DBV712 for Peanut Allergy

(EPOPEX Trial)

No longer recruiting at 26 trial locations

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: DBV Technologies

Disqualifiers: Generalized dermatologic disease, severe asthma

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the long-term effects of a treatment called DBV712 for individuals with peanut allergies. It follows participants who completed the previous EPITOPE study. The trial involves using a patch to administer the treatment, which might help reduce allergic reactions to peanuts. This trial suits those who finished the EPITOPE study and do not have widespread skin issues or severe, uncontrolled asthma. As a Phase 3 trial, it represents the final step before potential FDA approval, offering participants a chance to contribute to a treatment nearing widespread availability.

Do I have to stop taking my current medications for the DBV712 trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that DBV712 is likely to be safe for humans?

Research has shown that the DBV712 peanut patch is well-tolerated. In one study, children used the patch daily and became less sensitive to peanuts compared to a placebo. Another study confirmed that children with peanut allergies tolerated the patch well, aligning with earlier research. These findings suggest the treatment is generally safe for children with peanut allergies. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for peanut allergy?

Researchers are excited about DBV712 for peanut allergy because it offers a novel approach to managing this condition through epicutaneous immunotherapy. Unlike traditional treatments that involve oral immunotherapy or strict avoidance of peanuts, DBV712 is delivered via a skin patch, which could provide a safer and more convenient alternative. This method aims to gradually desensitize the immune system to peanuts by delivering small doses of peanut protein through the skin, potentially reducing the risk of severe allergic reactions. This innovative delivery system distinguishes DBV712 from current options and holds promise for improving the quality of life for those with peanut allergies.

What evidence suggests that DBV712 might be an effective treatment for peanut allergy?

Research has shown that DBV712, known as the peanut patch, helps treat peanut allergies. This trial will evaluate the effectiveness of DBV712 250mcg. Studies have found that people using the patch can gradually tolerate more peanuts without an allergic reaction. One study showed the patch was more effective than a placebo in helping users safely handle peanut exposure. Importantly, a long-term study found that using the patch daily for over a year continued to yield positive results. Overall, the patch is safe and easy to use daily, offering hope for those with peanut allergies. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for young children who have completed the EPITOPE study and are dealing with peanut allergies. It's not open to those who've developed severe, unstable asthma or have widespread skin conditions like active eczema that would prevent applying Viaskin patches on clear skin areas.

Inclusion Criteria

You have previously participated in the EPITOPE study.

Exclusion Criteria

I have widespread skin conditions like severe eczema, making it impossible to apply patches on my back or arms.

My asthma has become severe and hard to control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label Extension

Participants continue to receive DBV712 250mcg to evaluate long-term efficacy and safety

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DBV712

Trial Overview The trial is testing the long-term efficacy and safety of a treatment called DBV712 at a dose of 250 mcg. This is an open-label follow-up study, meaning everyone knows they're getting the treatment and it's a continuation from an earlier phase.

How Is the Trial Designed?

Group I: DBV712 250mcg Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

DBV Technologies

Lead Sponsor

Trials

17

Recruited

3,500+

Citations

1. 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8612061/

Epicutaneous immunotherapy for treatment of peanut allergy Peanut OIT has demonstrated robust desensitization outcomes, with 67% of those on peanut OIT in the PALISADE trial achieving a 600-mg single peanut protein dose ...

3. 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- ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S009167492030957X

Long-term, open-label extension study of the efficacy and ... These results demonstrate that daily EPIT treatment for peanut allergy beyond 1 year leads to continued response from a well-tolerated, simple-to-use regimen.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38323337/

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. trials.foodallergy.org trials.foodallergy.org/trials/NCT07003919

Safety Study of Viaskin® Peanut Patch in ... - Clinical Trial Finder The primary objective of this study is to assess the 6-month safety of DBV712 250 micrograms (mcg) in subjects 1 through 3 years of age with peanut allergy.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2213219821012952

Safety of Epicutaneous Immunotherapy in Peanut-Allergic ... In a study designed to mirror real-world use, VP250 was observed to be well tolerated in peanut-allergic children, consistent with previous phase 2b and 3 ...