Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01170286 | Safety of Epicutaneous Immunotherapy for the Treatment of Peanut Allergy | PHASE1 | COMPLETED | 100 | — | — | Jul 1, 2010 | Feb 1, 2012 | Mar 23, 2012 | 5 | United States |
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...