Peanut Allergy
Conditions
Keywords
Food allergy, Immediate hypersensitivity, Whole peanut extract, Allergenic product, Specific Immunotherapy, Epicutaneous Immunotherapy (EPIT)
Brief summary
The objectives of this dose-finding study for the treatment of peanut allergy are: * To determine the efficacy of 3 doses of Viaskin Peanut (50 mcg ,100 mcg and 250 mcg peanut protein per patch) to significantly desensitize peanut-allergic subjects to peanut after 12 months of treatment. * To evaluate the safety of a long-term 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 VIPES study is a 12-month double-blind, placebo-controlled,randomized trial to study the efficacy and safety of Viaskin Peanut in subjects from 6 to 55 years old with a history of immediate hypersensitive reaction to peanut protein. The trial will be conducted at sites 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. Three doses of peanut proteins, i.e. 50 mcg, 100 mcg and 250 mcg will be evaluated for the study. Following the confirmation of peanut allergy at screening, subjects will be randomized in a 1:1:1:1 ratio into four different treatment groups, including 50 mcg, 100 mcg and 250 mcg peanut protein or placebo. Treatment will be comprised of daily applications of Viaskin Peanut or placebo patch for 12 months. Each subject will undergo two DBPCFCs: one at screening and one at Month 12. A follow up visit will be performed 2 weeks after completion of treatment and the last DBPCFC.
Interventions
BIOLOGICALViaskin Peanut 50 mcg
Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 50 mcg peanut proteins as whole peanut extract
BIOLOGICALViaskin Peanut 100 mcg
Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 100 mcg peanut proteins as whole peanut extract
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
BIOLOGICALViaskin Placebo
Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing a matching placebo formulation
Sponsors
DBV Technologies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Peanut-allergic subjects between 6 and 55 years of age, with a well-documented medical history of systemic reactions after ingestion of peanut and currently following a strict peanut-free diet. * Peanut-specific immunoglobulin E (IgE) level (Phadia CAP-system) \> 0.7 kU/L and a positive skin prick test to peanut with a largest wheal diameter ≥ 8 mm * Positive double-blind placebo-controlled food challenge (DBPCFC) at ≤ 300 mg of peanut proteins: the eliciting dose of peanut proteins during the DBPCFC is capped at 300 mg, i.e. subjects must react to peanut before reaching or at the dose of 300 mg peanut proteins. * Negative pregnancy test for women of childbearing potential. Females of childbearing age 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. Sexual abstinence will be accepted as an effective method of contraception for girls below 15 years of age. * Ability to perform spirometry maneuvers in accordance with the American Thoracic Society guidelines (2005) for subjects 9 years of age and above Subjects below 9 years of age can perform peak expiratory flow (PEF) instead. * Willing to comply with all study requirements during their participation in the study. * Provide signed informed consent and assent as appropriate.
Exclusion criteria
* Subjects with a history of severe anaphylaxis to peanut with the following symptoms: hypotension, hypoxia, neurological compromise (collapse, loss of consciousness or incontinence). * Pregnancy or lactation. * FEV1 \<80% of the predicted value at screening for subjects 9 years of age and above. PEF \< 80% of predicted for subjects below 9 years of age. * Subjects who did not react at or below the dose of 300 mg of peanut proteins during the DBPCFC at screening. * Known allergy or known hypersensitivity to placebo excipients either of the Viaskin patches or of the food challenge formulas. * Subjects reacting objectively to the placebo formula at screening. * Severe reaction during the screening food challenge, defined as need for intubation, hypotension persisting after epinephrine administration, or the need for more than two doses of epinephrine. * 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 treated with systemic long-acting corticosteroids (depot corticosteroids) within 12 weeks prior to the screening visit and/or systemic short-acting corticosteroid within 4 weeks prior to the screening visit or any systemic corticosteroid at screening. * Subjects with asthma defined as follows: 1. 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; 2. at least two systemic corticosteroid courses for asthma in the past year or one oral corticosteroid course for asthma in the past three months; 3. prior intubation for asthma in the past two years. * Subjects on β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy. * Subjects undergoing any type of immunotherapy to any food within one year prior to the screening visit. * Subjects presently on aeroallergen immunotherapy and unwilling or unable to discontinue. * Subjects currently treated with anti-tumor necrosis factor drugs or anti-IgE drugs (such as omalizumab) or any biologic immunomodulatory therapy within one year prior to the screening visit. * Allergy or known history of reaction to Tegaderm®. * Subjects suffering from generalized dermatologic diseases (e.g. severe atopic dermatitis, uncontrolled generalized eczema, keratosis pilaris, ichthyosis vulgaris) with no intact skin zones to apply the patches. * Any disorder in which epinephrine is contraindicated such as coronary artery disease, uncontrolled hypertension, or serious ventricular arrhythmias. * Participation in another clinical intervention study in the three months prior to the screening visit. * Subjects on any experimental drugs or treatments. Other inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Treatment Responders at Month 12; Analyzed in Overall Population | At Month 12 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Treatment Responders at Month 12; Analyzed in Adolescents (12-17 Years of Age) | At Month 12 | 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, LOCF imputation was used (i.e., participants were considered as non-responders). |
| Percentage of Treatment Responders at Month 12; Analyzed in Adults (18-55 Years of Age) | At Month 12 | 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, LOCF imputation was used (i.e., participants were considered as non-responders). |
| Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Overall Population | At Month 12 | The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at the screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders). |
| Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Children (6-11 Years of Age) | At Month 12 | The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders). |
| Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Adolescents (12-17 Years of Age) | At Month 12 | The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders). |
| Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Adults (18-55 Years of Age) | At Month 12 | The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders). |
| Mean Cumulative Reactive Dose of Peanut Proteins at Month 12; Analyzed in Overall Population | At Month 12 | The peanut protein cumulative reactive dose was defined as the sum of all peanut protein doses up to and including the eliciting dose ingested during the peanut challenge. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders). |
| Change From Baseline in Severity of Symptoms Based on the Oral Food Challenge (OFC) Symptom Score Sheet at Month 12; Analyzed in Overall Population | Baseline and Month 12 | The symptoms of erythematous rash, pruritus, urticaria/angioedema, rash, sneezing/itching, nasal congestion, rhinorrhea, laryngeal symptoms (example, throat clearing, occasional cough, hoarseness, frequent dry cough, inspiratory stridor), wheezing, subjective complaints, objective complaints and cardiovascular symptoms (example, color change, weakness, dizziness, mental status change, tachycardia, decreased blood pressure, etc) were observed. The OFC score ranges from 0 to 3 for each symptom (0=Absent, 1=mild, 2=moderate or 3=severe). The total symptom score for each participant was calculated. Higher scores indicate worst outcome. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders). |
| Percentage of Treatment Responders at Month 12; Analyzed in Children (6-11 Years of Age) | At Month 12 | 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, LOCF imputation was used (i.e., participants were considered as non-responders). |
| Change From Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 3, 6 and 12; Analyzed in Overall Population | Baseline and Months 3, 6 and 12 | Venous blood samples were taken for assessment of the peanut-specific IgE at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values. |
| Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age) | Baseline and Months 3, 6 and 12 | Venous blood samples were taken for assessment of the peanut-specific IgE at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values. |
| Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age) | Baseline and Months 3, 6 and 12 | Venous blood samples were taken for assessment of the peanut-specific IgE at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values. |
| Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age) | Baseline and Months 3, 6 and 12 | Venous blood samples were taken for assessment of the peanut-specific IgE at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values. |
| Change From Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 3, 6 and 12; Analyzed in Overall Population | Baseline and Months 3, 6 and 12 | Venous blood samples were taken for assessment of the peanut-specific IgG4 at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values. |
| Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age) | Baseline and Months 3, 6 and 12 | Venous blood samples were taken for assessment of the peanut-specific IgG4 at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values. |
| Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age) | Baseline and Months 3, 6 and 12 | Venous blood samples were taken for assessment of the peanut-specific IgG4 at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values. |
| Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age) | Baseline and Months 3, 6 and 12 | Venous blood samples were taken for assessment of the peanut-specific IgG4 at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values. |
| Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Baseline and Months 3, 6 and 12 | The mean wheal diameter of skin prick test (sum of the orthogonal diameters divided by 2) at each time point is calculated for the 5 skin prick tests at baseline and at each time point, i.e., Months 3, 6 and 12: undiluted, diluted 1:10 millimeter (mm), diluted 1:100 (mm), diluted 1:1,000 (mm), diluted 1:10,000 (mm). The ratio of the mean wheal diameter at each time point for a specific dilution versus the baseline value for that specific dilution was calculated and classified as \<=0.5 or \>0.5, allowing to assess the number of participants of those mean wheal diameters that have been at least halved from the baseline value. |
Countries
Canada, France, Netherlands, Poland, United States
Participant flow
Recruitment details
This Phase IIb, placebo-controlled study was conducted in participants aged 6 to 55 years old with peanut allergy at 22 study centers in 5 countries (Canada, France, Netherlands, Poland and USA) between 31 July 2012 and 31 July 2014. All participants who completed the VIPES study up to Visit 11 (inclusive) were eligible for participation in the follow-up study (OLFUS-VIPES).
Pre-assignment details
Study had a 4-week screening period, 52-week treatment period and 2-week follow-up period. A total of 221 participants were randomized in a 1:1:1:1 ratio into 4 treatment groups (50 micrograms \[μg\], 100 μg, 250 μg peanut proteins and placebo). Each participant underwent dose-escalating double-blind, placebo-controlled food challenge (DBPCFC) at screening and Month 12. At screening, a dose-escalating DBPCFC confirmed peanut allergy to an eliciting dose \<=300 milligrams (mg) peanut protein.
Participants by arm
| Arm | Count |
|---|---|
| Viaskin Peanut 50 μg Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period. | 53 |
| Viaskin Peanut 100 μg Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period. | 56 |
| Viaskin Peanut 250 μg Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period. | 56 |
| Placebo Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period. | 56 |
| Total | 221 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 |
| Overall Study | Non-compliance | 0 | 0 | 0 | 1 |
| Overall Study | Participant unwilling to continue | 2 | 4 | 2 | 1 |
Baseline characteristics
| Characteristic | Viaskin Peanut 50 μg | Viaskin Peanut 100 μg | Viaskin Peanut 250 μg | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 12.3 years STANDARD_DEVIATION 6.72 | 13.9 years STANDARD_DEVIATION 6.66 | 13.6 years STANDARD_DEVIATION 7.48 | 12.5 years STANDARD_DEVIATION 6.84 | 13.1 years STANDARD_DEVIATION 6.92 |
| Age, Customized Adolescents (12-17 years) | 18 Participants | 19 Participants | 18 Participants | 18 Participants | 73 Participants |
| Age, Customized Adults (18-55 years) | 7 Participants | 11 Participants | 10 Participants | 7 Participants | 35 Participants |
| Age, Customized Children (6-11 years) | 28 Participants | 26 Participants | 28 Participants | 31 Participants | 113 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 9 Participants | 10 Participants | 5 Participants | 27 Participants |
| Race/Ethnicity, Customized Black | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Caucasian | 39 Participants | 33 Participants | 32 Participants | 31 Participants | 135 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Not applicable | 7 Participants | 8 Participants | 10 Participants | 12 Participants | 37 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 4 Participants | 4 Participants | 4 Participants | 14 Participants |
| Region of Enrollment Canada | 16 Participants | 19 Participants | 19 Participants | 17 Participants | 71 Participants |
| Region of Enrollment France | 7 Participants | 8 Participants | 10 Participants | 12 Participants | 37 Participants |
| Region of Enrollment Netherlands | 2 Participants | 3 Participants | 2 Participants | 2 Participants | 9 Participants |
| Region of Enrollment Poland | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 28 Participants | 26 Participants | 24 Participants | 25 Participants | 103 Participants |
| Sex: Female, Male Female | 22 Participants | 23 Participants | 18 Participants | 20 Participants | 83 Participants |
| Sex: Female, Male Male | 31 Participants | 33 Participants | 38 Participants | 36 Participants | 138 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 56 | 0 / 56 | 0 / 56 |
| other Total, other adverse events | 53 / 53 | 55 / 56 | 56 / 56 | 51 / 56 |
| serious Total, serious adverse events | 2 / 53 | 1 / 56 | 2 / 56 | 0 / 56 |
Outcome results
Primary
Percentage of Treatment Responders at Month 12; Analyzed in Overall Population
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).
Time frame: At Month 12
Population: The full analysis set included all participants who were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Viaskin Peanut 50 μg | Percentage of Treatment Responders at Month 12; Analyzed in Overall Population | 45.3 percentage of participants |
| Viaskin Peanut 100 μg | Percentage of Treatment Responders at Month 12; Analyzed in Overall Population | 41.1 percentage of participants |
| Viaskin Peanut 250 μg | Percentage of Treatment Responders at Month 12; Analyzed in Overall Population | 50.0 percentage of participants |
| Placebo | Percentage of Treatment Responders at Month 12; Analyzed in Overall Population | 25.0 percentage of participants |
Comparison: The three pair-wise comparisons of viaskin peanut versus placebo were analyzed using the Bonferroni stepwise procedure, keeping the overall false-positive (alpha) risk below 5%. The comparison of viaskin peanut 250 µg versus placebo is statistically significant at p\<0.05. The subsequent comparison of viaskin peanut 100 µg versus placebo is not statistically significant at p\<0.05. Thus, no conclusion can be made on the comparison of viaskin peanut 50 µg vs placebo.p-value: 0.029295% CI: [1.05, 3.11]Fisher Exact
Comparison: The three pair-wise comparisons of viaskin peanut versus placebo were analyzed using the Bonferroni stepwise procedure, keeping the overall false-positive (alpha) risk below 5%. The comparison of viaskin peanut 250 µg versus placebo is statistically significant at p\<0.05. The subsequent comparison of viaskin peanut 100 µg versus placebo is not statistically significant at p\<0.05.p-value: 0.107495% CI: [0.95, 2.85]Fisher Exact
Comparison: The three pair-wise comparisons of viaskin peanut versus placebo were analyzed using the Bonferroni stepwise procedure, keeping the overall false-positive (alpha) risk below 5%. The comparison of viaskin peanut 250 µg versus placebo is statistically significant at p\<0.05.p-value: 0.010895% CI: [1.18, 3.38]Fisher Exact
Secondary
Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age)
Venous blood samples were taken for assessment of the peanut-specific IgE at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.
Time frame: Baseline and Months 3, 6 and 12
Population: The full analysis set included all participants who were randomized. Only participants in the range of 12-17 years of age are reported.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Viaskin Peanut 50 μg | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age) | Month 3 | 11.5 kU/L |
| Viaskin Peanut 50 μg | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age) | Month 6 | 6.0 kU/L |
| Viaskin Peanut 50 μg | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age) | Month 12 | 5.2 kU/L |
| Viaskin Peanut 100 μg | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age) | Month 6 | 24.2 kU/L |
| Viaskin Peanut 100 μg | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age) | Month 12 | 24.9 kU/L |
| Viaskin Peanut 100 μg | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age) | Month 3 | 62.0 kU/L |
| Viaskin Peanut 250 μg | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age) | Month 6 | 90.0 kU/L |
| Viaskin Peanut 250 μg | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age) | Month 3 | 135.5 kU/L |
| Viaskin Peanut 250 μg | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age) | Month 12 | 39.4 kU/L |
| Placebo | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age) | Month 3 | 4.8 kU/L |
| Placebo | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age) | Month 12 | 1.0 kU/L |
| Placebo | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age) | Month 6 | 0.0 kU/L |
Secondary
Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age)
Venous blood samples were taken for assessment of the peanut-specific IgE at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.
Time frame: Baseline and Months 3, 6 and 12
Population: The full analysis set included all participants who were randomized. Only participants in the range of 18-55 years of age are reported.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Viaskin Peanut 50 μg | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age) | Month 12 | 22.3 kU/L |
| Viaskin Peanut 50 μg | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age) | Month 6 | 34.4 kU/L |
| Viaskin Peanut 50 μg | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age) | Month 3 | 65.3 kU/L |
| Viaskin Peanut 100 μg | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age) | Month 12 | 0.3 kU/L |
| Viaskin Peanut 100 μg | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age) | Month 3 | 12.3 kU/L |
| Viaskin Peanut 100 μg | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age) | Month 6 | 3.6 kU/L |
| Viaskin Peanut 250 μg | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age) | Month 6 | 1.6 kU/L |
| Viaskin Peanut 250 μg | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age) | Month 12 | -2.0 kU/L |
| Viaskin Peanut 250 μg | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age) | Month 3 | 3.1 kU/L |
| Placebo | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age) | Month 6 | -0.2 kU/L |
| Placebo | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age) | Month 12 | 0.9 kU/L |
| Placebo | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age) | Month 3 | 0.1 kU/L |
Secondary
Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age)
Venous blood samples were taken for assessment of the peanut-specific IgE at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.
Time frame: Baseline and Months 3, 6 and 12
Population: The full analysis set included all participants who were randomized. Only participants in the range of 6-11 years of age are reported.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Viaskin Peanut 50 μg | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age) | Month 3 | 63.6 kU/L |
| Viaskin Peanut 50 μg | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age) | Month 6 | 10.6 kU/L |
| Viaskin Peanut 50 μg | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age) | Month 12 | -3.1 kU/L |
| Viaskin Peanut 100 μg | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age) | Month 12 | 3.5 kU/L |
| Viaskin Peanut 100 μg | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age) | Month 3 | 63.1 kU/L |
| Viaskin Peanut 100 μg | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age) | Month 6 | 48.7 kU/L |
| Viaskin Peanut 250 μg | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age) | Month 3 | 50.7 kU/L |
| Viaskin Peanut 250 μg | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age) | Month 12 | 1.0 kU/L |
| Viaskin Peanut 250 μg | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age) | Month 6 | 21.2 kU/L |
| Placebo | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age) | Month 3 | 4.1 kU/L |
| Placebo | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age) | Month 6 | -1.8 kU/L |
| Placebo | Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age) | Month 12 | -12.0 kU/L |
Secondary
Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age)
Venous blood samples were taken for assessment of the peanut-specific IgG4 at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.
Time frame: Baseline and Months 3, 6 and 12
Population: The full analysis set included all participants who were randomized. Only participants in the range of 12-17 years of age are reported.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Viaskin Peanut 50 μg | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age) | Month 3 | 0.1 mg/L |
| Viaskin Peanut 50 μg | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age) | Month 12 | 0.4 mg/L |
| Viaskin Peanut 50 μg | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age) | Month 6 | 0.3 mg/L |
| Viaskin Peanut 100 μg | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age) | Month 12 | 0.7 mg/L |
| Viaskin Peanut 100 μg | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age) | Month 3 | 0.6 mg/L |
| Viaskin Peanut 100 μg | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age) | Month 6 | 0.8 mg/L |
| Viaskin Peanut 250 μg | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age) | Month 12 | 0.9 mg/L |
| Viaskin Peanut 250 μg | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age) | Month 6 | 0.7 mg/L |
| Viaskin Peanut 250 μg | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age) | Month 3 | 0.7 mg/L |
| Placebo | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age) | Month 3 | 0.1 mg/L |
| Placebo | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age) | Month 12 | 0.1 mg/L |
| Placebo | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age) | Month 6 | 0.1 mg/L |
Secondary
Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age)
Venous blood samples were taken for assessment of the peanut-specific IgG4 at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.
Time frame: Baseline and Months 3, 6 and 12
Population: The full analysis set included all participants who were randomized. Only participants in the range of 18-55 years of age are reported.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Viaskin Peanut 50 μg | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age) | Month 6 | 0.5 mg/L |
| Viaskin Peanut 50 μg | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age) | Month 12 | 0.6 mg/L |
| Viaskin Peanut 50 μg | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age) | Month 3 | 0.2 mg/L |
| Viaskin Peanut 100 μg | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age) | Month 6 | 0.5 mg/L |
| Viaskin Peanut 100 μg | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age) | Month 12 | 0.3 mg/L |
| Viaskin Peanut 100 μg | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age) | Month 3 | 0.5 mg/L |
| Viaskin Peanut 250 μg | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age) | Month 12 | 0.9 mg/L |
| Viaskin Peanut 250 μg | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age) | Month 6 | 0.6 mg/L |
| Viaskin Peanut 250 μg | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age) | Month 3 | 0.4 mg/L |
| Placebo | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age) | Month 12 | 0.1 mg/L |
| Placebo | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age) | Month 3 | 0.1 mg/L |
| Placebo | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age) | Month 6 | 0.0 mg/L |
Secondary
Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age)
Venous blood samples were taken for assessment of the peanut-specific IgG4 at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.
Time frame: Baseline and Months 3, 6 and 12
Population: The full analysis set included all participants who were randomized. Only participants in the range of 6-11 years of age are reported.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Viaskin Peanut 50 μg | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age) | Month 12 | 2.0 mg/L |
| Viaskin Peanut 50 μg | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age) | Month 3 | 0.6 mg/L |
| Viaskin Peanut 50 μg | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age) | Month 6 | 1.1 mg/L |
| Viaskin Peanut 100 μg | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age) | Month 3 | 0.4 mg/L |
| Viaskin Peanut 100 μg | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age) | Month 6 | 1.1 mg/L |
| Viaskin Peanut 100 μg | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age) | Month 12 | 1.6 mg/L |
| Viaskin Peanut 250 μg | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age) | Month 6 | 4.4 mg/L |
| Viaskin Peanut 250 μg | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age) | Month 3 | 1.7 mg/L |
| Viaskin Peanut 250 μg | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age) | Month 12 | 6.3 mg/L |
| Placebo | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age) | Month 12 | -0.0 mg/L |
| Placebo | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age) | Month 6 | -0.1 mg/L |
| Placebo | Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age) | Month 3 | 0.0 mg/L |
Secondary
Change From Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 3, 6 and 12; Analyzed in Overall Population
Venous blood samples were taken for assessment of the peanut-specific IgE at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.
Time frame: Baseline and Months 3, 6 and 12
Population: The full analysis set included all participants who were randomized.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Viaskin Peanut 50 μg | Change From Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 3, 6 and 12; Analyzed in Overall Population | Month 6 | 8.8 kilo units per liter (kU/L) |
| Viaskin Peanut 50 μg | Change From Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 3, 6 and 12; Analyzed in Overall Population | Month 12 | -0.2 kilo units per liter (kU/L) |
| Viaskin Peanut 50 μg | Change From Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 3, 6 and 12; Analyzed in Overall Population | Month 3 | 32.3 kilo units per liter (kU/L) |
| Viaskin Peanut 100 μg | Change From Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 3, 6 and 12; Analyzed in Overall Population | Month 6 | 22.0 kilo units per liter (kU/L) |
| Viaskin Peanut 100 μg | Change From Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 3, 6 and 12; Analyzed in Overall Population | Month 12 | 4.9 kilo units per liter (kU/L) |
| Viaskin Peanut 100 μg | Change From Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 3, 6 and 12; Analyzed in Overall Population | Month 3 | 29.9 kilo units per liter (kU/L) |
| Viaskin Peanut 250 μg | Change From Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 3, 6 and 12; Analyzed in Overall Population | Month 6 | 29.5 kilo units per liter (kU/L) |
| Viaskin Peanut 250 μg | Change From Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 3, 6 and 12; Analyzed in Overall Population | Month 3 | 50.7 kilo units per liter (kU/L) |
| Viaskin Peanut 250 μg | Change From Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 3, 6 and 12; Analyzed in Overall Population | Month 12 | 5.2 kilo units per liter (kU/L) |
| Placebo | Change From Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 3, 6 and 12; Analyzed in Overall Population | Month 6 | -1.1 kilo units per liter (kU/L) |
| Placebo | Change From Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 3, 6 and 12; Analyzed in Overall Population | Month 12 | -1.4 kilo units per liter (kU/L) |
| Placebo | Change From Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 3, 6 and 12; Analyzed in Overall Population | Month 3 | 2.8 kilo units per liter (kU/L) |
Comparison: The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all Baseline covariates in the analysis set.p-value: 0.033795% CI: [1.17, 38.82]ANCOVA
Comparison: The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all Baseline covariates in the analysis set.p-value: 0.00295% CI: [8.38, 49.45]ANCOVA
Comparison: The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all Baseline covariates in the analysis set.p-value: 0.01295% CI: [3.85, 40.91]ANCOVA
Secondary
Change From Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 3, 6 and 12; Analyzed in Overall Population
Venous blood samples were taken for assessment of the peanut-specific IgG4 at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.
Time frame: Baseline and Months 3, 6 and 12
Population: The full analysis set included all participants who were randomized.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Viaskin Peanut 50 μg | Change From Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 3, 6 and 12; Analyzed in Overall Population | Month 3 | 0.4 mg per liter (mg/L) |
| Viaskin Peanut 50 μg | Change From Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 3, 6 and 12; Analyzed in Overall Population | Month 12 | 1.0 mg per liter (mg/L) |
| Viaskin Peanut 50 μg | Change From Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 3, 6 and 12; Analyzed in Overall Population | Month 6 | 0.8 mg per liter (mg/L) |
| Viaskin Peanut 100 μg | Change From Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 3, 6 and 12; Analyzed in Overall Population | Month 6 | 0.8 mg per liter (mg/L) |
| Viaskin Peanut 100 μg | Change From Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 3, 6 and 12; Analyzed in Overall Population | Month 12 | 0.9 mg per liter (mg/L) |
| Viaskin Peanut 100 μg | Change From Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 3, 6 and 12; Analyzed in Overall Population | Month 3 | 0.4 mg per liter (mg/L) |
| Viaskin Peanut 250 μg | Change From Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 3, 6 and 12; Analyzed in Overall Population | Month 3 | 0.8 mg per liter (mg/L) |
| Viaskin Peanut 250 μg | Change From Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 3, 6 and 12; Analyzed in Overall Population | Month 6 | 1.4 mg per liter (mg/L) |
| Viaskin Peanut 250 μg | Change From Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 3, 6 and 12; Analyzed in Overall Population | Month 12 | 1.6 mg per liter (mg/L) |
| Placebo | Change From Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 3, 6 and 12; Analyzed in Overall Population | Month 12 | 0.0 mg per liter (mg/L) |
| Placebo | Change From Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 3, 6 and 12; Analyzed in Overall Population | Month 6 | 0.0 mg per liter (mg/L) |
| Placebo | Change From Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 3, 6 and 12; Analyzed in Overall Population | Month 3 | 0.0 mg per liter (mg/L) |
Comparison: The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.p-value: <0.000195% CI: [0.72, 1.9]ANCOVA
Comparison: The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.p-value: <0.000195% CI: [0.79, 2.01]ANCOVA
Comparison: The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.p-value: <0.000195% CI: [1.39, 3.11]ANCOVA
Secondary
Change From Baseline in Severity of Symptoms Based on the Oral Food Challenge (OFC) Symptom Score Sheet at Month 12; Analyzed in Overall Population
The symptoms of erythematous rash, pruritus, urticaria/angioedema, rash, sneezing/itching, nasal congestion, rhinorrhea, laryngeal symptoms (example, throat clearing, occasional cough, hoarseness, frequent dry cough, inspiratory stridor), wheezing, subjective complaints, objective complaints and cardiovascular symptoms (example, color change, weakness, dizziness, mental status change, tachycardia, decreased blood pressure, etc) were observed. The OFC score ranges from 0 to 3 for each symptom (0=Absent, 1=mild, 2=moderate or 3=severe). The total symptom score for each participant was calculated. Higher scores indicate worst outcome. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).
Time frame: Baseline and Month 12
Population: The full analysis set included all participants who were randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Viaskin Peanut 50 μg | Change From Baseline in Severity of Symptoms Based on the Oral Food Challenge (OFC) Symptom Score Sheet at Month 12; Analyzed in Overall Population | -1.9 units on a scale | Standard Deviation 4.79 |
| Viaskin Peanut 100 μg | Change From Baseline in Severity of Symptoms Based on the Oral Food Challenge (OFC) Symptom Score Sheet at Month 12; Analyzed in Overall Population | -0.9 units on a scale | Standard Deviation 4.21 |
| Viaskin Peanut 250 μg | Change From Baseline in Severity of Symptoms Based on the Oral Food Challenge (OFC) Symptom Score Sheet at Month 12; Analyzed in Overall Population | 0.2 units on a scale | Standard Deviation 4.65 |
| Placebo | Change From Baseline in Severity of Symptoms Based on the Oral Food Challenge (OFC) Symptom Score Sheet at Month 12; Analyzed in Overall Population | -1.4 units on a scale | Standard Deviation 4.35 |
Comparison: The LS mean for any given treatment group is the estimated mean OFC score for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.p-value: 0.25195% CI: [-1.55, 0.52]ANCOVA
Comparison: The LS mean for any given treatment group is the estimated mean OFC score for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.p-value: 0.68295% CI: [-1.24, 1.05]ANCOVA
Comparison: The LS mean for any given treatment group is the estimated mean OFC score for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.p-value: 0.211795% CI: [-0.42, 2.47]ANCOVA
Secondary
Mean Cumulative Reactive Dose of Peanut Proteins at Month 12; Analyzed in Overall Population
The peanut protein cumulative reactive dose was defined as the sum of all peanut protein doses up to and including the eliciting dose ingested during the peanut challenge. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).
Time frame: At Month 12
Population: The full analysis set included all participants who were randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Viaskin Peanut 50 μg | Mean Cumulative Reactive Dose of Peanut Proteins at Month 12; Analyzed in Overall Population | 730.8 mg | Standard Deviation 1020.53 |
| Viaskin Peanut 100 μg | Mean Cumulative Reactive Dose of Peanut Proteins at Month 12; Analyzed in Overall Population | 863.5 mg | Standard Deviation 1120.43 |
| Viaskin Peanut 250 μg | Mean Cumulative Reactive Dose of Peanut Proteins at Month 12; Analyzed in Overall Population | 1010.6 mg | Standard Deviation 1223.85 |
| Placebo | Mean Cumulative Reactive Dose of Peanut Proteins at Month 12; Analyzed in Overall Population | 451.4 mg | Standard Deviation 807.13 |
Comparison: The LS mean for any given treatment group was the estimated mean peanut protein cumulative reactive dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.p-value: 0.044495% CI: [2.3, 321.8]ANCOVA
Comparison: The LS mean for any given treatment group was the estimated mean peanut protein cumulative reactive dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.p-value: 0.017595% CI: [19.67, 365.51]ANCOVA
Comparison: The LS mean for any given treatment group was the estimated mean peanut protein cumulative reactive dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.p-value: <0.000195% CI: [159.67, 771.16]ANCOVA
Secondary
Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Adolescents (12-17 Years of Age)
The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).
Time frame: At Month 12
Population: The full analysis set included all participants who were randomized. Only participants in the range of 12-17 years of age are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Viaskin Peanut 50 μg | Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Adolescents (12-17 Years of Age) | 501.7 mg | Standard Deviation 726.14 |
| Viaskin Peanut 100 μg | Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Adolescents (12-17 Years of Age) | 281.6 mg | Standard Deviation 472.47 |
| Viaskin Peanut 250 μg | Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Adolescents (12-17 Years of Age) | 573.9 mg | Standard Deviation 716.01 |
| Placebo | Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Adolescents (12-17 Years of Age) | 331.8 mg | Standard Deviation 511.62 |
Comparison: The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.p-value: 0.659695% CI: [-59.58, 236]ANCOVA
Comparison: The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.p-value: 0.870295% CI: [-65.9, 189.96]ANCOVA
Comparison: The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.p-value: 0.06395% CI: [-5.5, 562.31]ANCOVA
Secondary
Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Adults (18-55 Years of Age)
The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).
Time frame: At Month 12
Population: The full analysis set included all participants who were randomized. Only participants in the range of 18-55 years of age are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Viaskin Peanut 50 μg | Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Adults (18-55 Years of Age) | 557.1 mg | Standard Deviation 711.47 |
| Viaskin Peanut 100 μg | Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Adults (18-55 Years of Age) | 1218.5 mg | Standard Deviation 822.74 |
| Viaskin Peanut 250 μg | Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Adults (18-55 Years of Age) | 620.0 mg | Standard Deviation 619.68 |
| Placebo | Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Adults (18-55 Years of Age) | 705.7 mg | Standard Deviation 893.01 |
Comparison: The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.p-value: 0.677695% CI: [-237.22, 782.24]ANCOVA
Comparison: The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.p-value: 0.506895% CI: [-166.1, 1478.83]ANCOVA
Comparison: The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.p-value: 0.797295% CI: [-193.9, 1085.38]ANCOVA
Secondary
Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Children (6-11 Years of Age)
The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).
Time frame: At Month 12
Population: The full analysis set included all participants who were randomized. Only participants in the range of 6-11 years of age are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Viaskin Peanut 50 μg | Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Children (6-11 Years of Age) | 397.1 mg | Standard Deviation 510.13 |
| Viaskin Peanut 100 μg | Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Children (6-11 Years of Age) | 441.2 mg | Standard Deviation 511.26 |
| Viaskin Peanut 250 μg | Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Children (6-11 Years of Age) | 652.5 mg | Standard Deviation 766.93 |
| Placebo | Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Children (6-11 Years of Age) | 160.5 mg | Standard Deviation 244 |
Comparison: The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.p-value: 0.037295% CI: [2.96, 225.85]ANCOVA
Comparison: The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.p-value: 0.014395% CI: [12.92, 278.11]ANCOVA
Comparison: The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.p-value: <0.000195% CI: [89.83, 625.95]ANCOVA
Secondary
Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Overall Population
The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at the screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).
Time frame: At Month 12
Population: The full analysis set included all participants who were randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Viaskin Peanut 50 μg | Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Overall Population | 453.8 mg | Standard Deviation 608.16 |
| Viaskin Peanut 100 μg | Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Overall Population | 539.7 mg | Standard Deviation 659.31 |
| Viaskin Peanut 250 μg | Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Overall Population | 621.4 mg | Standard Deviation 715.03 |
| Placebo | Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Overall Population | 283.7 mg | Standard Deviation 482.04 |
Comparison: The least squares (LS) mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.p-value: 0.060795% CI: [-2.41, 193.69]ANCOVA
Comparison: The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.p-value: 0.01595% CI: [14.45, 237.82]ANCOVA
Comparison: The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.p-value: <0.000195% CI: [100.03, 482.65]ANCOVA
Secondary
Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population
The mean wheal diameter of skin prick test (sum of the orthogonal diameters divided by 2) at each time point is calculated for the 5 skin prick tests at baseline and at each time point, i.e., Months 3, 6 and 12: undiluted, diluted 1:10 millimeter (mm), diluted 1:100 (mm), diluted 1:1,000 (mm), diluted 1:10,000 (mm). The ratio of the mean wheal diameter at each time point for a specific dilution versus the baseline value for that specific dilution was calculated and classified as \<=0.5 or \>0.5, allowing to assess the number of participants of those mean wheal diameters that have been at least halved from the baseline value.
Time frame: Baseline and Months 3, 6 and 12
Population: The full analysis set included all participants who were randomized.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Viaskin Peanut 50 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: diluted (1:100); > 0.5 | 39 Participants |
| Viaskin Peanut 50 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: diluted (1:100); > 0.5 | 37 Participants |
| Viaskin Peanut 50 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: diluted (1:10); > 0.5 | 43 Participants |
| Viaskin Peanut 50 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: diluted (1:1000); <= 0.5 | 13 Participants |
| Viaskin Peanut 50 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: diluted (1:100); <= 0.5 | 13 Participants |
| Viaskin Peanut 50 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: undiluted; > 0.5 | 46 Participants |
| Viaskin Peanut 50 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: diluted (1:10000); > 0.5 | 20 Participants |
| Viaskin Peanut 50 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: diluted (1:1000); > 0.5 | 33 Participants |
| Viaskin Peanut 50 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: diluted (1:1000); > 0.5 | 34 Participants |
| Viaskin Peanut 50 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: diluted (1:10); > 0.5 | 43 Participants |
| Viaskin Peanut 50 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: diluted (1:100); > 0.5 | 41 Participants |
| Viaskin Peanut 50 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: diluted (1:10); <= 0.5 | 10 Participants |
| Viaskin Peanut 50 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: diluted (1:10000); > 0.5 | 21 Participants |
| Viaskin Peanut 50 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: undiluted; > 0.5 | 45 Participants |
| Viaskin Peanut 50 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: undiluted; <= 0.5 | 8 Participants |
| Viaskin Peanut 50 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: diluted (1:10); <= 0.5 | 10 Participants |
| Viaskin Peanut 50 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: diluted (1:10000); <= 0.5 | 21 Participants |
| Viaskin Peanut 50 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: diluted (1:1000); <= 0.5 | 15 Participants |
| Viaskin Peanut 50 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: diluted (1:10); > 0.5 | 44 Participants |
| Viaskin Peanut 50 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: diluted (1:10000); <= 0.5 | 22 Participants |
| Viaskin Peanut 50 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: undiluted; <= 0.5 | 7 Participants |
| Viaskin Peanut 50 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: diluted (1:10); <= 0.5 | 9 Participants |
| Viaskin Peanut 50 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: undiluted; > 0.5 | 39 Participants |
| Viaskin Peanut 50 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: diluted (1:1000); <= 0.5 | 14 Participants |
| Viaskin Peanut 50 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: undiluted; <= 0.5 | 14 Participants |
| Viaskin Peanut 50 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: diluted (1:100); <= 0.5 | 11 Participants |
| Viaskin Peanut 50 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: diluted (1:10000); > 0.5 | 21 Participants |
| Viaskin Peanut 50 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: diluted (1:10000); <= 0.5 | 21 Participants |
| Viaskin Peanut 50 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: diluted (1:1000); > 0.5 | 35 Participants |
| Viaskin Peanut 50 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: diluted (1:100); <= 0.5 | 15 Participants |
| Viaskin Peanut 100 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: diluted (1:10000); > 0.5 | 21 Participants |
| Viaskin Peanut 100 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: undiluted; > 0.5 | 47 Participants |
| Viaskin Peanut 100 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: diluted (1:10); <= 0.5 | 5 Participants |
| Viaskin Peanut 100 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: diluted (1:10); > 0.5 | 51 Participants |
| Viaskin Peanut 100 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: diluted (1:100); <= 0.5 | 12 Participants |
| Viaskin Peanut 100 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: diluted (1:100); > 0.5 | 43 Participants |
| Viaskin Peanut 100 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: diluted (1:1000); <= 0.5 | 15 Participants |
| Viaskin Peanut 100 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: diluted (1:10000); > 0.5 | 18 Participants |
| Viaskin Peanut 100 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: undiluted; <= 0.5 | 7 Participants |
| Viaskin Peanut 100 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: undiluted; > 0.5 | 49 Participants |
| Viaskin Peanut 100 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: diluted (1:10); <= 0.5 | 10 Participants |
| Viaskin Peanut 100 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: diluted (1:100); <= 0.5 | 16 Participants |
| Viaskin Peanut 100 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: diluted (1:100); > 0.5 | 39 Participants |
| Viaskin Peanut 100 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: diluted (1:10000); <= 0.5 | 15 Participants |
| Viaskin Peanut 100 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: diluted (1:10000); > 0.5 | 20 Participants |
| Viaskin Peanut 100 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: undiluted; <= 0.5 | 4 Participants |
| Viaskin Peanut 100 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: undiluted; > 0.5 | 52 Participants |
| Viaskin Peanut 100 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: diluted (1:100); <= 0.5 | 14 Participants |
| Viaskin Peanut 100 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: diluted (1:100); > 0.5 | 41 Participants |
| Viaskin Peanut 100 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: diluted (1:1000); <= 0.5 | 9 Participants |
| Viaskin Peanut 100 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: diluted (1:1000); > 0.5 | 41 Participants |
| Viaskin Peanut 100 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: undiluted; <= 0.5 | 9 Participants |
| Viaskin Peanut 100 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: diluted (1:1000); > 0.5 | 35 Participants |
| Viaskin Peanut 100 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: diluted (1:10000); <= 0.5 | 17 Participants |
| Viaskin Peanut 100 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: diluted (1:10); > 0.5 | 46 Participants |
| Viaskin Peanut 100 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: diluted (1:1000); <= 0.5 | 11 Participants |
| Viaskin Peanut 100 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: diluted (1:1000); > 0.5 | 39 Participants |
| Viaskin Peanut 100 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: diluted (1:10); <= 0.5 | 6 Participants |
| Viaskin Peanut 100 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: diluted (1:10); > 0.5 | 50 Participants |
| Viaskin Peanut 100 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: diluted (1:10000); <= 0.5 | 14 Participants |
| Viaskin Peanut 250 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: diluted (1:10000); > 0.5 | 20 Participants |
| Viaskin Peanut 250 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: undiluted; > 0.5 | 51 Participants |
| Viaskin Peanut 250 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: undiluted; > 0.5 | 49 Participants |
| Viaskin Peanut 250 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: diluted (1:100); > 0.5 | 41 Participants |
| Viaskin Peanut 250 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: diluted (1:10); <= 0.5 | 8 Participants |
| Viaskin Peanut 250 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: undiluted; <= 0.5 | 7 Participants |
| Viaskin Peanut 250 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: diluted (1:1000); <= 0.5 | 18 Participants |
| Viaskin Peanut 250 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: diluted (1:10000); > 0.5 | 18 Participants |
| Viaskin Peanut 250 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: diluted (1:1000); > 0.5 | 34 Participants |
| Viaskin Peanut 250 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: diluted (1:100); <= 0.5 | 14 Participants |
| Viaskin Peanut 250 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: diluted (1:100); > 0.5 | 43 Participants |
| Viaskin Peanut 250 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: diluted (1:100); > 0.5 | 42 Participants |
| Viaskin Peanut 250 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: diluted (1:1000); > 0.5 | 29 Participants |
| Viaskin Peanut 250 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: diluted (1:10); > 0.5 | 48 Participants |
| Viaskin Peanut 250 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: diluted (1:10000); <= 0.5 | 24 Participants |
| Viaskin Peanut 250 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: diluted (1:1000); > 0.5 | 28 Participants |
| Viaskin Peanut 250 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: diluted (1:1000); <= 0.5 | 24 Participants |
| Viaskin Peanut 250 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: undiluted; <= 0.5 | 7 Participants |
| Viaskin Peanut 250 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: diluted (1:10); > 0.5 | 47 Participants |
| Viaskin Peanut 250 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: diluted (1:10000); > 0.5 | 20 Participants |
| Viaskin Peanut 250 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: diluted (1:100); <= 0.5 | 15 Participants |
| Viaskin Peanut 250 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: undiluted; > 0.5 | 49 Participants |
| Viaskin Peanut 250 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: diluted (1:10); <= 0.5 | 15 Participants |
| Viaskin Peanut 250 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: diluted (1:10000); <= 0.5 | 22 Participants |
| Viaskin Peanut 250 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: diluted (1:1000); <= 0.5 | 23 Participants |
| Viaskin Peanut 250 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: diluted (1:10); > 0.5 | 41 Participants |
| Viaskin Peanut 250 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: diluted (1:10); <= 0.5 | 9 Participants |
| Viaskin Peanut 250 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: undiluted; <= 0.5 | 5 Participants |
| Viaskin Peanut 250 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: diluted (1:100); <= 0.5 | 13 Participants |
| Viaskin Peanut 250 μg | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: diluted (1:10000); <= 0.5 | 22 Participants |
| Placebo | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: undiluted; > 0.5 | 54 Participants |
| Placebo | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: diluted (1:100); > 0.5 | 49 Participants |
| Placebo | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: diluted (1:1000); <= 0.5 | 8 Participants |
| Placebo | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: diluted (1:10000); <= 0.5 | 13 Participants |
| Placebo | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: diluted (1:1000); <= 0.5 | 11 Participants |
| Placebo | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: diluted (1:10000); > 0.5 | 26 Participants |
| Placebo | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: diluted (1:100); <= 0.5 | 6 Participants |
| Placebo | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: undiluted; <= 0.5 | 4 Participants |
| Placebo | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: undiluted; > 0.5 | 52 Participants |
| Placebo | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: diluted (1:10); <= 0.5 | 4 Participants |
| Placebo | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: diluted (1:10); > 0.5 | 52 Participants |
| Placebo | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: diluted (1:100); > 0.5 | 52 Participants |
| Placebo | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: diluted (1:10); > 0.5 | 51 Participants |
| Placebo | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: diluted (1:100); <= 0.5 | 7 Participants |
| Placebo | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: diluted (1:10000); <= 0.5 | 15 Participants |
| Placebo | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: diluted (1:10000); > 0.5 | 24 Participants |
| Placebo | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: undiluted; <= 0.5 | 2 Participants |
| Placebo | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: undiluted; > 0.5 | 54 Participants |
| Placebo | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: diluted (1:10); <= 0.5 | 5 Participants |
| Placebo | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: diluted (1:1000); > 0.5 | 40 Participants |
| Placebo | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: diluted (1:100); <= 0.5 | 4 Participants |
| Placebo | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: diluted (1:1000); <= 0.5 | 12 Participants |
| Placebo | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: diluted (1:1000); > 0.5 | 44 Participants |
| Placebo | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: diluted (1:1000); > 0.5 | 41 Participants |
| Placebo | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: diluted (1:10000); > 0.5 | 25 Participants |
| Placebo | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: undiluted; <= 0.5 | 2 Participants |
| Placebo | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 3: diluted (1:100); > 0.5 | 50 Participants |
| Placebo | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 6: diluted (1:10000); <= 0.5 | 14 Participants |
| Placebo | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: diluted (1:10); <= 0.5 | 3 Participants |
| Placebo | Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population | Month 12: diluted (1:10); > 0.5 | 53 Participants |
Secondary
Percentage of Treatment Responders at Month 12; Analyzed in Adolescents (12-17 Years of Age)
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, LOCF imputation was used (i.e., participants were considered as non-responders).
Time frame: At Month 12
Population: The full analysis set included all participants who were randomized. Only participants in the range of 12-17 years of age are reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Viaskin Peanut 50 μg | Percentage of Treatment Responders at Month 12; Analyzed in Adolescents (12-17 Years of Age) | 33.3 percentage of participants |
| Viaskin Peanut 100 μg | Percentage of Treatment Responders at Month 12; Analyzed in Adolescents (12-17 Years of Age) | 10.5 percentage of participants |
| Viaskin Peanut 250 μg | Percentage of Treatment Responders at Month 12; Analyzed in Adolescents (12-17 Years of Age) | 38.9 percentage of participants |
| Placebo | Percentage of Treatment Responders at Month 12; Analyzed in Adolescents (12-17 Years of Age) | 22.2 percentage of participants |
p-value: 0.711295% CI: [0.51, 4.43]Fisher Exact
p-value: 0.404895% CI: [0.1, 2.28]Fisher Exact
p-value: 0.470595% CI: [0.62, 4.95]Fisher Exact
Secondary
Percentage of Treatment Responders at Month 12; Analyzed in Adults (18-55 Years of Age)
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, LOCF imputation was used (i.e., participants were considered as non-responders).
Time frame: At Month 12
Population: The full analysis set included all participants who were randomized. Only participants in the range of 18-55 years of age are reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Viaskin Peanut 50 μg | Percentage of Treatment Responders at Month 12; Analyzed in Adults (18-55 Years of Age) | 28.6 percentage of participants |
| Viaskin Peanut 100 μg | Percentage of Treatment Responders at Month 12; Analyzed in Adults (18-55 Years of Age) | 81.8 percentage of participants |
| Viaskin Peanut 250 μg | Percentage of Treatment Responders at Month 12; Analyzed in Adults (18-55 Years of Age) | 60.0 percentage of participants |
| Placebo | Percentage of Treatment Responders at Month 12; Analyzed in Adults (18-55 Years of Age) | 57.1 percentage of participants |
p-value: 0.592195% CI: [0.13, 1.9]Fisher Exact
p-value: 0.32695% CI: [0.71, 2.88]Fisher Exact
p-value: 195% CI: [0.46, 2.38]Fisher Exact
Secondary
Percentage of Treatment Responders at Month 12; Analyzed in Children (6-11 Years of Age)
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, LOCF imputation was used (i.e., participants were considered as non-responders).
Time frame: At Month 12
Population: The full analysis set included all participants who were randomized. Only participants in the range of 6-11 years of age are reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Viaskin Peanut 50 μg | Percentage of Treatment Responders at Month 12; Analyzed in Children (6-11 Years of Age) | 57.1 percentage of participants |
| Viaskin Peanut 100 μg | Percentage of Treatment Responders at Month 12; Analyzed in Children (6-11 Years of Age) | 46.2 percentage of participants |
| Viaskin Peanut 250 μg | Percentage of Treatment Responders at Month 12; Analyzed in Children (6-11 Years of Age) | 53.6 percentage of participants |
| Placebo | Percentage of Treatment Responders at Month 12; Analyzed in Children (6-11 Years of Age) | 19.4 percentage of participants |
p-value: 0.003595% CI: [1.34, 6.49]Fisher Exact
p-value: 0.045395% CI: [1.04, 5.47]Fisher Exact
p-value: 0.007695% CI: [1.25, 6.14]Fisher Exact