A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab
Condition: Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Intervention: omalizumab; Placebo
Intervention description: omalizumab dosed IV based on IgE level and weight every 2 - 4 weeks; Placebo given IV once every 2-4 weeks based on weight
Intervention MeSH terms: Omalizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 12 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: eosinophilic esophagitis; omalizumab

Summary:

      Eosinophilic esophagitis (EE) is an increasingly recognized condition characterized by
      dysphagia, food impaction or other obstructive esophageal symptoms in children and young
      adults.

      The pathophysiology of EE appears to be an allergy/atopy mediated disease. A personal and
      family history of allergic diseases (food allergies, atopic dermatitis, asthma, allergic
      rhinitis or conjunctivitis) has been noted in 62-85% of patients with EE. The rising
      incidence of EE may be related to the worldwide allergy and asthma epidemic.

      Current treatment of EE is directed at decreasing esophageal allergic inflammation. Oral and
      topical corticosteroids, cromolyn sodium, montelukast and elemental/elimination diets have
      all been shown to be effective. However, none of these treatments are directed at the
      specific pathophysiologic mechanism of EE and some have significant side effects.

      The shared pathogenetic mechanisms of EE and asthma suggest that therapeutic strategies
      directed at asthma may also be effective for EE. Specifically those targeted at the allergic
      immune mechanisms involved with asthma may be effective. Omalizumab is a recently developed
      anti-IgE antibody that has been shown to decrease the use of inhaled and oral
      corticosteroids, reduce the frequency of asthma exacerbations, and improve asthma related
      symptoms in patients with allergic asthma. The objective of the study is to determine the
      efficacy of omalizumab in the treatment of eosinophilic esophagitis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects aged 12-60 years of age with EE as defined above

          -  Serum IgE level 30-700 IU/mL

          -  Subjects with acceptable medical history, physical exam and laboratory test results

          -  No history of bleeding diathesis, significant cardiopulmonary disease, or other
             contraindication to upper endoscopy

        Exclusion Criteria:

          -  Need for esophageal dilation at enrollment due to food impaction or inability to pass
             endoscope

          -  Inability of subject to provide informed consent (if ages 18-60), or inability of
             children (ages 12-17) to provide assent

          -  History of esophagogastric surgery

          -  Presence of other esophageal pathology that could account for patients' symptoms
             including eosinophil infiltration due to gastroesophageal reflux disease (GERD)

          -  Incarceration

          -  Pregnancy

          -  Women of childbearing potential not using the contraception method(s)

          -  Patients with elevated serum IgE levels for reasons other than atopy

          -  Patients taking cromolyn sodium or nedocromil sodium within 1 month of visit 1

          -  Patients taking oral or topical corticosteroids within one month of visit 1

          -  Patients taking leukotriene receptor inhibitors within one month of visit 1

          -  Patients with severe medical condition(s) that in the view of the investigator
             prohibits participation in the study

          -  Patients with a history of noncompliance to medical regimens or who were considered
             potentially unreliable

          -  Use of any other investigational agent in the last 30 days

          -  Patients with a known hypersensitivity to any ingredient of rhuMAb-E25, study rescue
             medication

          -  Patients with Barrett's esophagus will be excluded if found endoscopically or
             pathologically at biopsy

          -  Currently treated with omalizumab or treated with omalizumab within the past 6 months.