#1 Clinical Trials Search in Europe

Arachis Hypogaea (762)

The VITESSE study is a groundbreaking clinical trial investigating the use of DBV712, an epicutaneous immunotherapy treatment, for peanut allergy in children aged 4-7 years. This phase 3 study aims to assess the effectiveness and safety of DBV712 in inducing desensitization to peanut allergens over a 12-month period. The trial offers hope for families dealing with peanut allergies and may potentially revolutionize the management of this common and potentially life-threatening condition.

Table of Contents

What is ARACHIS HYPOGAEA (762)?

ARACHIS HYPOGAEA (762) is a medical product being studied as a potential treatment for peanut allergy in children. The scientific name “Arachis hypogaea” actually refers to the peanut plant itself. In this context, it’s being used as part of an allergen immunotherapy treatment[1]. This treatment is also known by other names, including ALK 762 Peanut, and it’s being developed as a solution for skin-prick tests and potentially for treatment purposes.

How It Works

The treatment works on the principle of immunotherapy, which aims to reduce allergic reactions by gradually exposing the immune system to small amounts of the allergen (in this case, peanut protein). The goal is to help the body build tolerance to peanuts over time, potentially reducing the severity of allergic reactions if accidental exposure occurs[1].

Clinical Trial: VITESSE Study

A major clinical trial, called VITESSE (ViaskinTM Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy), is currently underway to study the effectiveness and safety of this treatment[1]. Here are some key points about the study:

  • It’s a Phase 3 trial, which means it’s in an advanced stage of testing.
  • The study is double-blind and placebo-controlled, which helps ensure the results are reliable.
  • It focuses on children aged 4-7 years with peanut allergies.
  • The treatment period lasts for 12 months.
  • The main goal is to see if the treatment can help children tolerate larger amounts of peanut protein after the treatment period.

Who Can Participate in the Study?

The study has specific criteria for who can participate. Some key points include[1]:

  • Children aged 4-7 years with a diagnosed peanut allergy
  • Currently following a strict peanut-free diet
  • Have access to emergency medications, including self-injectable epinephrine (an emergency treatment for severe allergic reactions)
  • Show certain levels of peanut-specific antibodies in their blood and positive results on skin prick tests

There are also several conditions that would prevent a child from participating, such as severe skin diseases, certain medications, or a history of very severe allergic reactions to peanuts.

Safety and Effectiveness

The study is carefully monitoring both how well the treatment works and its safety. Here’s what they’re looking at[1]:

  • Effectiveness: They’re measuring how much peanut protein a child can tolerate after treatment compared to before. A successful response would be if a child can tolerate much more peanut protein after treatment.
  • Safety: The researchers are closely watching for any side effects, especially allergic reactions. They’re particularly interested in how the skin reacts where the treatment is applied, and any signs of allergic reactions elsewhere in the body.

How is ARACHIS HYPOGAEA (762) Administered?

In the VITESSE study, the treatment is given through a patch applied to the skin (called epicutaneous immunotherapy or EPIT)[1]. This patch, known as DBV712, contains a small amount of peanut protein. It’s applied daily to the skin between the shoulder blades. The study is testing a dose of 250 μg (micrograms) of peanut protein per day.

It’s important to note that this treatment is still being studied and is not yet approved for general use. Parents of children with peanut allergies should continue to follow their doctor’s advice and maintain strict peanut avoidance until more is known about this potential treatment.

Aspect Details
Study Name VITESSE (ViaskinTM Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy)
Treatment DBV712 250 μg epicutaneous patch
Participants Children aged 4-7 years with peanut allergy
Duration 12-month double-blind treatment period
Primary Endpoint Percentage of treatment responders in DBV712 group vs. placebo group
Secondary Endpoints Cumulative Reactive Dose, Eliciting Dose, percentage of subjects tolerating higher peanut protein doses
Safety Assessments Adverse events, local site reactions, systemic allergic reactions, physical examinations
Follow-up Opportunity for Open Label Extension or 2-week follow-up period

FAQ

  • What is the main goal of the VITESSE study? The main goal of the VITESSE study is to assess the efficacy and safety of DBV712 250 μg in inducing desensitization to peanut in peanut-allergic children aged 4-7 years over a 12-month treatment period.
  • How does the DBV712 treatment work? DBV712 is an epicutaneous immunotherapy treatment, which means it is applied to the skin. The treatment aims to desensitize the immune system to peanut allergens by exposing it to small amounts of peanut protein through the skin.
  • Who is eligible to participate in the VITESSE study? The study is open to children aged 4-7 years with a physician-diagnosed peanut allergy or a well-documented history of IgE-mediated reactions to peanut. Participants must be following a strict peanut-free diet and have access to emergency medications, including self-injectable epinephrine.
  • What does the treatment involve? Participants will apply either the DBV712 250 μg patch or a placebo patch daily for 12 months. The study is double-blind, meaning neither the participants nor the researchers will know who is receiving the active treatment or the placebo until the study is complete.
  • How will the effectiveness of the treatment be measured? The effectiveness will be measured by comparing the percentage of treatment responders in the DBV712 group to the placebo group after 12 months. A treatment responder is defined as a participant who can tolerate significantly higher doses of peanut protein at the end of the treatment period compared to their initial tolerance level.

Ongoing Clinical Trials on Arachis Hypogaea (762)

  • 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 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: A type of allergy treatment where small amounts of an allergen are applied to the skin to help 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: A study design where neither the participants nor the researchers know who is receiving the active treatment or the placebo, helping to reduce bias in the results.
  • IgE-mediated reaction: An allergic reaction involving immunoglobulin E (IgE) antibodies, which can cause symptoms ranging from mild to severe, including anaphylaxis.
  • Anaphylaxis: A severe, potentially life-threatening allergic reaction that can cause difficulty breathing, swelling, and a drop in blood pressure.
  • 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.
  • DBPCFC: Double-Blind, Placebo-Controlled Food Challenge – A standardized method to diagnose food allergies or assess the effectiveness of allergy treatments.
  • SCORAD: SCORing Atopic Dermatitis – A tool used to assess the extent and severity of atopic dermatitis (eczema).

References

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