Efficacy and Safety of Several Doses of Viaskin Peanut in... | NCT01675882

NCT01675882

ID	Type	Description	Link
2011-002550-32	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Viaskin Peanut 50 mcg	Experimental	Biological: Viaskin Peanut 50 mcg
Viaskin Peanut 100 mcg	Experimental	Biological: Viaskin Peanut 100 mcg
Viaskin Peanut 250 mcg	Experimental	Biological: Viaskin Peanut 250 mcg
Viaskin Placebo	Placebo Comparator	Biological: Viaskin Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Viaskin Peanut 50 mcg	Biological	Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 50 mcg peanut proteins as whole peanut extract	Viaskin Peanut 50 mcg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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).	At Month 12

Secondary Outcomes

Measure	Description	Time Frame
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).

Eligibility Module

Eligibility Criteria

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/exclusion criteria may apply.

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
University of California, Rady Childrens Hospital		San Diego	California	92123	United States
Stanford University School of Medicine

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30978404	Derived	Lewis MO, Brown-Whitehorn TF, Cianferoni A, Rooney C, Spergel JM. Peanut-allergic patient experiences after epicutaneous immunotherapy: peanut consumption and impact on QoL. Ann Allergy Asthma Immunol. 2019 Jul;123(1):101-103. doi: 10.1016/j.anai.2019.04.006. Epub 2019 Apr 10. No abstract available.
29136445	Derived

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Viaskin Peanut 50 μg	Participants applied 1 new Viaskin® Peanut (DBV712) 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.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	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.
BG003	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.
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00012.3± 6.72 BG00113.9± 6.66 BG00213.6± 7.48 BG003

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Children (6-11 years)	BG00028 BG00126 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00022 BG00123 BG002

Race/Ethnicity, Customized

The ethnicity of the participants at French local sites was not collected as it was not applicable as per local law. As such, these participants are included in the category of 'Not applicable'.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Caucasian	BG00039 BG001

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

Canada

Title	Measurements
	BG00016 BG00119 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of 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).

The full analysis set included all participants who were randomized.

Posted

Number

95% Confidence Interval

percentage of participants

At Month 12

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.
OG003	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.

Units	Counts
Participants	OG00053 OG00156 OG00256 OG003

Title

Denominators

Categories

Title	Measurements
	OG00045.3(31.56 to 59.55) OG00141.1(28.10 to 55.02) OG00250.0(36.34 to 63.66) OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG003	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.	Fisher Exact		0.0292		Relative risk	1.81			2-Sided	95	1.05	3.11					Superiority

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).

The full analysis set included all participants who were randomized. Only participants in the range of 6-11 years of age are reported.

Posted

Number

95% Confidence Interval

percentage of participants

At Month 12

ID	Title	Description
OG000	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.
OG001	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.

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).

The full analysis set included all participants who were randomized. Only participants in the range of 12-17 years of age are reported.

Posted

Number

95% Confidence Interval

percentage of participants

At Month 12

ID	Title	Description
OG000	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.
OG001	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.

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).

The full analysis set included all participants who were randomized. Only participants in the range of 18-55 years of age are reported.

Posted

Number

95% Confidence Interval

percentage of participants

At Month 12

ID	Title	Description
OG000	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.
OG001	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.

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).

The full analysis set included all participants who were randomized.

Posted

Mean

Standard Deviation

At Month 12

ID	Title	Description
OG000	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.
OG001	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.
OG002

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).

The full analysis set included all participants who were randomized. Only participants in the range of 6-11 years of age are reported.

Posted

Mean

Standard Deviation

At Month 12

ID	Title	Description
OG000	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.
OG001	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.

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).

The full analysis set included all participants who were randomized. Only participants in the range of 12-17 years of age are reported.

Posted

Mean

Standard Deviation

At Month 12

ID	Title	Description
OG000	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.
OG001	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.

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).

The full analysis set included all participants who were randomized. Only participants in the range of 18-55 years of age are reported.

Posted

Mean

Standard Deviation

At Month 12

ID	Title	Description
OG000	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.
OG001	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.

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).

The full analysis set included all participants who were randomized.

Posted

Mean

Standard Deviation

At Month 12

ID	Title	Description
OG000	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.
OG001	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.
OG002	Viaskin Peanut 250 μg

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).

The full analysis set included all participants who were randomized.

Posted

Mean

Standard Deviation

units on a scale

Baseline and Month 12

ID	Title	Description
OG000	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.
OG001	Viaskin Peanut 100 μg

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.

The full analysis set included all participants who were randomized.

Posted

Count of Participants

Participants

Baseline and Months 3, 6 and 12

ID	Title	Description
OG000	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.
OG001	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.

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.

The full analysis set included all participants who were randomized.

Posted

Median

Full Range

kilo units per liter (kU/L)

Baseline and Months 3, 6 and 12

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

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.

The full analysis set included all participants who were randomized. Only participants in the range of 6-11 years of age are reported.

Posted

Median

Full Range

kU/L

Baseline and Months 3, 6 and 12

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

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.

The full analysis set included all participants who were randomized. Only participants in the range of 12-17 years of age are reported.

Posted

Median

Full Range

kU/L

Baseline and Months 3, 6 and 12

ID	Title	Description
OG000	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.
OG001	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.
OG002	Viaskin Peanut 250 μg

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.

The full analysis set included all participants who were randomized. Only participants in the range of 18-55 years of age are reported.

Posted

Median

Full Range

kU/L

Baseline and Months 3, 6 and 12

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

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.

The full analysis set included all participants who were randomized.

Posted

Median

Full Range

mg per liter (mg/L)

Baseline and Months 3, 6 and 12

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

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.

The full analysis set included all participants who were randomized. Only participants in the range of 6-11 years of age are reported.

Posted

Median

Full Range

mg/L

Baseline and Months 3, 6 and 12

ID	Title	Description
OG000	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.
OG001	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.
OG002	Viaskin Peanut 250 μg

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.

The full analysis set included all participants who were randomized. Only participants in the range of 12-17 years of age are reported.

Posted

Median

Full Range

mg/L

Baseline and Months 3, 6 and 12

ID	Title	Description
OG000	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.
OG001	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.
OG002	Viaskin Peanut 250 μg

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.

The full analysis set included all participants who were randomized. Only participants in the range of 18-55 years of age are reported.

Posted

Median

Full Range

mg/L

Baseline and Months 3, 6 and 12

ID	Title	Description
OG000	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.
OG001	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.
OG002	Viaskin Peanut 250 μg

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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	2	53	53	53
EG001	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	1	56	55	56
EG002	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	2	56	56	56
EG003	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	0	56	51	56

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaphylactic reaction	Immune system disorders	MedDRA 15.0	Systematic Assessment	EG0003 events2 affected53 at risk EG0010 events0 affected56 at risk EG0021 events1 affected56 at risk EG0030 events0 affected56 at risk
Anaphylactic shock	Immune system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected56 at risk EG0021 events1 affected56 at risk EG003
Food allergy	Immune system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected56 at risk EG0020 events0 affected56 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Eye swelling	Eye disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0013 events2 affected56 at risk EG0023 events3 affected56 at risk EG0030 events0 affected56 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0009 events5 affected53 at risk EG0016 events3 affected56 at risk EG0022 events2 affected56 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0002 events2 affected53 at risk EG0014 events4 affected56 at risk EG0023 events3 affected56 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0008 events5 affected53 at risk EG0013 events3 affected56 at risk EG0022 events2 affected56 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0006 events2 affected53 at risk EG0011 events1 affected56 at risk EG0023 events3 affected56 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0005 events5 affected53 at risk EG0012 events2 affected56 at risk EG0021 events1 affected56 at risk EG003
Oral pruritus	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected56 at risk EG0023 events3 affected56 at risk EG003
Application site erythema	General disorders	MedDRA 15.0	Systematic Assessment	EG00053 events39 affected53 at risk EG00168 events33 affected56 at risk EG00261 events32 affected56 at risk EG003
Application site pruritus	General disorders	MedDRA 15.0	Systematic Assessment	EG00023 events18 affected53 at risk EG00152 events23 affected56 at risk EG00238 events23 affected56 at risk EG003
Pyrexia	General disorders	MedDRA 15.0	Systematic Assessment	EG00015 events9 affected53 at risk EG0018 events7 affected56 at risk EG0027 events6 affected56 at risk EG003
Application site eczema	General disorders	MedDRA 15.0	Systematic Assessment	EG0009 events7 affected53 at risk EG00112 events8 affected56 at risk EG00217 events10 affected56 at risk EG003
Application site swelling	General disorders	MedDRA 15.0	Systematic Assessment	EG0006 events5 affected53 at risk EG0018 events8 affected56 at risk EG00215 events12 affected56 at risk EG003
Application site papules	General disorders	MedDRA 15.0	Systematic Assessment	EG0006 events6 affected53 at risk EG0018 events8 affected56 at risk EG00212 events9 affected56 at risk EG003
Application site dermatitis	General disorders	MedDRA 15.0	Systematic Assessment	EG0005 events5 affected53 at risk EG0016 events6 affected56 at risk EG0029 events8 affected56 at risk EG003
Application site rash	General disorders	MedDRA 15.0	Systematic Assessment	EG00011 events7 affected53 at risk EG0011 events1 affected56 at risk EG0022 events1 affected56 at risk EG003
Application site reaction	General disorders	MedDRA 15.0	Systematic Assessment	EG0002 events2 affected53 at risk EG0014 events2 affected56 at risk EG0026 events4 affected56 at risk EG003
Application site urticaria	General disorders	MedDRA 15.0	Systematic Assessment	EG0003 events2 affected53 at risk EG0016 events5 affected56 at risk EG0027 events5 affected56 at risk EG003
Application site discolouration	General disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0012 events2 affected56 at risk EG0024 events4 affected56 at risk EG003
Application site irritation	General disorders	MedDRA 15.0	Systematic Assessment	EG0002 events2 affected53 at risk EG0011 events1 affected56 at risk EG0023 events3 affected56 at risk EG003
Application site oedema	General disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0012 events2 affected56 at risk EG0023 events3 affected56 at risk EG003
Application site pain	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0015 events3 affected56 at risk EG0020 events0 affected56 at risk EG003
Application site dryness	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected56 at risk EG0023 events3 affected56 at risk EG003
Food allergy	Immune system disorders	MedDRA 15.0	Systematic Assessment	EG00011 events8 affected53 at risk EG00122 events11 affected56 at risk EG00211 events7 affected56 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 15.0	Systematic Assessment	EG0009 events5 affected53 at risk EG0016 events3 affected56 at risk EG0027 events6 affected56 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 15.0	Systematic Assessment	EG0005 events4 affected53 at risk EG0013 events3 affected56 at risk EG0021 events1 affected56 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG00023 events14 affected53 at risk EG00118 events11 affected56 at risk EG00217 events12 affected56 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG00013 events12 affected53 at risk EG00117 events9 affected56 at risk EG00215 events10 affected56 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0003 events2 affected53 at risk EG0014 events3 affected56 at risk EG0026 events6 affected56 at risk EG003
Ear infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0005 events3 affected53 at risk EG0017 events5 affected56 at risk EG0021 events1 affected56 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0008 events6 affected53 at risk EG0014 events4 affected56 at risk EG0024 events4 affected56 at risk EG003
Pharyngitis streptococcal	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0004 events3 affected53 at risk EG0015 events4 affected56 at risk EG0022 events2 affected56 at risk EG003
Viral infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0016 events5 affected56 at risk EG0021 events1 affected56 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0005 events2 affected53 at risk EG0013 events2 affected56 at risk EG0022 events1 affected56 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0008 events5 affected53 at risk EG0011 events1 affected56 at risk EG0023 events3 affected56 at risk EG003
Influenza	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0004 events4 affected53 at risk EG0013 events3 affected56 at risk EG0022 events2 affected56 at risk EG003
Sinusitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0003 events3 affected53 at risk EG0011 events1 affected56 at risk EG0023 events3 affected56 at risk EG003
Rhinitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0015 events3 affected56 at risk EG0021 events1 affected56 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected56 at risk EG0021 events1 affected56 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0010 events0 affected56 at risk EG0024 events3 affected56 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected53 at risk EG0011 events1 affected56 at risk EG0020 events0 affected56 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected53 at risk EG0012 events2 affected56 at risk EG0023 events3 affected56 at risk EG003
Headache	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG00017 events11 affected53 at risk EG00116 events8 affected56 at risk EG00214 events8 affected56 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0009 events6 affected53 at risk EG0017 events7 affected56 at risk EG0025 events5 affected56 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0006 events6 affected53 at risk EG00114 events9 affected56 at risk EG0021 events1 affected56 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG00011 events6 affected53 at risk EG0017 events5 affected56 at risk EG0027 events7 affected56 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0006 events4 affected53 at risk EG0019 events8 affected56 at risk EG0024 events4 affected56 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0007 events5 affected53 at risk EG0014 events4 affected56 at risk EG0027 events7 affected56 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0004 events4 affected53 at risk EG0010 events0 affected56 at risk EG0027 events3 affected56 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0004 events1 affected53 at risk EG0012 events2 affected56 at risk EG0020 events0 affected56 at risk EG003
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0003 events3 affected53 at risk EG0011 events1 affected56 at risk EG0020 events0 affected56 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG00016 events8 affected53 at risk EG0015 events3 affected56 at risk EG0029 events8 affected56 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0006 events6 affected53 at risk EG0013 events3 affected56 at risk EG0027 events5 affected56 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0005 events4 affected53 at risk EG0011 events1 affected56 at risk EG0025 events5 affected56 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0003 events3 affected53 at risk EG0011 events1 affected56 at risk EG0022 events2 affected56 at risk EG003

ID	Term
D021183	Peanut Hypersensitivity
D005512	Food Hypersensitivity
D006969	Hypersensitivity, Immediate

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.

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.

ID	Term
D000074924	Nut and Peanut Hypersensitivity
D006967	Hypersensitivity
D007154	Immune System Diseases