A series of allergy shots may reduce symptoms of seasonal ragweed allergies. This study will
determine whether taking a drug called omalizumab (also known as Xolair) before getting the
allergy shots is more effective than allergy shots alone or other treatments, such as
prescription antihistamines.
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Inclusion Criteria
- Able to comprehend and grant a witnessed, written informed consent prior to any study
procedures.
- Female participants of child bearing age must have a negative urine pregnancy test at
Screening Visit and subsequent visits. In addition, female participants must be using
a medically acceptable form of birth control.
- History of seasonal allergic rhinitis for at least 2 years with symptoms during the
ragweed pollen season requiring pharmacotherapy.
- A positive skin test by prick method to ragweed pollen at the Screening Visit. A
positive skin prick test will be defined as a ragweed pollen-induced wheal greater
than 3 mm larger in diameter than diluent control (measurements will be made 15-20
minutes after application).
- Must be capable of faithfully completing the diary and of attending regularly
scheduled study visits.
- Must intend to remain in the ragweed pollen area during the entire ragweed season.
- Willing to avoid prohibited medications for the periods indicated in the protocol.
- Participants must meet pretrial eligibility requirements for trial enrollment
(acceptable medical history, physical examination results, normal electrocardiogram
and acceptable laboratory test results).
- Participants must have a baseline serum Immunoglobulin E (IgE) level greater than 10
and less than 700 IU/mL.
Exclusion Criteria
- weigh less than 30 kg or more than 120 kg.
- pregnant or lactating.
- history of severe anaphylactoid (non-IgE mediated) or anaphylactic reactions).
- history of immunotherapy within the past 10 years, if received one full year of
immunotherapy, or within the past 5 years if received less than one year of
immunotherapy.
- known hypersensitivity to trial rescue medication (fexofenadine HCl).
- taking beta-adrenergic antagonists in any form.
- taking allergic ophthalmologic medication.
- clinically significant perennial rhinitis that would interfere in assessment of
ragweed-induced seasonal allergic rhinitis symptoms.
- Presence of a severely deviated nasal septum, septal perforation, structural nasal
defect or large nasal polyps causing obstruction.
- History of an upper respiratory or sinus infection requiring treatment with an
antibiotic within 2 weeks prior to Screening Visit.
- Documented evidence of acute or significant chronic sinusitis, as determined by the
Investigator.
- Asthma (either history of, abnormal spirometry, [forced expiratory volume in 1 second
(FEV1) less than 80% predicted] or use of asthma medications).
- Chronic or intermittent use of inhaled, oral, intra-muscular, or intra-venous
corticosteroids; or chronic or intermittent use of topical corticosteroids within 4
weeks of Visit Screening Visit.
- Chronic use of medications (e. g., tricyclic antidepressants) that would affect
assessment of the effectiveness of the study medication.
- Rhinitis medicamentosa.
- History or presence of significant renal, hepatic, neurologic, cardiovascular,
hematologic, metabolic, cerebrovascular, respiratory, gastrointestinal or other
significant medical condition including, autoimmune or collagen vascular disorders,
aside from organ-specific autoimmune disease limited to the thyroid that in the
Investigator's opinion could interfere with the study or require medical treatment
that would interfere with the study.
- History of cancer other than basal cell carcinoma of the skin.
- History within the past year of excessive alcohol intake or drug addiction.
- Current smokers, greater than 10 pack year history, or participants who quit smoking
less than one year prior to Screening.
- Use of any prohibited concomitant medications during the washout period (i. e., before
screening) and throughout the study period.
- Participants currently undergoing immunotherapy.
- Participants with clinically significant abnormality on 12-lead Electrocardiogram
(ECG) on screening visit.
- Treatment with an experimental, non-approved drug, or investigational drug within the
past 30 days.
- Participants with a history of noncompliance to medical regimens and participants who
are considered potentially unreliable.
- Previous treatment with a monoclonal antibody for any reason including anti-IgE in
any form (e. g., omalizumab).
- Participants with known hypersensitivity to trial drug ingredients (i. e., sucrose,
histidine, polysorbate 20) or related drugs (i. e., monoclonal antibody; polyclonal
gamma-globulin).