Please select the eligibility criteria that correspond to the clinical trial below.
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
Brief Summary: 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.


Options:
A: Inclusion Criteria:

* every patient with the diagnosis Eosinophilic Esophagitis
* pediatric and adult EoE patients
B: Key Inclusion Criteria (Parts A \& B):

* A documented diagnosis of EoE by endoscopic biopsy
* Baseline endoscopic biopsies with a demonstration on central reading of intraepithelial eosinophilic infiltration
* History (by patient report) of an average of at least 2 episodes of dysphagia (with intake of solids) per week in the 4 weeks prior to screening

Key Exclusion Criteria (Parts A \& B):

* Body weight ≤40 kg
* Prior participation in a dupilumab clinical trial, or past or current treatment with dupilumab
* Initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food group in the 6 weeks prior to screening.
* Other causes of esophageal eosinophilia or the following conditions: hypereosinophilic syndrome and eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome)
* Active Helicobacter pylori infection
* History of achalasia, Crohn's disease, ulcerative colitis, celiac disease, and prior esophageal surgery
* Any esophageal stricture unable to be passed with a standard, diagnostic, 9 to10 mm upper endoscope or any critical esophageal stricture that requires dilation at screening
* History of bleeding disorders or esophageal varices
* Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study

Key Exclusion Criteria (Part C):

* Participants who, during Part A or Part B, developed a serious adverse event (SAE) and/or adverse event (AE) deemed related to study drug, which in the opinion of the investigator could indicate that continued treatment with study drug may present an unreasonable risk for the participant
* Participants who became pregnant during Part A or Part B
* Participants who are prematurely discontinued from study drug due to an AE (patients who are prematurely discontinued from study drug due to lack of efficacy are eligible to enter Part C)
* Patients who did not undergo endoscopy with biopsies prior to receiving rescue treatment

Note: Other inclusion/ exclusion criteria apply
C: 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/high power field (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-Immunoglobulin E (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.
D: Inclusion Criteria:

* New diagnosis of eosinophilic esophagitis (per 2007 consensus guidelines)

Exclusion Criteria:

* Age \< 18
* Inability to read or understand English
* Pregnant or nursing women
* Previous allergic reactions to steroid medications
* Current use of systemic steroids

Answer: C