Approval Probability
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Adjusted LOA
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Viaskin Peanut · 3 trials · 1 indication
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 |
|---|---|---|
| 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 |
|---|---|---|
| Viaskin Peanut 250mcg | BIOLOGICAL | Peanut extract cutaneous patch |
| Placebo | BIOLOGICAL | Cutaneous patch containing an inactive deposit manufactured to mimic peanut extract |
| 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 |
Main Inclusion Criteria: 1. Male or female children aged 4 through 11 years; 2. Physician-diagnosis of peanut allergy or children with a well documented medical history of IgE-mediated symptoms after ingestion of peanut and currently following a strict peanut-free diet, but without a physician diag...
Viaskin Peanut is an investigational immunotherapy being developed for the treatment of peanut allergy in children and adults with immunoglobulin E (IgE)-mediated peanut allergy. It is designed to desensitize patients to peanut protein through epicutaneous delivery. It has not been approved by the FDA and remains in clinical development.
Viaskin Peanut is being developed by DBV Technologies S.A., a French biopharmaceutical company traded on the Nasdaq under the ticker DBVT. DBV Technologies specializes in epicutaneous immunotherapy for food allergies and has conducted multiple clinical trials of Viaskin Peanut in the United States, Canada, Europe, and Australia.
Viaskin Peanut is in Phase 3 clinical development. The Phase 3 trial, NCT02636699, was completed and evaluated the efficacy and safety of Viaskin Peanut in children with IgE-mediated peanut allergy. The program also includes two completed Phase 2 trials, NCT01955109 and NCT01675882, which studied the treatment in adults and children.
Viaskin Peanut has been studied in three completed clinical trials: NCT02636699, a Phase 3 trial in children with peanut allergy; NCT01955109, a Phase 2 follow-up study of the VIPES trial in adults and children; and NCT01675882, a Phase 2 dose-ranging study in adults and children. All three trials are completed.
Viaskin Peanut has received an Accelerated Approval designation from the FDA. This designation is intended to expedite the approval of drugs that treat serious conditions and provide meaningful advantage over existing therapies. The product remains investigational and has not been approved by the FDA.