#1 Clinical Trials Search in Europe

Arachis Hypogaea Extract

This article examines the use of Arachis Hypogaea Extract, also known as peanut extract, in clinical trials for treating peanut allergies. The focus is on a novel approach called epicutaneous immunotherapy (EPIT) using a patch containing peanut protein. Two studies, VITESSE and EPOPEX, are investigating the efficacy and safety of this treatment in children with peanut allergies. These trials aim to induce desensitization and potentially improve the quality of life for individuals affected by this common and potentially dangerous food allergy.

Table of Contents

What is Viaskin Peanut?

Viaskin Peanut, also known as DBV712, is an innovative treatment being developed for children with peanut allergies[1]. It is a cutaneous patch that contains a small amount of peanut protein extract (250 micrograms)[2]. This treatment is a form of epicutaneous immunotherapy (EPIT), which means it delivers allergens through the skin to help desensitize the immune system[1].

How Does It Work?

The Viaskin Peanut patch is applied to the skin, typically between the shoulder blades, and worn daily[1]. The patch allows tiny amounts of peanut protein to enter the outer layers of the skin. This gradual exposure aims to train the immune system to become less reactive to peanut allergens over time, potentially increasing the amount of peanut protein a child can tolerate without an allergic reaction[2].

Who Is It For?

Viaskin Peanut is being studied for use in children with peanut allergies. Current clinical trials are focusing on children aged 4 to 7 years old[1]. To be eligible for the treatment, children must have:

  • A physician-diagnosed peanut allergy or a documented history of allergic reactions to peanuts
  • Positive peanut-specific blood tests (IgE levels) and skin prick tests
  • The ability to tolerate only small amounts of peanut protein (100 mg or less) in supervised food challenges[1]

Clinical Trials

Viaskin Peanut is currently being evaluated in several clinical trials:

  1. VITESSE Study: This is a Phase 3 trial assessing the efficacy and safety of Viaskin Peanut in children aged 4-7 years over a 12-month period[1].
  2. EPOPEX Study: This is an open-label extension study evaluating the long-term benefits and safety of Viaskin Peanut for up to 3 years of treatment[2].

Potential Benefits

The main goals of Viaskin Peanut treatment are to:

  • Increase the amount of peanut protein a child can tolerate without an allergic reaction (desensitization)
  • Reduce the risk of severe allergic reactions from accidental peanut exposure
  • Improve quality of life for children with peanut allergies and their families[1][2]

Researchers are measuring success by looking at how many children can tolerate higher doses of peanut protein after treatment. For example, they’re tracking the percentage of children who can tolerate 300 mg, 600 mg, or even 1000 mg of peanut protein without having an allergic reaction[1][2].

Safety Considerations

While Viaskin Peanut shows promise, it’s important to be aware of potential side effects and safety considerations:

  • Local skin reactions: The most common side effects are reactions at the patch site, which may include itching, redness, or swelling[1].
  • Systemic allergic reactions: There is a risk of more widespread allergic reactions, including anaphylaxis. This is why the treatment is closely monitored by healthcare professionals[1][2].
  • Asthma considerations: Children with uncontrolled asthma or severe asthma may not be eligible for this treatment due to increased risks[1][2].

It’s crucial to understand that Viaskin Peanut is a medical treatment that should only be used under the supervision of trained healthcare providers. It is not a cure for peanut allergies, and patients must continue to avoid peanuts in their diet during treatment[1][2].

Future Research

Ongoing and future studies aim to answer important questions about Viaskin Peanut, including:

  • Long-term effectiveness and safety beyond 3 years of treatment
  • Potential for sustained unresponsiveness (continued tolerance after stopping treatment)
  • Effects on quality of life and anxiety related to food allergies
  • Immunological changes and biomarkers associated with successful treatment[2]

As research continues, Viaskin Peanut represents a promising approach to managing peanut allergies in children, potentially offering a way to reduce the risk of severe allergic reactions and improve quality of life for affected families.

Aspect VITESSE Study EPOPEX Study
Study Type Phase 3, Double-blind, Placebo-controlled Open-label Extension
Age Group 4-7 years Children who completed EPITOPE study
Treatment Duration 12 months (with possible extension) Up to 3 years
Primary Objectives Assess efficacy and safety of DBV712 250 μg Evaluate long-term clinical benefit and safety
Key Endpoints Percentage of treatment responders, safety assessments Proportion reaching specific eliciting doses, safety assessments
Treatment DBV712 250 μg patch vs. placebo Viaskin Peanut 250 μg patch for all participants

FAQ

  • What is Arachis Hypogaea Extract? Arachis Hypogaea Extract is the scientific name for peanut extract. In these clinical trials, it is used as the active ingredient in a patch called Viaskin Peanut or DBV712, which is applied to the skin to treat peanut allergies.
  • How does the peanut patch work? The peanut patch works through epicutaneous immunotherapy (EPIT). It delivers small amounts of peanut protein through the skin, aiming to desensitize the immune system and reduce allergic reactions to peanuts over time.
  • Who is eligible for these clinical trials? The trials focus on children with peanut allergies. The VITESSE study includes children aged 4-7 years, while EPOPEX is an extension study for children who completed a previous trial called EPITOPE.
  • What are the main goals of these studies? The main goals are to assess the efficacy and safety of the peanut patch in inducing desensitization to peanuts. They aim to increase the amount of peanut protein a child can tolerate without an allergic reaction and evaluate long-term benefits and safety.
  • How long do the treatments last in these trials? The VITESSE study has a 12-month treatment period, with the possibility of an extension. The EPOPEX study evaluates long-term treatment for up to 3 years.

Ongoing Clinical Trials on Arachis Hypogaea Extract

  • Study of DBV712 skin patch safety in children aged 1-3 years with peanut allergy

    Recruiting

    3 1 1
    Investigated drugs:
    France Ireland The Netherlands Spain

  • Study on Long-term Benefits and Safety of DBV712 for Children with Peanut Allergy

    Not recruiting

    3 1 1
    Investigated drugs:
    Germany The Netherlands

  • Study on the Effectiveness and Safety of DBV712 for Peanut Allergy in Children Aged 4-7

    Not recruiting

    3 1 1
    Investigated drugs:
    France Germany Ireland The Netherlands Spain

Glossary

  • Epicutaneous Immunotherapy (EPIT): A method of allergy treatment that involves applying an allergen (in this case, peanut protein) to the skin through a patch to desensitize the immune system.
  • Desensitization: The process of reducing or eliminating an allergic response to a specific allergen through controlled exposure over time.
  • Double-blind, Placebo-controlled Food Challenge (DBPCFC): A test used to diagnose food allergies where neither the patient nor the doctor knows whether the food given contains the allergen or is a placebo.
  • Eliciting Dose (ED): The amount of an allergen that triggers an allergic reaction in a person with an allergy.
  • Cumulative Reactive Dose (CRD): The total amount of an allergen consumed before an allergic reaction occurs during a food challenge.
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Serious Adverse Event (SAE): An adverse event that results in death, is life-threatening, requires hospitalization, causes a significant incapacity, or is otherwise considered medically significant.
  • Treatment-Emergent Adverse Event (TEAE): An adverse event that appears or worsens during the course of a clinical trial treatment.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-dbv712-for-peanut-allergy-in-children-aged-4-7/
  2. http://clinicaltrials.eu/trial/study-on-long-term-benefits-and-safety-of-dbv712-for-children-with-peanut-allergy/