A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab

This study has been completed.

Sponsor:

Collaborator:

Novartis Pharmaceuticals

Information provided by (Responsible Party):

John C. Fang, M.D., University of Utah

ClinicalTrials.gov Identifier:

NCT00123630

First received: July 21, 2005

Last updated: August 9, 2013

Last verified: August 2013

History of Changes

Results First Received: September 5, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Condition:	Esophagitis
Interventions:	Drug: omalizumab Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo	Placebo 150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
Omalizumab	Xolair (Omalizumab)150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).

Participant Flow: Overall Study

	Placebo	Omalizumab
STARTED	15	15
COMPLETED	15	15
NOT COMPLETED	0	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Placebo	Placebo 150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
Omalizumab	Xolair (Omalizumab)150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
Total	Total of all reporting groups

Baseline Measures

	Placebo	Omalizumab	Total
Number of Participants [units: participants]	15	15	30
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	15	15	30
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	28 ± 6	32 ± 12	30 ± 10
Gender [units: participants]
Female	5	3	8
Male	10	12	22
Region of Enrollment [units: participants]
United States	15	15	30

Outcome Measures

1. Primary:

Change in Eosinophil Numbers Per High Power Field Proximally and Distally Between Baseline and Post-treatment and Between Both Groups [ Time Frame: 16 weeks ]

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2. Secondary:

To Determine the Effect of Omalizumab on Other Clinical and Histological Parameters of EE Including Reducing the Symptoms of EE Measured by Overall Improvement in Esophageal Symptoms [ Time Frame: 16 weeks ]

Results not yet reported. Anticipated Reporting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	2%

Reporting Groups

	Description
Placebo	Placebo 150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
Omalizumab	Xolair (Omalizumab)150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).

Other Adverse Events

	Placebo	Omalizumab
Total, other (not including serious) adverse events
# participants affected / at risk	0/30 (0.00%)	0/30 (0.00%)

Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
small numbers enrolled

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