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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00500539
• Other study ID #: CIGE025C2303
• Status: Completed
• Phase: Phase 3
• First received: July 11, 2007
• Last updated: May 31, 2011
• Start date: July 2007
• Est. completion date: September 2008

Study information

• Verified date: May 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaGermany: Paul-Ehrlich-InstitutSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site,	Buenos Aires,
Argentina	Novartis Investigative Site,	Corrientes,
Argentina	Novartis Investigative Site,	Mendoza
Germany	Novartis Investigator site	Nuremberg
United States	Georgia Pollen	Albany	Georgia
United States	Allergy & Asthma Specialists, PC	Blue Bell	Pennsylvania
United States	Allergy, Asthma and Clinical Immunology	Brick	New Jersey
United States	1st Allergy and Clinical Research Center	Centennial	Colorado
United States	Allergy Center at Brookstone	Columbus	Ohio
United States	The Corvallis Clinic, PC	Corvallis	Oregon
United States	North Texas Institute for Clinical Trials	Fort Worth	Texas
United States	Allergy and Asthma Center of NC, PA	High Point	North Carolina
United States	Clinical Trials of North Houston	Houston	Texas
United States	Allergy and Asthma Associates	Houston,	Texas
United States	Allergy, Asthma & Dermatology Research Center	Lake Oswego	Oregon
United States	Innovative Research of West Florida, Inc.	Largo	Florida
United States	Nassau Chest Pysicians, PC	Massapequa	New York
United States	Clinical Research Institute of Southern Oregon, PC	Medford	Oregon
United States	Asthma and Allergy Specialists, PA	Minneapolis	Minnesota
United States	Asthma & Allergy Research of NJ, Inc.	Mt. Laurel	New Jersey
United States	Kansas City Allergy & Asthma	Overland Park	Kansas
United States	California Allergy and Asthma Medical Group	Palmdale	California
United States	Asthma Allergy & Pulmonary Associates, PC	Philadelphia	Pennsylvania
United States	AAPRI Clinical Research Institute	Providence,	Rhode Island
United States	Allergy Associates Medical Group, Inc,	San Diego	California
United States	Allergy & Immunology Associates, Ltd	Scottsdale,	Arizona
United States	: The Clinical Research Center, LLC	St. Louis	Missouri
United States	Bensch Research Associates	Stockton	California
United States	Toledo Center for Clinical Research	Sylvania	Ohio
United States	Asthma and Allergy Center	Toledo	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Novartis	Genentech, Inc., Tanox

Countries where clinical trial is conducted

United States,  Argentina,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period	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.	24 weeks treatment period + 4 weeks for following up participants	Yes
Secondary	Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Follow-up Period	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).	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)	Yes