Efficacy and Safety of Viaskin Milk in Children With IgE-... | NCT02223182 | Trialant
NCT02223182
Sponsor
DBV Technologies
Status
Completed
Last Update Posted
Nov 20, 2024Actual
Enrollment
198Actual
Phase
Phase 1Phase 2
Conditions
Food Allergy
Interventions
Viaskin Milk 150 mcg
Viaskin Milk 300 mcg
Viaskin Milk 500 mcg
Viaskin Placebo
Countries
United States
Canada
Protocol Section
Identification Module
NCT ID
NCT02223182
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
MILES
Secondary IDs
Not provided
Brief Title
Efficacy and Safety of Viaskin Milk in Children With IgE-Mediated Cow's Milk Allergy
Official Title
A Double-Blind, Placebo-Controlled Randomized Trial to Study the Viaskin Milk Efficacy and Safety for Treating IgE-Mediated Cow's Milk Allergy in Children
Acronym
MILES
Organization
DBV TechnologiesINDUSTRY
Status Module
Record Verification Date
Oct 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 2014Actual
Primary Completion Date
Dec 14, 2017Actual
Completion Date
Dec 22, 2020Actual
First Submitted Date
Aug 20, 2014
First Submission Date that Met QC Criteria
Aug 21, 2014
First Posted Date
Aug 22, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 13, 2024
Results First Submitted that Met QC Criteria
Oct 30, 2024
Results First Posted Date
Nov 20, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jul 31, 2019
Certification/Extension First Submitted that Passed QC Review
Jul 31, 2019
Certification/Extension First Posted Date
Aug 8, 2019Actual
Last Update Submitted Date
Oct 30, 2024
Last Update Posted Date
Nov 20, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
DBV TechnologiesINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The objectives of this study are to evaluate the safety and efficacy of Viaskin Milk after 12 months of epicutaneous immunotherapy (EPIT) treatment, for desensitizing IgE-mediated cow's milk allergic children and to assess the long-term safety and therapeutic benefit with Viaskin Milk.
Detailed Description
This is a multi-center, double-blind, placebo-controlled, randomized trial to study the safety and efficacy of Viaskin Milk applied epicutaneously every day to subjects from 2 to 17 years of age with IgE-mediated cow's milk allergy (CMA). Subjects will receive blinded treatment for 1 year at one of the 3 doses of Viaskin Milk: 150µg, 300µg, 500µg or placebo. After the first year, all subjects were to switch to the highest dose of Viaskin Milk, 500µg, and continue treatment in an open-label manner for up to a maximum of 3 additional years. Following results of the 12-month blinded period, all eligible subjects who wish to continue participation in the study will switch from Viaskin Milk 500µg to Viaskin Milk 300µg for 24 months of treatment.
Eligible subjects with confirmed IgE-mediated CMA will perform a first Double-Blind Placebo-Controlled Food Challenge (DBPCFC) at screening with escalating doses of cow's milk proteins. Subjects showing a positive DBPCFC at screening, defined as the appearance of objective signs or symptoms to an eliciting dose of cow's milk proteins ≤300 mg (approximately ≤9.4mL of cow's milk) will be randomized in the study to receive a 12 month treatment (blinded treatment period), at which time a second DBPCFC will be performed to evaluate the primary efficacy endpoint of the study.
Approximately 194 subjects will be randomized in this study. The total duration of participation in the study will differ for each individual subject and could be up to approximately 6 years.
Conditions Module
Conditions
Food Allergy
Keywords
Milk Allergy,
Viaskin Milk,
Specific Immunotherapy,
Epicutaneous ImmunoTherapy (EPIT)
IgE-Mediated Cow's Milk Allergy
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
198Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Viaskin Milk 150 mcg
Experimental
One Viaskin epicutaneous delivery system (patch) containing 150µg of cow's milk proteins applied each day for 12 months.
Biological: Viaskin Milk 150 mcg
Viaskin Milk 300 mcg
Experimental
One Viaskin epicutaneous delivery system (patch) containing 300µg of cow's milk proteins applied each day for 12 months.
Biological: Viaskin Milk 300 mcg
Viaskin Milk 500 mcg
Experimental
One Viaskin epicutaneous delivery system (patch) containing 500µg of cow's milk proteins applied each day for 12 months.
Biological: Viaskin Milk 500 mcg
Viaskin Placebo
Placebo Comparator
One Viaskin epicutaneous delivery system (patch) containing placebo applied each day for 12 months.
Biological: Viaskin Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Viaskin Milk 150 mcg
Biological
Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 150 mcg cow's milk proteins.
Viaskin Milk 150 mcg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage (%) of Subjects Who Are Treatment Responders After 12 Months of EPIT Treatment.
A treatment responder is defined as a subject who meets at least one of the following criteria:
A ≥10-fold increase in the Cumulative Reactive Dose (CRD) of cow's milk proteins at the Month 12 double-blind placebo-controlled food challenge (DBPCFC) as compared to baseline value and reaching at least 144 mg of cow's milk proteins;
A CRD of cow's milk proteins ≥1444 mg at the Month 12 DBPCFC.
From baseline to Month 12 (double-blind period)
Secondary Outcomes
Measure
Description
Time Frame
Mean Cumulative Reactive Dose (CRD) of Cow's Milk Proteins.
Change in CRD from Month 0 (baseline) to Month 12 Double-Blind Placebo-Controlled Food Challenge expressed in mg of cow's milk proteins.
From baseline to Month 12 (double-blind period)
Median Cumulative Reactive Dose (CRD) of Cow's Milk Proteins.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Eligibility criteria for study enrollment:
Inclusion Criteria:
Signed Informed Consent Form (ICF) by parent(s)/guardian(s) of subjects and informed assent form (IAF) for subjects ≥7 years, or as per local or country specific guidelines or regulations.
Male or female subjects 2 to 17 years old at Visit 1.
Documented medical history or physician-confirmed diagnosis of IgE-mediated CMA with systemic symptoms related to ingestion of milk or dairy products.
Subjects currently following a strict cow's milk-free diet, with no consumption of dairy or baked milk products.
Cow's milk-specific IgE level at screening ≥10 kU/L
Positive Skin Prick Test (SPT) to cow's milk with a largest wheal diameter ≥6 mm.
Positive DBPCFC at screening with an eliciting dose ≤300 mg cow's milk proteins (approximately ≤9.4 mL of cow's milk).
Negative urine pregnancy test for female subjects of childbearing potential. Female subjects of childbearing potential must agree and commit to use effective medical methods of contraception for the entire duration of their 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 procedures in accordance with the American Thoracic Society guidelines (2005) for subjects ≥6 years old. Ability to perform peak expiratory flow (PEF) measurements for subjects ≥5 years old. Subjects <8 years of age who have documented inability to adequately perform spirometry can perform only the PEF evaluation. Subjects <5 years of age may be enrolled if they had no clinical features of moderate or severe persistent asthma severity (as defined by the 2007 National Heart, Lung, and Blood Institute [NHLBI] Guidelines) within 1 year before Visit 1.
Subjects and/or parents/guardians willing to comply with all study requirements during participation in the study.
Exclusion Criteria:
History of severe anaphylaxis to cow's milk resulting in hypotension, hypoxia or neurological compromise (collapse, loss of consciousness or incontinence) or requiring mechanical ventilation.
Pregnancy or lactation.
Spirometry forced expiratory volume in 1 second (FEV1) <80% of the predicted value at Visit 1 for subjects ≥6 years and able to perform the spirometry, or PEF <80% of predicted value at Visit 1 for subjects performing only the PEF measurements.
Any clinical features of moderate or severe persistent asthma severity (as defined by the 2007 NHLBI guidelines) and high daily doses of inhaled corticosteroids.
Known allergy to the Viaskin patch materials or excipients, or to any of the components of the food challenge formulas other than the cow's milk proteins.
Allergy or known history of reaction to Tegaderm® medical dressing with no possibility to use an alternative adhesive dressing authorized by the sponsor in replacement.
Subjects having objective symptoms to the placebo formula leading to stopping the challenge during the screening DBPCFC.
Severe reaction during the screening DBPCFC defined as need for intubation, and/or hypotension persisting after epinephrine administration, and/or the need for >2 doses of epinephrine.
Symptomatic allergy to pollens with symptoms during the pollen season that might interfere with the symptoms observed during the DBPCFC, if the DBPCFC is performed during the pollen season. Screening of such subjects should be made out of the pollen season.
Inability to discontinue short-acting antihistamines for 3 days or long-acting antihistamines for 5 to 7 days (depending on the half-life) before the DBPCFC.
Use of systemic long-acting corticosteroids within 12 weeks before Visit 1 and/or use of systemic short-acting corticosteroids within 4 weeks before Visit 1 or use of systemic long-acting or short-acting corticosteroids during screening (unless used to treat symptoms triggered by the DBPCFC or triggered by accidental allergen consumption; in the latter case DBPCFC must then be scheduled after a minimum of 7 wash-out days).
Subjects with asthma conditions meeting 1 or several criteria below:
Uncontrolled persistent asthma (as defined by the 2007 NHLBI guidelines) or subject being treated with a combination therapy of medium or high daily dose of inhaled corticosteroid with a long acting inhaled β2-agonist. Intermittent asthmatic subjects who require intermittent use of inhaled corticosteroids for rescue are permitted.
At least 2 systemic corticosteroid courses for asthma within 1 year before Visit 1 or 1 oral corticosteroid course for asthma within 3 months before Visit 1, or during screening (unless used to treat symptoms triggered by the DBPCFC).
Prior intubation/mechanical ventilation due to asthma within 2 years before Visit 1, or during screening.
Upper respiratory infection or gastroenteritis within 7 days of DBPCFC (DBPCFC must then be rescheduled at least 7 days after resolution of these conditions).
Any history of milk immunotherapy (eg, oral immunotherapy, sublingual immunotherapy or specific oral tolerance induction).
Prior history of any other food allergen immunotherapy (eg, oral immunotherapy, sublingual immunotherapy or specific oral tolerance induction) within 5 years before Visit 1.
Subjects currently under aeroallergen immunotherapy and unwilling or unable to discontinue at the time of Visit 1. Aeroallergen Immunotherapy must be discontinued at the time of Visit 1.
Use of any anti-IgE drug (eg, omalizumab), any immunomodulatory therapy, or any biological agent therapy (eg, anti-tumor necrosis factor drugs) within 1 year before Visit 1, or during screening.
Generalized dermatologic diseases (eg, severe atopic dermatitis, uncontrolled generalized eczema, icthyosis vulgaris) with no intact zones to apply the Viaskin patch, or urticarial and mast cells disorders such as chronic idiopathic urticaria.
Subject and/or subject's parents/guardians with obvious excessive anxiety and unlikely to cope with the conditions of a food challenge.
Past or current disease, including but not limited to active eosinophilic gastrointestinal disorders, autoimmune disorders, immunodeficiency, malignancy, uncontrolled disease (hypertension, diabetes, psychiatric disorder, cardiac disease), or other disorders (eg, liver, gastrointestinal, kidney, cardiovascular, pulmonary disease or blood disorder) which in the opinion of the Investigator or the sponsor may affect the subject's participation in the study or place the subject at increased risk.
Subjects and/or parents/guardians unable to use the epinephrine auto-injector properly in spite of being adequately trained.
Contraindicated condition for the use of epinephrine.
Use of any investigational drug or device, or participation in another interventional clinical study within 3 months before Visit 1.
Subjects receiving beta-blockers or Angiotensin converting-enzyme (ACE) inhibitors.
Subjects unable to follow the protocol requirements.
Petroni D, Begin P, Bird JA, Brown-Whitehorn T, Chong HJ, Fleischer DM, Gagnon R, Jones SM, Leonard S, Makhija MM, Oriel RC, Shreffler WG, Sindher SB, Sussman GL, Yang WH, Bee KJ, Bois T, Campbell DE, Green TD, Rutault K, Sampson HA, Wood RA. Varying Doses of Epicutaneous Immunotherapy With Viaskin Milk vs Placebo in Children With Cow's Milk Allergy: A Randomized Clinical Trial. JAMA Pediatr. 2024 Apr 1;178(4):345-353. doi: 10.1001/jamapediatrics.2023.6630.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Viaskin Milk 150 mcg
One Viaskin epicutaneous delivery system (patch) containing 150µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 150 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 150 mcg cow's milk proteins.
Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 300 mcg cow's milk proteins.
Viaskin Milk 300 mcg
Viaskin Milk 500 mcg
Biological
Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins.
Viaskin Milk 500 mcg
Viaskin Placebo
Biological
Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation.
Viaskin Placebo
Change in Median CRD from Month 0 (baseline) to Month 12 Double-Blind Placebo-Controlled Food Challenge expressed in mg of cow's milk proteins.
From baseline to Month 12 (double-blind period)
Change in Levels of sIgE to Cow's Milk.
Median change from baseline value in levels of IgE specific to cow's milk proteins
From baseline to Week 3, Month 3, Month 6, Month 12 (double-blind period)
Change in Levels of sIgG4 to Cow's Milk.
Median change from baseline value in levels of IgG4 specific to cow's milk proteins
From baseline to Week 3, Month 3, Month 6, Month 12 (double-blind period)
Change in Levels of sIgE to Caseins, α-lactalbumin and β-lactoglobulin
Median change from baseline in levels of IgE specific to caseins, α-lactalbumin and β-lactoglobulin proteins
From baseline to Week 3, Month 3, Month 6, Month 12 (double-blind period)
Change in Levels of sIgG4 to Caseins, α-lactalbumin and β-lactoglobulin
Median change from baseline in levels of IgG4 specific to caseins, α-lactalbumin and β-lactoglobulin proteins
From baseline to Week 3, Month 3, Month 6, Month 12 (double-blind period)
Change in Skin Prick Test (SPT) Wheal.
Median change from baseline in SPT Wheal diameter
From baseline to Month 3, Month 6, Month 12 (double-blind period)
Change in the Severity of Symptoms Elicited During the Milk Double-Blind Placebo-Controlled Food Challenge (DBPCFC).
Summary of total objective severity score for DBPCFC. The total objective severity score is calculated as the sum of the severity grades (0-Absent, 1-Mild, 2-Moderate or 3-Severe) of the following objective symptoms: pruritus, urticaria/angioedema, rash, sneezing/itching, nasal congestion, rhinorrhea, laryngeal, wheezing, diarrhea, vomiting, cardiovascular and conjunctivitis for DBPCFC with cow's milk formula.
The total objective score ranges from a minimum of 0 to a maximum of 36 (if the maximum grade 3 was reported for each of the 12 symptoms), with a higher score meaning a worse outcome. A negative score in the changes to Month 0 means improvement.
From baseline to Month 12 (double-blind period)
Change in Quality of Life (QoL) Assessments.
Summary of Global Score for Food Allergy Quality of Life Questionnaire Parent Child Form (FAQLQ-PF). The scores range from 1 (no problem/impairment) to 7 (maximal problem/impairment). A negative score in the changes to Month 0 means improvement.
From baseline to Month 12 (double-blind period)
Percentage (%) of Subjects Who Are Treatment Responders Over the Course of the Viaskin Milk 300µg Open-label Treatment Period Using Observed Data
A treatment responder is defined as a subject who meets at least one of the following criteria:
A ≥10-fold increase in the Cumulative Reactive Dose (CRD) of cow's milk proteins at the Month 12 double-blind placebo-controlled food challenge (DBPCFC) as compared to baseline value and reaching at least 144 mg of cow's milk proteins; A CRD of cow's milk proteins ≥1444 mg at the Month 12 DBPCFC.
DBPCFC at Month 12 and Month 24 after switch to Viaskin Milk 300µg was optional and therefore outcome measure was assessed on observed data only.
From baseline to Month 12 and Month 24 after switch to Viaskin Milk 300µg (Open-Label 300µg period)
Cumulative Reactive Dose (CRD) of Cow's Milk Protein Over the Course of the Open-label Treatment Period
Median CRD during Double-Blind Placebo-Controlled Food Challenge expressed in mg of cow's milk proteins.
Baseline, Month 12 and Month 24 after switch to Viaskin Milk 300µg (Open-Label 300µg period)
Treatment-Emergent Adverse Events
Overview of Treatment Emergent Adverse Events (TEAEs) and serious Treatment-Emergent Adverse Events
Whole study including double-blind and open-label periods (up to 6 years).
San Diego
California
92123
United States
Stanford University School of Medicine
Stanford
California
94305
United States
Children's Hospital Colorado
Aurora
Colorado
80045
United States
Ann & Robert H. Lurie Children's Hospital of Chicago
One Viaskin epicutaneous delivery system (patch) containing 300µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 300 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 300 mcg cow's milk proteins.
FG002
Viaskin Milk 500 mcg
One Viaskin epicutaneous delivery system (patch) containing 500µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 500 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins.
FG003
Viaskin Placebo
One Viaskin epicutaneous delivery system (patch) containing placebo applied each day for 12 months.
Viaskin Placebo: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation.
FG00049 subjects
FG00149 subjects
FG00247 subjects
FG00353 subjects
COMPLETED
FG00047 subjects
FG00145 subjects
FG00245 subjects
FG00352 subjects
NOT COMPLETED
FG0002 subjects
FG0014 subjects
FG0022 subjects
FG0031 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Non Compliance
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Sponsor or Regulatory Authorities Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Open-Label 500 Period
Type
Comment
Milestone Data
STARTED
FG00046 subjects
FG00145 subjects
FG00244 subjects
FG00352 subjects
COMPLETED
FG00040 subjects
FG00143 subjects
FG00232 subjects
FG00342 subjects
NOT COMPLETED
FG0006 subjects
FG0012 subjects
FG00212 subjects
FG00310 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG003
Open-Label 300 Period
Type
Comment
Milestone Data
STARTED
FG00034 subjects
FG00138 subjects
FG00229 subjects
FG00339 subjects
COMPLETED
FG00023 subjects
FG00123 subjects
FG00214 subjects
FG00324 subjects
NOT COMPLETED
FG00011 subjects
FG00115 subjects
FG00215 subjects
FG00315 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG00010 subjects
FG00113 subjects
FG00213 subjects
FG003
Overall Intent-to-Treat population
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Viaskin Milk 150 mcg
One Viaskin epicutaneous delivery system (patch) containing 150µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 150 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 150 mcg cow's milk proteins.
BG001
Viaskin Milk 300 mcg
One Viaskin epicutaneous delivery system (patch) containing 300µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 300 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 300 mcg cow's milk proteins.
BG002
Viaskin Milk 500 mcg
One Viaskin epicutaneous delivery system (patch) containing 500µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 500 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins.
BG003
Viaskin Placebo
One Viaskin epicutaneous delivery system (patch) containing placebo applied each day for 12 months.
Viaskin Placebo: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00049
BG00149
BG00247
BG00353
BG004198
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
BG0007.6± 4.56
BG0017.7± 4.34
BG0028.7± 3.37
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00024
BG00112
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Caucasian
Title
Measurements
BG00033
BG00128
BG002
Skin Prick Test Mean wheal diameter
Skin Prick Test Mean wheal diameter to Cow's milk
Median
Inter-Quartile Range
millimeters
Title
Denominators
Categories
Title
Measurements
BG00010.5(9.0 to 12.0)
BG00111.0(9.0 to 13.5)
Cumulative Reactive Dose (CRD) of Cow's milk
Cumulative Reactive Dose of Cow's Milk proteins during the screening Double-Blind Placebo-Controlled Food Challenge
Median
Inter-Quartile Range
mg of cow's milk proteins
Title
Denominators
Categories
Title
Measurements
BG000144(44 to 444)
BG001
Cow's milk sIgE
Median
Inter-Quartile Range
kU/L
Title
Denominators
Categories
Title
Measurements
BG00058.2(31.5 to 115)
BG00167.6(31.0 to 187.0)
BG002
Cow's milk sIgG4
Median
Inter-Quartile Range
mgA/L
Title
Denominators
Categories
Title
Measurements
BG00014.0(11.5 to 17.1)
BG00114.5(12.3 to 16.4)
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 Subjects Who Are Treatment Responders After 12 Months of EPIT Treatment.
A treatment responder is defined as a subject who meets at least one of the following criteria:
A ≥10-fold increase in the Cumulative Reactive Dose (CRD) of cow's milk proteins at the Month 12 double-blind placebo-controlled food challenge (DBPCFC) as compared to baseline value and reaching at least 144 mg of cow's milk proteins;
A CRD of cow's milk proteins ≥1444 mg at the Month 12 DBPCFC.
Overall Intent-to-Treat Population
Posted
Number
percent of participants
From baseline to Month 12 (double-blind period)
ID
Title
Description
OG000
Viaskin Milk 150 mcg
One Viaskin epicutaneous delivery system (patch) containing 150µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 150 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 150 mcg cow's milk proteins.
OG001
Viaskin Milk 300 mcg
One Viaskin epicutaneous delivery system (patch) containing 300µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 300 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 300 mcg cow's milk proteins.
OG002
Viaskin Milk 500 mcg
One Viaskin epicutaneous delivery system (patch) containing 500µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 500 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins.
OG003
Viaskin Placebo
One Viaskin epicutaneous delivery system (patch) containing placebo applied each day for 12 months.
Viaskin Placebo: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation.
Units
Counts
Participants
OG00049
OG00149
OG00247
OG003
Title
Denominators
Categories
Title
Measurements
OG00036.7
OG00149.0
OG00236.2
OG003
Secondary
Mean Cumulative Reactive Dose (CRD) of Cow's Milk Proteins.
Change in CRD from Month 0 (baseline) to Month 12 Double-Blind Placebo-Controlled Food Challenge expressed in mg of cow's milk proteins.
All subjects from the Intent-to-Treat population for whom this outcome measure was collected and analyzed
Posted
Mean
Standard Deviation
milligrams (mg) of cow's milk proteins
From baseline to Month 12 (double-blind period)
ID
Title
Description
OG000
Viaskin Milk 150 mcg
One Viaskin epicutaneous delivery system (patch) containing 150µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 150 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 150 mcg cow's milk proteins.
OG001
Viaskin Milk 300 mcg
One Viaskin epicutaneous delivery system (patch) containing 300µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 300 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 300 mcg cow's milk proteins.
OG002
Viaskin Milk 500 mcg
One Viaskin epicutaneous delivery system (patch) containing 500µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 500 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins.
Secondary
Median Cumulative Reactive Dose (CRD) of Cow's Milk Proteins.
Change in Median CRD from Month 0 (baseline) to Month 12 Double-Blind Placebo-Controlled Food Challenge expressed in mg of cow's milk proteins.
All subjects from the Intent-to-Treat population for whom this outcome measure was collected and analyzed
Posted
Median
Inter-Quartile Range
milligrams (mg) of cow's milk proteins
From baseline to Month 12 (double-blind period)
ID
Title
Description
OG000
Viaskin Milk 150 mcg
One Viaskin epicutaneous delivery system (patch) containing 150µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 150 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 150 mcg cow's milk proteins.
OG001
Viaskin Milk 300 mcg
One Viaskin epicutaneous delivery system (patch) containing 300µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 300 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 300 mcg cow's milk proteins.
OG002
Viaskin Milk 500 mcg
One Viaskin epicutaneous delivery system (patch) containing 500µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 500 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins.
Secondary
Change in Levels of sIgE to Cow's Milk.
Median change from baseline value in levels of IgE specific to cow's milk proteins
All subjects from the Intent-to-Treat population for whom this outcome measure was collected and analyzed
Posted
Median
Inter-Quartile Range
kU/L
From baseline to Week 3, Month 3, Month 6, Month 12 (double-blind period)
ID
Title
Description
OG000
Viaskin Milk 150 mcg
One Viaskin epicutaneous delivery system (patch) containing 150µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 150 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 150 mcg cow's milk proteins.
OG001
Viaskin Milk 300 mcg
One Viaskin epicutaneous delivery system (patch) containing 300µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 300 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 300 mcg cow's milk proteins.
OG002
Viaskin Milk 500 mcg
One Viaskin epicutaneous delivery system (patch) containing 500µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 500 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins.
Secondary
Change in Levels of sIgG4 to Cow's Milk.
Median change from baseline value in levels of IgG4 specific to cow's milk proteins
All subjects from the Intent-to-Treat population for whom this outcome measure was collected and analyzed
Posted
Median
Inter-Quartile Range
mgA/L
From baseline to Week 3, Month 3, Month 6, Month 12 (double-blind period)
ID
Title
Description
OG000
Viaskin Milk 150 mcg
One Viaskin epicutaneous delivery system (patch) containing 150µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 150 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 150 mcg cow's milk proteins.
OG001
Viaskin Milk 300 mcg
One Viaskin epicutaneous delivery system (patch) containing 300µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 300 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 300 mcg cow's milk proteins.
OG002
Viaskin Milk 500 mcg
One Viaskin epicutaneous delivery system (patch) containing 500µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 500 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins.
Secondary
Change in Levels of sIgE to Caseins, α-lactalbumin and β-lactoglobulin
Median change from baseline in levels of IgE specific to caseins, α-lactalbumin and β-lactoglobulin proteins
All subjects from the Intent-to-Treat population for whom this outcome measure was collected and analyzed
Posted
Median
Inter-Quartile Range
kU/L
From baseline to Week 3, Month 3, Month 6, Month 12 (double-blind period)
ID
Title
Description
OG000
Viaskin Milk 150 mcg
One Viaskin epicutaneous delivery system (patch) containing 150µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 150 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 150 mcg cow's milk proteins.
OG001
Viaskin Milk 300 mcg
One Viaskin epicutaneous delivery system (patch) containing 300µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 300 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 300 mcg cow's milk proteins.
OG002
Viaskin Milk 500 mcg
One Viaskin epicutaneous delivery system (patch) containing 500µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 500 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins.
Secondary
Change in Levels of sIgG4 to Caseins, α-lactalbumin and β-lactoglobulin
Median change from baseline in levels of IgG4 specific to caseins, α-lactalbumin and β-lactoglobulin proteins
All subjects from the Intent-to-Treat population for whom this outcome measure was collected and analyzed
Posted
Median
Inter-Quartile Range
mgA/L
From baseline to Week 3, Month 3, Month 6, Month 12 (double-blind period)
ID
Title
Description
OG000
Viaskin Milk 150 mcg
One Viaskin epicutaneous delivery system (patch) containing 150µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 150 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 150 mcg cow's milk proteins.
OG001
Viaskin Milk 300 mcg
One Viaskin epicutaneous delivery system (patch) containing 300µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 300 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 300 mcg cow's milk proteins.
OG002
Viaskin Milk 500 mcg
One Viaskin epicutaneous delivery system (patch) containing 500µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 500 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins.
Secondary
Change in Skin Prick Test (SPT) Wheal.
Median change from baseline in SPT Wheal diameter
All subjects from the Intent-to-Treat population for whom this outcome measure was collected and analyzed
Posted
Median
Inter-Quartile Range
millimeters (mm)
From baseline to Month 3, Month 6, Month 12 (double-blind period)
ID
Title
Description
OG000
Viaskin Milk 150 mcg
One Viaskin epicutaneous delivery system (patch) containing 150µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 150 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 150 mcg cow's milk proteins.
OG001
Viaskin Milk 300 mcg
One Viaskin epicutaneous delivery system (patch) containing 300µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 300 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 300 mcg cow's milk proteins.
OG002
Viaskin Milk 500 mcg
One Viaskin epicutaneous delivery system (patch) containing 500µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 500 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins.
Secondary
Change in the Severity of Symptoms Elicited During the Milk Double-Blind Placebo-Controlled Food Challenge (DBPCFC).
Summary of total objective severity score for DBPCFC. The total objective severity score is calculated as the sum of the severity grades (0-Absent, 1-Mild, 2-Moderate or 3-Severe) of the following objective symptoms: pruritus, urticaria/angioedema, rash, sneezing/itching, nasal congestion, rhinorrhea, laryngeal, wheezing, diarrhea, vomiting, cardiovascular and conjunctivitis for DBPCFC with cow's milk formula.
The total objective score ranges from a minimum of 0 to a maximum of 36 (if the maximum grade 3 was reported for each of the 12 symptoms), with a higher score meaning a worse outcome. A negative score in the changes to Month 0 means improvement.
All subjects from the Intent-to-Treat population for whom this outcome measure was collected and analyzed
Posted
Median
Inter-Quartile Range
score on a scale
From baseline to Month 12 (double-blind period)
ID
Title
Description
OG000
Viaskin Milk 150 mcg
One Viaskin epicutaneous delivery system (patch) containing 150µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 150 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 150 mcg cow's milk proteins.
OG001
Viaskin Milk 300 mcg
One Viaskin epicutaneous delivery system (patch) containing 300µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 300 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 300 mcg cow's milk proteins.
Secondary
Change in Quality of Life (QoL) Assessments.
Summary of Global Score for Food Allergy Quality of Life Questionnaire Parent Child Form (FAQLQ-PF). The scores range from 1 (no problem/impairment) to 7 (maximal problem/impairment). A negative score in the changes to Month 0 means improvement.
All subjects from the Intent-to-Treat population for whom this outcome measure was collected and analyzed
Posted
Median
Inter-Quartile Range
score on a scale
From baseline to Month 12 (double-blind period)
ID
Title
Description
OG000
Viaskin Milk 150 mcg
One Viaskin epicutaneous delivery system (patch) containing 150µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 150 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 150 mcg cow's milk proteins.
OG001
Viaskin Milk 300 mcg
One Viaskin epicutaneous delivery system (patch) containing 300µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 300 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 300 mcg cow's milk proteins.
OG002
Viaskin Milk 500 mcg
One Viaskin epicutaneous delivery system (patch) containing 500µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 500 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins.
Secondary
Percentage (%) of Subjects Who Are Treatment Responders Over the Course of the Viaskin Milk 300µg Open-label Treatment Period Using Observed Data
A treatment responder is defined as a subject who meets at least one of the following criteria:
A ≥10-fold increase in the Cumulative Reactive Dose (CRD) of cow's milk proteins at the Month 12 double-blind placebo-controlled food challenge (DBPCFC) as compared to baseline value and reaching at least 144 mg of cow's milk proteins; A CRD of cow's milk proteins ≥1444 mg at the Month 12 DBPCFC.
DBPCFC at Month 12 and Month 24 after switch to Viaskin Milk 300µg was optional and therefore outcome measure was assessed on observed data only.
All subjects from the Open-Label Set 300 (OLS-300) for whom this outcome measure was collected and analyzed. OLS-300 includes all subjects who entered the open-label treatment period after switch to Viaskin Milk 300µg and applied at least one Viaskin Milk 300µg patch during this open-label period.
Posted
Number
Percentage of participants
From baseline to Month 12 and Month 24 after switch to Viaskin Milk 300µg (Open-Label 300µg period)
ID
Title
Description
OG000
Viaskin Milk 150 mcg
One Viaskin epicutaneous delivery system (patch) containing 150µg of cow's milk proteins applied each day for 12 months (double-blind period), followed by a patch containing 500µg of cow's milk proteins (Open-label 500µg period), followed by a patch containing 300µg for up to 24 months (Open-label 300µg period).
One patch applied each day (up to 24 hours) during the double-blind and open-label periods.
OG001
Secondary
Cumulative Reactive Dose (CRD) of Cow's Milk Protein Over the Course of the Open-label Treatment Period
Median CRD during Double-Blind Placebo-Controlled Food Challenge expressed in mg of cow's milk proteins.
All subjects from the Open-Label Set 300 (OLS-300) for whom this outcome measure was collected and analyzed. OLS-300 includes all subjects who entered the open-label treatment period after switch to Viaskin Milk 300µg and applied at least one Viaskin Milk 300µg patch during this open-label period.
Posted
Median
Inter-Quartile Range
milligrams (mg) of cow's milk proteins
Baseline, Month 12 and Month 24 after switch to Viaskin Milk 300µg (Open-Label 300µg period)
ID
Title
Description
OG000
Viaskin Milk 150 mcg
One Viaskin epicutaneous delivery system (patch) containing 150µg of cow's milk proteins applied each day for 12 months (double-blind period), followed by a patch containing 500µg of cow's milk proteins (Open-label 500µg period), followed by a patch containing 300µg for up to 24 months (Open-label 300µg period).
One patch applied each day (up to 24 hours) during the double-blind and open-label periods.
OG001
Viaskin Milk 300 mcg
One Viaskin epicutaneous delivery system (patch) containing 300µg of cow's milk proteins applied each day for 12 months (double-blind period), followed by a patch containing 500µg of cow's milk proteins (Open-label 500µg period), followed by a patch containing 300µg for up to 24 months (Open-label 300µg period).
One patch applied each day (up to 24 hours) during the double-blind and open-label periods.
Secondary
Treatment-Emergent Adverse Events
Overview of Treatment Emergent Adverse Events (TEAEs) and serious Treatment-Emergent Adverse Events
Safety set. It includes all subjects who applied at least one Viaskin patch.
Posted
Number
participants
Whole study including double-blind and open-label periods (up to 6 years).
ID
Title
Description
OG000
Viaskin Milk 150 mcg
One Viaskin epicutaneous delivery system (patch) containing 150µg of cow's milk proteins applied each day for 12 months (double-blind period), followed by a patch containing 500µg of cow's milk proteins (Open-label 500µg period), followed by a patch containing 300µg for up to 24 months (Open-label 300µg period).
One patch applied each day (up to 24 hours) during the double-blind and open-label periods.
OG001
Viaskin Milk 300 mcg
One Viaskin epicutaneous delivery system (patch) containing 300µg of cow's milk proteins applied each day for 12 months (double-blind period), followed by a patch containing 500µg of cow's milk proteins (Open-label 500µg period), followed by a patch containing 300µg for up to 24 months (Open-label 300µg period).
One patch applied each day (up to 24 hours) during the double-blind and open-label periods.
OG002
Viaskin Milk 500 mcg
Time Frame
Adverse events collected over the entire course of the study including the double-blind period and the open-label periods, up to 6 years overall.
Description
Treatment-Emergent Adverse events during the whole study period.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Double-Blind Viaskin Milk 150 mcg
One Viaskin epicutaneous delivery system (patch) containing 150µg of cow's milk proteins applied each day for 12 months (double-blind period).
0
49
3
49
49
49
EG001
Double-Blind Viaskin Milk 300 mcg
One Viaskin epicutaneous delivery system (patch) containing 300µg of cow's milk proteins applied each day for 12 months (double-blind period).
0
49
2
49
48
49
EG002
Double-Blind Viaskin Milk 500 mcg
One Viaskin epicutaneous delivery system (patch) containing 500µg of cow's milk proteins applied each day for 12 months (double-blind period).
0
47
1
47
47
47
EG003
Double-Blind Viaskin Placebo
One Viaskin epicutaneous delivery system (patch) containing placebo applied each day for 12 months (double-blind period).
0
53
2
53
53
53
EG004
Open-Label Viaskin Milk 500 mcg
One Viaskin epicutaneous delivery system (patch) containing 500µg of cow's milk proteins applied each day for up to 3 years.
Open-Label Set 500 (OLS-500) that includes all subjects who entered the OL-500 period and applied at least one Viaskin Milk 500µg patch during this Open-Label period (N=185).
0
185
16
185
181
185
EG005
Open-Label Viaskin Milk 300 mcg
One Viaskin epicutaneous delivery system (patch) containing 300µg of cow's milk proteins applied each day for 24 months
Open-Label Set 300 (OLS-300) that includes all subjects who entered the OL-300 period after switch to Viaskin Milk 300µg and applied at least one Viaskin Milk 300µg patch during this Open-label period (N=140).
One Viaskin epicutaneous delivery system (patch) containing placebo applied each day for 12 months.
Viaskin Placebo: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation.
Units
Counts
Participants
OG00048
OG00145
OG00245
OG00352
Title
Denominators
Categories
Title
Measurements
OG000745.1± 1197.08
OG0011201.0± 1675.90
OG002723.5± 1218.26
OG003555.5± 1143.21
OG003
Viaskin Placebo
One Viaskin epicutaneous delivery system (patch) containing placebo applied each day for 12 months.
Viaskin Placebo: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation.
Units
Counts
Participants
OG00048
OG00145
OG00245
OG00352
Title
Denominators
Categories
Title
Measurements
OG000300(3 to 1145)
OG001400(100 to 1325)
OG00293(0 to 1300)
OG003100(0 to 900)
OG003
Viaskin Placebo
One Viaskin epicutaneous delivery system (patch) containing placebo applied each day for 12 months.
Viaskin Placebo: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation.
Units
Counts
Participants
OG00048
OG00149
OG00247
OG00353
Title
Denominators
Categories
Week 3
ParticipantsOG00048
ParticipantsOG00149
ParticipantsOG00247
ParticipantsOG00353
Title
Measurements
OG000-2.43(-15.75 to 8.20)
OG0012.80(-3.90 to 17.10)
OG002-2.30(-11.40 to 11.70)
OG003
Month 3
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00244
ParticipantsOG00353
Month 6
ParticipantsOG00047
ParticipantsOG00147
ParticipantsOG00244
ParticipantsOG00352
Month 12
ParticipantsOG00047
ParticipantsOG00145
ParticipantsOG00245
ParticipantsOG00353
OG003
Viaskin Placebo
One Viaskin epicutaneous delivery system (patch) containing placebo applied each day for 12 months.
Viaskin Placebo: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation.
Units
Counts
Participants
OG00049
OG00149
OG00247
OG00353
Title
Denominators
Categories
Week 3
ParticipantsOG00049
ParticipantsOG00149
ParticipantsOG00247
ParticipantsOG00352
Title
Measurements
OG0000.24(-1.74 to 2.00)
OG0010.90(-1.30 to 2.80)
OG0020.80(-0.70 to 2.70)
OG003
Month 3
ParticipantsOG00048
ParticipantsOG00146
ParticipantsOG00243
ParticipantsOG00353
Month 6
ParticipantsOG00047
ParticipantsOG00147
ParticipantsOG00244
ParticipantsOG00353
Month 12
ParticipantsOG00049
ParticipantsOG00145
ParticipantsOG00245
ParticipantsOG00353
OG003
Viaskin Placebo
One Viaskin epicutaneous delivery system (patch) containing placebo applied each day for 12 months.
Viaskin Placebo: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation.
Units
Counts
Participants
OG00048
OG00149
OG00247
OG00353
Title
Denominators
Categories
Caseins - Week 3
ParticipantsOG00048
ParticipantsOG00149
ParticipantsOG00247
ParticipantsOG00352
Title
Measurements
OG000-2.09(-14.80 to 4.44)
OG0010.15(-5.00 to 19.00)
OG0020.50(-8.50 to 10.70)
OG003
Caseins - Month 3
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00244
ParticipantsOG00353
Caseins - Month 6
ParticipantsOG00047
ParticipantsOG00147
ParticipantsOG00244
ParticipantsOG00352
Caseins - Month 12
ParticipantsOG00047
ParticipantsOG00145
ParticipantsOG00245
ParticipantsOG00353
α-lactalbumin - Week 3
ParticipantsOG00048
ParticipantsOG00149
ParticipantsOG00247
ParticipantsOG00353
α-lactalbumin - Month 3
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00244
ParticipantsOG00353
α-lactalbumin - Month 6
ParticipantsOG00047
ParticipantsOG00147
ParticipantsOG00244
ParticipantsOG00352
α-lactalbumin - Month 12
ParticipantsOG00047
ParticipantsOG00145
ParticipantsOG00245
ParticipantsOG00353
β-lactoglobulin - Week 3
ParticipantsOG00048
ParticipantsOG00149
ParticipantsOG00247
ParticipantsOG00353
β-lactoglobulin - Month 3
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00244
ParticipantsOG00353
β-lactoglobulin - Month 6
ParticipantsOG00047
ParticipantsOG00147
ParticipantsOG00244
ParticipantsOG00352
β-lactoglobulin - Month 12
ParticipantsOG00047
ParticipantsOG00145
ParticipantsOG00245
ParticipantsOG00353
OG003
Viaskin Placebo
One Viaskin epicutaneous delivery system (patch) containing placebo applied each day for 12 months.
Viaskin Placebo: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation.
Units
Counts
Participants
OG00049
OG00149
OG00247
OG00353
Title
Denominators
Categories
Caseins - Week 3
ParticipantsOG00049
ParticipantsOG00149
ParticipantsOG00247
ParticipantsOG00352
Title
Measurements
OG0000.11(-0.06 to 0.25)
OG0010.15(-0.07 to 1.05)
OG0020.15(-0.14 to 1.19)
OG003
Caseins - Month 3
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00243
ParticipantsOG00353
Caseins - Month 6
ParticipantsOG00047
ParticipantsOG00146
ParticipantsOG00244
ParticipantsOG00353
Caseins - Month 12
ParticipantsOG00049
ParticipantsOG00145
ParticipantsOG00245
ParticipantsOG00353
α-lactalbumin - Week 3
ParticipantsOG00049
ParticipantsOG00149
ParticipantsOG00247
ParticipantsOG00352
α-lactalbumin - Month 3
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00243
ParticipantsOG00353
α-lactalbumin - Month 6
ParticipantsOG00047
ParticipantsOG00146
ParticipantsOG00244
ParticipantsOG00353
α-lactalbumin - Month 12
ParticipantsOG00049
ParticipantsOG00145
ParticipantsOG00245
ParticipantsOG00353
β-lactoglobulin - Week 3
ParticipantsOG00049
ParticipantsOG00149
ParticipantsOG00247
ParticipantsOG00352
β-lactoglobulin - Month 3
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00243
ParticipantsOG00353
β-lactoglobulin - Month 6
ParticipantsOG00047
ParticipantsOG00146
ParticipantsOG00244
ParticipantsOG00353
β-lactoglobulin - Month 12
ParticipantsOG00049
ParticipantsOG00145
ParticipantsOG00245
ParticipantsOG00353
OG003
Viaskin Placebo
One Viaskin epicutaneous delivery system (patch) containing placebo applied each day for 12 months.
Viaskin Placebo: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation.
Units
Counts
Participants
OG00048
OG00147
OG00246
OG00352
Title
Denominators
Categories
Month 3
ParticipantsOG00048
ParticipantsOG00145
ParticipantsOG00246
ParticipantsOG00352
Title
Measurements
OG000-1(-3 to 2)
OG001-1(-4 to 2)
OG002-1(-3 to 2)
OG003
Month 6
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00242
ParticipantsOG00351
Month 12
ParticipantsOG00048
ParticipantsOG00145
ParticipantsOG00245
ParticipantsOG00352
OG002
Viaskin Milk 500 mcg
One Viaskin epicutaneous delivery system (patch) containing 500µg of cow's milk proteins applied each day for 12 months.
Viaskin Milk 500 mcg: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins.
OG003
Viaskin Placebo
One Viaskin epicutaneous delivery system (patch) containing placebo applied each day for 12 months.
Viaskin Placebo: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation.
Units
Counts
Participants
OG00049
OG00149
OG00247
OG00353
Title
Denominators
Categories
Month 0
ParticipantsOG00049
ParticipantsOG00149
ParticipantsOG00247
ParticipantsOG00353
Title
Measurements
OG0006(4 to 9)
OG0016(4 to 8)
OG0026(4 to 10)
OG003
Month 12
ParticipantsOG00048
ParticipantsOG00145
ParticipantsOG00245
ParticipantsOG00352
Change from Month 0 to Month 12
ParticipantsOG00048
ParticipantsOG00145
ParticipantsOG00245
ParticipantsOG00352
OG003
Viaskin Placebo
One Viaskin epicutaneous delivery system (patch) containing placebo applied each day for 12 months.
Viaskin Placebo: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation.
Units
Counts
Participants
OG00039
OG00139
OG00241
OG00344
Title
Denominators
Categories
Month 0
ParticipantsOG00039
ParticipantsOG00139
ParticipantsOG00241
ParticipantsOG00344
Title
Measurements
OG0004.6(3.3 to 5.4)
OG0014.4(3.4 to 5.2)
OG0024.6(3.6 to 5.2)
OG003
Month 12
ParticipantsOG00039
ParticipantsOG00138
ParticipantsOG00239
ParticipantsOG00344
Change from Month 0 to Month 12
ParticipantsOG00039
ParticipantsOG00138
ParticipantsOG00239
ParticipantsOG00344
Viaskin Milk 300 mcg
One Viaskin epicutaneous delivery system (patch) containing 300µg of cow's milk proteins applied each day for 12 months (double-blind period), followed by a patch containing 500µg of cow's milk proteins (Open-label 500µg period), followed by a patch containing 300µg for up to 24 months (Open-label 300µg period).
One patch applied each day (up to 24 hours) during the double-blind and open-label periods.
OG002
Viaskin Milk 500 mcg
One Viaskin epicutaneous delivery system (patch) containing 500µg of cow's milk proteins applied each day for 12 months (double-blind period), followed by a patch containing 500µg of cow's milk proteins (Open-label 500µg period), followed by a patch containing 300µg for up to 24 months (Open-label 300µg period).
One patch applied each day (up to 24 hours) during the double-blind and open-label periods.
OG003
Viaskin Placebo
One Viaskin epicutaneous delivery system (patch) containing placebo applied each day for 12 months (double-blind period), followed by a patch containing 500µg of cow's milk proteins (Open-label 500µg period), followed by a patch containing 300µg for up to 24 months (Open-label 300µg period).
One patch applied each day (up to 24 hours) during the double-blind and open-label periods.
Units
Counts
Participants
OG00015
OG00113
OG0028
OG00314
Title
Denominators
Categories
Month 12 after switch to Viaskin Milk 300µg
ParticipantsOG00014
ParticipantsOG00111
ParticipantsOG0028
ParticipantsOG00311
Title
Measurements
OG00085.7
OG00172.7
OG00262.5
OG003
Month 24 after switch to Viaskin Milk 300µg
ParticipantsOG00015
ParticipantsOG00113
ParticipantsOG0028
ParticipantsOG00314
OG002
Viaskin Milk 500 mcg
One Viaskin epicutaneous delivery system (patch) containing 500µg of cow's milk proteins applied each day for 12 months (double-blind period), followed by a patch containing 500µg of cow's milk proteins (Open-label 500µg period), followed by a patch containing 300µg for up to 24 months (Open-label 300µg period).
One patch applied each day (up to 24 hours) during the double-blind and open-label periods.
OG003
Viaskin Placebo
One Viaskin epicutaneous delivery system (patch) containing placebo applied each day for 12 months (double-blind period), followed by a patch containing 500µg of cow's milk proteins (Open-label 500µg period), followed by a patch containing 300µg for up to 24 months (Open-label 300µg period).
One patch applied each day (up to 24 hours) during the double-blind and open-label periods.
Units
Counts
Participants
OG00034
OG00138
OG00229
OG00339
Title
Denominators
Categories
Month 0
ParticipantsOG00034
ParticipantsOG00138
ParticipantsOG00229
ParticipantsOG00339
Title
Measurements
OG000144(44 to 444)
OG001144(44 to 444)
OG002144(44 to 444)
OG003
Month 12 after switch to Viaskin Milk 300µg
ParticipantsOG00014
ParticipantsOG00111
ParticipantsOG0028
ParticipantsOG00311
Month 24 after switch to Viaskin Milk 300µg
ParticipantsOG00015
ParticipantsOG00113
ParticipantsOG0028
ParticipantsOG00314
One Viaskin epicutaneous delivery system (patch) containing 500µg of cow's milk proteins applied each day for 12 months (double-blind period), followed by a patch containing 500µg of cow's milk proteins (Open-label 500µg period), followed by a patch containing 300µg for up to 24 months (Open-label 300µg period).
One patch applied each day (up to 24 hours) during the double-blind and open-label periods.
OG003
Viaskin Placebo
One Viaskin epicutaneous delivery system (patch) containing placebo applied each day for 12 months (double-blind period), followed by a patch containing 500µg of cow's milk proteins (Open-label 500µg period), followed by a patch containing 300µg for up to 24 months (Open-label 300µg period).
One patch applied each day (up to 24 hours) during the double-blind and open-label periods.
Units
Counts
Participants
OG00049
OG00149
OG00247
OG00353
Title
Denominators
Categories
Any TEAE
Title
Measurements
OG00049
OG00148
OG00247
OG00353
Any serious TEAE
Title
Measurements
OG0009
OG0016
OG0026
OG003
Any TEAE related to the Investigational Product
Title
Measurements
OG00046
OG00143
OG00239
OG003
Any serious TEAE related to the Investigational Product