Viaskin Peanut 250µg for Peanut Allergies

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
St.-Marien-Hospital, Bonn, Germany
Peanut Allergies+2 More
Viaskin Peanut 250µg - Drug
Eligibility
Any Age
All Sexes
Eligible conditions
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Study Summary

This study is evaluating whether Viaskin Peanut can be used for an additional 2 years.

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Eligible Conditions

  • Peanut Allergies

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Peanut Allergies

Study Objectives

This trial is evaluating whether Viaskin Peanut 250µg will improve 1 primary outcome in patients with Peanut Allergies. Measurement will happen over the course of Month 24.

Month 24
% of subjects originating from the active arm of PEPITES reaching an Eliciting Dose (ED) ≥ 1,000 mg after 24 months of additional treatment in PEOPLE

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Peanut Allergies

Trial Design

1 Treatment Group

Viaskin Peanut 250µg
1 of 1
Experimental Treatment

This trial requires 300 total participants across 1 different treatment group

This trial involves a single treatment. Viaskin Peanut 250µg is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Viaskin Peanut 250µg
Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: month 24
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly month 24 for reporting.

Closest Location

Children's Hospital of Pittsburgh - Pittsburgh, PA

Eligibility Criteria

This trial is for patients born any sex of any age. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Subjects who completed the PEPITES study.

Patient Q&A Section

What are the signs of peanut hypersensitivity?

"Peanut hypersensitivity is a complex condition that includes both cutaneous and systemic symptoms. The diagnosis can be suspected if patients have any of the symptom combinations in conjunction with the patient characteristics described in this article." - Anonymous Online Contributor

Unverified Answer

What are common treatments for peanut hypersensitivity?

"While there are many different treatment options available, most are based on exclusion of allergen from the diet or use of immunotherapy. Immunotherapy is not widely used due to lack of support by the medical community. Additionally, many patients do not want to take immunosuppressive doses of immunotherapy due to side effects. Immunotherapy often does not guarantee that symptoms will disappear without continuing immunosuppression. A meta-analysis published by the Cochrane Collaboration, which reviewed all trials of immunotherapy for peanut hypersensitivity found the most recent evidence suggests that immunotherapy treatment may be of benefit but there is much heterogeneity in these studies. Thus, further studies are certainly needed." - Anonymous Online Contributor

Unverified Answer

How many people get peanut hypersensitivity a year in the United States?

"Between 10 and 150 people per year in the US fall victim to a reaction to the peanut allergen Ara h 1, a major reason for accidental food allergy in children. These numbers represent only the most severe cases and only if other factors like sensitizing factors and risk factors such as peanut allergy, environmental exposure, and HLA genotypes have been taken into account." - Anonymous Online Contributor

Unverified Answer

What causes peanut hypersensitivity?

"Food allergies and other clinical and laboratory features characterize the hypersensitive reaction to peanut and other foods. The majority of nonfood hypersensitivities to the same foods are IgE-mediated. The cause may be a mixture of genetic and environmental factors." - Anonymous Online Contributor

Unverified Answer

Can peanut hypersensitivity be cured?

"The treatment for peanut-allergic patients with desensitization is not only an effective means of preventing anaphylaxis and allergic reaction to peanuts, but it also improves their quality of life." - Anonymous Online Contributor

Unverified Answer

What is peanut hypersensitivity?

"Peanut hypersensitivity can present many manifestations, and be caused by mast cell activation. This disease often presents itself during childhood, and is characterized by non-IgE-mediated mast cell activation and subsequent mast cell degranulation." - Anonymous Online Contributor

Unverified Answer

What does viaskin peanut 250µg usually treat?

"Viaskin 100µg and the other peanut products tested did not adequately relieve symptoms in patients receiving epinephrine autoinjection and cannot provide treatment for patients receiving adrenaline." - Anonymous Online Contributor

Unverified Answer

What is viaskin peanut 250µg?

"Viaskin peanut 250µg is an orally-administered, ultra-diluted peanut extract intended to reduce peanut-related allergic reactions in children ages 6 months through 5 years. Although the manufacturer recommends use of peanut protein/oil in a minimum ratio of 0.3:1, Viaskin peanut extract (Viashkin) is a peanut protein/oil content ratio of 0.1:1. As Viaskin's product is made of peanut protein extract with an oil content of 10%, it's an ultra-diluted extract. The peanut protein extract is made from roasted peanut kernels by a proprietary processing method that keeps the natural content of essential peanut proteins and oils." - Anonymous Online Contributor

Unverified Answer

How serious can peanut hypersensitivity be?

"We summarize the different manifestations of peanut allergy, their treatment, prognosis, and prognoses as of 2014, but we emphasize the severity of peanut allergy because of the severity of the complications." - Anonymous Online Contributor

Unverified Answer

How does viaskin peanut 250µg work?

"Viaskin should be ingested 15 minutes before eating foods containing peanuts or peanut-containing extracts and be avoided 1 hour after eating a treatment dose of the investigational product." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of viaskin peanut 250µg?

"The side effects from viaskin peanut 250µg used in this study were not as common as reported in previous studies, with the most common side effects being cough, headache, insomnia, and fever. More randomized controlled trials of this amount of peanut would be helpful." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in viaskin peanut 250µg for therapeutic use?

"These data demonstrate the ease with which the therapeutic utilization of Viaskin peanut can be implemented in clinical practice. Viaskin peanut, as demonstrated here, can be a potentially useful and safe alternative to immuno-enhanced sublingual therapies. Furthermore, this formulation may pave the way for an improved treatment of peanut allergy in the future." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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