Identifying Responders to Xolair (Omalizumab) Using Eosinophilic Esophagitis as a Disease Model
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).
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Identifying Responders to Xolair (Omalizumab) Using Eosinophilic Esophagitis as a Disease Model|
- Our primary objective is to determine markers that will predict responders to Omalizumab(Xolair) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Secondary objectives will be determining the immunological changes in the tissue before and after treatment with Xolair (omalizumab) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01040598
|United States, Virginia|
|O & O Alpan LLC|
|Springfield, Virginia, United States, 22152|
|Principal Investigator:||Oral Alpan, MD||O & O Alpan LLC|