Please select the eligibility criteria that correspond to the clinical trial below.
Title: Oral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11-40 Years of Age)With Eosinophilic Esophagitis: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study With an Open Label Extension
Brief Summary: This is a clinical trial to test an experimental drug for the treatment of Eosinophilic Esophagitis (EoE)


Options:
A: 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
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:

* Males and Females, age 11-40
* Histologic evidence of EoE
* History of clinical symptoms of EoE including dysphagia
* Willing to continue with dietary, environmental or medical therapy
* Ability to read and understand english
* Written Consent

Exclusion Criteria:

* Any Medical condition that may compromise the safety of the subjects or interfere with the signs and symptoms of EoE
* Use of immunomodulatory therapy
* Current use of swallowed corticosteroids
* Esophageal strictures,varices or upper GI bleed
* Other current diseases of the GI tract
* Current viral infection or immunodeficiency condition
* Pregnancy
* Hypersensitivity to budesonide
* History of non compliance
D: Inclusion Criteria:

* Document evidence/presence of Oesophagitis prior to commencing trial drug.
* a)Histological evidence of Oesophagitis: greater than 20x eosinophils per high power field (X400) on histology of esophageal mucosal biopsy
* b. at least one episode of dysphagia per week
* c.Inadequate response to routine EE treatment
* D. No other known causes of oesophagitis, or esophageal or generalized eosinophilia
* Not pregnant or nursing

Exclusion criteria:

* History of seasonal worsening of EE symptoms or requirement of Esophageal dilation.
* Churg-Strauss Syndrome
* Wegener's Granulomatosis
* Lymphoma, hematological malignancy, advanced and metastatic solid tumors
* Active H. pylori infection.
* Any previous treatment with anti-hIL-5, anti-IgE monoclonal antibody or other biological agents.

Answer: C