Phase 4
Completed N=17
Predicting the Clinical Response to Omalizumab With Anti-Immunoglobulin E (IgE) Ab Response or Syk Expression in Basophils
Source: ClinicalTrials.gov NCT02023151 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcomePrimary: Changes in the Peripheral Blood Basophil Response to Crosslinking Anti-IgE Ab — 7.8 Fold change in basophil Syk expression
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in the Peripheral Blood Basophil Response to Crosslinking Anti-IgE Ab |
7.8 | — |
| SECONDARY Changes in Syk Expression |
2.3 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with moderate-to-severe asthma; male and females aged 18-75 who are symptomatic despite treatment with inhaled corticosteroids if they also had an asthma duration > 1 year.
- Positive blood testing to at least one common allergen (including must mite, D. F. and D. P., cockroach, dog or cat)
- Serum IgE within the bounds of the dosing table (>30 IU/ml to 12% within 30 minutes after administration of albuterol or history of reversibility in past or history of positive methacholine in past
- Baseline Forced expiratory volume (FEV1) of > 0% and 141.4 micromolar/L), or aminotransferase (AST) (>100 IU/L).
- Patients with current malignancy, history of malignancy, or currently under work-up for suspected malignancy, or bleeding disorder.
- History of any medical condition that is unstable
- Inability to comply with study and follow-up procedures
- Patients may not take systemic corticosteroids within 2 weeks prior to screening\
- Women of childbearing potential who are pregnant or nursing mothers, or who are of childbearing potential (post-menarche) and are not practicing an acceptable form of contraception ( as determined by the site investigator)
- Individuals with body weight less than 30 kg or greater than 150 kg.
Data sourced from ClinicalTrials.gov (NCT02023151). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.