| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02916446 | Safety Study of Viaskin Peanut to Treat Peanut Allergy | PHASE3 | COMPLETED | 393 | — | — | Oct 1, 2016 | Oct 7, 2020 | Feb 3, 2021 | 32 | United States, Canada |
| NCT02636699 | Efficacy and Safety of Viaskin Peanut in Children With Immunoglobulin E (IgE)-Mediated Peanut Allergy | PHASE3 | COMPLETED | 500 | — | — | Dec 1, 2015 | Aug 18, 2017 | Jun 18, 2025 | 31 | United States, Australia +3 |
| NCT01955109 | Follow-up of the VIPES Study to Evaluate Efficacy and Safety of Viaskin Peanut in Adults and Children | PHASE2 | COMPLETED | 171 | — | — | Sep 1, 2013 | Sep 1, 2016 | Jun 30, 2022 | 22 | United States, Canada +2 |
| NCT01675882 | Efficacy and Safety of Several Doses of Viaskin Peanut in Adults and Children With Peanut Allergy | PHASE2 | COMPLETED | 221 | — | — | Aug 1, 2012 | Jul 1, 2014 | Oct 27, 2021 | 24 | United States, Canada +3 |
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 250 mcg | EXPERIMENTAL | Viaskin Peanut 250 mcg, daily administration |
| Placebo | PLACEBO_COMPARATOR | Placebo patch, daily administration |
| 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. |
| Viaskin Peanut 50 mcg | EXPERIMENTAL | - |
| Viaskin Peanut 100 mcg | EXPERIMENTAL | - |
| Viaskin Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Viaskin Peanut 250 mcg | BIOLOGICAL | - |
| Placebo | BIOLOGICAL | - |
| Viaskin Peanut 250mcg | BIOLOGICAL | Peanut extract cutaneous patch |
| 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 |
Inclusion Criteria: * Physician-diagnosed peanut allergy; * A peanut Skin Prick Test (SPT) with a wheal largest diameter ≥8 mm; * A specific-peanut Immunoglobulin E (IgE) ≥14 kU/L; * Subjects following a strict peanut-free diet. Exclusion Criteria: * Generalized dermatologic disease * Spirometry ...