Follow-up of the PEPITES Study to Evaluate Long-term Efficacy and Safety of Viaskin Peanut in Children (PEOPLE)
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|ClinicalTrials.gov Identifier: NCT03013517|
Recruitment Status : Unknown
Verified December 2020 by DBV Technologies.
Recruitment status was: Active, not recruiting
First Posted : January 6, 2017
Last Update Posted : December 2, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Peanut Allergy||Drug: Viaskin Peanut 250µg||Phase 3|
Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-label Follow-up Study of the PEPITES Study to Evaluate the Long-term Efficacy and Safety of Viaskin Peanut|
|Actual Study Start Date :||January 23, 2017|
|Actual Primary Completion Date :||November 23, 2019|
|Estimated Study Completion Date :||March 2023|
|Experimental: Viaskin Peanut 250µg||
Drug: Viaskin Peanut 250µg
DBV712 250 µg, once daily
- % of subjects originating from the active arm of PEPITES reaching an Eliciting Dose (ED) ≥ 1,000 mg after 24 months of additional treatment in PEOPLE [ Time Frame: Month 24 ]
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Subjects who completed the PEPITES study.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03013517
|Responsible Party:||DBV Technologies|
|Other Study ID Numbers:||
|First Posted:||January 6, 2017 Key Record Dates|
|Last Update Posted:||December 2, 2020|
|Last Verified:||December 2020|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Immune System Diseases
Nut and Peanut Hypersensitivity