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A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00123630
Recruitment Status : Completed
First Posted : July 25, 2005
Results First Posted : October 21, 2013
Last Update Posted : May 20, 2016
Novartis Pharmaceuticals
Information provided by (Responsible Party):
John C. Fang, M.D., University of Utah

Brief 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

Condition or disease Intervention/treatment Phase
Esophagitis Drug: omalizumab Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab
Study Start Date : November 2005
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Omalizumab

Arm Intervention/treatment
Placebo Comparator: placebo
placebo group
Drug: Placebo
Placebo given IV once every 2-4 weeks based on weight
Other Name: saline

Experimental: omalizumab
Xolair group
Drug: omalizumab
omalizumab dosed IV based on IgE level and weight every 2 - 4 weeks
Other Name: Xolair

Primary Outcome Measures :
  1. Change in Eosinophil Numbers Per High Power Field Proximally and Distally Between Baseline and Post-treatment and Between Both Groups [ Time Frame: 16 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00123630

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United States, Utah
University of Utah HSC
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Novartis Pharmaceuticals
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Principal Investigator: John C. Fang, M.D. University of Utah HSC
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: John C. Fang, M.D., Principal Investigator, University of Utah Identifier: NCT00123630    
Other Study ID Numbers: 13623
First Posted: July 25, 2005    Key Record Dates
Results First Posted: October 21, 2013
Last Update Posted: May 20, 2016
Last Verified: March 2016
Keywords provided by John C. Fang, M.D., University of Utah:
eosinophilic esophagitis
Additional relevant MeSH terms:
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Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Immune System Diseases
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents