Peanut Patch for Peanut Allergy

Recruiting at 90 trial locations

Overseen By DBV Technologies

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: DBV Technologies

Must not be taking: Monoclonal antibodies, Biologics

Disqualifiers: Severe anaphylaxis, Immunotherapy, Asthma, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

480 Participants Needed

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. ^{1 2 3 4 5}

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. ^{2 3 4 6 7}

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

Physician-diagnosed peanut allergy and following a strict peanut-free diet

Peanut-specific IgE > 0.7 kUA/L

I am between 1 and 3 years old.

Exclusion Criteria

I have undergone immunotherapy for peanut allergy.

Peanut allergic subjects presenting a medical history of severe anaphylaxis to peanut

I have severe skin disease on my upper back.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

6 weeks

DBPC Treatment

Participants apply DBV712 250 mcg or placebo patch daily for 6 months

26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Open-label extension (optional)

Eligible participants receive DBV712 250 mcg for an additional 18 months

78 weeks

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?

Group I: Optional Open-Label Extension-Period: DBV712 250 mcg Experimental Treatment 1 Intervention

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).

Group II: DBPC Treatment Period: DBV712 250 mcg Experimental Treatment 1 Intervention

Participants will apply DBV712 250 mcg, epicutaneous system (or patch), daily for a period of 6 months.

Group III: DBPC Treatment Period: Placebo Placebo Group 1 Intervention

Participants will apply DBV712 matching placebo epicutaneous system (or patch), daily for a period of 6 months.

Who Is Running the Clinical Trial?

DBV Technologies

Lead Sponsor

Trials

17

Recruited

3,500+

Citations

1. aaaai.org aaaai.org/about/news/news/2025/patch

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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05741476

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- ...

3. jacionline.org jacionline.org/article/S0091-6749(24)02242-5/fulltext

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 ...

4. acaai.org acaai.org/news/peanut-patch-treatment-continues-to-help-toddlers-safely-build-tolerance-over-three-years/

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.

5. tandfonline.com tandfonline.com/doi/full/10.1080/1744666X.2024.2315221

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 ...

6. dbv-technologies.com dbv-technologies.com/pipeline/viaskin-peanut/

VIASKIN® peanut patch This study is evaluating an investigational drug patch called DBV712 for 4 to 7 year old children with peanut allergy.

7. choa.org choa.org/about-us/newsroom/study-at-childrens-shows-safety-and-efficacy-of-new-treatment-for-severe-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.