Trial Search Results

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

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

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

DBV Technologies

Stanford Investigator(s):

Intervention(s):

  • Biological: Viaskin Milk 150 mcg
  • Biological: Viaskin Milk 300 mcg
  • Biological: Viaskin Milk 500 mcg
  • Biological: Viaskin Placebo

Phase:

Phase 1/Phase 2

Eligibility


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.

Ages Eligible for Study

2 Years - 17 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kari Nadeau
650-724-0293
Not Recruiting