Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation.
- Conditions
- Asthma
- Registration Number
- NCT00500539
- Lead Sponsor
- Novartis
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 155
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period 16 weeks after last dose An assessment of the immunogenic potential of omalizumab liquid was a primary objective of the study, and was based on the results of the human anti-human antibody (HAHA) assays at the end of the follow-up period. A participant was considered potentially HAHA positive if either Fab or Fc was more than 2.0 titer. All values more than 2.0 titer were re-assayed to obtain a confirmatory result. Confirmatory results were used to determine those participants who were HAHA positive.
- Secondary Outcome Measures
Name Time Method Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period 24 weeks treatment period + 4 weeks for following up participants The assessment of safety was based on the number of patients with AEs (mild, moderate and severe) and SAEs. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. The duration of the treatment period was 24 weeks, but patients were followed for an additional 4 weeks, so that the total duration of the treatment period for purposes of AE reporting was 28 weeks.
Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Follow-up Period Last 12 weeks of the follow-up period (initial 4 weeks of the follow-up period were included in the treatment period for AE reporting) The assessment of safety was based on the number of patients with AEs (mild, moderate and severe) and SAEs. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. The duration of the follow-up period was 16 weeks, but for purposes of AE reporting the follow-up period was 12 weeks (as the first 4 weeks of follow-up were included in the treatment period).
Trial Locations
- Locations (29)
Kansas City Allergy & Asthma
🇺🇸Overland Park, Kansas, United States
Allergy, Asthma and Clinical Immunology
🇺🇸Brick, New Jersey, United States
Asthma & Allergy Research of NJ, Inc.
🇺🇸Mt. Laurel, New Jersey, United States
Novartis Investigative Site
🇦🇷Buenos Aires, Argentina
Allergy & Asthma Specialists, PC
🇺🇸Blue Bell, Pennsylvania, United States
North Texas Institute for Clinical Trials
🇺🇸Fort Worth, Texas, United States
Allergy & Immunology Associates, Ltd
🇺🇸Scottsdale,, Arizona, United States
California Allergy and Asthma Medical Group
🇺🇸Palmdale, California, United States
1st Allergy and Clinical Research Center
🇺🇸Centennial, Colorado, United States
Bensch Research Associates
🇺🇸Stockton, California, United States
Toledo Center for Clinical Research
🇺🇸Sylvania, Ohio, United States
AAPRI Clinical Research Institute
🇺🇸Providence,, Rhode Island, United States
Allergy Center at Brookstone
🇺🇸Columbus, Ohio, United States
Asthma Allergy & Pulmonary Associates, PC
🇺🇸Philadelphia, Pennsylvania, United States
Allergy Associates Medical Group, Inc,
🇺🇸San Diego, California, United States
Nassau Chest Pysicians, PC
🇺🇸Massapequa, New York, United States
Clinical Research Institute of Southern Oregon, PC
🇺🇸Medford, Oregon, United States
Clinical Trials of North Houston
🇺🇸Houston, Texas, United States
Novartis Investigator site
🇩🇪Nuremberg, Germany
Innovative Research of West Florida, Inc.
🇺🇸Largo, Florida, United States
Asthma and Allergy Center
🇺🇸Toledo, Ohio, United States
Allergy, Asthma & Dermatology Research Center
🇺🇸Lake Oswego, Oregon, United States
The Corvallis Clinic, PC
🇺🇸Corvallis, Oregon, United States
Novartis Investigative Site,
🇦🇷Mendoza, Argentina
Allergy and Asthma Associates
🇺🇸Houston,, Texas, United States
: The Clinical Research Center, LLC
🇺🇸St. Louis, Missouri, United States
Georgia Pollen
🇺🇸Albany, Georgia, United States
Asthma and Allergy Specialists, PA
🇺🇸Minneapolis, Minnesota, United States
Allergy and Asthma Center of NC, PA
🇺🇸High Point, North Carolina, United States