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

Study 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 therapeutic benefit with Viaskin Milk.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 2 Years - 17 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02223182
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

DBV Technologies
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Food Allergy
Arms & Interventions

Arms

Experimental: Viaskin Milk 150 mcg

Experimental: Viaskin Milk 300 mcg

Experimental: Viaskin Milk 500 mcg

Placebo Comparator: Viaskin Placebo

Interventions

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.

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.

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.

Biological: - Viaskin Placebo

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Arkansas Children's Hospital, Little Rock, Arkansas

Status

Address

Arkansas Children's Hospital

Little Rock, Arkansas, 72202

Rady Children's Hospital, San Diego, California

Status

Address

Rady Children's Hospital

San Diego, California, 92123

Stanford University School of Medicine, Stanford, California

Status

Address

Stanford University School of Medicine

Stanford, California, 94305

Children's Hospital Colorado, Aurora, Colorado

Status

Address

Children's Hospital Colorado

Aurora, Colorado, 80045

Chicago, Illinois

Status

Address

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

Chicago, Illinois, 60611

Johns Hopkins Hospital, Baltimore, Maryland

Status

Address

Johns Hopkins Hospital

Baltimore, Maryland, 21287

Massachusetts General Hospital, Boston, Massachusetts

Status

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Mount Sinai Medical Center, New York, New York

Status

Address

Mount Sinai Medical Center

New York, New York, 10029

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Address

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania

Status

Address

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224

Children's Medical Center of Dallas, Dallas, Texas

Status

Address

Children's Medical Center of Dallas

Dallas, Texas, 75235

ASTHMA, Inc., Seattle, Washington

Status

Address

ASTHMA, Inc.

Seattle, Washington, 98115

International Sites

Cheema Research Inc., Mississauga, Ontario, Canada

Status

Address

Cheema Research Inc.

Mississauga, Ontario, L5A 3V4

Ottawa Allergy Research Corporation, Ottawa, Ontario, Canada

Status

Address

Ottawa Allergy Research Corporation

Ottawa, Ontario, K1G6C6

Gordon Sussman Clinical Research Inc., Toronto, Ontario, Canada

Status

Address

Gordon Sussman Clinical Research Inc.

Toronto, Ontario, M4V 1R2

Montréal, Quebec, Canada

Status

Address

Centre Hospitalier Universitaire Sainte Justine

Montréal, Quebec, H3T 1C4

Québec, Canada

Status

Address

Clinique Spécialisée en allergie de la Capitale

Québec, , G1V 4W2

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