Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-01-03 @ 1:53 PM
Study NCT ID:
NCT02023151
Status:
COMPLETED
Last Update Posted:
2017-12-11
First Post:
2013-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Predicting the Clinical Response to Omalizumab With Anti-Immunoglobulin E (IgE) Ab Response or Syk Expression in Basophils
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
Predicting the Clinical Response to Omalizumab With Anti-IgE Response or Syk Expression in Basophils
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research is being done to test whether differences in blood cells at baseline (start of the study) can be used to predict how well omalizumab will work in a patient. Omalizumab (Xolair) is a drug approved by the U.S. Food and Drug Administration (FDA) to treat asthma. Studies show that omalizumab improves the symptoms of asthma but some people experience better improvement than others.
Detailed Description:
From a therapeutic perspective, the study will determine whether changes in the peripheral blood basophil response to crosslinking anti-IgE Ab during treatment with omalizumab predicts the clinical efficacy of treatment with the drug. Secondary outcomes measures would focus on whether the starting level of anti-IgE-mediated histamine release, or the changes syk expression or its starting level would be sufficient to predict the clinical outcome.
The study is a single-site trial to evaluate the utility of baseline basophil measures to predict the efficacy of subcutaneously administered omalizumab as an add-on therapy for the treatment of adult patients 18-75 years old who have been diagnosed with moderate to severe asthma according to current approved guidelines. Patients will be treated with omalizumab according to the standard FDA approved dosing table for a period of 16 weeks.
The study is a single-site trial to evaluate the utility of baseline basophil measures to predict the efficacy of subcutaneously administered omalizumab as an add-on therapy for the treatment of adult patients 18-75 years old who have been diagnosed with moderate to severe asthma according to current approved guidelines. Patients will be treated with omalizumab according to the standard FDA approved dosing table for a period of 16 weeks.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: