A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab

Utah System of Higher Education (USHE)

Status and phase

Completed

Phase 2

Conditions

Esophagitis

Treatments

Drug: omalizumab

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00123630

13623

Details and patient eligibility

About

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

Full 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.

Enrollment

30 patients

Sex

All

Ages

12 to 60 years old

Volunteers

No Healthy Volunteers

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.