Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

EPITOPE Open-label Extension Study to Evaluate the Long-term Clinical Benefit and Safety of DBV712 in Peanut-Allergic Children (EPOPEX)

The EPOPEX study is an ongoing clinical trial for children with peanut allergy. It's looking at the long-term effects of a treatment called Viaskin Peanut, a patch applied to the skin. The main goal is to see if this patch continues to reduce allergic reactions to peanuts and if it's safe to use over one, two, and even three years. Researchers will check if children can safely eat more peanuts after treatment without severe reactions. They'll also carefully watch for any side effects and how well children tolerate the patch. This study aims to provide important information about the lasting benefits and safety of this new therapy for peanut allergy.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Dbv Technologies

Enrolment target

Start

17 Sep 2024

Peanut allergy

What is this study about?

This study, called EPOPEX, is a long-term follow-up to an earlier trial looking at a new treatment for peanut allergy in children. The treatment is a skin patch called Viaskin Peanut, which delivers tiny amounts of peanut protein through the skin. The idea is to help children slowly get used to peanuts so their bodies don't react so strongly if they accidentally eat some.

The main aim of this study is to see how well Veaskin Peanut works over a longer period – up to three years. Researchers want to know if the benefits from the earlier study continue and if children can safely tolerate even more peanut protein as time goes on. They will also be looking very closely at how safe the treatment is, checking for any side effects or problems with the patch itself.

By continuing to study these children, the doctors hope to gather valuable information about the lasting effects of Viaskin Peanut. This will help them understand if it's a helpful and safe long-term treatment option for children living with peanut allergy, making their lives a little less risky and stressful.

Key takeaways

The study investigates the long-term benefits and safety of a peanut allergy patch for children.
It aims to see if the Veaskin Peanut patch helps reduce sensitivity to peanuts over several years.
Regular checks and supervised peanut food challenges will be part of the study.
Researchers will closely monitor for any side effects or skin reactions.
Participation lasts up to three years to understand lasting effects.

Who may be eligible?

This study is designed for children who have a peanut allergy. It doesn't mention any specific age limits, so it's open to children of various ages.

Both boys and girls can take part in this research.

You would likely have been part of the previous 'EPITOPE' study to be considered for this long-term follow-up, as this study is extending that original research.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child currently living with a peanut allergy?
Has your child previously taken part in the EPITOPE study?
Is your child able to attend regular study appointments?
Are you comfortable with your child undergoing supervised peanut food challenges?

Answer every question to see your result.

What does participation involve?

If you or your child takes part, you would continue using the Viaskin Peanut patch as instructed. The study will involve regular visits over one, two, and three years to check on progress. During these visits, there will be special tests called "peanut food challenges." This is when a controlled amount of peanut protein is given by mouth to see how much can be tolerated without a strong allergic reaction. These challenges are done very carefully under medical supervision. The study also involves closely monitoring any side effects or skin reactions from the patch. You would be expected to keep a record of how your child feels and any reactions they have. The total duration of participation for this particular extended study is up to three years.

Potential risks and benefits

Taking part in this study might offer a potential benefit if the Viaskin Peanut patch continues to help your child become less sensitive to peanuts, potentially reducing the severity of accidental reactions. However, there are potential risks, including allergic reactions during the peanut food challenges, which is why these are done under strict medical supervision. There might also be skin reactions or other side effects from the patch. It's important to remember that you can stop participating in the study at any time, for any reason, without it affecting your child's medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany
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Unverified
Netherlands

Common questions

What is Viaskin Peanut?

Viaskin Peanut is a special skin patch designed to deliver tiny amounts of peanut protein into the body, aiming to reduce allergic reactions over time.

What is a 'peanut food challenge'?

This is a controlled medical test where small, increasing amounts of peanut are given by mouth to see how much your child can safely eat before experiencing an allergic reaction. It's done under careful supervision.

How long will the study last?

This particular extension study will follow children for up to three years to see the long-term effects of the treatment.

Will my child still need to avoid peanuts?

Yes, even if the treatment helps, it's still crucial to continue avoiding peanuts and carry emergency medication as advised by your doctor, as the treatment aims to reduce sensitivity, not cure the allergy completely.

What kind of side effects might there be?

Potential side effects could include skin reactions where the patch is applied, or allergic reactions during the monitored peanut food challenges. All side effects will be carefully watched and recorded.