGAEA L., SEMEN (PEANUTS) | Protein / enzyme biologic | 250 ug | Other |