Dareen Siri M.D FAAAAI FACAAI FISAAI
Sneeze Wheeze & Itch Associates LLC
309-451-7509 (Stephanie CRC)
Please mention Red Sneakers For Food Allergy Awareness - Peoria Chapter if you or someone you know decides to participate.
They are so close to completing enrollment and just need an extra push to get the last patients. Their office anticipates a trial later this year for 1-3 year old's as well. Thank you so much for your consideration and support!
Dr. Siri's office is participating in a clinical trial called the VITESSE study, a phase 3 pivotal study to evaluate the efficacy and safety of an investigational drug patch called DBV712 in pediatric participants 4 to 7 years of age with peanut allergy. To qualify for this study, participants must have a physician-diagnosed peanut allergy or a well-documented medical history of IgE-mediated reaction(s) after ingestion of peanut.
More information at https://vitesseallergystudy.co
Epicutaneous immunotherapy (EPIT) is an emerging therapeutic approach to food allergy that utilizes the unique immune properties of the skin to deliver allergen directly to antigen-presenting cells in the epidermis and dermis to initiate desensitization.1-3 DBV712 is designed to provide EPIT using a dry deposit of a formulation of peanut protein extract, designed for the potential treatment of peanut allergy. Results from previous clinical studies in the DBV712 development program suggest that DBV712 could provide clinically meaningful desensitization in children with peanut allergy while providing an acceptable safety profile with very good compliance. DBV712 has not yet been approved by any regulatory agencies, such as the United States Food and Drug Administration or the European Medicines Agency.
VITESSE is a double-blind, placebo-controlled, randomized study to assess the efficacy and safety of daily DBV712 in peanut-allergic children aged 4 to 7 years. Approximately 600 participants will be enrolled to evaluate DBV712 as follows:
At screening, a peanut double-blind placebo-controlled food challenge (DBPCFC) will occur to confirm a participant’s peanut allergy and establish an entry peanut eliciting dose of ≤ 100 mg peanut protein
Participants will be randomized in a 2:1 ratio to receive the DBV712 patch or placebo patch, respectively
The study drug patch or placebo patch will be applied to the skin daily for 12 months
At Month 12, a post-study treatment DBPCFC will be performed to determine the primary
efficacy endpoint
After completion of the VITESSE study, participants may be offered the possibility to participate in an extension study where all participants will receive the DBV712 patch (regardless of their assignment in this study).
To pre-qualify for the VITESSE study, a patient must:
Be aged 4 through 7 years at screening
Have a physician-diagnosed peanut allergy or a well-documented medical history of IgE-mediated reaction(s) after ingestion of peanut
Have a peanut skin prick test (SPT) mean wheal of ≥ 6 mm and a peanut-specific IgE of > 0.7 kUA/L (will be performed during screening if not already performed in the last 6 months)
Be currently following a strict peanut-free diet
Have access to emergency medications (including self-injectable epinephrine) and a current food allergy emergency action plan
This is not a complete list of eligibility criteria. The study protocol will provide all inclusion and exclusion criteria. Study enrollment is currently active, and visits are conducted at my research location. There will be no charge to study participants for their participation in this study. The study drug patch, study-related procedures, and study visits will be provided at no charge.
If you have a patient you think may qualify and may be interested in participating, please call my office at the number below. When referring a patient to this study, please be assured that our involvement will be strictly study-related and the primary care of the patient will remain unchanged.
If you have questions about the VITESSE clinical research study, please do not hesitate to contact my office. Thank you for your consideration.
Sincerely,
Dareen Siri M.D
Principal Investigator
Study coordinator: Stephanie Oliver
Phone number: 309-451-7509
References
Bird JA, Sanchez-Borges M, Ansotegui IJ, Ebisawa M, Martell JAO. Skin as an immune organ and clinical applications
of skin-based immunotherapy. World Allergy Organ J. 2018;1(1):38.Wang J, Sampson HA. Safety and efficacy of epicutaneous immunotherapy for food allergy. Pediatr Allergy Immunol. 2018;29(4):341-349.
Tordesillas L, Mondoulet L, Blazquez AB, Benhamou PH, Sampson HA, Berin MC. Epicutaneous immunotherapy induces gastrointestinal LAP+ regulatory T cells and prevents food-induced anaphylaxis. J Allergy Clin Immunol. 2017;139(1):189-201.
-
An Event By
-
-
Sponsored By
-
-
Timing & Scoring By
-
-
Partners
-
