Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    viaskin milk
Previous Study | Return to List | Next Study

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

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.
 
ClinicalTrials.gov Identifier: NCT02223182
Recruitment Status : Active, not recruiting
First Posted : August 22, 2014
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
DBV Technologies

Tracking Information
First Submitted Date  ICMJE August 20, 2014
First Posted Date  ICMJE August 22, 2014
Last Update Posted Date August 8, 2019
Actual Study Start Date  ICMJE November 2014
Actual Primary Completion Date December 14, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2019)
  • Mean and median CRD of cow's milk proteins. [ Time Frame: From baseline to Month 12 ]
  • Change in levels of sIgE and sIgG4 to cow's milk. [ Time Frame: From baseline to Week 3, Month 3, Month 6, Month 12 ]
  • 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 ]
  • Change in Skin Prick Test wheal. [ Time Frame: From baseline to Month 3, Month 6, Month 12 ]
  • Change in the severity of symptoms elicited during the milk DBPCFC. [ Time Frame: From baseline to Month 12 ]
  • Change in Quality of Life (QoL) assessments. [ Time Frame: From baseline to Month 12 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2014)
  • The percentage (%) of subjects who are treatment responders at Month 24. [ Time Frame: From baseline to Month 24. ]
  • The change in cow's milk-specific Immunoglobulin E (IgE) and Immunoglobulin G4 (IgG4). [ Time Frame: From baseline to Week 3, Month 3, Month 6, Month 12, Month 18, and Month 24. ]
  • The change in basophil activation tests. [ Time Frame: From baseline to Month 3, Month 6, Month 12 and Month 24. ]
  • The change in IgE and IgG4 specific to caseins, α-lactalbumin or β-lactoglobulin. [ Time Frame: From baseline to Week 3, Month 3, Month 6, Month 12, Month 18 and Month 24. ]
  • The change in skin prick test wheal. [ Time Frame: From baseline to Month 3, Month 6, Month 12, Month 18 and Month 24. ]
  • The change in the severity of symptoms elicited during the milk DBPCFC. [ Time Frame: From baseline to Month 12 and Month 24. ]
  • The change in Quality of Life (QoL) assessments. [ Time Frame: From baseline to Month 12 and Month 24. ]
  • Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) by system organ class, severity and relatedness to the investigational product. [ Time Frame: Throughout the treatment period (24 months). ]
  • Viaskin Milk-induced local Adverse Events (AEs). [ Time Frame: Throughout the treatment period (24 months). ]
  • Systemic allergic symptoms and relatedness to Viaskin Milk. [ Time Frame: Throughout the treatment period (24 months). ]
  • Severity of TEAEs or TESAEs elicited during the DBPCFC. [ Time Frame: Throughout the treatment period (24 months). ]
  • Mean CRD of cow's milk proteins. [ Time Frame: From baseline to Month 12 and Month 24. ]
  • Median CRD of cow's milk proteins. [ Time Frame: From baseline to Month 12 and Month 24. ]
  • Composite measure of Vital signs. [ Time Frame: up to 24 months ]
  • Composite measure of Physical examinations. [ Time Frame: up to 24 months ]
  • Composite measure of Laboratory data. [ Time Frame: Baseline, Week 3, Month 3, Month 6, Month 12, Month 18 and Month 24. ]
  • Spirometry. [ Time Frame: Baseline, Day 1, Week 3, Month 3, Month 6, Month 12, Month 18 and Month 24. ]
  • Peak Expiratory Flow (PEF). [ Time Frame: up to 24 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Viaskin Milk in Children With IgE-Mediated Cow's Milk Allergy
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Food Allergy
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Viaskin Milk 150 mcg
    Intervention: Biological: Viaskin Milk 150 mcg
  • Experimental: Viaskin Milk 300 mcg
    Intervention: Biological: Viaskin Milk 300 mcg
  • Experimental: Viaskin Milk 500 mcg
    Intervention: Biological: Viaskin Milk 500 mcg
  • Placebo Comparator: Viaskin Placebo
    Intervention: Biological: Viaskin Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 16, 2016)
198
Original Estimated Enrollment  ICMJE
 (submitted: August 21, 2014)
150
Estimated Study Completion Date  ICMJE December 2020
Actual Primary Completion Date December 14, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02223182
Other Study ID Numbers  ICMJE MILES
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party DBV Technologies
Study Sponsor  ICMJE DBV Technologies
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account DBV Technologies
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP