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Also known as ViaskinTM Peanut, Viaskin Peanut
DBV712 · 6 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.
A participant was defined as treatment responder if: * The V712-304 (EPITOPE) baseline ED was \>10 mg peanut protein and the ED was ≥1000 mg peanut protein at the post-baseline DBPCFCs or; * The V712-304 (EPITOPE) baseline ED was ≤10 mg and the ED is ≥300 mg peanut protein at the post-baseline DBPCFCs. DBPCFC occurred at baseline and every 12 months, with the first post-baseline one being performed at the end of the EPITOPE trial (corresponding to Month 12).
The Double-Blind Placebo-Controlled Food Challenges (DBPCFCs) to determine Eliciting Dose (ED) were performed at screening and Month 12, with each challenge occurring over 2 days. The participant was gradually fed increasing amounts of standardized blinded oral formulas containing either peanut protein (during 1 of the 2 days of the challenge), or without any peanut protein (during the other day of the challenge). A participant was defined as a treatment responder if: * ED was ≥300 mg peanut protein at Month 12 DBPCFC (for screening ED subgroup 1), or * ED was ≥1,000 mg peanut protein at Month 12 DBPCFC (for screening ED subgroup 2). Participants with missing treatment response at Month 12 were imputed as non-responders. The percentage of treatment responders at Month 12 is presented. Analysis of the difference in response rates between treatment groups is presented in the subsequent statistical analysis table. Analysis was performed in the overall population.
A treatment responder was defined as a participant with a peanut protein eliciting dose (ED) equal to or greater than 1000 milligram (mg) peanut protein or with at least a 10-fold increase of the ED compared to their initial ED observed at the VIPES baseline, as determined by double-blind placebo-controlled food challenge (DBPCFC) at Months 12 and 24. At Month 12, participants had received 24 months of active treatment for those who received Viaskin Peanut in the VIPES study, and 12 months of active treatment for those who received placebo in the VIPES study. At Month 24, participants had received 36 months of active treatment for those who received Viaskin Peanut in the VIPES study, and 24 months of active treatment for those who received placebo in the VIPES study. The percentage of responders at Month 12 and Month 24 are presented according to whether participants received Viaskin Peanut or placebo during the VIPES study.
A treatment responder was defined as a participant with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPCFC after 12 months of treatment or a participant with a \>=10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose. For participants with missing treatment response at Month 12, last observation carried forward (LOCF) imputation was used (i.e., participants were considered as non-responders).
| 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 | DBV712 250 mcg, once daily |
| Viaskin Peanut 250mcg | EXPERIMENTAL | One Viaskin epicutaneous delivery system (patch) containing 250 µg of peanut protein applied on the skin for 24 hours (±4 hours of allowance) daily for a period of 12 months. |
| Placebo | PLACEBO_COMPARATOR | One Viaskin epicutaneous delivery system (patch) containing placebo applied on the skin for 24 hours (±4 hours of allowance) daily for a period of 12 months. |
| Viaskin Peanut 250 mcg | EXPERIMENTAL | - |
| Viaskin Peanut 50 mcg | EXPERIMENTAL | - |
| Viaskin Peanut 100 mcg | EXPERIMENTAL | - |
| Viaskin Placebo | PLACEBO_COMPARATOR | - |
| 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. |
| Viaskin Peanut 250mcg | BIOLOGICAL | Peanut extract cutaneous patch |
| Viaskin Peanut 250 mcg | BIOLOGICAL | Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 250 mcg peanut proteins as whole peanut extract |
| Viaskin Peanut 50 mcg | BIOLOGICAL | Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 50 mcg peanut proteins as whole peanut extract |
| Viaskin Peanut 100 mcg | BIOLOGICAL | Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 100 mcg peanut proteins as whole peanut extract |
| Viaskin Placebo | BIOLOGICAL | Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing a matching placebo formulation |
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 developed by DBV Technologies S.A. for peanut allergy. It is a small molecule designed to target peanut protein and is being studied in children with peanut allergy. DBV712 is also known as DBV712 250 mcg and is delivered as the Viaskin Peanut patch.
DBV712 is being developed to treat peanut allergy in children. Clinical trials have enrolled peanut-allergic children as young as 1 year of age. The program includes studies in toddlers 1 through 3 years old and children 4 to 7 years old, with a completed follow-up study in young children.
DBV712 targets peanut protein. It is a small molecule immunotherapy designed to expose patients to peanut protein through the skin, with the goal of modifying the immune response to peanut. This approach is known as epicutaneous immunotherapy.
DBV712 is developed by DBV Technologies S.A., which trades under the ticker DBVT. The company is running the clinical development program for the Viaskin Peanut patch, including Phase 3 trials in peanut-allergic children.
DBV712 is in Phase 3 clinical development. It is investigational and has not been approved. The program includes two active Phase 3 trials and one completed Phase 3 follow-up study, with a total of 904 participants enrolled across the trials.
DBV712 has been studied in three Phase 3 trials. NCT07003919 is the COMFORT Toddlers safety study in children 1 through 3 years old, and NCT05741476 is a safety and efficacy study in children 4 to 7 years old. NCT03859700 is a completed long-term follow-up of the EPITOPE study.