- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02223182
Efficacy and Safety of Viaskin Milk in Children With IgE-Mediated Cow's Milk Allergy (MILES)
February 1, 2021 updated by: DBV Technologies
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
198
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Québec, Canada, G1V 4W2
- Clinique Specialisee en Allergie de la Capitale
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Ontario
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Mississauga, Ontario, Canada, L5A 3V4
- Cheema Research Inc.
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Ottawa, Ontario, Canada, K1G6C6
- Ottawa Allergy Research Corporation
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Toronto, Ontario, Canada, M4V 1R2
- Gordon Sussman Clinical Research Inc.
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Quebec
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Montréal, Quebec, Canada, H3T 1C4
- Centre Hospitalier Universitaire Sainte Justine
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Arkansas
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Little Rock, Arkansas, United States, 72202
- Arkansas Children's Hospital
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California
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San Diego, California, United States, 92123
- Rady Children's Hospital
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Stanford, California, United States, 94305
- Stanford University School of Medicine
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Colorado
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Aurora, Colorado, United States, 80045
- Children's Hospital Colorado
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Illinois
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Chicago, Illinois, United States, 60611
- Ann & Robert H. Lurie Children's Hospital of Chicago
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Hospital
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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New York
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New York, New York, United States, 10029
- Mount Sinai Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, United States, 15224
- Children's Hospital of Pittsburgh
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Texas
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Dallas, Texas, United States, 75235
- Children's Medical Center of Dallas
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Washington
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Seattle, Washington, United States, 98115
- ASTHMA, Inc.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Viaskin Milk 150 mcg
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Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 150 mcg cow's milk proteins.
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Experimental: Viaskin Milk 300 mcg
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Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 300 mcg cow's milk proteins.
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Experimental: Viaskin Milk 500 mcg
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Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins.
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Placebo Comparator: Viaskin Placebo
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Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The primary efficacy endpoint will be the percentage (%) of subjects who are treatment responders after 12 months of EPIT treatment.
Time Frame: From baseline to Month 12.
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A treatment responder is defined as a subject who meets at least one of the following criteria:
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From baseline to Month 12.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean and median CRD of cow's milk proteins.
Time Frame: From baseline to Month 12
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From baseline to Month 12
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Change in levels of sIgE and sIgG4 to cow's milk.
Time Frame: From baseline to Week 3, Month 3, Month 6, Month 12
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From baseline to Week 3, Month 3, Month 6, Month 12
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Change in levels of sIgE and sIgG4 to caseins, α-lactalbumin and β-lactoglobulin
Time Frame: From baseline to Week 3, Month 3, Month 6, Month 12
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From baseline to Week 3, Month 3, Month 6, Month 12
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Change in Skin Prick Test wheal.
Time Frame: From baseline to Month 3, Month 6, Month 12
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From baseline to Month 3, Month 6, Month 12
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Change in the severity of symptoms elicited during the milk DBPCFC.
Time Frame: From baseline to Month 12
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From baseline to Month 12
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Change in Quality of Life (QoL) assessments.
Time Frame: From baseline to Month 12
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From baseline to Month 12
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Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Time Frame: Up to 6 years
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Up to 6 years
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Percentage of subjects who are treatment responders over the course of the open-label treatment period.
Time Frame: Up to 5 years in the open-label treatment period
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Up to 5 years in the open-label treatment period
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CRD of cow's milk protein over the course of the open-label treatment period
Time Frame: Up to 5 years in the open-label treatment period
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Up to 5 years in the open-label treatment period
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2014
Primary Completion (Actual)
December 14, 2017
Study Completion (Actual)
December 22, 2020
Study Registration Dates
First Submitted
August 20, 2014
First Submitted That Met QC Criteria
August 21, 2014
First Posted (Estimate)
August 22, 2014
Study Record Updates
Last Update Posted (Actual)
February 3, 2021
Last Update Submitted That Met QC Criteria
February 1, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MILES
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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