Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation.

Completed · Phase 3

Conditions studied: Asthma

In brief

The primary objective of this study is to assess the immunogenic potential of the liquid formulation of omalizumab administered over a period of 6 months in moderate to severe persistent allergic asthma patients 12 years of age or older, with no previous exposure to the drug (omalizumab naïve patients). The secondary objective of this study is to assess the safety of the liquid formulation of omalizumab in the same patients.

Key facts

Study ID

NCT00500539

Run by

Novartis

People needed

155

Starts

2007-07-01

Expected to finish

2008-09-01

Last updated by the study team

2011-06-02

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients 12 years old or above with moderate to severe allergic asthma
• 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.

You may not qualify if…

• Previous exposure to omalizumab
• 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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