Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation.
Condition: Asthma
MeSH terms: Asthma
Intervention: omalizumab
Intervention description: 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.
Intervention MeSH terms: Omalizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 155.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Asthma; omalizumab; safety; allergic asthma; adolescents

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)