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

NCT02023151 | Completed Phase 4 Results DMC

• 1 other identifier: NA_00081287
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Asthma

Outcome Measures

Primary Outcomes (1)

• Changes in the Peripheral Blood Basophil Response to Crosslinking Anti-IgE Ab

  Data will be analyzed for the fold change in the in vitro anti-IgE-mediated histamine release response

  baseline and 26 weeks

Secondary Outcomes (1)

• Changes in Syk Expression

  baseline and 26 weeks

Study Arms (1)

Omalizumab

OTHER

Active

Drug: Omalizumab

Interventions

Omalizumab DRUG

Also known as: xolair

Omalizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Johns Hopkins Asthma & Allergy Center

Baltimore, Maryland, 21212, United States

Location

MeSH Terms

Interventions

Omalizumab

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Limitations and Caveats

Small study with difficult enrollment

Results Point of Contact

• Title: Sarbjit Saini
• Organization: Johns Hopkins University

ssaini@jhmi.edu

4105502191

Study Officials

• Sarbjit S. Saini, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: December 30, 2013
• Study Start: February 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2016
• Last Updated: December 11, 2017
• Results First Posted: December 11, 2017

Record last verified: 2017-11

Locations

US (1)