CompletedNCT02223182MILESUpdated Nov 20, 2024Results posted

Efficacy and Safety of Viaskin Milk in Children With IgE-Mediated Cow's Milk Allergy

A Phase 1/2 interventional study of Viaskin Milk 150 mcg and Viaskin Milk 300 mcg in Food Allergy, sponsored by DBV Technologies. Completed at 17 sites in 2 countries. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-11-20.

Primary conditionMilk HypersensitivityRegistry: Food HypersensitivityReclassifiedWhy we changed it

Registry

Food Hypersensitivity — the first condition term the registry derived for this study.

ClinicalTrials.gg

Milk Hypersensitivity

Why

The study's title name Milk Hypersensitivity, a narrower term within Food Hypersensitivity.

Confidence

High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →

Wrong?

Tell us the study's main condition →

Sponsored by DBV Technologies · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 198
Allocation: Randomized
Ages: 2 Years to 17 Years
Sex: All

Study 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.

Read the 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 studied

Food Allergy

Browse trials for

Food Hypersensitivity 376Registry's first term
Milk Hypersensitivity 147Primary · reclassified

Keywords

Milk Allergy,
Viaskin Milk,
Specific Immunotherapy,
Epicutaneous ImmunoTherapy (EPIT)
IgE-Mediated Cow's Milk Allergy

In context

Milk Hypersensitivity Reclassified

147 studies on the registry are indexed under Milk Hypersensitivity; 26 are open to participants now.

This study's enrollment of 198 is above the median of 68 across 95 interventional studies indexed under Milk Hypersensitivity.

Browse Milk Hypersensitivity studies →

Lead sponsor

DBV Technologies is the lead sponsor of 16 studies on the registry; 1 is open to participants now.

Compared within Milk Hypersensitivity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Food Hypersensitivity. The counts are of registry records indexed under each term, refreshed daily. How we classify →

Who can participate

Ages eligible: 2 Years to 17 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Eligibility criteria for study enrollment:

Inclusion criteria

Inclusion Criteria:

Signed 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 . Female subjects of childbearing potential must agree and commit to use effective medical methods of 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

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 (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 .
Known allergy to the Viaskin patch materials or , 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, disorders, immunodeficiency, , 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.
condition for the use of epinephrine.
Use of any 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.

Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 198 participants (actual)

Study arms

Experimental
Viaskin Milk 150 mcg
One Viaskin epicutaneous delivery system (patch) containing 150µg of cow's milk proteins applied each day for 12 months.
Biological: Viaskin Milk 150 mcg
Experimental
Viaskin Milk 300 mcg
One Viaskin epicutaneous delivery system (patch) containing 300µg of cow's milk proteins applied each day for 12 months.
Biological: Viaskin Milk 300 mcg
Experimental
Viaskin Milk 500 mcg
One Viaskin epicutaneous delivery system (patch) containing 500µg of cow's milk proteins applied each day for 12 months.
Biological: Viaskin Milk 500 mcg
Placebo comparator
Viaskin Placebo
One Viaskin epicutaneous delivery system (patch) containing placebo applied each day for 12 months.
Biological: Viaskin Placebo

Interventions

BiologicalViaskin Milk 150 mcg
Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 150 mcg cow's milk proteins.
BiologicalViaskin Milk 300 mcg
Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 300 mcg cow's milk proteins.
BiologicalViaskin Milk 500 mcg
Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins.
BiologicalViaskin Placebo
Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation.

What researchers measure

Primary outcomes

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.
Time frame: From baseline to Month 12 (double-blind period)

Secondary outcomes

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.
Time frame: From baseline to Month 12 (double-blind period)
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Whole study including double-blind and open-label periods (up to 6 years).

Results

Posted Nov 20, 2024

Participant flow

Double-Blind Period

Participant flow — Double-Blind Period
Milestone	Viaskin Milk 150 mcg	Viaskin Milk 300 mcg	Viaskin Milk 500 mcg	Viaskin Placebo
Started	49	49	47	53
Completed	47	45	45	52
Not completed	2	4	2	1
Withdrew: Adverse event	0	2	1	0
Withdrew: Withdrawal by subject	1	1	1	0
Withdrew: Lost to follow-up	0	1	0	0
Withdrew: Non compliance	0	0	0	1
Withdrew: Sponsor or regulatory authorities decision	1	0	0	0

Open-Label 500 Period

Participant flow — Open-Label 500 Period
Milestone	Viaskin Milk 150 mcg	Viaskin Milk 300 mcg	Viaskin Milk 500 mcg	Viaskin Placebo
Started	46	45	44	52
Completed	40	43	32	42
Not completed	6	2	12	10
Withdrew: Adverse event	1	0	2	1
Withdrew: Withdrawal by subject	5	2	9	8
Withdrew: Physician decision	0	0	0	1
Withdrew: Sponsor or regulatory authorities decision	0	0	1	0

Open-Label 300 Period

Participant flow — Open-Label 300 Period
Milestone	Viaskin Milk 150 mcg	Viaskin Milk 300 mcg	Viaskin Milk 500 mcg	Viaskin Placebo
Started	34	38	29	39
Completed	23	23	14	24
Not completed	11	15	15	15
Withdrew: Withdrawal by subject	10	13	13	15
Withdrew: Lost to follow-up	1	0	1	0
Withdrew: Non compliance	0	2	1	0

Outcome measures

PrimaryPercentage (%) 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.

Time frame:: From baseline to Month 12 (double-blind period)
Reported as:: Number · percent of participants

Percentage (%) of Subjects Who Are Treatment Responders After 12 Months of EPIT Treatment.
percent of participants	Viaskin Milk 150 mcg	Viaskin Milk 300 mcg	Viaskin Milk 500 mcg	Viaskin Placebo
Percentage (%) of Subjects Who Are Treatment Responders After 12 Months of EPIT Treatment.	36.7	49.0	36.2	30.2

SecondaryMean 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.

Time frame:: From baseline to Month 12 (double-blind period)
Reported as:: Mean · milligrams (mg) of cow's milk proteins

Mean Cumulative Reactive Dose (CRD) of Cow's Milk Proteins.
milligrams (mg) of cow's milk proteins	Viaskin Milk 150 mcg	Viaskin Milk 300 mcg	Viaskin Milk 500 mcg	Viaskin Placebo
Mean Cumulative Reactive Dose (CRD) of Cow's Milk Proteins.	745.1 ± 1197.08	1201.0 ± 1675.90	723.5 ± 1218.26	555.5 ± 1143.21

SecondaryMedian 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.

Time frame:: From baseline to Month 12 (double-blind period)
Reported as:: Median · milligrams (mg) of cow's milk proteins

Median Cumulative Reactive Dose (CRD) of Cow's Milk Proteins.
milligrams (mg) of cow's milk proteins	Viaskin Milk 150 mcg	Viaskin Milk 300 mcg	Viaskin Milk 500 mcg	Viaskin Placebo
Median Cumulative Reactive Dose (CRD) of Cow's Milk Proteins.	300 (3 to 1145)	400 (100 to 1325)	93 (0 to 1300)	100 (0 to 900)

SecondaryChange in Levels of sIgE to Cow's Milk.

Median change from baseline value in levels of IgE specific to cow's milk proteins

Time frame:: From baseline to Week 3, Month 3, Month 6, Month 12 (double-blind period)
Reported as:: Median · kU/L

Change in Levels of sIgE to Cow's Milk.
kU/L	Viaskin Milk 150 mcg	Viaskin Milk 300 mcg	Viaskin Milk 500 mcg	Viaskin Placebo
Week 3	-2.43 (-15.75 to 8.20)	2.80 (-3.90 to 17.10)	-2.30 (-11.40 to 11.70)	-5.40 (-28.00 to 1.10)
Month 3	-0.70 (-18.20 to 11.90)	3.20 (-10.00 to 27.00)	-6.99 (-20.75 to 7.10)	-7.20 (-28.50 to 0.90)
Month 6	-5.80 (-37.80 to 3.80)	-5.00 (-19.40 to 6.00)	-14.40 (-54.95 to 2.70)	-5.45 (-31.30 to 4.25)
Month 12	-5.90 (-40.50 to 7.30)	-2.70 (-16.10 to 13.30)	-20.60 (-69.00 to -6.00)	-7.70 (-27.70 to 1.80)

SecondaryChange in Levels of sIgG4 to Cow's Milk.

Median change from baseline value in levels of IgG4 specific to cow's milk proteins

Time frame:: From baseline to Week 3, Month 3, Month 6, Month 12 (double-blind period)
Reported as:: Median · mgA/L

Change in Levels of sIgG4 to Cow's Milk.
mgA/L	Viaskin Milk 150 mcg	Viaskin Milk 300 mcg	Viaskin Milk 500 mcg	Viaskin Placebo
Week 3	0.24 (-1.74 to 2.00)	0.90 (-1.30 to 2.80)	0.80 (-0.70 to 2.70)	-0.35 (-2.10 to 1.89)
Month 3	0.90 (-0.75 to 2.45)	2.45 (0.10 to 4.50)	2.60 (-1.60 to 5.90)	-0.80 (-2.60 to 1.00)
Month 6	0.10 (-2.00 to 3.29)	1.30 (-1.20 to 5.00)	1.40 (-1.70 to 5.75)	-1.60 (-3.10 to 0.40)
Month 12	1.20 (-1.40 to 4.10)	3.50 (-0.50 to 10.00)	1.96 (-0.20 to 11.80)	-1.60 (-2.74 to -0.30)

SecondaryChange 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

Time frame:: From baseline to Week 3, Month 3, Month 6, Month 12 (double-blind period)
Reported as:: Median · kU/L

Change in Levels of sIgE to Caseins, α-lactalbumin and β-lactoglobulin
kU/L	Viaskin Milk 150 mcg	Viaskin Milk 300 mcg	Viaskin Milk 500 mcg	Viaskin Placebo
Caseins - Week 3	-2.09 (-14.80 to 4.44)	0.15 (-5.00 to 19.00)	0.50 (-8.50 to 10.70)	-1.80 (-7.75 to 6.10)
Caseins - Month 3	1.15 (-20.35 to 11.49)	-0.20 (-9.50 to 27.20)	1.15 (-8.95 to 11.45)	-2.46 (-14.70 to 10.00)
Caseins - Month 6	-5.60 (-38.40 to 4.98)	-5.80 (-31.00 to 6.10)	-8.45 (-46.50 to 3.10)	-2.55 (-17.75 to 5.50)
Caseins - Month 12	-5.80 (-32.40 to 1.58)	-2.00 (-29.00 to 2.90)	-12.60 (-92.00 to -1.20)	-4.45 (-16.30 to 7.90)
α-lactalbumin - Week 3	0.07 (-2.18 to 2.50)	-0.06 (-1.89 to 4.10)	-0.10 (-3.20 to 2.60)	-0.48 (-3.00 to 0.46)
α-lactalbumin - Month 3	-0.16 (-4.35 to 1.31)	0.18 (-2.90 to 5.20)	-1.78 (-5.70 to 0.40)	-1.00 (-2.84 to 0.90)
α-lactalbumin - Month 6	-1.21 (-7.88 to 0.51)	-0.53 (-3.93 to 3.80)	-3.72 (-13.10 to -0.03)	-0.71 (-4.41 to 0.60)
α-lactalbumin - Month 12	-4.60 (-11.30 to 0.09)	-1.76 (-9.30 to 0.05)	-7.20 (-18.90 to -1.10)	-1.20 (-6.50 to 0.00)
β-lactoglobulin - Week 3	-0.04 (-2.45 to 0.71)	0.45 (-0.54 to 3.79)	0.00 (-2.07 to 3.23)	-0.41 (-3.30 to 0.33)
β-lactoglobulin - Month 3	-0.02 (-2.25 to 1.06)	1.40 (-1.60 to 6.00)	-1.17 (-3.46 to 0.55)	-0.60 (-3.33 to 1.54)
β-lactoglobulin - Month 6	-0.29 (-7.40 to 0.06)	-0.12 (-4.02 to 6.10)	-3.55 (-11.83 to -0.02)	-1.11 (-5.52 to 0.24)
β-lactoglobulin - Month 12	-1.36 (-11.00 to -0.24)	-0.92 (-7.33 to 0.58)	-4.02 (-14.50 to -1.63)	-2.29 (-7.00 to -0.01)

SecondaryChange 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

Time frame:: From baseline to Week 3, Month 3, Month 6, Month 12 (double-blind period)
Reported as:: Median · mgA/L

Change in Levels of sIgG4 to Caseins, α-lactalbumin and β-lactoglobulin
mgA/L	Viaskin Milk 150 mcg	Viaskin Milk 300 mcg	Viaskin Milk 500 mcg	Viaskin Placebo
Caseins - Week 3	0.11 (-0.06 to 0.25)	0.15 (-0.07 to 1.05)	0.15 (-0.14 to 1.19)	0.03 (-0.22 to 0.17)
Caseins - Month 3	0.39 (0.00 to 0.99)	1.08 (0.31 to 2.66)	0.78 (0.11 to 2.00)	-0.06 (-0.35 to 0.14)
Caseins - Month 6	0.32 (0.14 to 1.64)	1.04 (0.20 to 2.69)	0.69 (0.19 to 1.75)	-0.01 (-0.37 to 0.14)
Caseins - Month 12	0.47 (-0.18 to 1.47)	1.05 (0.04 to 2.73)	0.61 (0.10 to 4.43)	-0.11 (-0.51 to 0.17)
α-lactalbumin - Week 3	0.00 (-0.07 to 0.17)	0.06 (-0.01 to 0.43)	0.00 (-0.05 to 0.65)	0.00 (-0.08 to 0.09)
α-lactalbumin - Month 3	0.63 (0.22 to 1.19)	0.81 (0.23 to 2.04)	0.65 (0.00 to 2.32)	0.00 (-0.05 to 0.13)
α-lactalbumin - Month 6	1.09 (0.25 to 2.20)	1.64 (0.62 to 2.80)	1.19 (0.08 to 3.48)	0.00 (-0.04 to 0.13)
α-lactalbumin - Month 12	1.28 (0.52 to 3.48)	2.72 (0.74 to 7.38)	1.94 (0.46 to 6.46)	0.00 (-0.18 to 0.08)
β-lactoglobulin - Week 3	0.03 (-0.01 to 0.24)	0.08 (-0.03 to 0.29)	0.11 (-0.02 to 0.61)	0.00 (-0.10 to 0.07)
β-lactoglobulin - Month 3	0.22 (0.01 to 1.00)	0.67 (0.35 to 1.73)	0.65 (0.12 to 2.11)	-0.01 (-0.21 to 0.13)
β-lactoglobulin - Month 6	0.36 (0.04 to 1.20)	0.94 (0.33 to 2.37)	0.88 (0.06 to 2.30)	-0.03 (-0.20 to 0.11)
β-lactoglobulin - Month 12	0.47 (0.09 to 2.17)	2.06 (0.63 to 4.78)	1.55 (0.23 to 3.33)	-0.06 (-0.27 to 0.03)

SecondaryChange in Skin Prick Test (SPT) Wheal.

Median change from baseline in SPT Wheal diameter

Time frame:: From baseline to Month 3, Month 6, Month 12 (double-blind period)
Reported as:: Median · millimeters (mm)

Change in Skin Prick Test (SPT) Wheal.
millimeters (mm)	Viaskin Milk 150 mcg	Viaskin Milk 300 mcg	Viaskin Milk 500 mcg	Viaskin Placebo
Month 3	-1 (-3 to 2)	-1 (-4 to 2)	-1 (-3 to 2)	0 (-3 to 4)
Month 6	0 (-3 to 3)	-2 (-4 to 1)	-1 (-4 to 1)	0 (-4 to 3)
Month 12	0 (-4 to 3)	-1 (-4 to 1)	-1 (-3 to 2)	0 (-3 to 2)

SecondaryChange 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.

Time frame:: From baseline to Month 12 (double-blind period)
Reported as:: Median · score on a scale

Change in the Severity of Symptoms Elicited During the Milk Double-Blind Placebo-Controlled Food Challenge (DBPCFC).
score on a scale	Viaskin Milk 150 mcg	Viaskin Milk 300 mcg	Viaskin Milk 500 mcg	Viaskin Placebo
Month 0	6 (4 to 9)	6 (4 to 8)	6 (4 to 10)	6 (4 to 9)
Month 12	5 (4 to 9)	6 (3 to 9)	6 (4 to 9)	6 (3 to 10)
Change from Month 0 to Month 12	-1 (-3 to 3)	0 (-2 to 2)	0 (-2 to 2)	0 (-3 to 3)

SecondaryChange 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.

Time frame:: From baseline to Month 12 (double-blind period)
Reported as:: Median · score on a scale

Change in Quality of Life (QoL) Assessments.
score on a scale	Viaskin Milk 150 mcg	Viaskin Milk 300 mcg	Viaskin Milk 500 mcg	Viaskin Placebo
Month 0	4.6 (3.3 to 5.4)	4.4 (3.4 to 5.2)	4.6 (3.6 to 5.2)	4.9 (3.3 to 5.5)
Month 12	4.3 (3.4 to 5.2)	4.5 (3.5 to 5.4)	4.3 (3.7 to 5.1)	4.1 (3.4 to 5.2)
Change from Month 0 to Month 12	-0.1 (-0.6 to 0.5)	0.1 (-0.2 to 0.5)	0 (-0.8 to 0.5)	-0.4 (-0.8 to 0.5)

SecondaryPercentage (%) 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.

Time frame:: From baseline to Month 12 and Month 24 after switch to Viaskin Milk 300µg (Open-Label 300µg period)
Reported as:: Number · Percentage of participants

Percentage (%) of Subjects Who Are Treatment Responders Over the Course of the Viaskin Milk 300µg Open-label Treatment Period Using Observed Data
Percentage of participants	Viaskin Milk 150 mcg	Viaskin Milk 300 mcg	Viaskin Milk 500 mcg	Viaskin Placebo
Month 12 after switch to Viaskin Milk 300µg	85.7	72.7	62.5	81.8
Month 24 after switch to Viaskin Milk 300µg	80.0	84.6	50.0	64.3

SecondaryCumulative 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.

Time frame:: Baseline, Month 12 and Month 24 after switch to Viaskin Milk 300µg (Open-Label 300µg period)
Reported as:: Median · milligrams (mg) of cow's milk proteins

Cumulative Reactive Dose (CRD) of Cow's Milk Protein Over the Course of the Open-label Treatment Period
milligrams (mg) of cow's milk proteins	Viaskin Milk 150 mcg	Viaskin Milk 300 mcg	Viaskin Milk 500 mcg	Viaskin Placebo
Month 0	144 (44 to 444)	144 (44 to 444)	144 (44 to 444)	144 (44 to 444)
Month 12 after switch to Viaskin Milk 300µg	1444 (944 to 6444)	1444 (444 to 2194)	1319 (444 to 3481)	1444 (444 to 6444)
Month 24 after switch to Viaskin Milk 300µg	1444 (474 to 3444)	1444 (444 to 3444)	1219 (144 to 2819)	1444 (444 to 6444)

SecondaryTreatment-Emergent Adverse Events

Overview of Treatment Emergent Adverse Events (TEAEs) and serious Treatment-Emergent Adverse Events

Time frame:: Whole study including double-blind and open-label periods (up to 6 years).
Reported as:: Number · participants

Treatment-Emergent Adverse Events
participants	Viaskin Milk 150 mcg	Viaskin Milk 300 mcg	Viaskin Milk 500 mcg	Viaskin Placebo
Any TEAE	49	48	47	53
Any serious TEAE	9	6	6	7
Any TEAE related to the Investigational Product	46	43	39	48
Any serious TEAE related to the Investigational Product	0	0	0	0
Any TEAE leading to death	0	0	0	0

Adverse events

Collected over 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.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Double-Blind Viaskin Milk 150 mcg	0/49 (0%)	3/49 (6.1%)	49/49 (100%)
Double-Blind Viaskin Milk 300 mcg	0/49 (0%)	2/49 (4.1%)	48/49 (98%)
Double-Blind Viaskin Milk 500 mcg	0/47 (0%)	1/47 (2.1%)	47/47 (100%)
Double-Blind Viaskin Placebo	0/53 (0%)	2/53 (3.8%)	53/53 (100%)
Open-Label Viaskin Milk 500 mcg	0/185 (0%)	16/185 (8.6%)	181/185 (97.8%)
Open-Label Viaskin Milk 300 mcg	0/140 (0%)	7/140 (5%)	131/140 (93.6%)

Most frequent serious events

Showing 10 of 26

Most frequent serious events
Event	Double-Blind Viaskin Milk 150 mcg	Double-Blind Viaskin Milk 300 mcg	Double-Blind Viaskin Milk 500 mcg	Double-Blind Viaskin Placebo	Open-Label Viaskin Milk 500 mcg	Open-Label Viaskin Milk 300 mcg
Anaphylactic reactionImmune system disorders	1/49	0/49	0/47	1/53	5/185	3/140
Croup InfectiousInfections and infestations	0/49	0/49	1/47	0/53	0/185	0/140
PneumoniaInfections and infestations	0/49	1/49	0/47	0/53	1/185	0/140
AsthmaRespiratory, thoracic and mediastinal disorders	1/49	0/49	0/47	1/53	0/185	0/140
Status AsthmaticusRespiratory, thoracic and mediastinal disorders	0/49	1/49	0/47	0/53	0/185	0/140
Eosinophilic oesophagitisGastrointestinal disorders	1/49	0/49	0/47	0/53	0/185	0/140
Road Traffic accidentInjury, poisoning and procedural complications	0/49	0/49	0/47	0/53	2/185	0/140
AppendicitisInfections and infestations	0/49	0/49	0/47	0/53	1/185	1/140
CellulitisInfections and infestations	0/49	0/49	0/47	0/53	0/185	1/140
EpilepsyNervous system disorders	0/49	0/49	0/47	0/53	0/185	1/140

Most frequent other events

Showing 10 of 56

Most frequent other events
Event	Double-Blind Viaskin Milk 150 mcg	Double-Blind Viaskin Milk 300 mcg	Double-Blind Viaskin Milk 500 mcg	Double-Blind Viaskin Placebo	Open-Label Viaskin Milk 500 mcg	Open-Label Viaskin Milk 300 mcg
Application site erythemaGeneral disorders	29/49	25/49	24/47	16/53	92/185	39/140
Upper respiratory tract infectionInfections and infestations	27/49	23/49	16/47	19/53	60/185	38/140
Application site pruritusGeneral disorders	26/49	26/49	18/47	10/53	86/185	30/140
AsthmaRespiratory, thoracic and mediastinal disorders	19/49	10/49	14/47	20/53	49/185	37/140
Anaphylactic reactionImmune system disorders	18/49	10/49	15/47	11/53	45/185	26/140
Application site swellingGeneral disorders	14/49	13/49	14/47	3/53	47/185	14/140
UrticariaSkin and subcutaneous tissue disorders	13/49	14/49	11/47	7/53	21/185	17/140
CoughRespiratory, thoracic and mediastinal disorders	13/49	10/49	7/47	13/53	19/185	11/140
Viral upper respiratory tract infectionInfections and infestations	11/49	9/49	11/47	10/53	34/185	22/140
PyrexiaGeneral disorders	11/49	7/49	5/47	12/53	29/185	21/140

Baseline characteristics

Overall Intent-to-Treat population

Age, Continuous
Age, Continuous(years)	Viaskin Milk 150 mcg	Viaskin Milk 300 mcg	Viaskin Milk 500 mcg	Viaskin Placebo	Total
Mean	7.6 ± 4.56	7.7 ± 4.34	8.7 ± 3.37	8.1 ± 4.31	8.0 ± 4.17

Sex: Female, Male
Sex: Female, Male(Participants)	Viaskin Milk 150 mcg	Viaskin Milk 300 mcg	Viaskin Milk 500 mcg	Viaskin Placebo	Total
Female	24	12	20	18	74
Male	25	37	27	35	124

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Viaskin Milk 150 mcg	Viaskin Milk 300 mcg	Viaskin Milk 500 mcg	Viaskin Placebo	Total
Caucasian	33	28	31	41	133
Black	1	2	4	1	8
Hispanic	2	1	1	1	5
Asian	8	10	9	5	32
Other	5	8	2	5	20

Skin Prick Test Mean wheal diameter
Skin Prick Test Mean wheal diameter(millimeters)	Viaskin Milk 150 mcg	Viaskin Milk 300 mcg	Viaskin Milk 500 mcg	Viaskin Placebo	Total
Median	10.5 (9.0 to 12.0)	11.0 (9.0 to 13.5)	10.5 (9.5 to 13.8)	11.0 (9.0 to 14.5)	10.5 (9.0 to 13.5)

Cumulative Reactive Dose (CRD) of Cow's milk
Cumulative Reactive Dose (CRD) of Cow's milk(mg of cow's milk proteins)	Viaskin Milk 150 mcg	Viaskin Milk 300 mcg	Viaskin Milk 500 mcg	Viaskin Placebo	Total
Median	144 (44 to 444)	144 (44 to 444)	144 (44 to 444)	144 (44 to 444)	144 (44 to 444)

Cow's milk sIgE
Cow's milk sIgE(kU/L)	Viaskin Milk 150 mcg	Viaskin Milk 300 mcg	Viaskin Milk 500 mcg	Viaskin Placebo	Total
Median	58.2 (31.5 to 115)	67.6 (31.0 to 187.0)	64.6 (32.1 to 291.0)	61.1 (24.8 to 163.0)	61.9 (31.5 to 163)

Cow's milk sIgG4
Cow's milk sIgG4(mgA/L)	Viaskin Milk 150 mcg	Viaskin Milk 300 mcg	Viaskin Milk 500 mcg	Viaskin Placebo	Total
Median	14.0 (11.5 to 17.1)	14.5 (12.3 to 16.4)	14.0 (12.7 to 16.3)	13.5 (11.9 to 16.9)	14.0 (12.0 to 16.9)

Study locations

17 sites

Arkansas Children's Hospital
Little Rock, Arkansas 72202, United States
Rady Children's Hospital
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
Chicago, Illinois 60611, United States
Johns Hopkins Hospital
Baltimore, Maryland 21287, United States
Massachusetts General Hospital
Boston, Massachusetts 02114, United States
Mount Sinai Medical Center
New York, New York 10029, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania 15224, United States
Children's Medical Center of Dallas
Dallas, Texas 75235, United States
ASTHMA, Inc.
Seattle, Washington 98115, United States
Cheema Research Inc.
Mississauga, Ontario L5A 3V4, Canada
Ottawa Allergy Research Corporation
Ottawa, Ontario K1G6C6, Canada
Gordon Sussman Clinical Research Inc.
Toronto, Ontario M4V 1R2, Canada
Centre Hospitalier Universitaire Sainte Justine
Montréal, Quebec H3T 1C4, Canada
Clinique Spécialisée en allergie de la Capitale
Québec, G1V 4W2, Canada

References and documents

Study documents

Study protocol ↗ · Jun 24, 2019
Statistical analysis plan ↗ · Oct 30, 2020

PDFs hosted by the registry, ClinicalTrials.gov.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2014 to primary completion in Dec 2017, 37 months.

Results were first posted in Nov 2024, 6 years 11 months after primary completion. A results delay was requested in Jul 2019.

How these figures are worked out, and which studies are left out of them.

Registered: Aug 20, 2014
First posted: Aug 22, 2014
StartActual: Nov 2014
Primary completionActual: Dec 14, 2017
CompletionActual: Dec 22, 2020
Results delay requested: Jul 31, 2019
Results first posted: Nov 20, 2024
Last update: Nov 20, 2024

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Nov 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02223182
Lead sponsor: DBV Technologies
Responsible party: Sponsor
First posted: Aug 22, 2014
Start date: Nov 2014
Primary completion: Dec 14, 2017
Completion: Dec 22, 2020
Results posted: Nov 20, 2024
Last update: Nov 20, 2024

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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