Approval Probability
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DBV712 · 3 trials · 3 indications
A participant is defined as a treatment responder if: The initial ED was ≤30 mg peanut protein and the ED is ≥ 300 mg peanut protein at the post-treatment DBPCFC at Month 12; OR the initial ED was \> 30 mg peanut protein and the ED is ≥600 mg peanut protein at the post-treatment DBPCFC at Month 12. Percentage of treatment responders in the DBV712 250 mcg group compared to the placebo group after 12 months of treatment in the target population will be reported.
| Arm | Type | Description |
|---|---|---|
| DBPC Treatment Period: DBV712 250 mcg | EXPERIMENTAL | Participants will apply DBV712 250 mcg, epicutaneous system (or patch), daily for a period of 6 months. |
| DBPC Treatment Period: Placebo | PLACEBO_COMPARATOR | Participants will apply DBV712 matching placebo epicutaneous system (or patch), daily for a period of 6 months. |
| Optional Open-Label Extension-Period: DBV712 250 mcg | EXPERIMENTAL | The 6-month DBPC period will be followed by an optional open-label extension (OLE) period during which eligible participants will receive DBV712 250 mcg for a duration of 18 months (representing 24 months of active treatment for those participants initially randomized to DBV712 250 mcg and 18 months of active treatment for those participants that were initially randomized to placebo). |
| Open Label Extension Period: DBV712 250 mcg | EXPERIMENTAL | Participants will apply DBV712 250 mcg, epicutaneous system (or patch), daily for a period of 2 additional years if they were randomized DBV712 250 mcg or for 3 years if they were randomized placebo. After 12 months of open-label treatment with DBV712 250 mcg, (i.e., at the end of Month 24), participants will undergo a peanut DBPCFC according to the following schedule: 3, 10, 30, 100, 300, 600, 1000, and 2000 mg (4043 mg cumulative dose). Participants who were randomized to placebo will also undergo an additional peanut DBPCFC after 24 months of open-label treatment with DBV712 250 mcg, (i.e., at the end of Month 36). |
| DBV712 250mcg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| DBV712 250 mcg | COMBINATION_PRODUCT | DBV712 250 mcg epicutaneous system. |
| Placebo | COMBINATION_PRODUCT | DBV712 matching placebo epicutaneous system. |
| DBV712 | DRUG | DBV712 250 mcg epicutaneous system. |
Key Inclusion Criteria: * Aged 1 through 3 years at Visit 1 (screening). * Physician-diagnosed peanut allergy and following a strict peanut-free diet * Peanut-specific IgE \> 0.7 kUA/L. * A positive peanut SPT with the largest wheal diameter of ≥ 6 mm at Visit 1 (screening). * An ED ≤ 300 mg peanut...