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Arachis Hypogaea Flour

The EPOPEX clinical trial is an open-label extension study designed to evaluate the long-term clinical benefits and safety of DBV712, also known as Viaskin Peanut, in children with peanut allergies. This study aims to assess the effectiveness of epicutaneous immunotherapy (EPIT) in inducing and maintaining desensitization to peanuts over a period of up to 3 years. The trial focuses on children who have completed the previous EPITOPE study and will provide valuable insights into the sustained effects of this innovative treatment approach for peanut allergies.

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What is ARACHIS HYPOGAEA FLOUR?

ARACHIS HYPOGAEA FLOUR, also known as peanut flour, is a substance derived from peanuts[1]. In the context of medical research, it is being studied as a potential treatment for peanut allergies in children. This flour contains peanut proteins, which are the components that typically trigger allergic reactions in people with peanut allergies.

How is it used in peanut allergy treatment?

Researchers are exploring the use of ARACHIS HYPOGAEA FLOUR in a treatment approach called epicutaneous immunotherapy (EPIT)[1]. This method involves exposing the patient to small amounts of peanut protein through the skin, with the goal of gradually desensitizing the immune system to peanuts.

The EPOPEX Study

The EPOPEX (EPITOPE Open-label Extension) study is a clinical trial designed to evaluate the long-term benefits and safety of a treatment called DBV712 (also known as Viaskin Peanut) for children with peanut allergies[1]. This study follows up on a previous trial called EPITOPE, which tested the initial effectiveness of the treatment.

Who can participate in the study?

The study is primarily aimed at children who completed the previous EPITOPE study. Participants must have:

  • Completed the EPITOPE study, including a final food challenge test
  • Parents or guardians willing to provide informed consent
  • The ability to comply with all study requirements

However, children with certain conditions may not be eligible, including those with:

  • Severe anaphylactic reactions during the previous study
  • Uncontrolled asthma or other serious medical conditions
  • Certain skin conditions that might interfere with the treatment

What does the treatment involve?

The treatment in the EPOPEX study involves:

  1. Application of a patch containing peanut protein (Viaskin Peanut) to the skin
  2. Regular check-ups and tests to monitor progress and safety
  3. Food challenges, where participants consume small amounts of peanut protein under medical supervision to assess their tolerance

The study uses different formulations of peanut protein, including:

  • A low-dose oral paste (6.6 mg/g peanut proteins)
  • A high-dose oral paste (133.3 mg/g peanut proteins)
  • A placebo (for comparison in some parts of the study)

Potential Benefits

The researchers hope to see several potential benefits from this treatment, including:

  • Increased tolerance to peanuts, potentially allowing children to safely consume larger amounts
  • Reduced risk of severe allergic reactions from accidental peanut exposure
  • Improved quality of life for children with peanut allergies and their families

Safety Considerations

As with any medical treatment, there are potential risks and side effects. The study closely monitors participants for:

  • Allergic reactions, including anaphylaxis
  • Skin reactions at the patch application site
  • Any other adverse events that may occur during the study

Participants will have access to emergency medications and medical care throughout the study[1].

Conclusion

The EPOPEX study represents an important step in researching potential treatments for peanut allergies in children. By using ARACHIS HYPOGAEA FLOUR (peanut flour) in a controlled manner, researchers hope to develop a safe and effective way to reduce the impact of peanut allergies. However, it’s important to remember that this is still a research study, and the treatment is not yet approved for general use. Parents of children with peanut allergies should continue to follow their doctor’s advice for managing the allergy.

Aspect Details
Study Type Phase III, single-arm, open-label, uncontrolled study
Treatment Viaskin Peanut patch (250 μg peanut protein)
Duration Up to 3 years
Primary Objectives Assess clinical benefit and safety of long-term Viaskin Peanut treatment
Key Endpoints Proportion of subjects tolerating ≥1000 mg peanut protein, treatment responders, cumulative reactive dose, adverse events
Eligibility Children who completed the EPITOPE study with documented DBPCFC at Month 12
Safety Monitoring Adverse events, local skin reactions, laboratory data, physical examinations, vital signs, spirometry results
Additional Assessments Peanut-specific antibodies, skin prick tests, quality of life questionnaires, epigenetic modifications

FAQ

  • What is the main goal of the EPOPEX clinical trial? The main goal of the EPOPEX clinical trial is to assess the clinical benefit of Viaskin Peanut (DBV712) after up to 3 years of epicutaneous immunotherapy (EPIT) in peanut-allergic children. The study aims to evaluate the treatment's ability to induce and maintain desensitization to peanuts, as well as to assess its long-term safety.
  • Who is eligible to participate in the EPOPEX study? Eligible participants are children who have completed the previous EPITOPE study, including a documented double-blind, placebo-controlled food challenge (DBPCFC) at Month 12. Parents or guardians must provide informed consent, and both parents and children must be willing to comply with all study requirements.
  • What is epicutaneous immunotherapy (EPIT)? Epicutaneous immunotherapy (EPIT) is a method of allergy treatment that involves applying an allergen (in this case, peanut protein) to the skin through a patch. The Viaskin Peanut patch used in this study contains 250 micrograms of peanut protein and is designed to help desensitize the immune system to peanuts over time.
  • How long does the EPOPEX study last? The EPOPEX study is designed to evaluate the long-term effects of Viaskin Peanut treatment for up to 3 years. This extended period allows researchers to assess the sustained clinical benefits and safety of the treatment in peanut-allergic children.
  • What are some of the key outcomes being measured in the EPOPEX trial? The EPOPEX trial measures several key outcomes, including the proportion of subjects who can tolerate higher doses of peanut protein (such as ≥1000 mg), the percentage of treatment responders, changes in peanut-specific antibodies (IgE and IgG4), skin prick test results, and quality of life assessments. The study also closely monitors safety aspects, including adverse events and local skin reactions to the patch.

Ongoing Clinical Trials on Arachis Hypogaea Flour

  • 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

Glossary

  • Epicutaneous Immunotherapy (EPIT): A method of allergy treatment that involves applying an allergen to the skin through a patch to help desensitize the immune system.
  • Viaskin Peanut: The brand name for DBV712, a patch containing peanut protein used in epicutaneous immunotherapy for peanut allergies.
  • Double-Blind, Placebo-Controlled Food Challenge (DBPCFC): A standardized test used to diagnose food allergies or assess treatment effectiveness, where neither the patient nor the administrator knows whether the food contains the allergen or a placebo.
  • Desensitization: The process of reducing allergic sensitivity to a substance through controlled, repeated exposure.
  • Eliciting Dose (ED): The amount of an allergen that triggers an allergic reaction in a person with a food allergy.
  • Cumulative Reactive Dose (CRD): The total amount of an allergen consumed before an allergic reaction occurs during a food challenge.
  • Treatment Responder: In this study, a subject who shows a significant increase in the amount of peanut protein they can tolerate without an allergic reaction after treatment.
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease that occurs during a clinical trial, whether or not it is related to the treatment being studied.
  • Serious Adverse Event (SAE): An adverse event that results in death, is life-threatening, requires hospitalization, causes persistent or significant disability, or is a birth defect.
  • IgE (Immunoglobulin E): An antibody that plays a crucial role in allergic reactions, including food allergies.
  • IgG4 (Immunoglobulin G4): A subclass of antibodies that may be associated with tolerance to allergens after immunotherapy.
  • Skin Prick Test (SPT): A diagnostic test used to identify allergies by observing skin reactions to small amounts of potential allergens.
  • Quality of Life (QoL): A measure of an individual's overall well-being and ability to function in daily life, often assessed through questionnaires in clinical trials.
  • SCORAD (SCORing Atopic Dermatitis): A tool used to assess the extent and severity of atopic dermatitis (eczema) in clinical settings.

References

  1. http://clinicaltrials.eu/trial/study-on-long-term-benefits-and-safety-of-dbv712-for-children-with-peanut-allergy/