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Food AllergyPhase 1/2MILESNCT02223182

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

A Phase 1/2 study testing Viaskin Milk 150 mcg, Viaskin Milk 300 mcg and Viaskin Milk 500 mcg in people with Food Allergy, run by DBV Technologies at 17 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 2 to 17 years
Conditions the study is for
Food Allergy
What is being tested?
Viaskin Milk 150 mcg, Viaskin Milk 300 mcg and Viaskin Milk 500 mcg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
198 participants
Where
17 sitesin 2 countries
Study dates
Nov 2014to 22 Dec 2020
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
Show all 28Show fewer
  • 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.

Trial locations and contacts

17 sites in 2 countries.

17 sites in 2 countries

United States12 sites

  • Children's Hospital Colorado

    Aurora, Colorado, 80045

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611

  • Children's Medical Center of Dallas

    Dallas, Texas, 75235

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224

  • Rady Children's Hospital

    San Diego, California, 92123

  • ASTHMA, Inc.

    Seattle, Washington, 98115

  • Stanford University School of Medicine

    Stanford, California, 94305

Other trials in United States

Canada5 sites

  • Cheema Research Inc.

    Mississauga, Ontario, L5A 3V4

  • Centre Hospitalier Universitaire Sainte Justine

    Montreal, Quebec, H3T 1C4

  • Ottawa Allergy Research Corporation

    Ottawa, Ontario, K1G6C6

  • Clinique Spécialisée en allergie de la Capitale

    Québec, G1V 4W2

  • Gordon Sussman Clinical Research Inc.

    Toronto, Ontario, M4V 1R2

Other trials in Canada

About this study

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

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
Food Allergy
Being tested
Viaskin Milk 150 mcg, Viaskin Milk 300 mcg, Viaskin Milk 500 mcg, Viaskin Placebo
Keywords
Milk Allergy,, Viaskin Milk,, Specific Immunotherapy,, Epicutaneous ImmunoTherapy (EPIT), IgE-Mediated Cow's Milk Allergy
Medical subject headings
Food Hypersensitivity, Milk Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Viaskin Milk 150 mcgBiological

    Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 150 mcg cow's milk proteins.

  • Viaskin Milk 300 mcgBiological

    Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 300 mcg cow's milk proteins.

  • Viaskin Milk 500 mcgBiological

    Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins.

  • Viaskin PlaceboBiological

    Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation.

Study groups in NCT02223182
Study groupRoleWhat they receive
Viaskin Milk 150 mcgExperimentalOne Viaskin epicutaneous delivery system (patch) containing 150µg of cow's milk proteins applied each day for 12 months.
Receives: Biological: Viaskin Milk 150 mcg
Viaskin Milk 300 mcgExperimentalOne Viaskin epicutaneous delivery system (patch) containing 300µg of cow's milk proteins applied each day for 12 months.
Receives: Biological: Viaskin Milk 300 mcg
Viaskin Milk 500 mcgExperimentalOne Viaskin epicutaneous delivery system (patch) containing 500µg of cow's milk proteins applied each day for 12 months.
Receives: Biological: Viaskin Milk 500 mcg
Viaskin PlaceboPlacebo comparatorOne Viaskin epicutaneous delivery system (patch) containing placebo applied each day for 12 months.
Receives: Biological: Viaskin Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From baseline to Month 12 (double-blind period)

Secondary outcomes (12)

  1. 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.

    Measured: From baseline to Month 12 (double-blind period)

  2. 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.

    Measured: From baseline to Month 12 (double-blind period)

  3. Change in Levels of sIgE to Cow's Milk.

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

    Measured: From baseline to Week 3, Month 3, Month 6, Month 12 (double-blind period)

  4. Change in Levels of sIgG4 to Cow's Milk.

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

    Measured: From baseline to Week 3, Month 3, Month 6, Month 12 (double-blind period)

  5. 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

    Measured: From baseline to Week 3, Month 3, Month 6, Month 12 (double-blind period)

  6. 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

    Measured: From baseline to Week 3, Month 3, Month 6, Month 12 (double-blind period)

  7. Change in Skin Prick Test (SPT) Wheal.

    Median change from baseline in SPT Wheal diameter

    Measured: From baseline to Month 3, Month 6, Month 12 (double-blind period)

  8. 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.

    Measured: From baseline to Month 12 (double-blind period)

  9. 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.

    Measured: From baseline to Month 12 (double-blind period)

  10. 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.

    Measured: From baseline to Month 12 and Month 24 after switch to Viaskin Milk 300µg (Open-Label 300µg period)

  11. 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.

    Measured: Baseline, Month 12 and Month 24 after switch to Viaskin Milk 300µg (Open-Label 300µg period)

  12. Treatment-Emergent Adverse Events

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

    Measured: Whole study including double-blind and open-label periods (up to 6 years).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2014 (estimated)
  2. Study startNov 2014
  3. Primary completion14 Dec 2017
  4. Study completion22 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
198 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02223182
Sponsor's protocol ID
MILES
Acronym
MILES
Status last verified
Oct 2024
First submitted
20 Aug 2014
Last updated
20 Nov 2024
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 38407859

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Viaskin Milk 150 mcg, Viaskin Milk 300 mcg and Viaskin Milk 500 mcg in people with Food Allergy, run by DBV Technologies at 17 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage (%) of Subjects Who Are Treatment Responders After 12 Months of EPIT Treatment. (time frame: From baseline to Month 12 (double-blind period)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02223182, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.

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