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

Part of paid clinical trials in Springfield, Virginia.

Sponsor
O & O Alpan LLC
Study ID
NCT01040598
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 76 Years
Healthy Volunteers
Not accepted

Interventions

  • Omalizumab — BIOLOGICAL
    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.

Study Details

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).

Key Dates

Start date
Jun 30, 2009
Status verified
Mar 2012
Primary completion
Dec 31, 2011

Study Design

Enrollment
19 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
O & O Alpan LLCSpringfieldVirginia22152-

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By research site
O & O Alpan LLC· Springfield, VA

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