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Open-label, follow-up study for subjects who completed the EPITOPE study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DBV712 250mcg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DBV712 250 mcg | Biological | DBV712 250 mcg, once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects reaching an ED ≥1000 mg | 12 months | |
| Proportion of subjects reaching an ED ≥1000 mg | 24 months | |
| Proportion of subjects reaching an ED ≥1000 mg | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) | Throughout the study during 36 months |
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center Tucson | Tucson | Arizona | 85724-5030 | United States | ||
| Arkansas Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39956162 | Derived | 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. | |
| 37163622 |
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| Little Rock |
| Arkansas |
| 72202 |
| United States |
| David Geffen School of Medicine at University of California Los Angeles | Los Angeles | California | 90095 | United States |
| Rady Children's Hospital San Diego | San Diego | California | 92123 | United States |
| University of California San Francisco | San Francisco | California | 94158 | United States |
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| Children's National Health Center | Washington D.C. | District of Columbia | 20010 | United States |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30329 | United States |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States |
| Comer Children's Hospital | Chicago | Illinois | 60637 | United States |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21205 | United States |
| Boston Childrens' Hospital | Boston | Massachusetts | 02115 | United States |
| University of Michigan - Allergy Specialty Clinic and Food Allergy Clinic | Ann Arbor | Michigan | 48106 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| The University of North Carolina - Chapell Hill | Chapel Hill | North Carolina | 27599 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| Le Bonheur Children's Hospital | Memphis | Tennessee | 38105 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37204 | United States |
| Dell Children's Medical Center of Central Texas | Austin | Texas | 78723 | United States |
| Children's Medical Center Dallas | Dallas | Texas | 75235 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Seattle Allergy & Asthma Research Institute | Seattle | Washington | 98115 | United States |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D021183 | Peanut Hypersensitivity |
| ID | Term |
|---|---|
| D000074924 | Nut and Peanut Hypersensitivity |
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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