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 (EPITOPE)
Study ID: STU 022017-070
This is a 12-month, double-blind, placebo-controlled, randomized phase iii trial to assess the safety and efficacy of Viaskin[RegisteredTM] Peanut (doses of 100 [MiCRo-SYMBoL]g or 250 [MiCRo-SYMBoL]g peanut protein per patch) in peanut-allergic children 1 to 3 years of age. The trial will be conducted in between 20-40 sites in 3 to 6 countries with investigators and staffs trained and experienced in the diagnosis and the management of peanut allergy and anaphylaxis, and capable of performing DBPCFC in young children. During the screening period, subjects will undergo an entry/screening DBPCFC to peanut to confirm their allergy to peanut and to determine their entry or screening peanut eD. The starting dose of the challenge will be 1 mg peanut protein and will escalate up to the highest dose of 300 mg peanut protein. Subjects who react at or below the dose of 300 mg peanut protein are considered eligible. The primary efficacy endpoint is the difference between the percentage of treatment responders in the selected active Viaskin[RegisteredTM] Peanut group (250 [MiCRo-SYMBoL]g) compared to the placebo group.
Subjects will be enrolled in this study only if they meet all of the following criteria: 1. Male or female from 1-3 years of age at Visit 1. 2. Physician-diagnosed peanut allergy or high suspicion of peanut allergy as assessed by the physician: child presenting signs, symptoms and a medical and/or a family history putting him/her at high risk of having a peanut allergy and/or history of presence of peanut-specific IgE and/or positive SPT. 3. Subject currently following a strict peanut-free diet. 4. Signed informed consent of parent(s)/guardian(s) of the children aged 1-3 years. 5. Peanut-specific IgE level (ImmunoCAP system) > 0.7 kU/L. 6. Positive peanut SPT with a largest wheal diameter >= 6 mm. 7. Positive DBPCFC to peanut, with symptoms meeting the challenge stopping criteria at an ED <=300 mg peanut protein. 8. Parents/guardians and subjects willing to comply with all study requirements during their participation in the study.
- Cancer Related
- Healthy Volunteers
- UT Southwestern Principal Investigator
- CHRISTOPHER PAUL PARRISH
DBV TECHNOLOGIES SA
The objective of this study is to verify the safety and local tolerance of the 2 Viaskin[RegisteredTM] Peanut doses of 100 and 250 [MiCRo-SYMBoL]g and to assess the efficacy and safety of Viaskin[RegisteredTM] Peanut to induce desensitization to peanut in peanut-allergic subjects 1 to 3 years of age after a 12-month treatment period by ePiT. The rational of this study is Viaskin[RegisteredTM] Peanut is a ready-to-use and easy-to-administer form of allergen immunotherapy, particularly adapted to the pediatric population. it is intended to induce clinical desensitization/tolerization to peanut in subjects allergic to peanut through interaction with the local antigen Presenting Cells such as the epidermic Langerhans and dendritic cells. By utilizing the epicutaneous route of administration, Viaskin[RegisteredTM] Peanut is able to initiate these immunomodulatory processes while minimizing the potential safety concerns associated with systemic exposure to peanut allergenic proteins.