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Trial record 1 of 2 for:    DBV Technologies milk
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Efficacy and Safety of Viaskin Milk in Children With IgE-Mediated Cow's Milk Allergy (MILES)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02223182
First Posted: August 22, 2014
Last Update Posted: December 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
DBV Technologies
  Purpose
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 treatment efffect of up to 48 months of treatment with Viaskin Milk

Condition Intervention Phase
Food Allergy Biological: Viaskin Milk 150 mcg Biological: Viaskin Milk 300 mcg Biological: Viaskin Milk 500 mcg Biological: Viaskin Placebo Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by DBV Technologies:

Primary Outcome Measures:
  • 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. ]

    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.


Secondary Outcome Measures:
  • The percentage (%) of subjects who are treatment responders at Months 24, 36 and 48. [ Time Frame: From baseline to Months 24, 36 and 48. ]
  • The change in levels of sIgE to cow's milk. [ Time Frame: From baseline to Week 3, Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36, Month 42 and Month 48. ]
  • The change in levels of allergen-specific Immunoglobulin G4 (sIgG4) to cow's milk. [ Time Frame: From baseline to Week 3, Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36, Month 42 and Month 48. ]
  • The change in levels of specific Immunoglobulin E (sIgE) to caseins. [ Time Frame: From baseline to Week 3, Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36, Month 42 and Month 48. ]
  • The change in levels of sIgG4 to caseins. [ Time Frame: From baseline to Week 3, Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36, Month 42 and Month 48. ]
  • The change in levels of sIgE to α-lactalbumin. [ Time Frame: From baseline to Week 3, Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36, Month 42 and Month 48. ]
  • The change in levels of sIgG4 to α-lactalbumin. [ Time Frame: From baseline to Week 3, Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36, Month 42 and Month 48. ]
  • The change in levels of sIgE to β-lactoglobulin. [ Time Frame: From baseline to Week 3, Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36, Month 42 and Month 48. ]
  • The change in levels of sIgG4 to β-lactoglobulin. [ Time Frame: From baseline to Week 3, Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36, Month 42 and Month 48. ]
  • The change in skin prick test wheal. [ Time Frame: From baseline to Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36, Month 42 and Month 48. ]
  • The change in the severity of symptoms elicited during the milk DBPCFC. [ Time Frame: From baseline to Month 12, Month 24, Month 36 and Month 48. ]
  • The change in Quality of Life (QoL) assessments. [ Time Frame: From baseline to Month 12, Month 24, Month 36 and Month 48. ]
  • Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) by system organ class, preferred term, maximum severity and relatedness to the investigational product. [ Time Frame: Throughout the treatment period (48 months). ]
  • TEAEs leading to study discontinuation, and relatedness to the investigational product. [ Time Frame: Throughout the treatment period (48 months). ]
  • Incidence, duration and maximum severity of local cutaneous reactions, as assessed by the subject. [ Time Frame: up to 48 months ]
  • Severity of local cutaneous reactions, as assessed by the Investigator [ Time Frame: up to 48 months ]
  • Systemic allergic symptoms and relatedness to the investigational product [ Time Frame: Throughout the treatment period (48 months). ]
  • Frequency and severity of symptoms elicited during the DBPCFC. [ Time Frame: Throughout the treatment period (48 months). ]
  • Mean CRD of cow's milk proteins. [ Time Frame: From baseline to Month 12, Month 24, Month 36 and Month 48. ]
  • Median CRD of cow's milk proteins. [ Time Frame: From baseline to Month 12, Month 24, Month 36 and Month 48. ]
  • Composite measure of Vital signs. [ Time Frame: up to 48 months ]
  • Composite measure of Physical examinations. [ Time Frame: up to 48 months ]
  • Composite measure of Laboratory data. [ Time Frame: Baseline, Week 3, Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36, Month 42 and Month 48. ]
  • Spirometry. [ Time Frame: Baseline, Day 1, Week 3, Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36, Month 42 and Month 48. ]
  • Peak Expiratory Flow (PEF). [ Time Frame: up to 48 months ]

Enrollment: 198
Study Start Date: November 2014
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Viaskin Milk 150 mcg Biological: 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.
Experimental: Viaskin Milk 300 mcg Biological: 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.
Experimental: Viaskin Milk 500 mcg Biological: 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.
Placebo Comparator: Viaskin Placebo Biological: Viaskin Placebo
Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Eligibility criteria for Study Extension (Months 24 to 48)

The inclusion and exclusion criteria for entry in the study extension up to Month 48 are listed below.

Inclusion Criteria:

  1. Signed study extension ICF by parent(s)/guardian(s) of subjects and informed assent form for subjects ≥7 years, or as per local or country specific guidelines or regulations.
  2. Subjects who completed the first 2 years in MILES, including a complete documented DBPCFC at Month 24.
  3. Negative urine pregnancy test at Month 24 for female subjects of childbearing potential. Female subjects of childbearing potential must continue to agree and commit to using 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 females below 15 years of age.
  4. Subjects must agree to continue following a strict cow's milk-free diet, with no consumption of dairy or baked milk products during participation in the study (except during the DBPCFCs).
  5. Subjects and/or parents/guardians willing to comply with all study requirements during participation in the study extension.

Exclusion Criteria:

  1. Any new disorder or disease that may affect the subject's participation in the study, or place the subject at increased risk, or for which epinephrine use is contraindicated.
  2. Poor compliance in patch application (below 80%), defined as patch not applied at all for >73 days (either consecutive or not) during the second year of participation in MILES.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02223182


Locations
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, California
Rady Children's Hospital
San Diego, California, United States, 92123
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
Children's Medical Center of Dallas
Dallas, Texas, United States, 75235
United States, Washington
ASTHMA, Inc.
Seattle, Washington, United States, 98115
Canada, Ontario
Cheema Research Inc.
Mississauga, Ontario, Canada, L5A 3V4
Ottawa Allergy Research Corporation
Ottawa, Ontario, Canada, K1G6C6
Gordon Sussman Clinical Research Inc.
Toronto, Ontario, Canada, M4V 1R2
Canada, Quebec
Centre Hospitalier Universitaire Sainte Justine
Montréal, Quebec, Canada, H3T 1C4
Clinique Spécialisée en allergie de la Capitale
Québec, Quebec, Canada, G1V 4W2
Sponsors and Collaborators
DBV Technologies
  More Information

Responsible Party: DBV Technologies
ClinicalTrials.gov Identifier: NCT02223182     History of Changes
Other Study ID Numbers: MILES
First Submitted: August 20, 2014
First Posted: August 22, 2014
Last Update Posted: December 19, 2016
Last Verified: December 2016

Keywords provided by DBV Technologies:
Milk Allergy,
Viaskin Milk,
Specific Immunotherapy,
Epicutaneous ImmunoTherapy (EPIT)
IgE-Mediated Cow's Milk Allergy

Additional relevant MeSH terms:
Hypersensitivity
Food Hypersensitivity
Milk Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate