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

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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.

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Latest Food Allergy News

ARS Pharmaceuticals Provides Update for neffy® Epinephrine Nasal Spray
ARS Pharmaceuticals, Inc. recently shared an update on their medicine called neffy®. Neffy is an epinephrine nasal spray meant to treat severe allergic reactions, like anaphylaxis. Epinephrine is the treatment of choice for severe allergic reactions, called anaphylaxis. If approved, neffy could provide a safe, effective, and easy to use needle-free epinephrine when needed.

In September 2023, the Food and Drug Administration (FDA) requested more information on the use of neffy for the treatment of anaphylaxis, including a repeat dosing study and updated testing. In February 2024, ARS successfully completed these requests for further testing.

ARS is hopeful that neffy will be approved soon to help people who need a needle-free and easy-to-use epinephrine solution. The FDA will review the information and is expected to make a decision about approval by October 2024.

Some Families May Need Support with Early Introduction of Peanut
Early introduction of peanut to prevent peanut allergy in at-risk infants has been an active area of research for the past several years. A recent study published in “The Journal of Allergy and Clinical Immunology: In Practice” looked at how infants without peanut allergies, aged 4 to 11 months, responded to introducing peanuts into their diet. These infants hadn’t tried peanut before but were at higher risk for peanut allergies due to factors like moderate-to-severe eczema, other food allergies, and/or family history of peanut allergy. Peanut was introduced by current recommended guidelines.

Most of the infants did well with peanut introduction, and very few developed a peanut allergy. Families generally found it easy to introduce peanuts, but some faced challenges, especially if they had a family member with a peanut allergy. Despite concerns, reactions in siblings were rare. But parents with peanut allergies themselves were more likely to have reactions related to their infant’s peanut intake.

Overall, the study suggests that early introduction of peanut is very effective and is usually safe and easy to do for most families. But some families might need extra support, especially if they have a family history of peanut allergy. Moving forward, more education about the benefits and risks of early peanut introduction to prevent peanut allergy will be helpful for families and health care providers.

Food Aversion and Anxiety Are Barriers to Food Oral Immunotherapy
Oral immunotherapy (OIT) for food allergy is a treatment option for some people with food allergy, but there can be barriers to starting and continuing the treatment. A new study looks at the challenges people face with OIT for food allergies. The researchers surveyed over 300 families in Canada and the United States who were in OIT programs.

The results showed that many people were afraid or anxious of having a reaction to the treatment, which made it hard to start. Also, taste aversion, or not liking the taste of the treatment, was a big reason why some people stopped the treatment. Taste aversion was also a big reason why some people took longer to complete the treatment or took less of the treatment. Older children had more trouble with taste aversion than younger children.

Many families also felt bored with the food options during treatment, specifically with peanut, egg, sesame, and hazelnuts. Despite these concerns about diet, most families didn't see a dietitian. But most families thought seeing a dietitian could be helpful to support the process.

The study suggests that taste aversion and anxiety are the main challenges for people going through food OIT, especially for older children. Using guidance from dietitians and psychology support efforts could help improve the overall success of OIT.

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