Peanut Allergy
Conditions
Keywords
Food allergy, Immediate hypersensitivity, Whole peanut extract, Allergenic product, Specific Immunotherapy, Epicutaneous Immunotherapy (EPIT)
Brief summary
The objectives of this open-label follow-up study for subjects who previously were randomized and have completed the VIPES study for the treatment of peanut allergy, are: * To assess the efficacy of Viaskin Peanut after up to 36 months of treatment. * To evaluate the safety of long-term treatment with Viaskin Peanut. * To evaluate sustained unresponsiveness to peanut after a period of 2 months without treatment in subjects showing desensitization to peanut after treatment with Viaskin Peanut.
Detailed description
Peanut allergy is a common allergy in the United States, with a prevalence in the general population as high as 1%. Peanut allergy management is based on strict peanut avoidance and injectable epinephrine after the allergic systemic reactions have started. Specific Immunotherapy methods currently available have shown some limitations in their use because of safety issues. Hence, there is an important unmet medical need for efficient and safe treatment of peanut allergy. DBV Technologies has developed an epicutaneous delivery system, called Viaskin, a method based on delivering precise quantity of the allergen on the upper layers of the skin. Avoiding contact between the allergen and the bloodstream should confer to epicutaneous immunotherapy (EPIT) a higher level of safety as systemic reactions should be circumvented The OLFUS-VIPES study is an open-label follow-up study for subjects who previously were randomized and have completed the VIPES efficacy and safety study. Subjects will be offered enrollment in this follow-up study to receive an additional 24 months of Viaskin Peanut treatment followed by a period of 2 months without treatment while maintaining a peanut-free diet. The trial will be conducted at the same sites as the VIPES study with investigators and staff trained and experienced in the diagnosis and the management of peanut allergy and anaphylaxis, and who are capable of performing a double-blind placebo-controlled food challenge (DBPCFC) in adult and/or pediatric subjects. According to the current amended study protocol, all subjects enrolling into the OLFUS-VIPES study after having completed the VIPES study will receive the highest dose of Viaskin Peanut, i.e. 250 mcg peanut protein, regardless of prior treatment (placebo, 50 mcg, 100 mcg or 250 mcg Viaskin Peanut) they were receiving in the VIPES study. Subjects who already enrolled into the OLFUS-VIPES study under the initial protocol design will all switch to receive the 250 mcg dose at Month 6 or at Month 12 of treatment in the OLFUS-VIPES study upon approval of the amended protocol at their sites. The study will remain blinded for all subjects until the VIPES study is unblinded. All subjects completing the OLFUS-VIPES study should receive overall 24 months of active treatment followed by a period of 2 months without treatment for those subjects being assessed for sustained unresponsiveness.
Interventions
BIOLOGICALViaskin Peanut 250 mcg
Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 250 mcg peanut proteins as whole peanut extract
Sponsors
DBV Technologies
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 56 Years
Healthy volunteers
No
Inclusion criteria
* Adult and pediatric subjects (≥7 years) who completed the VIPES study, with a mandatory and documented DBPCFC at Month 12 in the VIPES study. * Signed informed consent from adult subjects or parent(s)/guardian(s) of children \<18 years and children's assent for children \>7 years or as per country-specific regulations or laws. This consent should be signed no later than Visit 11 in the VIPES study. * Negative pregnancy test for women of childbearing potential at Visit 10 in the VIPES study. * Female subject of childbearing potential must use effective methods of contraception to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of participation in the study. Documented sexual abstinence will be accepted as an effective method of contraception for girls below 15 years of age. * Subjects and/or parents/guardians willing to comply with all study requirements during their participation in the study.
Exclusion criteria
* Severe reaction during the DBPCFC at Month 12 in the VIPES study, defined as need for intubation, hypotension persisting after epinephrine administration, and/or the need for more than two doses of epinephrine. * Pregnancy or lactation. * Females of childbearing potential planning a pregnancy in the coming 2 to 3 years. * Subjects who became allergic to chocolate or who do not want to consume the chocolate study challenge vehicle anymore. * Subjects who developed hypersensitivity to excipients of the Viaskin patches or of the food challenge formula used during the VIPES study. * Inability to discontinue short-acting antihistamines for three days or long-acting antihistamines for five to seven days (depending on half-life) prior to skin prick testing or food challenges. * Subjects with asthma that has evolved and now fulfills any of the criteria defined as follows: * uncontrolled persistent asthma by National Asthma Education and Prevention Program Asthma guidelines (2007) or by Global Initiative for Asthma (2011) or being treated with combination therapy of medium dose inhaled corticosteroid with a long acting inhaled β2-agonists. * at least two systemic corticosteroid courses for asthma in the past year or one oral corticosteroid course for asthma in the past three months. * prior intubation for asthma in the past year. * Subjects receiving β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy. * Subjects receiving or planning to receive anti-tumor necrosis factor drugs or anti-IgE drugs (such as omalizumab) or any biologic immunomodulatory therapy. * Subjects receiving or planning to receive any type of immunotherapy to any food (e.g. oral immunotherapy, sublingual immunotherapy, specific oral tolerance induction) during their participation in the study. * Subjects receiving or planning to receive any aeroallergen immunotherapy during their participation in the study. * Allergy or known history of reaction to Tegaderm® with no possibilities to use an alternative dressing approved by the sponsor. * Subjects suffering from generalized dermatologic disease (e.g. severe atopic dermatitis, uncontrolled generalized eczema, ichthyosis vulgaris) with no intact zones to apply the patches. * Any new disorder in which epinephrine is contraindicated such as coronary artery disease, uncontrolled hypertension, or serious ventricular arrhythmias. * A history of non compliance in the VIPES study. Non compliance is defined as subjects not applying the patch at all for 60 days or more (this can be either consecutive or intermittent non-application of the patches) during the whole VIPES study duration * Participation in another clinical intervention study in the past year, other than the VIPES study. * Subjects on any experimental drugs in the past year, other than those used in the VIPES study. Other inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Treatment Responders at Months 12 and 24 | Month 12 and Month 24 (end of treatment) of the OLFUS-VIPES study | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Sustained Unresponsiveness to a Cumulative Dose of at Least 1440 mg Peanut Protein at Month 26 | Month 26 (2 months post-treatment) of the OLFUS-VIPES study | Participants who were unresponsive to a cumulative dose of 1440 mg of peanut protein or above at the Month 24 DBPCFC, had an additional 2-month period without treatment and continued on a peanut-free diet to assess for sustained unresponsiveness by a DBPCFC at Month 26. The percentage of participants with this sustained unresponsiveness, i.e, who showed no objective symptoms leading to stopping the challenge during the DBPCFC to a cumulative dose of 1440 mg of peanut protein or above at Month 26, are presented according to whether participants received Viaskin Peanut or placebo during the VIPES study. |
| Median Cumulative Reactive Dose of Peanut Protein at Months 12 and 24 | Month 12 and Month 24 (end of treatment) of the OLFUS-VIPES study | The cumulative reactive dose was defined as the sum of all peanut protein doses taken by the participant during the DBPCFC. To distinguish participants who reached the highest dose of the DBPCFC without objective symptoms 1000 mg was added to the cumulative reactive dose to obtain an adjusted value. The median cumulative reactive doses at Months 12 and 24 are presented according to whether participants received Viaskin Peanut or placebo during the VIPES study. |
| Mean Cumulative Reactive Dose of Peanut Protein at Months 12 and 24 | Month 12 and Month 24 (end of treatment) of the OLFUS-VIPES study | The cumulative reactive dose was defined as the sum of all peanut protein doses taken by the participant during the DBPCFC. To distinguish participants who reached the highest dose of the DBPCFC without objective symptoms 1000 mg was added to the cumulative reactive dose to obtain an adjusted value. The mean cumulative reactive doses at Months 12 and 24 are presented according to whether participants received Viaskin Peanut or placebo during the VIPES study. |
| Percentage of Participants Unresponsive to a Cumulative Dose of at Least 1440 mg Peanut Protein at Month 24 | Month 24 (end of treatment) of the OLFUS-VIPES study | Participants were considered unresponsive if they showed no objective symptoms leading to stopping the challenge during the Month 24 DBPCFC with a cumulative dose of at least 1440 mg of peanut protein, up to a cumulative dose of 5044 mg peanut protein. The percentage of unresponsive participants is presented according to whether participants received Viaskin Peanut or placebo during the VIPES study. |
| Change From VIPES Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 6, 12, 18 and 24 | VIPES Baseline to Months 6, 12, 18 and 24 (end of treatment) of the OLFUS-VIPES study | The change from the VIPES Baseline in peanut-specific IgG4 values at Months 6, 12, 18 and 24 of the OLFUS-VIPES study are presented according to whether participants received Viaskin Peanut or placebo during the VIPES study. |
| Change From VIPES Baseline in Wheal Diameter During Skin Prick Testing at Months 6, 12, 18 and 24 | VIPES Baseline to Months 6, 12, 18 and 24 (end of treatment) in the OLFUS-VIPES study | The change from the VIPES Baseline in the wheal diameter from the undiluted skin prick tests at Months 6, 12, 18 and 24 of the OLFUS-VIPES study are presented according to whether participants received Viaskin Peanut or placebo during the VIPES study. |
| Change From VIPES Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 6, 12, 18 and 24 | VIPES Baseline to Months 6, 12, 18 and 24 (end of treatment) of the OLFUS-VIPES study | The change from the VIPES Baseline in peanut-specific IgE values at Months 6, 12, 18 and 24 of the OLFUS-VIPES study are presented according to whether participants received Viaskin Peanut or placebo during the VIPES study. |
Countries
Canada, France, Netherlands, United States
Participant flow
Recruitment details
Children, adolescent and adult participants who were previously randomized in and completed the VIPES study (V712-202; NCT01675882) were eligible to enroll in this Phase II open-label follow-up study to receive an additional 24 months of Viaskin® Peanut (DBV712) Epicutaneous Immunotherapy (EPIT). Participants were enrolled in 21 study centers in 4 countries in France, the Netherlands, Canada and the USA from 30 August 2013 and the last participant completed 29 September 2016.
Pre-assignment details
Participants who received 50, 100 or 250 micrograms (μg) Viaskin Peanut in VIPES continued on same dose in OLFUS-VIPES; those receiving placebo were re-randomized 1:1:1 to 50, 100 or 250 μg Viaskin Peanut. After protocol amendment 1, all participants received 250 μg dose from start of OLFUS-VIPES; those already enrolled were switched to 250 μg at Month 6 visit.
Participants by arm
| Arm | Count |
|---|---|
| VIPES Initial Treatment Group: All Viaskin Peanut Doses Participants were randomized in the VIPES study to receive either 50 μg, 100 μg or 250 μg Viaskin Peanut for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 36 months. | 123 |
| VIPES Initial Treatment Group: Placebo Participants were randomized in the VIPES study to receive placebo for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 24 months. | 48 |
| Total | 171 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Lost to Follow-up | 3 | 1 |
| Overall Study | Non-compliance | 3 | 1 |
| Overall Study | Participant unwilling to continue | 35 | 7 |
| Overall Study | Physician Decision | 2 | 0 |
Baseline characteristics
| Characteristic | VIPES Initial Treatment Group: All Viaskin Peanut Doses | VIPES Initial Treatment Group: Placebo | Total |
|---|---|---|---|
| Age, Continuous | 13.7 years STANDARD_DEVIATION 6.64 | 13.0 years STANDARD_DEVIATION 6.59 | 13.5 years STANDARD_DEVIATION 6.61 |
| Age, Customized Adolescents (12-17 years) | 34 Participants | 18 Participants | 52 Participants |
| Age, Customized Adolescents and Adults (12-55 years) | 63 Participants | 25 Participants | 88 Participants |
| Age, Customized Adults (18-55 years) | 29 Participants | 7 Participants | 36 Participants |
| Age, Customized Children (6-11 years) | 60 Participants | 23 Participants | 83 Participants |
| Race/Ethnicity, Customized Asian | 16 Participants | 4 Participants | 20 Participants |
| Race/Ethnicity, Customized Black | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Caucasian | 80 Participants | 28 Participants | 108 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Not applicable | 18 Participants | 9 Participants | 27 Participants |
| Race/Ethnicity, Customized Other | 5 Participants | 3 Participants | 8 Participants |
| Region of Enrollment Canada | 40 participants | 14 participants | 54 participants |
| Region of Enrollment France | 18 participants | 9 participants | 27 participants |
| Region of Enrollment Netherlands | 5 participants | 1 participants | 6 participants |
| Region of Enrollment United States | 60 participants | 24 participants | 84 participants |
| Sex: Female, Male Female | 43 Participants | 18 Participants | 61 Participants |
| Sex: Female, Male Male | 80 Participants | 30 Participants | 110 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 123 | 0 / 48 |
| other Total, other adverse events | 113 / 123 | 47 / 48 |
| serious Total, serious adverse events | 7 / 123 | 3 / 48 |
Outcome results
Primary
Percentage of Treatment Responders at Months 12 and 24
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.
Time frame: Month 12 and Month 24 (end of treatment) of the OLFUS-VIPES study
Population: The full analysis set was the intent-to-treat population which consisted of all participants and results are reported for those participants who had the Months 12 and 24 DBPCFC performed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VIPES Initial Treatment Group: All Viaskin Peanut Doses | Percentage of Treatment Responders at Months 12 and 24 | Month 12 | 64.1 percentage of participants |
| VIPES Initial Treatment Group: All Viaskin Peanut Doses | Percentage of Treatment Responders at Months 12 and 24 | Month 24 | 67.5 percentage of participants |
| VIPES Initial Treatment Group: Placebo | Percentage of Treatment Responders at Months 12 and 24 | Month 12 | 50.0 percentage of participants |
| VIPES Initial Treatment Group: Placebo | Percentage of Treatment Responders at Months 12 and 24 | Month 24 | 58.5 percentage of participants |
Secondary
Change From VIPES Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 6, 12, 18 and 24
The change from the VIPES Baseline in peanut-specific IgE values at Months 6, 12, 18 and 24 of the OLFUS-VIPES study are presented according to whether participants received Viaskin Peanut or placebo during the VIPES study.
Time frame: VIPES Baseline to Months 6, 12, 18 and 24 (end of treatment) of the OLFUS-VIPES study
Population: The full analysis set was the intent-to-treat population which consisted of all participants and results are reported for those participants who had the Months 6, 12, 18 and 24 DBPCFC performed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| VIPES Initial Treatment Group: All Viaskin Peanut Doses | Change From VIPES Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 6, 12, 18 and 24 | VIPES Baseline to Month 6 | 2.150 kilo units per liter |
| VIPES Initial Treatment Group: All Viaskin Peanut Doses | Change From VIPES Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 6, 12, 18 and 24 | VIPES Baseline to Month 12 | -0.370 kilo units per liter |
| VIPES Initial Treatment Group: All Viaskin Peanut Doses | Change From VIPES Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 6, 12, 18 and 24 | VIPES Baseline to Month 18 | -1.870 kilo units per liter |
| VIPES Initial Treatment Group: All Viaskin Peanut Doses | Change From VIPES Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 6, 12, 18 and 24 | VIPES Baseline to Month 24 | -3.160 kilo units per liter |
| VIPES Initial Treatment Group: Placebo | Change From VIPES Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 6, 12, 18 and 24 | VIPES Baseline to Month 24 | -10.060 kilo units per liter |
| VIPES Initial Treatment Group: Placebo | Change From VIPES Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 6, 12, 18 and 24 | VIPES Baseline to Month 6 | 18.900 kilo units per liter |
| VIPES Initial Treatment Group: Placebo | Change From VIPES Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 6, 12, 18 and 24 | VIPES Baseline to Month 18 | -0.710 kilo units per liter |
| VIPES Initial Treatment Group: Placebo | Change From VIPES Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 6, 12, 18 and 24 | VIPES Baseline to Month 12 | 4.785 kilo units per liter |
Secondary
Change From VIPES Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 6, 12, 18 and 24
The change from the VIPES Baseline in peanut-specific IgG4 values at Months 6, 12, 18 and 24 of the OLFUS-VIPES study are presented according to whether participants received Viaskin Peanut or placebo during the VIPES study.
Time frame: VIPES Baseline to Months 6, 12, 18 and 24 (end of treatment) of the OLFUS-VIPES study
Population: The full analysis set was the intent-to-treat population which consisted of all participants and results are reported for those participants who had the Months 6, 12, 18 and 24 DBPCFC performed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| VIPES Initial Treatment Group: All Viaskin Peanut Doses | Change From VIPES Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 6, 12, 18 and 24 | VIPES Baseline to Month 6 | 1.935 mg/L |
| VIPES Initial Treatment Group: All Viaskin Peanut Doses | Change From VIPES Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 6, 12, 18 and 24 | VIPES Baseline to Month 12 | 2.890 mg/L |
| VIPES Initial Treatment Group: All Viaskin Peanut Doses | Change From VIPES Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 6, 12, 18 and 24 | VIPES Baseline to Month 18 | 2.780 mg/L |
| VIPES Initial Treatment Group: All Viaskin Peanut Doses | Change From VIPES Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 6, 12, 18 and 24 | VIPES Baseline to Month 24 | 2.170 mg/L |
| VIPES Initial Treatment Group: Placebo | Change From VIPES Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 6, 12, 18 and 24 | VIPES Baseline to Month 24 | 1.950 mg/L |
| VIPES Initial Treatment Group: Placebo | Change From VIPES Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 6, 12, 18 and 24 | VIPES Baseline to Month 6 | 0.775 mg/L |
| VIPES Initial Treatment Group: Placebo | Change From VIPES Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 6, 12, 18 and 24 | VIPES Baseline to Month 18 | 2.370 mg/L |
| VIPES Initial Treatment Group: Placebo | Change From VIPES Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 6, 12, 18 and 24 | VIPES Baseline to Month 12 | 1.510 mg/L |
Secondary
Change From VIPES Baseline in Wheal Diameter During Skin Prick Testing at Months 6, 12, 18 and 24
The change from the VIPES Baseline in the wheal diameter from the undiluted skin prick tests at Months 6, 12, 18 and 24 of the OLFUS-VIPES study are presented according to whether participants received Viaskin Peanut or placebo during the VIPES study.
Time frame: VIPES Baseline to Months 6, 12, 18 and 24 (end of treatment) in the OLFUS-VIPES study
Population: The full analysis set was the intent-to-treat population which consisted of all participants and results are reported for those participants who had the Months 6, 12, 18 and 24 DBPCFC performed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| VIPES Initial Treatment Group: All Viaskin Peanut Doses | Change From VIPES Baseline in Wheal Diameter During Skin Prick Testing at Months 6, 12, 18 and 24 | VIPES Baseline to Month 6 | -2.30 millimeters |
| VIPES Initial Treatment Group: All Viaskin Peanut Doses | Change From VIPES Baseline in Wheal Diameter During Skin Prick Testing at Months 6, 12, 18 and 24 | VIPES Baseline to Month 12 | -3.00 millimeters |
| VIPES Initial Treatment Group: All Viaskin Peanut Doses | Change From VIPES Baseline in Wheal Diameter During Skin Prick Testing at Months 6, 12, 18 and 24 | VIPES Baseline to Month 18 | -3.00 millimeters |
| VIPES Initial Treatment Group: All Viaskin Peanut Doses | Change From VIPES Baseline in Wheal Diameter During Skin Prick Testing at Months 6, 12, 18 and 24 | VIPES Baseline to Month 24 | -2.00 millimeters |
| VIPES Initial Treatment Group: Placebo | Change From VIPES Baseline in Wheal Diameter During Skin Prick Testing at Months 6, 12, 18 and 24 | VIPES Baseline to Month 24 | -1.50 millimeters |
| VIPES Initial Treatment Group: Placebo | Change From VIPES Baseline in Wheal Diameter During Skin Prick Testing at Months 6, 12, 18 and 24 | VIPES Baseline to Month 6 | -1.50 millimeters |
| VIPES Initial Treatment Group: Placebo | Change From VIPES Baseline in Wheal Diameter During Skin Prick Testing at Months 6, 12, 18 and 24 | VIPES Baseline to Month 18 | -1.40 millimeters |
| VIPES Initial Treatment Group: Placebo | Change From VIPES Baseline in Wheal Diameter During Skin Prick Testing at Months 6, 12, 18 and 24 | VIPES Baseline to Month 12 | -1.00 millimeters |
Secondary
Mean Cumulative Reactive Dose of Peanut Protein at Months 12 and 24
The cumulative reactive dose was defined as the sum of all peanut protein doses taken by the participant during the DBPCFC. To distinguish participants who reached the highest dose of the DBPCFC without objective symptoms 1000 mg was added to the cumulative reactive dose to obtain an adjusted value. The mean cumulative reactive doses at Months 12 and 24 are presented according to whether participants received Viaskin Peanut or placebo during the VIPES study.
Time frame: Month 12 and Month 24 (end of treatment) of the OLFUS-VIPES study
Population: The full analysis set was the intent-to-treat population which consisted of all participants and results are reported for those participants who had the Months 12 and 24 DBPCFC performed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VIPES Initial Treatment Group: All Viaskin Peanut Doses | Mean Cumulative Reactive Dose of Peanut Protein at Months 12 and 24 | Month 12 | 1419.6 mg | Standard Deviation 1595.92 |
| VIPES Initial Treatment Group: All Viaskin Peanut Doses | Mean Cumulative Reactive Dose of Peanut Protein at Months 12 and 24 | Month 24 | 1751.1 mg | Standard Deviation 1962.12 |
| VIPES Initial Treatment Group: Placebo | Mean Cumulative Reactive Dose of Peanut Protein at Months 12 and 24 | Month 24 | 758.4 mg | Standard Deviation 1176.38 |
| VIPES Initial Treatment Group: Placebo | Mean Cumulative Reactive Dose of Peanut Protein at Months 12 and 24 | Month 12 | 895.9 mg | Standard Deviation 1329.14 |
Secondary
Median Cumulative Reactive Dose of Peanut Protein at Months 12 and 24
The cumulative reactive dose was defined as the sum of all peanut protein doses taken by the participant during the DBPCFC. To distinguish participants who reached the highest dose of the DBPCFC without objective symptoms 1000 mg was added to the cumulative reactive dose to obtain an adjusted value. The median cumulative reactive doses at Months 12 and 24 are presented according to whether participants received Viaskin Peanut or placebo during the VIPES study.
Time frame: Month 12 and Month 24 (end of treatment) of the OLFUS-VIPES study
Population: The full analysis set was the intent-to-treat population which consisted of all participants and results are reported for those participants who had the Months 12 and 24 DBPCFC performed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| VIPES Initial Treatment Group: All Viaskin Peanut Doses | Median Cumulative Reactive Dose of Peanut Protein at Months 12 and 24 | Month 12 | 480.0 mg |
| VIPES Initial Treatment Group: All Viaskin Peanut Doses | Median Cumulative Reactive Dose of Peanut Protein at Months 12 and 24 | Month 24 | 440.0 mg |
| VIPES Initial Treatment Group: Placebo | Median Cumulative Reactive Dose of Peanut Protein at Months 12 and 24 | Month 12 | 365.0 mg |
| VIPES Initial Treatment Group: Placebo | Median Cumulative Reactive Dose of Peanut Protein at Months 12 and 24 | Month 24 | 440.0 mg |
Secondary
Percentage of Participants Unresponsive to a Cumulative Dose of at Least 1440 mg Peanut Protein at Month 24
Participants were considered unresponsive if they showed no objective symptoms leading to stopping the challenge during the Month 24 DBPCFC with a cumulative dose of at least 1440 mg of peanut protein, up to a cumulative dose of 5044 mg peanut protein. The percentage of unresponsive participants is presented according to whether participants received Viaskin Peanut or placebo during the VIPES study.
Time frame: Month 24 (end of treatment) of the OLFUS-VIPES study
Population: The full analysis set was the intent-to-treat population which consisted of all participants and results are reported for those participants who had the Month 24 DBPCFC performed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VIPES Initial Treatment Group: All Viaskin Peanut Doses | Percentage of Participants Unresponsive to a Cumulative Dose of at Least 1440 mg Peanut Protein at Month 24 | 31.3 percentage of participants |
| VIPES Initial Treatment Group: Placebo | Percentage of Participants Unresponsive to a Cumulative Dose of at Least 1440 mg Peanut Protein at Month 24 | 7.3 percentage of participants |
Secondary
Percentage of Participants With a Sustained Unresponsiveness to a Cumulative Dose of at Least 1440 mg Peanut Protein at Month 26
Participants who were unresponsive to a cumulative dose of 1440 mg of peanut protein or above at the Month 24 DBPCFC, had an additional 2-month period without treatment and continued on a peanut-free diet to assess for sustained unresponsiveness by a DBPCFC at Month 26. The percentage of participants with this sustained unresponsiveness, i.e, who showed no objective symptoms leading to stopping the challenge during the DBPCFC to a cumulative dose of 1440 mg of peanut protein or above at Month 26, are presented according to whether participants received Viaskin Peanut or placebo during the VIPES study.
Time frame: Month 26 (2 months post-treatment) of the OLFUS-VIPES study
Population: The full analysis set was the intent-to-treat population which consisted of all participants and results are reported for participants who had the Month 26 DBPCFC performed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VIPES Initial Treatment Group: All Viaskin Peanut Doses | Percentage of Participants With a Sustained Unresponsiveness to a Cumulative Dose of at Least 1440 mg Peanut Protein at Month 26 | 77.3 percentage of participants |
| VIPES Initial Treatment Group: Placebo | Percentage of Participants With a Sustained Unresponsiveness to a Cumulative Dose of at Least 1440 mg Peanut Protein at Month 26 | 100 percentage of participants |