A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
John C. Fang, M.D., University of Utah
ClinicalTrials.gov Identifier:
NCT00123630
First received: July 21, 2005
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Esophagitis
Drug: omalizumab
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Change in Eosinophil Numbers Per High Power Field Proximally and Distally Between Baseline and Post-treatment and Between Both Groups [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To Determine the Effect of Omalizumab on Other Clinical and Histological Parameters of EE Including Reducing the Symptoms of EE Measured by Overall Improvement in Esophageal Symptoms [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: November 2005
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   12 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123630

Locations
United States, Utah
University of Utah HSC
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Novartis Pharmaceuticals
Investigators
Principal Investigator: John C. Fang, M.D. University of Utah HSC
  More Information

No publications provided

Responsible Party: John C. Fang, M.D., Principal Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT00123630     History of Changes
Other Study ID Numbers: 13623
Study First Received: July 21, 2005
Results First Received: September 5, 2012
Last Updated: August 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
eosinophilic esophagitis
omalizumab

Additional relevant MeSH terms:
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Omalizumab
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 11, 2014