Predicting the Clinical Response to Omalizumab With Anti-Immunoglobulin E (IgE) Ab Response or Syk Expression in Basophils

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: Novartis Pharmaceuticals
• Treatments: Omalizumab

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 < 700 IU/ml)

• Reversibility of > 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 < 80% of predicted

• Treatment with 400 to 800 ug day of beclomethasone dipropionate or its equivalent.

• Patients must be willing to give written informed consent and be able to adhere to dose and visit schedules and meet trial requirements.

• Patients will be excluded if they have prior sensitivity to omalizumab, and acute respiratory tract infection prior to or during the run-in period, or a need for regular B-agonist use.

Exclusion Criteria:

• Treatment with an investigational agent within 30 days of screening

• Previously treated with omalizumab within a year prior to screening

• Treatment 1 month prior to screening with: hydroxychloroquine, methotrexate, cyclosporine, cyclophosphamide, intravenous immunoglobulin G, and plasmapheresis

• Clinically relevant laboratory anomalies at screening including individuals with reduced hematocrit (<32%), White Blood Cell (WBC) count (2400/microliter), platelet count (< 75000/microliter), and increased creatinine (> 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.