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Whole peanut extract · 1 trial · 1 indication
The primary outcome measure is safety and the subjects will undergo the following procedures: physical examination including patch application site examination for evaluation of any skin reaction, vital signs, blood and urine collection for blood and urine analysis, ECG, Peak Expiratory Flow and spirometry (FEV1). Adverse events, treatment-emergent adverse events, and serious adverse events will be classified according to severity, treatment relatedness, the system/organ class affected, and the countermeasures taken.
| Arm | Type | Description |
|---|---|---|
| DBV712 Viaskin | EXPERIMENTAL | The experimental arm is composed of subjects treated with whole peanut extract on an epicutaneous delivery system (Viaskin patch) |
| Placebo Viaskin | PLACEBO_COMPARATOR | The placebo arm is composed of subjects treated with a placebo formulation on an epicutaneous delivery system (Viaskin patch) |
| Name | Type | Description |
|---|---|---|
| Whole peanut extract | BIOLOGICAL | Four different doses of whole peanut extract expressed as micrograms (mcg) of peanut proteins (20, 100, 250, 500 mcg) and two different dosing regimen (epicutaneous application for 24 hours every 24 hours and epicutaneous application for 48 hours every 48 hours) will be tested for determination of the maximum tolerated dose during a 2-week treatment period. |
| Placebo formulation | BIOLOGICAL | Matching placebo at two different dosing regimen (epicutaneous application for 24 hours every 24 hours and epicutaneous application for 48 hours every 48 hours) will be tested in parallel to the peanut proteins doses for determination of the maximum tolerated dose during a 2-week treatment period. |
Inclusion Criteria: * Male or Female age 6 to 50 years at enrollment, any race, and any ethnicity. * Physician-diagnosed peanut allergy or convincing history of peanut allergy regardless of the degree of the reaction. Subjects with history of severe anaphylaxis to peanuts (Grades 4 or 5 with dyspne...
Whole peanut extract is an investigational immunotherapy being studied for the treatment of peanut allergy. It is designed to reduce allergic reactions in patients with this condition. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
Whole peanut extract is being developed by DBV Technologies S.A., a biopharmaceutical company listed on the stock exchange under the ticker DBVT. The company is conducting clinical research to evaluate the safety and efficacy of this investigational therapy for peanut allergy.
Whole peanut extract is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval. The Phase 1 trial has been completed, and the drug remains under study for the treatment of peanut allergy.
Whole peanut extract has been studied in one clinical trial with the identifier NCT01170286, titled "Safety of Epicutaneous Immunotherapy for the Treatment of Peanut Allergy." This Phase 1 trial was completed and enrolled 100 participants with peanut allergy in the United States.
Whole peanut extract is the drug substance being investigated in the clinical trial NCT01170286. The trial title refers to epicutaneous immunotherapy, which is the route of administration. The drug is developed by DBV Technologies, which is known for its Viaskin patch technology, but the specific product name is not provided.