- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01040598
Identifying Responders to Xolair (Omalizumab) Using Eosinophilic Esophagitis as a Disease Model
Eosinophilic Esophagitis(EoE) is a condition characterized commonly by vomiting, nausea, epigastric pain, dysphagia, heartburn and food impaction among other gastrointestinal symptoms along with obstructive esophageal symptoms in both pediatric and adult population. The pathology of this disease is postulated to be allergy mediated and the incidence of this disease is seen to parallel an increase in the incidence of allergies and asthma.
Most of the current therapies for EoE are directed at decreasing esophageal allergic inflammation and mirror the treatment options for allergic asthma. Swallowed corticosteroids and elimination diets or elemental diets have shown variable efficacy is improving symptoms. However, specific pathophysiologic mechanism of EoE is still largely unknown and there is no definitive treatment that completely resolves symptoms and histological findings. Omalizumab is a recently developed anti-IgE antibody that has been shown to decrease the use of inhaled and oral corticosteroids and improve asthma related symptoms in patients with allergic asthma. In this study, Eosinophilic esophagitis is being used as a disease model to study the mechanism of action of monoclonal Anti-IgE antibody in vivo. The resolution of symptoms clinically, and histological changes (and improvements) in response to treatment with Xolair (omalizumab) in patients suffering from EoE will be determined. The primary objective of this open label, study is to determine mucosal markers that will predict responders to Omalizumab (Xolair).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Virginia
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Springfield, Virginia, United States, 22152
- O & O Alpan LLC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria
- Established diagnosis of eosinophilic esophagitis, determined by eosinophils >15/high power field in the distal esophagus and/or microabscesses.
- Patients should be on therapy either by food avoidance or swallowed steroids, with no change in the food avoidance and steroid dose during therapy.
- One active symptom of disease (epigastric pain, vomiting, nausea, dysphagia or heartburn) at least 2 days of the week.
- Failed response to proton pump inhibitors or a negative ph probe test or Negative impedance study.
- Males and females between ages 12-76 years.
Exclusion criteria
- Patients with gastrointestinal reflux disease.
- Eosinophilic disease in the stomach or duodenum.
- Peripheral eosinophil counts >1500 (hyper eosinophilic syndrome).
- Women of childbearing potential not using two forms of contraception method(s) including but not limited to condoms, diaphragm, oral contraceptive pills, other hormonal methods, intrauterine device or tubal ligation and vasectomy, as well as women who are breastfeeding
- Known sensitivity to study drug(s) or class of study drug(s).
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required).
- Use of any other investigational agent in the last 30 days.
- Use of systemic or inhaled steroids within the past 1 month.
- History of malignancy.
- Require chronic immunosuppressive therapy including cyclosporine, methotrexate, etc.
- Have been treated with Xolair within the 12 months prior to screening.
- Patients with eosinophilic esophagitis in remission on swallowed steroids.
- Patients with asthma taking inhaled steroids.
- Serum IgE levels < 30 IU/l or > 700 IU/l
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Our primary objective is to determine markers that will predict responders to Omalizumab(Xolair)
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Secondary objectives will be determining the immunological changes in the tissue before and after treatment with Xolair (omalizumab)
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Oral Alpan, MD, O & O Alpan LLC
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary 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
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
- EE001
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.
Clinical Trials on Eosinophilic Esophagitis
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Children's Hospital Medical Center, CincinnatiNational Institute of Allergy and Infectious Diseases (NIAID); National Institute... and other collaboratorsCompletedEosinophilic Esophagitis (EoE) | Eosinophilic Gastrointestinal Disorders (EGIDs)United States
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Federico II UniversityRecruitingEsophagitis, EosinophilicItaly
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Ann & Robert H Lurie Children's Hospital of ChicagoRecruitingEosinophilic Gastroenteritis | Eosinophilic Esophagitis | Eosinophilic Colitis | Eosinophilic Gastrointestinal DiseaseUnited States
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Medical University of GrazRecruiting
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AQILION ABCompletedEosinophilic Esophagitis (EoE)United Kingdom
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Regeneron PharmaceuticalsSanofiActive, not recruitingEosinophilic Esophagitis (EoE)United States, Canada
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ShireTakeda Development Center Americas, Inc.TerminatedEosinophilic Esophagitis (EoE)United States
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ShireCompletedEosinophilic Esophagitis (EoE)United States
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ShireCompleted
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ShireCompletedEosinophilic Esophagitis (EoE)United States
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Novartis PharmaceuticalsCompletedCHRONIC SPONTANEOUS URTICARIAFrance
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Bernstein Clinical Research CenterWithdrawn
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Stanford UniversityCompletedAtopic DermatitisUnited States
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Boston Children's HospitalStanford UniversityCompleted
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IRCCS Policlinico S. MatteoCompletedInterstitial Cystitis | Painful Bladder SyndromeItaly