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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: omalizumab


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, omalizumab, safety, allergic asthma, adolescents