Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation.
An Open Label, Single Arm Study to Assess the Safety and Immunogenicity of Omalizumab Liquid Administered Subcutaneously to Male and Female Adolescents and Adults With Persistent Allergic Asthma
1 other identifier
interventional
155
3 countries
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 asthma
Started Jul 2007
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 11, 2007
CompletedFirst Posted
Study publicly available on registry
July 12, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedResults Posted
Study results publicly available
April 27, 2011
CompletedJune 2, 2011
May 1, 2011
1.2 years
July 11, 2007
November 17, 2010
May 31, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period
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.
16 weeks after last dose
Secondary Outcomes (2)
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
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)
Interventions
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
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
- Genentech, Inc.collaborator
- Tanoxcollaborator
Study Sites (31)
Allergy & Immunology Associates, Ltd
Scottsdale, Arizona, AZ 85251, United States
California Allergy and Asthma Medical Group
Palmdale, California, CA 93551, United States
Allergy Associates Medical Group, Inc,
San Diego, California, CA 92120, United States
Bensch Research Associates
Stockton, California, CA 95207, United States
1st Allergy and Clinical Research Center
Centennial, Colorado, CO 80112, United States
Innovative Research of West Florida, Inc.
Largo, Florida, FL 33770, United States
Georgia Pollen
Albany, Georgia, GA 31707, United States
Kansas City Allergy & Asthma
Overland Park, Kansas, 66210, United States
Asthma and Allergy Specialists, PA
Minneapolis, Minnesota, MN 55402, United States
: The Clinical Research Center, LLC
St Louis, Missouri, MO 63141, United States
Allergy, Asthma and Clinical Immunology
Brick, New Jersey, NJ 08724, United States
Asthma & Allergy Research of NJ, Inc.
Mount Laurel, New Jersey, NJ 08054, United States
Nassau Chest Pysicians, PC
Massapequa, New York, NY 11758, United States
Allergy and Asthma Center of NC, PA
High Point, North Carolina, NC 27262, United States
Allergy Center at Brookstone
Columbus, Ohio, OH 31904, United States
Toledo Center for Clinical Research
Sylvania, Ohio, OH 43650, United States
Asthma and Allergy Center
Toledo, Ohio, OH 43617, United States
The Corvallis Clinic, PC
Corvallis, Oregon, OR 97330, United States
Allergy, Asthma & Dermatology Research Center
Lake Oswego, Oregon, OR97037, United States
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, OR 97504, United States
Allergy & Asthma Specialists, PC
Blue Bell, Pennsylvania, PA 19422, United States
Asthma Allergy & Pulmonary Associates, PC
Philadelphia, Pennsylvania, PA 19107, United States
AAPRI Clinical Research Institute
Providence, Rhode Island, RI 02906, United States
North Texas Institute for Clinical Trials
Fort Worth, Texas, TX 76132, United States
Allergy and Asthma Associates
Houston, Texas, TX 77054, United States
Clinical Trials of North Houston
Houston, Texas, TX 77070, 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
Related Publications (1)
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.
PMID: 24028677DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- PRINCIPAL INVESTIGATOR
Jose Bardelas, MD
Allergy and Asthma center of North Carolina, PA, High Point, NC 27262
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 11, 2007
First Posted
July 12, 2007
Study Start
July 1, 2007
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
June 2, 2011
Results First Posted
April 27, 2011
Record last verified: 2011-05