Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5U19AI066738-07 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Consortium of Food Allergy Research | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Food allergy occurs when the immune system reacts against foods. The immune system is the part of the body that protects us from illness and germs, but it can also cause allergies. Peanut allergy occurs in 1 - 2% of people in the United States and other Western countries. There is proof that allergy to peanut is increasing. Allergic reactions to peanut can be severe and life threatening. The only way that you can prevent an allergic reaction is to avoid exposure to peanuts. However, peanut proteins are found in a variety of foods and people can be accidently exposed to peanut proteins. Treatment for accidental exposure include antihistamines (medications like Benadryl), and injectable epinephrine (adrenalin) which must be carried at all times. DBV Technologies has developed an epicutaneous delivery system, a patch that puts the peanut protein on the skin.
This study will evaluate whether peanut epicutaneous immunotherapy can protect individuals who are allergic to peanuts from having severe allergic reactions, when accidentally exposed to peanuts. The study also looks at the safety of the treatment and the effects it has on the immune system.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Patch | Placebo Comparator | Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks). |
|
| 100 µg Peanut Patch | Experimental | Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks). |
|
| 250 µg Peanut Patch | Experimental | Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Viaskin® Patch | Biological | Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With a Successful Treatment Response | Treatment response is defined as a subject who can either (a) successfully consume a cumulative dose of peanut protein equal to or greater than 5044 mg or (b) successfully consume at least a 10-fold increase in peanut protein at the Week 52 oral food challenge (OFC), when compared to the cumulative successfully consumed dose at the baseline OFC. | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Desensitized to Peanut Protein | Desensitization is defined based on successfully consumed dose in mg protein at the Week 130 oral food challenge (OFC) as follows: 1) 0-44 mg at BL, >=444 mg at Wk 130 2) >44-<444 mg at BL, 10-fold increase at Wk 130 3) >=444 mg at BL, >=5,044 mg at Wk 130. BL=Baseline, Wk 130=Week 130 (Month 30) | Week 130 (Month 30) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stacie M. Jones, MD | University of Arkansas | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | United States | ||
| National Jewish Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24789880 | Background | Keet CA, Wood RA. Emerging therapies for food allergy. J Clin Invest. 2014 May;124(5):1880-6. doi: 10.1172/JCI72061. Epub 2014 May 1. | |
| 28091362 | Result | Jones SM, Sicherer SH, Burks AW, Leung DY, Lindblad RW, Dawson P, Henning AK, Berin MC, Chiang D, Vickery BP, Pesek RD, Cho CB, Davidson WF, Plaut M, Sampson HA, Wood RA; Consortium of Food Allergy Research. Epicutaneous immunotherapy for the treatment of peanut allergy in children and young adults. J Allergy Clin Immunol. 2017 Apr;139(4):1242-1252.e9. doi: 10.1016/j.jaci.2016.08.017. Epub 2016 Oct 26. |
| Label | URL |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) Website | View source |
Not provided
The plan is to share data in ImmPort [https://immport.niaid.nih.gov/ ], a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
Not provided
After completion of the trial.
After completion of the trial.
Not provided
Recruitment took place from September 2013 to July 2014 at the five listed university-based medical centers located in the United States.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Patch | Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks). Placebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Low-dose DBV712 Viaskin® Patch | Biological | 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours. |
|
| High-dose DBV712 Viaskin® Patch | Biological | 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours. |
|
| Percentage of Subjects Who Can Successfully Consume 1044 mg or 5044 mg Peanut Protein | Subjects who successfully consumed without dose-limiting symptoms 1044 mg or 5044 mg peanut protein during the Week 130 oral food challenge (OFC). This is referred to as the successfully consumed dose (SCD). The maximum SCD for this OFC was 5044 mg peanut protein. | Week 130 (Month 30) |
| Percentage of Desensitized Subjects in the Active Treatment Arms as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC) | Desensitization is defined based on successfully consumed dose in mg protein at the Week 52 oral food challenge (OFC) as follows: 0-44 mg at BL, >=444 mg at Wk52 2) >44-<444 mg at BL, 10-fold increase at Wk 52 3) >=444 mg at BL, >=5,044 mg at Wk 52. BL=Baseline, Wk 52=Week 52 | Week 52 |
| Average Successfully Consumed Dose as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC) | The successfully consumed dose (SCD) is the cumulative dose consumed during an oral food challenge without dose-limiting symptoms that led to the termination of the challenge. | Week 52 |
| Percentage of Subjects Who Pass an OFC to 5044 mg of Peanut Protein Followed by an Open Feeding of Peanut Butter After 8 Weeks or 20 Weeks of Discontinuation of Dosing Subsequent to Passing the Week 130 Oral Food Challenge (OFC) | Subjects who after passing the Week 130 (Month 30) discontinue dosing for 8 weeks and later 20 weeks successfully consumed 5044 mg peanut protein during an OFC followed by an open feeding of peanut butter. | 8 and 20 weeks after the Week 130 (Month 30) OFC |
| Percentage of Subjects With Adverse Events Related to Therapy Through Week 52 and Through 30 Months | Adverse events (AEs) related to study therapy includes both unsolicited AEs where there was a reasonable possibility that the study product caused the event as well as solicited AEs related to dosing. | Week 52 and Month 30 (Week 130) |
| Percentage of Subjects Who Successfully Complete the Dosing Regimen With no More Than Mild Symptoms Related to Peanut Patch Dosing After 30 Months of Therapy | Mild symptoms related to peanut patch dosing are defined as patch site reactions up to Grade 2 in severity or mild systemic dosing symptoms. | Month 30 (Week 130) |
| Denver |
| Colorado |
| 80206 |
| United States |
| The Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| University of North Carolina at Chapel Hill School of Medicine | Chapel Hill | North Carolina | 27599 | United States |
| 33290772 | Derived | Scurlock AM, Burks AW, Sicherer SH, Leung DYM, Kim EH, Henning AK, Dawson P, Lindblad RW, Berin MC, Cho CB, Davidson WF, Plaut M, Sampson HA, Wood RA, Jones SM; Consortium for Food Allergy Research (CoFAR). Epicutaneous immunotherapy for treatment of peanut allergy: Follow-up from the Consortium for Food Allergy Research. J Allergy Clin Immunol. 2021 Mar;147(3):992-1003.e5. doi: 10.1016/j.jaci.2020.11.027. Epub 2020 Dec 5. |
| 29408715 | Derived | Chiang D, Chen X, Jones SM, Wood RA, Sicherer SH, Burks AW, Leung DYM, Agashe C, Grishin A, Dawson P, Davidson WF, Newman L, Sebra R, Merad M, Sampson HA, Losic B, Berin MC. Single-cell profiling of peanut-responsive T cells in patients with peanut allergy reveals heterogeneous effector TH2 subsets. J Allergy Clin Immunol. 2018 Jun;141(6):2107-2120. doi: 10.1016/j.jaci.2017.11.060. Epub 2018 Jan 31. |
| Consortium of Food Allergy Research (CoFAR) Website | View source |
| FG001 | 100 µg Peanut Patch | Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks). Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours. |
| FG002 | 250 µg Peanut Patch | Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks). High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours. |
| Completed Week 52 OFC | Completion of the Week 52 OFC was required to assess the primary endpoint of the study. |
|
| Began Crossover Treatment |
|
| Completed Week 130 OFC |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized subjects who received study treatment. Note that 1 subject in the 100 µg Peanut Patch group who never received treatment was not included.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Patch | Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks). Placebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours. |
| BG001 | 100 µg Peanut Patch | Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks). Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours. |
| BG002 | 250 µg Peanut Patch | Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks). High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Atopic Dermatitis Total Score | The Atopic Dermatitis Total Score is scored on a 10 point scale of 0 to 9 where a higher score indicates increasing severity of atopic dermatitis. This score is a combination of three scores that range from 0 to 3 in the following areas: body surface area score, disease course, and disease intensity. | Mean | Standard Deviation | Scores on a scale |
| ||||||||||||||
| Total IgE | Total amount of serum immunoglobulin E. | Mean | Standard Deviation | kU/L |
| ||||||||||||||
| Peanut IgE | Amount of serum peanut-specific immunoglobulin E. Individuals with a peanut IgE of <0.35 kUA/L are considered not to be sensitized to peanut. | Mean | Standard Deviation | kUA/L |
| ||||||||||||||
| Skin Prick Test Score | This score is calculated by subtracting the size of the saline wheal (in mm) from the size of the peanut wheal (in mm) observed for a skin prick test. Individuals with a peanut skin prick test score of < 3 mm are considered to have a negative result. | Mean | Standard Deviation | mm |
| ||||||||||||||
| Age at Initial Peanut Allergic Reaction | Mean | Standard Deviation | years |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects With a Successful Treatment Response | Treatment response is defined as a subject who can either (a) successfully consume a cumulative dose of peanut protein equal to or greater than 5044 mg or (b) successfully consume at least a 10-fold increase in peanut protein at the Week 52 oral food challenge (OFC), when compared to the cumulative successfully consumed dose at the baseline OFC. | All randomized subjects who received study treatment. | Posted | Number | percentage of participants | Week 52 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Desensitized to Peanut Protein | Desensitization is defined based on successfully consumed dose in mg protein at the Week 130 oral food challenge (OFC) as follows: 1) 0-44 mg at BL, >=444 mg at Wk 130 2) >44-<444 mg at BL, 10-fold increase at Wk 130 3) >=444 mg at BL, >=5,044 mg at Wk 130. BL=Baseline, Wk 130=Week 130 (Month 30) | All randomized subjects who received active (not placebo) study treatment. For the Placebo Patch group, this only includes the 20 subjects who crossed over to active treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 130 (Month 30) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Who Can Successfully Consume 1044 mg or 5044 mg Peanut Protein | Subjects who successfully consumed without dose-limiting symptoms 1044 mg or 5044 mg peanut protein during the Week 130 oral food challenge (OFC). This is referred to as the successfully consumed dose (SCD). The maximum SCD for this OFC was 5044 mg peanut protein. | All randomized subjects who received active (not placebo) study treatment. For the Placebo Patch group, this only includes the 20 subjects who crossed over to active treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 130 (Month 30) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Desensitized Subjects in the Active Treatment Arms as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC) | Desensitization is defined based on successfully consumed dose in mg protein at the Week 52 oral food challenge (OFC) as follows: 0-44 mg at BL, >=444 mg at Wk52 2) >44-<444 mg at BL, 10-fold increase at Wk 52 3) >=444 mg at BL, >=5,044 mg at Wk 52. BL=Baseline, Wk 52=Week 52 | All randomized subjects who received active (not placebo) study treatment. | Posted | Number | percentage of participants | Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Successfully Consumed Dose as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC) | The successfully consumed dose (SCD) is the cumulative dose consumed during an oral food challenge without dose-limiting symptoms that led to the termination of the challenge. | All randomized subjects who completed the Week 52 OFC. | Posted | Median | Full Range | mg protein | Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Who Pass an OFC to 5044 mg of Peanut Protein Followed by an Open Feeding of Peanut Butter After 8 Weeks or 20 Weeks of Discontinuation of Dosing Subsequent to Passing the Week 130 Oral Food Challenge (OFC) | Subjects who after passing the Week 130 (Month 30) discontinue dosing for 8 weeks and later 20 weeks successfully consumed 5044 mg peanut protein during an OFC followed by an open feeding of peanut butter. | None of the participants passed the Week 130 OFC so this could not be assessed. | Posted | 8 and 20 weeks after the Week 130 (Month 30) OFC |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Adverse Events Related to Therapy Through Week 52 and Through 30 Months | Adverse events (AEs) related to study therapy includes both unsolicited AEs where there was a reasonable possibility that the study product caused the event as well as solicited AEs related to dosing. | All randomized subjects who received study treatment were included in the analysis. For the Placebo Patch group, at Week 130 only the 20 participants who crossed over to active treatment were included. | Posted | Number | percentage of participants | Week 52 and Month 30 (Week 130) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Who Successfully Complete the Dosing Regimen With no More Than Mild Symptoms Related to Peanut Patch Dosing After 30 Months of Therapy | Mild symptoms related to peanut patch dosing are defined as patch site reactions up to Grade 2 in severity or mild systemic dosing symptoms. | All randomized subjects who received active (not placebo) study treatment. The Placebo Patch group includes the 20 subjects who crossed over to active treatment. | Posted | Number | percentage of participants | Month 30 (Week 130) |
|
For the Placebo Patch group, data were collected for 52 weeks of double-blind dosing with a placebo patch and 130 weeks of open label dosing on active treatment with the DBV712 Viaskin® Patch with 250 µg peanut protein. For the 100 µg Peanut Patch group and the 250 µg Peanut Patch group, data were collected for 52 weeks of double-blind dosing and then 78 weeks of open label dosing for a total of 130 weeks of active treatment.
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Patch Before Week 52 OFC (Double Blind) | Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks). Placebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours. | 0 | 25 | 1 | 25 | 23 | 25 |
| EG001 | Placebo Patch Crossed Over to 250 µg Peanut Patch (Open Label) | After 52 weeks of double-blind Placebo Patch therapy, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks). High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours. | 0 | 20 | 0 | 20 | 20 | 20 |
| EG002 | 100 µg Peanut Patch | Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks). Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours. | 0 | 24 | 2 | 24 | 24 | 24 |
| EG003 | 250 µg Peanut Patch | Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks). High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours. | 0 | 25 | 0 | 25 | 25 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Application site erythema | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Application site extravasation | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Application site papules | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Application site pruritus | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Application site reaction | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Allergy to animal | Immune system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Croup infectious | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Gastoenteritis viral | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Mole excision | Surgical and medical procedures | MedDRA 20.0 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Gastrointestinal viral infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Tonsilitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research Program | DAIT/NIAID | (301) 594-7669 | DAITClinicalTrialsGov@niaid.nih.gov |
| ID | Term |
|---|---|
| D021183 | Peanut Hypersensitivity |
| D005512 | Food Hypersensitivity |
| D006967 | Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| ID | Term |
|---|---|
| D000074924 | Nut and Peanut Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
The null hypothesis was that there was no difference between treatment groups. Subjects who did not complete the Week 52 oral food challenge were counted as treatment failures. |
| Barnard's statistic |
| 0.003 |
A one-sided test was used with the a priori threshold for statistical significance of 0.0125. No adjustments were made to the p-value. |
| Risk Difference (RD) |
| 36.0 |
| 2-Sided |
| 36.0 |
| 12.6 |
| 59.4 |
| Superiority or Other |
| Barnard's statistic | 0.48 | A one-sided test was used with the a priori threshold for statistical significance of 0.0125. No adjustments were made to the p-value. | Risk Difference (RD) | 2.2 | 2-Sided | 2.2 | -25.8 | 30.1 | Superiority or Other |
Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).
Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.
| OG002 | 250 µg Peanut Patch | Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks). High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours. |
|
|
Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).
Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.
| OG002 | 250 µg Peanut Patch | Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks). High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours. |
|
|
Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks). High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours. |
|
|
| OG002 | 250 µg Peanut Patch | Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks). High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours. |
|
|
|
| OG002 | 250 µg Peanut Patch | Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks). High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours. |
|
| OG002 | 250 µg Peanut Patch | Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks). High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours. |
|
|
| OG002 | 250 µg Peanut Patch | Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks). High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours. |
|
|