Identifying Responders to Xolair (Omalizumab) Using Eosinophilic Esophagitis as a Disease Model

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01040598
• Date of registration: 27/12/2009
• Prospective Registration: No
• Primary sponsor: O & O Alpan LLC
• Public title: Identifying Responders to Xolair (Omalizumab) Using Eosinophilic Esophagitis as a Disease Model
• Scientific title: Identifying Responders to Xolair (Omalizumab) Using Eosinophilic Esophagitis as a Disease Model
• Date of first enrolment: June 2009
• Target sample size: 19
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01040598
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Oral Alpan, MD
• Affiliation: O & O Alpan LLC

Key inclusion & exclusion 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



Age minimum: 12 Years
Age maximum: 76 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Eosinophilic Esophagitis

Intervention(s)

Biological: Omalizumab

Primary Outcome(s)

Our primary objective is to determine markers that will predict responders to Omalizumab(Xolair) [Time Frame: 12 weeks]

Secondary Outcome(s)

Secondary objectives will be determining the immunological changes in the tissue before and after treatment with Xolair (omalizumab) [Time Frame: 12 weeks]

Secondary ID(s)

EE001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Genentech, Inc.