Back to resultsIdentifying Responders to Xolair (Omalizumab) Using Eosinophilic Esophagitis as a Disease Model
Primary Purpose
Eosinophilic Esophagitis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Omalizumab
Sponsored by
About this trial
This is an interventional basic science trial for Eosinophilic Esophagitis focused on measuring Eosinophilic Esophagitis, Xolair, Omalizumab, Esophagitis, Eosinophils, monoclonal antibody
Eligibility Criteria
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
Sites / Locations
- O & O Alpan LLC
Outcomes
Primary Outcome Measures
Our primary objective is to determine markers that will predict responders to Omalizumab(Xolair)
Secondary Outcome Measures
Secondary objectives will be determining the immunological changes in the tissue before and after treatment with Xolair (omalizumab)
Full Information
NCT ID
NCT01040598
First Posted
December 27, 2009
Last Updated
March 13, 2012
Sponsor
O & O Alpan LLC
Collaborators
Genentech, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01040598
Brief Title
Identifying Responders to Xolair (Omalizumab) Using Eosinophilic Esophagitis as a Disease Model
Official Title
Identifying Responders to Xolair (Omalizumab) Using Eosinophilic Esophagitis as a Disease Model
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
O & O Alpan LLC
Collaborators
Genentech, Inc.
4. Oversight
5. Study Description
Brief Summary
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).
Detailed Description
This is an open label mechanistic study to learn about the effect of Omalizumab on the clinical symptoms and immunohistological findings in established cases of EoE. The dosage for Omalizumab will be based on patient's body weight and baseline IgE level. Omalizumab will be administered subcutaneously every 2 or 4 weeks for total duration of 12 weeks. At enrollment, subjects will have EGD with biopsies performed to confirm diagnosis of EoE and further histologic analysis and special staining. Blood will be drawn for baseline testing and monthly for safety labs. At the end of the 12 week period, repeat endoscopy will be performed and biopsies taken to stain again for various mucosal markers like IgE, IL-13, IL-5 and Tryptase. The patients will be followed for response to therapy with regards to resolution of symptoms and improvement in histology findings on biopsy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis
Keywords
Eosinophilic Esophagitis, Xolair, Omalizumab, Esophagitis, Eosinophils, monoclonal antibody
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Omalizumab
Other Intervention Name(s)
Xolair
Intervention Description
Omalizumab, an anti-IgE monoclonal antibody is dosed on the basis of subject's weight and IgE levels. It is administered as a subcutaneous injection every 2 weeks or 4 weeks based on the total dose required.
Primary Outcome Measure Information:
Title
Our primary objective is to determine markers that will predict responders to Omalizumab(Xolair)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Secondary objectives will be determining the immunological changes in the tissue before and after treatment with Xolair (omalizumab)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oral Alpan, MD
Organizational Affiliation
O & O Alpan LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
O & O Alpan LLC
City
Springfield
State/Province
Virginia
ZIP/Postal Code
22152
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25789989
Citation
Loizou D, Enav B, Komlodi-Pasztor E, Hider P, Kim-Chang J, Noonan L, Taber T, Kaushal S, Limgala R, Brown M, Gupta R, Balba N, Goker-Alpan O, Khojah A, Alpan O. A pilot study of omalizumab in eosinophilic esophagitis. PLoS One. 2015 Mar 19;10(3):e0113483. doi: 10.1371/journal.pone.0113483. eCollection 2015.
Results Reference
derived
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Identifying Responders to Xolair (Omalizumab) Using Eosinophilic Esophagitis as a Disease Model
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