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Trial record 2 of 2 for:    DBV Technologies milk

Milk Patch for Eosinophilic Esophagitis (SMILEE)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02579876
First Posted: October 20, 2015
Last Update Posted: October 20, 2017
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.
Collaborator:
DBV Technologies
Information provided by (Responsible Party):
Antonella Cianferoni, Children's Hospital of Philadelphia
  Purpose
This is a single-site, double-blind, placebo-controlled, randomized trial to study efficacy and safety of the Viaskin® Milk Patch for children with milk induced Eosinophilic Esophagitis (EoE). 20 subjects will be randomized 3:1 to Viaskin® Milk or placebo patch.

Condition Intervention Phase
Eosinophilic Esophagitis Milk Allergy Drug: Viaskin Milk 500 mcg Drug: Viaskin Placebo 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 Efficacy and Safety of the Viaskin Milk for Treating Milk Induced Eosinophilic Esophagitis in Children

Resource links provided by NLM:


Further study details as provided by Antonella Cianferoni, Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Change in maximum esophageal eosinophil count from baseline to end of double-blind treatment. [ Time Frame: From baseline to month 11 ]
    Esophageal biopsy samples will be obtained prior to randomization and after completion of treatment. Intraepithelial eosinophils will be counted in all high powered fields (HPFs) using light microscopy. A HPF will be counted only if at least half of the field is occupied by tissue. The maximum eosinophil count per HPF will be reported for each esophageal biopsy site (at each of 2 levels).


Secondary Outcome Measures:
  • Change in Eosinophilic Esophagitis symptom score between baseline and end of each treatment period. [ Time Frame: From baseline to end of treatment at month 11 and month 22 ]
    Symptoms of Eosinophilic Esophagitis range from abdominal pain, gastroesophageal reflux, vomiting, and difficult swallowing. The symptoms will range from none to very severe as in Spergel54. The symptoms will be in 3 categories and individual symptoms and total symptoms scores will be collected on a range of 0-4 (0-none, 1-mild, 2-moderate, 3-severe and 4-very severe).

  • Change in Esophageal Endoscopy Score between baseline and end of each treatment period. [ Time Frame: From baseline to end of treatment at month 11 and month 22 ]
    Upper endoscopies with biopsies (2 each of proximal and distal, plus any inflamed areas) will be completed before and after each treatment period. Each endoscopy will be scored using a validated standardized measure which examines 4 major esophageal features (rings, furrows, exudates and edema) and the presence of minor features of narrow caliber esophagus, feline esophagus, stricture and crepe paper esophagus. Each feature is graded: 0-none, 1 mild, 2-moderate, 3-severe.

  • Change in the Eosinophilic Esophagitis Quality of Life (QOL) Score between baseline and end of each treatment period. [ Time Frame: From baseline to end of treatment at month 11 and month 22 ]
    Quality of life is a measurement of a subject's overall well-being. QOL will be measured by the validated age specific PedsQL Eosinophilic Esophagitis tool. The 33-item questionnaire includes for self-rating of symptoms (chest/throat/stomach pain and nausea/vomiting, trouble swallowing), Treatment, Worry (about treatment and disease), Communication with others, Food and Eating (allergies and limitations), Food Feelings (emotions associated with food allergies). The format is a Likert response scale, with higher scores indicating better HRQOL and lower EoE symptoms and problems.

  • Time to development symptoms after milk reintroduction (month 9) until the end of each treatment period. [ Time Frame: At Month 9 and Month 20 ]
    Milk will be reintroduced to all subjects 9 months after the second endoscopy in a similar amount and duration as done during the screening period while the subject is on a proton pump inhibitor. A daily symptom diary will be completed by subjects to record dietary information, symptoms and medications or treatment taken for symptoms.

  • Change in T cell count between baseline and end of each treatment period. [ Time Frame: From baseline to end of treatment at month 11 and month 22 ]
  • Change in immunoglobulin E (IgE) levels specific to milk between baseline and end of each treatment period. [ Time Frame: From baseline to end of treatment at month 11 and month 22 ]
  • Change in immunoglobulin G4 (IgG4) levels specific to milk between baseline and end of each treatment period. [ Time Frame: From baseline to end of treatment at month 11 and month 22 ]

Enrollment: 20
Study Start Date: October 2015
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Viaskin Milk 500 mcg
Viaskin patch containing milk protein. The patch is applied to the skin
Drug: 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.
Other Names:
  • Milk Patch
  • Viaskin Epicutaneous ImmunoTherapy (EPIT)
Placebo Comparator: Viaskin Placebo
Viaksin patch without any milk protein.
Drug: Viaskin Placebo
Biological: Viaskin Placebo Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation.
Other Names:
  • Placebo Patch
  • Placebo Epicutaneous ImmunoTherapy (EPIT)

Detailed Description:

This is a double-blind, placebo-controlled, randomized trial to study the efficacy and safety of Viaskin® Milk, an allergen extract of milk administered epicutaneously using the Viaskin® epicutaneous delivery system (EPIT) in subjects from 4 to 17 years old with a milk induced Eosinophilic Esophagitis. Subjects will be randomized in a 3:1 ratio into two different treatment groups, to receive EPIT with Viaskin® Milk (500 µg of milk proteins) or placebo.

Subjects who complete the double-blind treatment period (approximately 11 months), will automatically rollover into an open label treatment period (additional 11 months). All subjects will receive the 500 µg (micrograms) Viaskin Milk patch.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Well-documented medical history of Eosinophilic Esophagitis after ingestion of milk and currently following a strict milk-free diet.
  • Upper endoscopy and biopsy at initial clinical evaluation during Visit 2 showing greater than 15 eosinophils/HPF isolated to the esophagus meeting the consensus diagnosis of Eosinophilic Esophagitis, after milk was re-introduced into the subject's diet (30 ml/day for 1 week to 2 months), while the subject was on proton pump inhibitor.
  • Upper endoscopy and biopsy at second clinical evaluation during Visit 3 showing less than 5 eosinophils per HPF isolated to the esophagus after a minimum of 6 weeks under milk-free diet, and while the subject is on proton pump inhibitor.
  • Negative pregnancy test for female subjects of childbearing potential. Females of childbearing potential must use effective method of contraception to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of participation in the study. Sexual abstinence will be accepted as an effective method of contraception for girls below 18 years of age.
  • Subjects and/or parents/guardians willing to comply with all study requirements during their participation in the study.
  • Signed informed consent from parent(s)/guardian(s) of children < 18 years + children's assent.
  • Subjects agree to maintain a constant diet during the trial, with the exception of milk.
  • Subjects will maintain constant medications for asthma and allergic rhinitis during the trial.

Exclusion Criteria:

  • Subjects with a history of severe anaphylaxis to milk with the following symptoms: hypotension, hypoxia, neurological compromise (collapse, loss of consciousness or incontinence), Quincke Edema or requiring intubation.
  • Active IgE- mediated milk allergy.
  • Pregnancy or lactation.
  • Subjects with other eosinophilic gastrointestinal disorders.
  • Subjects on swallowed corticosteroids or anti-leukotrienes for Eosinophilic Esophagitis.
  • Subjects with symptomatic allergy to pollens whose symptoms during the corresponding pollen season might interfere with the recording of symptoms during the upper endoscopy/biopsy, if the upper endoscopy/biopsy is conducted during the pollen season. The Investigator will have to ensure that the period for conducting the upper endoscopy for such a subject will be outside of the pollen season.
  • Subjects treated with systemic long-acting corticosteroids (depot corticosteroids) within 12 weeks prior to Visit 1 and/or systemic short-acting corticosteroid within 4 weeks prior to Visit 1 or any systemic corticosteroid at screening.
  • Subjects with asthma conditions defined as follows:

    1. Uncontrolled persistent asthma by National Asthma Education and Prevention Program Asthma guidelines (2007).
    2. at least two systemic corticosteroid courses for asthma in the past year or one oral corticosteroid course for asthma in the past three months;
    3. prior intubation for asthma in the past two years.
  • Subjects on β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, calcium channel blockers or tricyclic antidepressant therapy.
  • Subjects undergoing any type of immunotherapy to any food within one year prior to Visit 1.
  • Subjects presently on aeroallergen immunotherapy and unwilling or unable to discontinue.
  • Subjects currently treated with anti-tumor necrosis factor drugs or anti-IgE drugs or any biologic immunomodulatory therapy within one year prior to Visit 1.
  • Allergy or known hypersensitivity to placebo excipients either of the Viaskin® or Tegaderm®.
  • Subjects suffering from generalized dermatologic diseases with no intact skin zones to apply the Viaskin®, or urticarial and mast cell disorders such as chronic idiopathic urticaria.
  • Subjects (or parents of subjects) with obvious excessive anxiety and unlikely to cope with the conditions of an upper endoscopy and biopsy.
  • Past or current disease(s), which in the opinion the sponsor-investigator, may affect the subject's participation in this study including but not limited to active autoimmune disorders, immunodeficiency, malignancy, uncontrolled diseases (hypertension, psychiatric (especially anxiety), cardiac), or other disorders (e.g., liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, or blood disorders).
  • Any history of drug or alcohol abuse in the past five years.
  • Subjects unable to follow the protocol and the protocol requirements.
  • Participation in another clinical intervention study in the three months prior to Study Visit 1.
  • Subjects on any experimental drugs or treatments.
  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): NCT02579876


Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
DBV Technologies
Investigators
Principal Investigator: Antonella Cianferoni, MD, PhD Children's Hospital of Philadelphia
  More Information

Responsible Party: Antonella Cianferoni, Assistant Professor, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT02579876     History of Changes
Other Study ID Numbers: 13-010148
First Submitted: October 14, 2015
First Posted: October 20, 2015
Last Update Posted: October 20, 2017
Last Verified: October 2017

Keywords provided by Antonella Cianferoni, Children's Hospital of Philadelphia:
Milk Allergy
Viaskin Milk
Epicutaneous ImmunoTherapy (EPIT)
Eosinophilic Esophagitis
Milk-Induced Eosinophilic Esophagitis

Additional relevant MeSH terms:
Milk Hypersensitivity
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Food Hypersensitivity