A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab

NCT00123630 | Completed Phase 2 Results

• 1 other identifier: 13623
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Esophagitis

Keywords

eosinophilic esophagitis; omalizumab

Outcome Measures

Primary Outcomes (1)

• Change in Eosinophil Numbers Per High Power Field Proximally and Distally Between Baseline and Post-treatment and Between Both Groups

  16 weeks

Study Arms (2)

placebo

PLACEBO COMPARATOR

placebo group

Drug: Placebo

omalizumab

EXPERIMENTAL

Xolair group

Drug: omalizumab

Interventions

omalizumab DRUG

omalizumab dosed IV based on IgE level and weight every 2 - 4 weeks

Also known as: Xolair

omalizumab

Placebo DRUG

Placebo given IV once every 2-4 weeks based on weight

Also known as: saline

placebo

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

University of Utah HSC

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

• 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.

  PMID: 24907494 DERIVED

MeSH Terms

Conditions

Esophagitis; Eosinophilic Esophagitis

Interventions

Omalizumab; Sodium Chloride

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

small numbers enrolled

Results Point of Contact

• Title: Dr. John Fang
• Organization: University of Utah

john.fang@hsc.utah.edu

801-581-7802

Study Officials

• John C. Fang, M.D.

  University of Utah HSC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 21, 2005
• First Posted: July 25, 2005
• Study Start: November 1, 2005
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: May 20, 2016
• Results First Posted: October 21, 2013

Record last verified: 2016-03

Locations

US (1)