- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00123630
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
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84132
- University of Utah HSC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: placebo
placebo group
|
Placebo given IV once every 2-4 weeks based on weight
Other Names:
|
EXPERIMENTAL: omalizumab
Xolair group
|
omalizumab dosed IV based on IgE level and weight every 2 - 4 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Eosinophil Numbers Per High Power Field Proximally and Distally Between Baseline and Post-treatment and Between Both Groups
Time Frame: 16 weeks
|
16 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Hematologic Diseases
- Gastrointestinal Diseases
- Gastroenteritis
- Hypersensitivity
- Esophageal Diseases
- Leukocyte Disorders
- Eosinophilia
- Eosinophilic Esophagitis
- Esophagitis
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Omalizumab
Other Study ID Numbers
- 13623
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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