Clinical trial NCT00500539: Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
omalizumab
safety
allergic asthma
adolescents
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Genentech, Inc.
name: Tanox
First posted: 2007-07-12
Enrollment: 155
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period
timeFrame: 16 weeks after last dose
Secondary outcomes:
measure: Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period
timeFrame: 24 weeks treatment period + 4 weeks for following up participants
measure: Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Follow-up Period
timeFrame: 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)
Other outcomes:
Locations:
city: Scottsdale,
country: United States
facility: Allergy & Immunology Associates, Ltd
state: Arizona
city: Palmdale
country: United States
facility: California Allergy and Asthma Medical Group
state: California
city: San Diego
country: United States
facility: Allergy Associates Medical Group, Inc,
state: California
city: Stockton
country: United States
facility: Bensch Research Associates
state: California
city: Centennial
country: United States
facility: 1st Allergy and Clinical Research Center
state: Colorado
city: Largo
country: United States
facility: Innovative Research of West Florida, Inc.
state: Florida
city: Albany
country: United States
facility: Georgia Pollen
state: Georgia
city: Overland Park
country: United States
facility: Kansas City Allergy & Asthma
state: Kansas
city: Minneapolis
country: United States
facility: Asthma and Allergy Specialists, PA
state: Minnesota
city: St. Louis
country: United States
facility: : The Clinical Research Center, LLC
state: Missouri
city: Brick
country: United States
facility: Allergy, Asthma and Clinical Immunology
state: New Jersey
city: Mt. Laurel
country: United States
facility: Asthma & Allergy Research of NJ, Inc.
state: New Jersey
city: Massapequa
country: United States
facility: Nassau Chest Pysicians, PC
state: New York
city: High Point
country: United States
facility: Allergy and Asthma Center of NC, PA
state: North Carolina
city: Columbus
country: United States
facility: Allergy Center at Brookstone
state: Ohio
city: Sylvania
country: United States
facility: Toledo Center for Clinical Research
state: Ohio
city: Toledo
country: United States
facility: Asthma and Allergy Center
state: Ohio
city: Corvallis
country: United States
facility: The Corvallis Clinic, PC
state: Oregon
city: Lake Oswego
country: United States
facility: Allergy, Asthma & Dermatology Research Center
state: Oregon
city: Medford
country: United States
facility: Clinical Research Institute of Southern Oregon, PC
state: Oregon
city: Blue Bell
country: United States
facility: Allergy & Asthma Specialists, PC
state: Pennsylvania
city: Philadelphia
country: United States
facility: Asthma Allergy & Pulmonary Associates, PC
state: Pennsylvania
city: Providence,
country: United States
facility: AAPRI Clinical Research Institute
state: Rhode Island
city: Fort Worth
country: United States
facility: North Texas Institute for Clinical Trials
state: Texas
city: Houston,
country: United States
facility: Allergy and Asthma Associates
state: Texas
city: Houston
country: United States
facility: Clinical Trials of North Houston
state: Texas
city: Buenos Aires,
country: Argentina
facility: Novartis Investigative Site,
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Corrientes,
country: Argentina
facility: Novartis Investigative Site,
city: Mendoza
country: Argentina
facility: Novartis Investigative Site,
city: Nuremberg
country: Germany
facility: Novartis Investigator site
Study officials:
affiliation: Allergy and Asthma center of North Carolina, PA, High Point, NC 27262
name: Jose Bardelas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.