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Defatted Powder Of Arachis Hypogaea L., Semen (Peanuts)

Clinical trials are currently underway to investigate the use of defatted powder from peanuts (Arachis hypogaea L.) as a potential treatment for peanut allergies. These studies aim to evaluate the safety and effectiveness of various methods to desensitize patients to peanut allergens, potentially improving quality of life for those with peanut allergies. The trials involve different approaches, including epicutaneous immunotherapy and oral food challenges, to assess how well patients can tolerate increasing amounts of peanut protein over time.

Table of Contents

What is Defatted Powder of Arachis Hypogaea L., Semen (Peanuts)?

Defatted powder of Arachis Hypogaea L., Semen (Peanuts) is a medical product derived from peanuts. It is being studied as a potential treatment for peanut allergies. This powder is created by removing most of the fat content from peanuts, leaving behind the protein components that are responsible for allergic reactions[1].

Medical Conditions Treated

The primary medical condition targeted by this treatment is peanut allergy. Peanut allergy is one of the most common food allergies and can cause severe, potentially life-threatening reactions in some individuals[1][2].

How It Works

This treatment works on the principle of immunotherapy. By exposing the patient to small, controlled amounts of peanut protein, the immune system can gradually become desensitized to the allergen. This process, known as desensitization, aims to reduce the severity of allergic reactions when accidentally exposed to peanuts[1].

Administration and Dosage

The defatted peanut powder is typically administered as granules for oral suspension. In some studies, it’s also being tested as part of a patch applied to the skin, known as epicutaneous immunotherapy or EPIT[1]. The dosage and administration method can vary depending on the specific study protocol and the patient’s age and sensitivity to peanuts.

Clinical Trials and Research

Several clinical trials are currently underway to evaluate the effectiveness and safety of this treatment:

  • A Phase 3 study called VITESSE is testing a product called DBV712 in children aged 4-7 years with peanut allergy[1].
  • Another long-term study is evaluating the safety and efficacy of a drug called ligelizumab in patients who have completed previous Phase III studies in food allergy[2].

Efficacy and Benefits

The main goal of these treatments is to induce desensitization to peanuts. This means increasing the amount of peanut protein a person can tolerate without having an allergic reaction. For example, one study aims to have patients tolerate at least 300-600 mg of peanut protein after 12 months of treatment[1]. Another study is looking at whether patients can tolerate 600 mg or more of peanut protein during an open-label oral food challenge[2].

Safety and Side Effects

As with any medical treatment, safety is a primary concern. The clinical trials are closely monitoring for adverse events, including:

  • Local reactions at the site of application (for patch treatments)
  • Systemic allergic reactions
  • Any events requiring the use of epinephrine
  • Changes in asthma control

It’s important to note that these treatments are still being studied, and the full range of potential side effects may not yet be known[1][2].

Patient Eligibility

Not all patients with peanut allergies may be eligible for these treatments. Eligibility criteria often include:

  • Age (often between 4-7 years for pediatric studies)
  • Confirmed peanut allergy diagnosis
  • No history of severe anaphylaxis to peanuts
  • Absence of certain medical conditions (e.g., uncontrolled asthma, certain skin conditions)
  • Willingness to follow a strict peanut-free diet during the study

It’s crucial to consult with an allergist or immunologist to determine if you or your child might be eligible for such treatments[1][2].

Impact on Quality of Life

One of the secondary objectives of these studies is to assess the impact of treatment on patients’ health-related quality of life (HRQoL). Living with a peanut allergy can significantly affect a person’s daily life, causing anxiety and limiting food choices. If successful, these treatments could potentially improve patients’ quality of life by reducing the fear and risks associated with accidental peanut exposure[2].

Aspect Details
Study Types Phase 3 clinical trials
Main Objectives Evaluate safety and efficacy of defatted peanut powder for peanut allergy treatment
Treatment Methods Epicutaneous immunotherapy, oral food challenges
Key Participants Children aged 4-7 with diagnosed peanut allergies
Duration 12 months initial treatment, with potential extensions up to 3 years
Primary Outcomes Increased tolerance to peanut protein, safety assessments
Secondary Outcomes Quality of life improvements, long-term efficacy and safety
Key Measurements Eliciting dose (ED), adverse events, immunological changes

FAQ

  • What is the main purpose of these clinical trials? The main purpose of these clinical trials is to evaluate the safety and effectiveness of using defatted peanut powder to treat peanut allergies. Researchers are investigating whether this approach can help patients become desensitized to peanut allergens, potentially allowing them to tolerate larger amounts of peanut protein without allergic reactions.
  • Who can participate in these clinical trials? Eligibility varies between trials, but generally includes children aged 4-7 years with diagnosed peanut allergies. Participants must have a documented history of peanut allergy, follow a strict peanut-free diet, and meet specific criteria related to peanut-specific IgE levels and skin prick test results. Some trials may exclude individuals with severe asthma or other medical conditions that could increase risks.
  • What treatments are being studied in these trials? The trials are studying different approaches, including epicutaneous immunotherapy (applying a patch containing peanut protein to the skin) and oral food challenges (consuming gradually increasing amounts of peanut protein). Some trials also involve the use of medications like ligelizumab alongside peanut protein exposure to potentially enhance treatment effectiveness.
  • How long do these clinical trials last? The duration of the trials varies. Some initial treatment periods last for 12 months, followed by additional open-label extension periods that can last up to 2-3 years. Long-term follow-up is important to assess the ongoing safety and effectiveness of the treatments.
  • What are the potential benefits and risks of participating? Potential benefits include increased tolerance to peanut protein, which could reduce the risk of severe allergic reactions from accidental exposure. However, risks may include allergic reactions during treatment, skin irritation from patches, and other side effects. It's important to note that all experimental treatments carry potential risks, and participants are closely monitored throughout the trials.

Ongoing Clinical Trials on Defatted Powder Of Arachis Hypogaea L., Semen (Peanuts)

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

    Not recruiting

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

  • Study on Long-Term Safety of Ligelizumab for Patients with Food Allergies

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy The Netherlands Spain

Glossary

  • Epicutaneous Immunotherapy: A method of allergy treatment that involves applying an allergen (in this case, peanut protein) to the skin through a patch, aiming to desensitize the immune system gradually.
  • Oral Food Challenge (OFC): A medical procedure where a patient consumes gradually increasing amounts of a specific food (here, peanut) under medical supervision to diagnose or assess food allergies.
  • Desensitization: The process of reducing sensitivity to an allergen, typically through controlled, gradual exposure, with the goal of reducing or eliminating allergic reactions.
  • IgE (Immunoglobulin E): An antibody produced by the immune system that plays a key role in allergic reactions. High levels of peanut-specific IgE indicate a peanut allergy.
  • Skin Prick Test (SPT): An allergy test where small amounts of allergens are placed on the skin, which is then pricked. A positive reaction (wheal) indicates a potential allergy.
  • Eliciting Dose (ED): The amount of an allergen that triggers an allergic reaction in a sensitive individual. In these trials, increasing the ED is a goal of treatment.
  • Double-blind, Placebo-controlled Food Challenge (DBPCFC): A type of oral food challenge where neither the patient nor the administrator knows whether the substance being consumed contains the allergen or is a placebo.
  • Ligelizumab: An experimental medication being studied for its potential to enhance the effectiveness of food allergy treatments.
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Quality of Life (QoL): A measure of an individual's overall well-being and life satisfaction, often assessed in clinical trials to determine the impact of treatments on daily life.

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-safety-of-ligelizumab-for-patients-with-food-allergies/