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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03211247 | Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age | PHASE3 | COMPLETED | 414 | — | — | Jul 31, 2017 | Apr 27, 2022 | Dec 16, 2024 | 51 | United States, Australia +6 |
A participant was defined as a treatment responder if the initial eliciting dose (ED) was \> 10 milligram (mg) peanut protein and the ED was ≥1000 mg peanut protein at the post-treatment double-blind placebo-controlled food challenge (DBPCFC) at Month 12 OR the initial ED at baseline was ≤10 mg peanut protein and the ED was ≥300 mg peanut protein at the post-treatment DBPCFC at Month 12.
| Arm | Type | Description |
|---|---|---|
| Part A Viaskin Peanut 250 mcg | EXPERIMENTAL | - |
| Part A Viaskin Peanut 100 mcg | EXPERIMENTAL | - |
| Part A Placebo | PLACEBO_COMPARATOR | - |
| Part B Viaskin Peanut 250 mcg | EXPERIMENTAL | - |
| Part B Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Part A Viaskin Peanut 250 mcg | BIOLOGICAL | Viaskin Peanut 250 mcg, once daily |
| Part A Viaskin Peanut 100 mcg | BIOLOGICAL | Viaskin Peanut 100 mcg, once daily |
| Part A Placebo | BIOLOGICAL | Placebo patch, once daily |
| Part B Viaskin Peanut 250 mcg | BIOLOGICAL | Viaskin Peanut 250 mcg, once daily |
| Part B Placebo | BIOLOGICAL | Placebo patch, once daily |
Key Inclusion Criteria: * Male or female from 1-3 years of age; * Physician-diagnosed peanut allergy; * Peanut-specific IgE level \> 0.7 kU/L; * Positive peanut SPT with a largest wheal diameter ≥ 6 mm; * Positive DBPCFC at ≤ 300 mg peanut protein; Key Exclusion Criteria: * Uncontrolled asthma; *...