DBV Technologies Announces Last Patient Visit Completed in VITESSE Phase 3 Clinical Trial of VIASKIN® Peanut Patch in Peanut Allergic Children Aged 4-7 Years
DBV Technologies (NASDAQ:DBVT) announced completion of the last patient visit in the VITESSE Phase 3 trial of the VIASKIN® Peanut patch in peanut-allergic children aged 4–7 years. The double-blind, placebo-controlled treatment phase is complete and the company remains on track to report topline data in Q4 2025.
The 12-month study enrolled 654 subjects randomized 2:1 across 86 sites in the U.S., Canada, Europe, the UK, and Australia. DBV described VITESSE as the largest treatment intervention study in peanut allergy and thanked investigators, patients, and caregivers for participation.
DBV Technologies (NASDAQ:DBVT) ha annunciato il completamento della visita dell'ultimo paziente nello studio di fase 3 VITESSE della patch VIASKIN® contro l'allergia al burro d'arachidi nei bambini allergici di età 4–7 anni. La fase di trattamento in doppio cieco e controllata con placebo è conclusa e l'azienda resta in linea per riportare dati principali nel Q4 2025.
Lo studio di 12 mesi ha arruolato 654 soggetti randomizzati 2:1 in 86 siti negli Stati Uniti, in Canada, in Europa, nel Regno Unito e in Australia. DBV ha descritto VITESSE come il più grande studio di intervento terapeutico nell'allergia alle arachidi e ha ringraziato i ricercatori, i pazienti e i caregiver per la partecipazione.
DBV Technologies (NASDAQ:DBVT) anunció la finalización de la visita del último paciente en el ensayo de fase 3 VITESSE del parche VIASKIN® Peanut para niños alérgicos al maní con edades de 4–7 años. La fase de tratamiento, doble ciego y controlada con placebo, está completada y la compañía mantiene su objetivo de reportar datos principales en el cuarto trimestre de 2025.
El estudio de 12 meses incluyó 654 sujetos aleatorizados 2:1 en 86 sitios en EE. UU., Canadá, Europa, el Reino Unido y Australia. DBV describió VITESSE como el mayor estudio de intervención en el tratamiento de la alergia al maní y agradeció a los investigadores, pacientes y cuidadores por su participación.
DBV Technologies (NASDAQ:DBVT)는 VIASKIN® 땅콩 패치의 VITESSE 3상 시험에서 4–7세의 땅콩 알레르기 아동의 마지막 환자 방문이 완료되었다고 발표했습니다. 이중 맹검, 위약 대조 치료 단계가 완료되었으며, 회사는 2025년 4분기에 주요 데이터를 발표할 계획을 유지하고 있습니다.
12개월 연구에는 654명의 피험자가 미국, 캐나다, 유럽, 영국, 호주에 걸친 86곳의 사이트에서 2:1로 무작위 배정되었습니다. DBV는 VITESSE를 땅콩 알레르기에 대한 가장 큰 치료 개입 연구로 설명했고, 연구자들, 환자들 및 간병인들의 참여에 감사를 표했습니다.
DBV Technologies (NASDAQ:DBVT) a annoncé l’achèvement de la visite du dernier patient dans l’essai de phase 3 VITESSE du patch VIASKIN® Peanut chez les enfants allergiques à l’arachide âgés de 4–7 ans. La phase de traitement en double aveugle et contrôlée par placebo est terminée et la société reste sur la bonne voie pour communiquer les données principales au T4 2025.
L’étude de 12 mois a recruté 654 sujets randomisés 2:1 sur 86 sites aux États‑Unis, au Canada, en Europe, au Royaume‑Uni et en Australie. DBV a décrit VITESSE comme la plus grande étude d’intervention dans l’allergie à l’arachide et a remercier les investigateurs, les patients et les aidants pour leur participation.
DBV Technologies (NASDAQ:DBVT) gab den Abschluss des Besuchs des letzten Patienten in der Phase-3-Studie VITESSE des VIASKIN®-Erdnuss-Patches bei erdnussallergischen Kindern im Alter von 4–7 Jahren bekannt. Die doppelblinde, placebokontrollierte Behandlungsphase ist abgeschlossen, und das Unternehmen bleibt auf Kurs, Topline-Daten im Q4 2025 zu berichten.
Die 12-monatige Studie rekrutierte 654 Probanden, randomisiert 2:1 an 86 Standorten in den USA, Kanada, Europa, dem Vereinigten Königreich und Australien. DBV beschrieb VITESSE als die größte Interventionsstudie bei einer Erdnussallergie und dankte den Untersuchern, Patienten und Betreuern für die Teilnahme.
DBV Technologies (NASDAQ:DBVT) أعلنت عن إكمال زيارة آخر مريض في تجربة المرحلة 3 VITESSE للاصقة VIASKIN® للفول السوداني لدى الأطفال المصابين بحساسية نحو الفول السوداني الذين تراوح أعمارهم بين 4–7 سنوات. انتهت مرحلة العلاج المزدوجة التعمية والخاضعة للتحكم بالعلاج الوهمي بنجاح وتبقى الشركة على المسار للإبلاغ عن البيانات الأولية في الربع الرابع من 2025.
أشارت الدراسة التي امتدت 12 شهراً إلى أن عدد المشاركين بلغ 654 مشاركاً، وموزعين عشوائياً بنسبة 2:1 عبر 86 موقعاً في الولايات المتحدة وكندا وأوروبا والمملكة المتحدة وأستراليا. وصفت DBV VITESSE بأنها أكبر دراسة تدخل علاجي في الحساسية من الفول السوداني وشكرت المحققين والمرضى ومقدمي الرعاية على مشاركتهم.
- Last patient visit completed, marking a regulatory milestone
- Topline data scheduled for Q4 2025 (near-term catalyst)
- 654 subjects enrolled (randomized 2:1) across 86 sites
- No efficacy or safety results released yet; outcomes remain unknown
Châtillon, France, November 11, 2025
DBV Technologies Announces Last Patient Visit Completed in VITESSE Phase 3 Clinical Trial of VIASKIN® Peanut Patch in Peanut Allergic Children Aged 4-7 Years
- Company remains on track for VITESSE topline data in Q4 of this year
DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT – CUSIP: 23306J309), a clinical-stage biopharmaceutical company, today announced that the last patient visit has been completed in the Company’s Phase 3 VITESSE clinical trial of the VIASKIN® Peanut patch in peanut allergic children aged 4-7 years.
With the completion of the double-blind, placebo-controlled treatment phase of the study, DBV remains on track to announce topline data from VITESSE in the fourth quarter of this year.
“Last patient last visit represents a very important milestone for DBV, as it brings us one step closer to the potential of bringing this treatment option to peanut allergic children, their physicians and caregivers, if approved,” stated Daniel Tassé, Chief Executive Officer of DBV Technologies. “We’re grateful to the investigators, internal teams, and most importantly patients and caregivers for their time and commitment to this study. We look forward to sharing topline results this quarter.”
The VITESSE Phase 3 trial in peanut-allergic children ages 4 – 7 is a 12-month study evaluating the efficacy and safety of the VIASKIN® Peanut patch in 654 subjects (randomized 2:1), representing individuals across 86 sites in the U.S., Canada, Europe, the UK, and Australia. VITESSE is currently the largest treatment intervention study in peanut allergy.
About DBV Technologies
DBV Technologies is a clinical-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV is currently focused on investigating the use of its proprietary VIASKIN® patch technology to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT), the VIASKIN® patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of VIASKIN Peanut in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age).
DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Market (Ticker: DBVT; CUSIP: 23306J309).
For more information, please visit www.dbv-technologies.com and engage with us on X (formerly Twitter) and LinkedIn.
VIASKIN is a registered trademark of DBV Technologies.
Forward Looking Statements
This press release may contain forward-looking statements and estimates, including statements regarding the therapeutic potential of VIASKIN® Peanut patch and EPIT, designs of DBV’s anticipated clinical trials, DBV’s planned regulatory and clinical efforts including timing and results of communications with regulatory agencies, plans and expectations regarding initiation of the confirmatory study, plans and expectations with respect to the submission of BLAs to FDA, anticipated support for the BLA submission, , and the ability of any of DBV’s product candidates, if approved, to improve the lives of patients with food allergies. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties. At this stage, DBV’s product candidates have not been authorized for sale in any country. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and DBV’s ability to successfully execute on its budget discipline measures. A further list and description of risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements in this press release can be found in DBV’s regulatory filings with the French Autorité des Marchés Financiers (“AMF”), DBV’s filings and reports with the U.S. Securities and Exchange Commission (“SEC”), including in DBV’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on April 11, 2025, as amended by Amendment No. 1 on Form 10-K/A filed with the SEC on April 28, 2025, and as amended further by Amendment No. 2 on Form 10-K/A filed with the SEC on May 14, 2025, and future filings and reports made with the AMF and SEC by DBV. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, DBV Technologies undertakes no obligation to update or revise the information contained in this Press Release.
Investor Contact
Katie Matthews
DBV Technologies
katie.matthews@dbv-technologies.com
Media Contact
Brett Whelan
DBV Technologies
brett.whelan@dbv-technologies.com
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