Identifying Responders to Xolair (Omalizumab) Using Eosinophilic Esophagitis as a Disease Model
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Eosinophilic Esophagitis(EoE) is a condition characterized commonly by vomiting, nausea,
      epigastric pain, dysphagia, heartburn and food impaction among other gastrointestinal
      symptoms along with obstructive esophageal symptoms in both pediatric and adult population.
      The pathology of this disease is postulated to be allergy mediated and the incidence of this
      disease is seen to parallel an increase in the incidence of allergies and asthma.

      Most of the current therapies for EoE are directed at decreasing esophageal allergic
      inflammation and mirror the treatment options for allergic asthma. Swallowed corticosteroids
      and elimination diets or elemental diets have shown variable efficacy is improving symptoms.
      However, specific pathophysiologic mechanism of EoE is still largely unknown and there is no
      definitive treatment that completely resolves symptoms and histological findings. Omalizumab
      is a recently developed anti-IgE antibody that has been shown to decrease the use of inhaled
      and oral corticosteroids and improve asthma related symptoms in patients with allergic
      asthma. In this study, Eosinophilic esophagitis is being used as a disease model to study the
      mechanism of action of monoclonal Anti-IgE antibody in vivo. The resolution of symptoms
      clinically, and histological changes (and improvements) in response to treatment with Xolair
      (omalizumab) in patients suffering from EoE will be determined. The primary objective of this
      open label, study is to determine mucosal markers that will predict responders to Omalizumab
      (Xolair).
    

Detailed description: 
      This is an open label mechanistic study to learn about the effect of Omalizumab on the
      clinical symptoms and immunohistological findings in established cases of EoE. The dosage for
      Omalizumab will be based on patient's body weight and baseline IgE level. Omalizumab will be
      administered subcutaneously every 2 or 4 weeks for total duration of 12 weeks. At enrollment,
      subjects will have EGD with biopsies performed to confirm diagnosis of EoE and further
      histologic analysis and special staining. Blood will be drawn for baseline testing and
      monthly for safety labs. At the end of the 12 week period, repeat endoscopy will be performed
      and biopsies taken to stain again for various mucosal markers like IgE, IL-13, IL-5 and
      Tryptase. The patients will be followed for response to therapy with regards to resolution of
      symptoms and improvement in histology findings on biopsy.
    

Intervention name(s): Omalizumab
Intervention type(s): Biological
Intervention description(s): Omalizumab, an anti-IgE monoclonal antibody is dosed on the basis of subject's weight and IgE levels. It is administered as a subcutaneous injection every 2 weeks or 4 weeks based on the total dose required.
Other intervention name(s): Xolair
Intervention MeSH terms: Omalizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Eosinophilic Esophagitis; Xolair; Omalizumab; Esophagitis; Eosinophils; monoclonal antibody