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Also known as DBV712 250 mcg
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...
DBV712 is an investigational immunotherapy for peanut allergy. It is being studied in children as young as 1 year old to reduce allergic reactions to peanuts. The drug is delivered through a skin patch called Viaskin Peanut. It is not yet approved and remains in Phase 3 clinical development.
DBV712 targets peanut protein. It is designed to desensitize the immune system to peanut allergens by delivering small amounts of peanut protein through the skin via the Viaskin patch. This approach aims to reduce the severity of allergic reactions upon accidental peanut exposure.
DBV712 is developed by DBV Technologies S.A., a biopharmaceutical company listed on the stock exchange under the ticker DBVT. The company is conducting Phase 3 clinical trials to evaluate the safety and efficacy of the Viaskin Peanut patch in peanut-allergic children.
DBV712 is in Phase 3 clinical development. It is an investigational drug and has not received FDA approval. Multiple Phase 3 trials are ongoing or completed to assess its safety and efficacy in treating peanut allergy in pediatric populations.
DBV712 is being evaluated in several Phase 3 trials. NCT07003919 studies the Viaskin Peanut patch in children aged 1-3 years. NCT05741476 assesses it in children aged 4-7 years. NCT03859700 is a completed follow-up study in young children. All trials are placebo-controlled and double-blind.
Yes, DBV712 is also known as DBV712 250 mcg and is administered using the Viaskin Peanut patch. The patch delivers a 250 mcg dose of peanut protein through the skin. This delivery system is central to the drug's mechanism in treating peanut allergy.