The Effect of Xolair on Inhibiting Leukotriene and Cytokine (IL-4 and IL-13) Release From Blood Basophils

NCT00673218 | Unknown Phase 4

• 1 other identifier: CIGE025AUS22
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

If you are allergic to ragweed, and not taking certain medications, you will be asked to have blood drawn. We will perform experiments on your blood cells.

Conditions

Allergy

Keywords

IL13; Cytokines; Basophil stimulation

Outcome Measures

Primary Outcomes (1)

• Basophil histamine release

  After 4 weeks treatment

Study Arms (2)

1

PLACEBO COMPARATOR

Saline injection to match active

Drug: Placebo

Treatment

EXPERIMENTAL

Active treatment with Xolair 150 to 375 mg is administered SC every 2 or 4 weeks

Drug: Xolair

Interventions

Placebo DRUG

Placebo, Q2 or 4 weeks depending on Ige level and weight as appropriate for active treatment.

Also known as: Saline

1

Xolair DRUG

150 to 375 mg is administered SC every 2 or 4 weeks

Also known as: Omalizumab, rhumab-E25

Treatment

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ages 19 to 50
• At least 2 year history of ragweed allergic rhinitis
• Positive skin prick tests to ragweed \>5 mm wheal diameter
• IgE \<700 iU/m

You may not qualify if:

• Use of prohibited medications (e.g. antihistamine in past 7 days and topical or oral corticosteroids in past 1 month, beta-agonist or theophylline for 2 days.
• History of immunotherapy in the past 2 years
• Exposure to Omalizumab in the past 2 years
• Clinically significant non-allergic or perennial rhinitis to avoid mediator release due to environmental allergens
• Asthma other than mild intermittent
• Women of childbearing potential who are not on an accepted form of birth control, as well as women who are breastfeeding
• Known sensitivity to study drug Xolair
• Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
• Patients with a previous history of cancer
• Use of any other investigational agent in the last 30 days

Sponsors & Collaborators

• Creighton University: lead
• Novartis: collaborator

Study Sites (1)

Creighton University

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

Hypersensitivity

Interventions

Sodium Chloride; Omalizumab; rhuMAb-E25

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Robert G Townley, MD

  Creighton University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2008
• First Posted: May 7, 2008
• Study Start: June 1, 2007
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: July 6, 2012

Record last verified: 2012-07

Locations

US (1)