Peanut Patch for Peanut Allergy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a peanut patch (Viaskin Peanut Patch) that may reduce allergic reactions in young children with peanut allergies. The main goal is to assess the patch's safety when used daily for six months. Participants will receive either the peanut patch or a placebo patch, which looks the same but contains no active ingredients. It is designed for children aged 1 to 3 who have a diagnosed peanut allergy and follow a strict peanut-free diet. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot be on current immunotherapy for any allergen or have had certain treatments like monoclonal antibodies in the past 6 months.
Is there any evidence suggesting that the Viaskin Peanut Patch is likely to be safe for humans?
Research shows that the Viaskin Peanut Patch is generally safe for children with peanut allergies. Studies have found similar side effects across different projects, indicating a consistent safety profile. In one study, children who used the patch for a year had fewer reactions to peanuts during food tests, suggesting that the treatment is both effective and safe over time. Additionally, research indicates that the Viaskin Peanut Patch results in fewer severe allergic reactions compared to not using it, providing reassurance about its safety for young children.12345
Why do researchers think this study treatment might be promising for peanut allergy?
Unlike the standard of care for peanut allergies, which often involves oral immunotherapy or strict avoidance, the Viaskin Peanut Patch offers a unique delivery method by using an epicutaneous patch. This patch delivers a small, precise dose of peanut protein through the skin, potentially reducing the risk of severe allergic reactions compared to ingesting allergens. Researchers are excited about this treatment because it provides a non-invasive, easy-to-apply option that could improve adherence and safety for those with peanut allergies. Additionally, the patch could offer a more gradual and controlled exposure to the allergen, potentially increasing the body’s tolerance over time.
What evidence suggests that the Viaskin Peanut Patch might be an effective treatment for peanut allergy?
Research has shown that the Viaskin Peanut Patch, which participants in this trial may receive, helps children become more tolerant to peanuts. In earlier studies, over 70% of toddlers using the patch could safely eat about three to four peanuts after three years. The patch reduced certain antibodies linked to peanut allergies while increasing others that help fight allergies, indicating a positive immune response. The treatment is safe, easy to use daily, and more effective than placebo patches. Overall, it has shown promising results in reducing peanut allergies in young children.23467
Are You a Good Fit for This Trial?
This trial is for young children aged 1 to 3 who have a peanut allergy. It's not suitable for kids with other specific allergies like folinic acid or tree nuts, and there may be additional criteria that could exclude some children.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
DBPC Treatment
Participants apply DBV712 250 mcg or placebo patch daily for 6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Eligible participants receive DBV712 250 mcg for an additional 18 months
What Are the Treatments Tested in This Trial?
Interventions
- Viaskin Peanut Patch
Trial Overview
The study is testing the safety of a peanut patch called Viaskin (DBV712) at a dose of 250 mcg over six months. Some kids will get this active patch while others will receive a placebo, which has no active ingredient.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
The 6-month DBPC period will be followed by an optional open-label extension (OLE) period during which eligible participants will receive DBV712 250 mcg for a duration of 18 months (representing 24 months of active treatment for those participants initially randomized to DBV712 250 mcg and 18 months of active treatment for those participants that were initially randomized to placebo).
Participants will apply DBV712 250 mcg, epicutaneous system (or patch), daily for a period of 6 months.
Participants will apply DBV712 matching placebo epicutaneous system (or patch), daily for a period of 6 months.
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Who Is Running the Clinical Trial?
DBV Technologies
Lead Sponsor
Citations
Long term Use of Peanut Patch Shows Increased Benefit
VIASKIN peanut patch is a well-tolerated treatment for children with peanut allergies according to research being presented at the 2025 AAAAI / WAO Joint ...
NCT05741476 | Safety and Efficacy Study of Viaskin ...
The primary purpose of this study is to assess the efficacy and safety of daily DBV712 250 micrograms (mcg) to induce desensitization to peanut in peanut- ...
Long-Term Efficacy Results of Epicutaneous ...
Median peanut-specific IgE and IgG4 levels decreased and increased, respectively, from baseline, consistent with other VIASKIN and allergen immunotherapy ...
Peanut Patch Treatment Continues to Help Toddlers Safely ...
November 6, 2025. After three years of treatment, more than 70% could tolerate about three to four peanut kernels. ORLANDO (Nov.
Safety and efficacy of epicutaneous immunotherapy with ...
Overall, the results from these studies have demonstrated the peanut patch to be superior in desensitization compared with placebo and safe for daily use over ...
VIASKIN® peanut patch
This study is evaluating an investigational drug patch called DBV712 for 4 to 7 year old children with peanut allergy.
Children's Shows: New Treatment for Severe Peanut Allergy
After one year of treatment, Viaskin Peanut was superior to placebo in desensitization, with treatment responder rates of 67.0% and 33.5%, respectively.
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