Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation.
NCT ID: NCT00500539
Last Updated: 2011-06-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
155 participants
INTERVENTIONAL
2007-07-31
2008-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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omalizumab
The liquid formulation of omalizumab was packaged in a pre-filled safety syringe containing either 75 mg (0.5ml) or 150 mg (1.0 ml) of drug. The syringes were clearly marked so that the health care provider could differentiate between the 75 mg or 150 mg syringe.
Eligibility Criteria
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Inclusion Criteria
* Body weight greater than 30kg and less than 150 kg and total serum IgE level greater than 30 to less than 700 IU/ml
* Diagnosis of allergic asthma greater than 1 year duration, according to the American Thoracic Society criteria (14) and at screening, a history consistent with clinical features of moderate to severe persistent asthma.
* Positive skin prick test (diameter of wheel is greater than 3mm) to at least one perennial allergen within the previous one year to visit 1, to which the patient will be exposed on a regular basis (most days) for the duration of the study.
* No clinically significant asthma exacerbations that required treatment with systemic corticosteroids during the four weeks immediately prior to screening visit (Visit 1) and during screening period (between Visit 1 and 2)
* Demonstrated evidence of inadequate asthma symptom control, despite treatment with ICS according to clinical features of moderate to severe persistent asthma.
Exclusion Criteria
* Previous exposure to other humanized proteins or monoclonal antibodies
* Known HAHA to other monoclonal antibodies
* History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
* Known hypersensitivity to any ingredients, including excipients of the study medication or drugs related to omalizumab (e.g. monoclonal antibodies, polyclonal gamma globulin)
* Active lung disease other than allergic asthma (e.g. cystic fibrosis, bronchiectasis)
* Elevated serum IgE levels for reasons other than allergy (e.g. parasite infections, hyperimmunoglobulin E syndrome, Wiskott-Aldrich Syndrome or allergic bronchopulmonary aspergillosis)
12 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Tanox
INDUSTRY
Novartis
INDUSTRY
Responsible Party
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Novartis
Principal Investigators
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Jose Bardelas, MD
Role: PRINCIPAL_INVESTIGATOR
Allergy and Asthma center of North Carolina, PA, High Point, NC 27262
Locations
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Allergy & Immunology Associates, Ltd
Scottsdale, Arizona, United States
California Allergy and Asthma Medical Group
Palmdale, California, United States
Allergy Associates Medical Group, Inc,
San Diego, California, United States
Bensch Research Associates
Stockton, California, United States
1st Allergy and Clinical Research Center
Centennial, Colorado, United States
Innovative Research of West Florida, Inc.
Largo, Florida, United States
Georgia Pollen
Albany, Georgia, United States
Kansas City Allergy & Asthma
Overland Park, Kansas, United States
Asthma and Allergy Specialists, PA
Minneapolis, Minnesota, United States
: The Clinical Research Center, LLC
St Louis, Missouri, United States
Allergy, Asthma and Clinical Immunology
Brick, New Jersey, United States
Asthma & Allergy Research of NJ, Inc.
Mount Laurel, New Jersey, United States
Nassau Chest Pysicians, PC
Massapequa, New York, United States
Allergy and Asthma Center of NC, PA
High Point, North Carolina, United States
Allergy Center at Brookstone
Columbus, Ohio, United States
Toledo Center for Clinical Research
Sylvania, Ohio, United States
Asthma and Allergy Center
Toledo, Ohio, United States
The Corvallis Clinic, PC
Corvallis, Oregon, United States
Allergy, Asthma & Dermatology Research Center
Lake Oswego, Oregon, United States
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, United States
Allergy & Asthma Specialists, PC
Blue Bell, Pennsylvania, United States
Asthma Allergy & Pulmonary Associates, PC
Philadelphia, Pennsylvania, United States
AAPRI Clinical Research Institute
Providence, Rhode Island, United States
North Texas Institute for Clinical Trials
Fort Worth, Texas, United States
Allergy and Asthma Associates
Houston, Texas, United States
Clinical Trials of North Houston
Houston, Texas, United States
Novartis Investigative Site,
Buenos Aires, , Argentina
Novartis Investigative Site
Buenos Aires, , Argentina
Novartis Investigative Site,
Corrientes, , Argentina
Novartis Investigative Site,
Mendoza, , Argentina
Novartis Investigator site
Nuremberg, , Germany
Countries
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References
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Somerville L, Bardelas J, Viegas A, D'Andrea P, Blogg M, Peachey G. Immunogenicity and safety of omalizumab in pre-filled syringes in patients with allergic (IgE-mediated) asthma. Curr Med Res Opin. 2014 Jan;30(1):59-66. doi: 10.1185/03007995.2013.844115. Epub 2013 Oct 1.
Other Identifiers
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CIGE025C2303
Identifier Type: -
Identifier Source: org_study_id
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