Trial Profile
A Double-blind, Placebo-controlled, Randomized Phase III Trial to Assess the Safety and Efficacy of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 21 Mar 2024
Price :
$35
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At a glance
- Drugs Peanut allergy immunotherapy (Primary)
- Indications Peanut hypersensitivity
- Focus Registrational; Therapeutic Use
- Acronyms EPITOPE
- Sponsors DBV Technologies
- 07 Mar 2024 According to a DBV Technologies media release, company announce topline efficacy and safety data from year three of EPITOPE, corresponding to end-of-study results for participants completing three years of active treatment.
- 07 Mar 2024 According to a DBV Technologies media release, interim safety and efficacy data from the open-label extension of EPITOPE, which demonstrate a robust continued treatment effect with Viaskin Peanut after two years of treatment, at The American College of Allergy, Asthma, and Immunology annual meeting.
- 07 Mar 2024 According to a DBV Technologies media release, companys Phase 3 efficacy and safety study of Viaskin Peanut in peanut-allergic toddlers aged 1 through 3 years, is sufficient for the clinical portion of a BLA, and no additional efficacy studies were requested by the FDA.