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

July 21, 2005
July 25, 2005
September 5, 2012
October 21, 2013
May 20, 2016
November 2005
January 2010   (Final data collection date for primary outcome measure)
Change in Eosinophil Numbers Per High Power Field Proximally and Distally Between Baseline and Post-treatment and Between Both Groups [ Time Frame: 16 weeks ]
The determination of the efficacy of omaluzimab in the treatment of eosinophilic eosophageal infiltration in EE patients
Complete list of historical versions of study NCT00123630 on Archive Site
Not Provided
To determine the effect of omaluzimab on other clinical and histological parameters of EE including reducing the symptoms of EE measured by overall improvement in esophageal symptoms
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Not Provided
A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab
A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab

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

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.
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Drug: omalizumab
    omalizumab dosed IV based on IgE level and weight every 2 - 4 weeks
    Other Name: Xolair
  • Drug: Placebo
    Placebo given IV once every 2-4 weeks based on weight
    Other Name: saline
  • Placebo Comparator: placebo
    placebo group
    Intervention: Drug: Placebo
  • Experimental: omalizumab
    Xolair group
    Intervention: Drug: omalizumab
Clayton F, Fang JC, Gleich GJ, Lucendo AJ, Olalla JM, Vinson LA, Lowichik A, Chen X, Emerson L, Cox K, O'Gorman MA, Peterson KA. Eosinophilic esophagitis in adults is associated with IgG4 and not mediated by IgE. Gastroenterology. 2014 Sep;147(3):602-9. doi: 10.1053/j.gastro.2014.05.036. Epub 2014 Jun 4.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2010
January 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
12 Years to 60 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Not Provided
John C. Fang, M.D., University of Utah
University of Utah
Novartis Pharmaceuticals
Principal Investigator: John C. Fang, M.D. University of Utah HSC
University of Utah
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP