Welcome to our May research update! Getting involved with research is an important way to impact food allergy treatments, education, and awareness.
This month, we are highlighting research opportunities and news on:
- Clinical trial for children with peanut allergy
- Clinical trial for teens and adults with eosinophilic gastritis (EoG) with or without eosinophilic duodenitis (EoD)
- Shared decision-making tool for peanut allergy management
- Disparities in peanut oral immunotherapy
Clinical Trials
Now Enrolling: The VITESSE Phase 3 Study for Peanut Allergy
The VITESSE phase 3 clinical research study is looking for children 4 to 7 years of age who have been diagnosed with peanut allergy and are currently following a strict peanut-free diet. Study doctors are testing an investigational drug patch (also called study drug patch) to learn how well it works and how safe it is in children with peanut allergy.
- What should I know about the VITESSE study?
- To be eligible for this study, participants must be*:
- 4 to 7 years of age
- Diagnosed with peanut allergy
- Currently following a strict peanut-free diet
*Other inclusion/exclusion criteria will apply.
- This study will consist of at least 12 study visits and 5 phone calls over a period of approximately 58 weeks (about 1 year)
- Participants will be randomly assigned (by chance) to receive the study drug patch or placebo patch (looks like the study drug but contains no active drug). Participants will have about a 67% (2 in 3) chance of receiving the study drug patch and about a 33% (1 in 3) chance of receiving the placebo patch
- The health and safety of participants will be monitored throughout the study
- Participant data and information will be kept confidential according to applicable laws for clinical research studies
- Study participants will receive all study-related procedures and the study drug patch or placebo patch at no cost
To learn more about the VITESSE phase 3 study and eligibility criteria, please visit VitesseAllergyStudy.com or ClinicalTrials.gov (identifier: NCT05741476).
Study sponsored by DBV Technologies
Is Eosinophilic Gastritis with or without Eosinophilic Duodenitis Affecting Your Daily Life?
You may be eligible for the Engage clinical study, which aims to investigate a study drug for EoG with or without EoD.
You may be eligible if you:
- Are ≥ 12 years old
- Have been diagnosed with EoG by endoscopic biopsy
- Have had at least 2 EoG episodes every week in the 8 weeks prior to joining the study (stomach pain, stomach cramping, nausea, bloating, early satiety, loss of appetite, vomiting, diarrhea)
There are other requirements to participate. To learn more about Engage, and whether it may be right for you, please visit the study website.
Protocol Number: R668-EGE-2213
© Regeneron Pharmaceuticals, Inc. All rights reserved.
Latest Food Allergy News
Evaluation and Update of a Shared Decision-Making Tool for Peanut Allergy Management
Many people with peanut allergies manage their allergy by avoiding contact with peanut. There's also a treatment approved by the Food and Drug Administration (FDA) called peanut oral immunotherapy (OIT) approved for kids aged 4 to 17. It is important for people with peanut allergy, as well as their caregivers, to be aware of their options for food allergy management.
Recently, a workgroup of allergy treatment experts and patient advocates got together to evaluate and update a tool to help people decide how to effectively manage peanut allergies. The tool was developed using shared decision-making (SDM) principles, in which health care providers work directly with their patients and their caregivers to make informed decisions that are best for the patient. This review process listened to patients and caregivers about their experiences to improve the existing tool.
Allergy therapy experts and patient advocates worked together to update the decision aid. The group then talked to teenagers with peanut allergies and their caregivers to see if the tool would be easy to understand and use. These interviews found that teens understood the tool and felt it was important and relevant. Some changes were made to the tool based on participant feedback. Overall, the study showed that the Peanut Allergy Treatment SDM tool can be helpful in making decisions about peanut allergy management.
Disparities in Peanut Oral Immunotherapy
OIT is a way to treat food allergies that retrains the immune system to respond differently to food allergens like peanuts, egg, or cow’s milk over time. At one hospital, researchers found differences in who gets this treatment for peanut allergy.
The researchers looked at data from 1,028 kids with peanut allergies. Of those, 148 were getting peanut OIT, and the rest managed their food allergy by avoiding peanuts. They found that there were no differences in gender or ethnicity between the two groups, but Black patients made up a much smaller part of the group getting OIT compared to those avoiding peanuts. Also, more kids getting OIT had private insurance, and they tended to live in neighborhoods with higher incomes.
The results of this recent study show there are significant differences in who gets OIT based on race and income. More research is needed in this area to better understand why these differences happen and how to improve fairness in who gets this treatment.
Medical Review: May 2024 by John James, MD
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