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EPITOPE OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG- TERM CLINICAL BENEFIT AND SAFETY OF DBV712 IN PEANUT-ALLERGIC CHILDREN (EPOPEX)
Study ID: STU-2019-1180
Summary
This is an open-label, follow-up study for subjects who completed the ePiToPe study. eligible subjects will be offered enrollment in this follow-up study to receive Viaskin Peanut treatment at the dose selected in ePiToPe study (250 [MiCRo-SYMBoL]g). additional treatment duration will be 2 years, if subjects were previously randomized to active treatment in the ePiToPe study, or 3 years if subjects were randomized to placebo in the ePiToPe study. The treatment group during the ePiToPe study will remain blinded until the ePiToPe database is locked and the study results are unblinded. eligible subjects who decide to participate in the ePoPeX follow-up study will transition into this study during Visit 11 of the ePiToPe study. Subjects continuing into the ePoPeX study will not perform Visit 12 of ePiToPe study. Visit 11 of the ePiToPe study and Visit 1 of the ePoPeX study will be conducted concurrently, as far as possible; however, considering practical aspects for the center and for the subject's family, Visit 1 might be conducted within a week of Visit 11. The ePoPeX study population will consist of 2 sub-groups, based on the treatment received during the ePiToPe study: * Subjects who received placebo in the ePiToPe study (Placebo+VP group); * Subjects who received Viaskin Peanut (any dose) in the ePiToPe study (VP+VP group). The overall maximum study duration for each subject is approximately 2 years and 1 month for subjects previously randomized to Viaskin Peanut (any dose) in the ePiToPe study and 3 years and 1 month for subjects previously randomized to placebo in the ePiToPe study (including visit windows). The objectives of this follow-up study of the ePiToPe study are: * To assess the clinical benefit of Viaskin Peanut after up to 3 years of epicutaneous immunotherapy (ePiT) to induce/maintain desensitization to peanut in peanut-allergic children; * To evaluate the safety of long-term treatment with Viaskin Peanut in peanut-allergic children.
- Cancer Related
- No
- Healthy Volunteers
- No
- UT Southwestern Principal Investigator
- CHRISTOPHER PAUL PARRISH
DBV TECHNOLOGIES SA
The objectives of this follow-up study of the ePiToPe study are: * To assess the clinical benefit of Viaskin Peanut after up to 3 years of epicutaneous immunotherapy (ePiT) to induce/maintain desensitization to peanut in peanut-allergic children; * To evaluate the safety of long-term treatment with Viaskin Peanut in peanut- allergic children.