At a glance
ClinicalIndex Comparison Record- ✓Age 12-60 years with diagnosed eosinophilic esophagitis
- ✓Serum IgE level between 30-700 IU/mL
- ✓Acceptable medical history, physical exam, and laboratory results
- ✓No contraindication to upper endoscopy (no bleeding diathesis, significant cardiopulmonary disease, or other contraindications)
- ✕Need for esophageal dilation at enrollment due to food impaction or inability to pass endoscope
- ✕History of esophagogastric surgery
- ✕Other esophageal pathology that could account for symptoms, including eosinophil infiltration due to GERD
- ✕Barrett's esophagus identified endoscopically or pathologically at biopsy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab
In Brief
A Phase 2 clinical trial evaluating omalizumab and Placebo for Esophagitis. Completed, enrolled 30 participants across 1 site.
Detailed 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
Study Details
Timeline
Interventions
omalizumab dosed IV based on IgE level and weight every 2 - 4 weeks
Placebo given IV once every 2-4 weeks based on weight