A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab
Condition: Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 2

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
    

Detailed description: 
      This is a dual-center double-blind, placebo controlled trial of omalizumab for the treatment
      of EE. Omalizumab will be dosed depending on the patient's body weight and baseline IgE
      level. Omalizumab or placebo will be administered subcutaneously every 4 weeks for 16 weeks.
      At study entry subjects will have EGD with biopsies performed to ensure the diagnosis and
      obtain tissue for histologic analysis. No dilation will be performed at this time. Baseline
      validated questionnaires for dysphagia, GERD, and atopy will also be administered. Blood will
      be drawn for baseline serum testing. Repeat questionnaires and rating of overall symptom
      improvement will be administered at 4 week intervals for the rest of the study period. At the
      end of the 16 week period, repeat endoscopy will be performed and biopsies taken. Esophageal
      dilation may be performed if clinically indicated at this time. Blood will also be drawn for
      repeat serum testing.
    

Intervention name(s): omalizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): omalizumab dosed IV based on IgE level and weight every 2 - 4 weeks; Placebo given IV once every 2-4 weeks based on weight
Other intervention name(s): Xolair; saline
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: eosinophilic esophagitis; omalizumab