Treatment of Idiopathic Angioedema With Xolair as Add-on Therapy
Condition: Idiopathic Angioedema
MeSH terms: Angioedema
Intervention: Omalizumab; Placebos
Intervention description: Omalizumab 300mg subcutaneous injection once monthly for 6 months. Total dose will be divided into two 150mg/1.2mL injections.; Placebo Group (Sodium Chloride 0.9%) two 1.2mL subcutaneous injections once monthly for 6 months.
Intervention MeSH terms: Omalizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Angioedema; Idiopathic Angioedema; IAE

Summary:

      The overall hospitalizations for a diagnosis of angioedema doubled from the year 2000 to
      2009. Although some of the cases represented hereditary angioedema or ace-inhibitor induced
      angioedema, the majority of episodes were idiopathic. Idiopathic Angioedema (IAE) can be
      life- threatening especially when affecting tissues within the respiratory tract. No clear
      guidelines exist for management of this important condition for clinicians. Current therapies
      typically include avoidance of potential triggers and use of medications either for
      prophylaxis or for acute events, such as antihistamines, corticosteroids, and epinephrine.
      There remains a critical need for therapeutic options to provide more effective prophylaxis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults or adolescents who are 18 years or older at the time of screening with
             physician diagnosis of idiopathic angioedema

          -  Minimum of two episodes of idiopathic angioedema in the past 6 months at the time of
             screening

          -  Management of idiopathic angioedema with a stable controller treatment plan for the
             prior 6 months

          -  Complement profile (C1 Esterase inhibitor panel) within normal reference values

          -  If a woman is of child-bearing potential, she must agree to a reliable form of birth
             control including: abstinence, oral contraceptives (birth control pills),
             Depo-provera, an intrauterine device (IUD), or double-barrier contraception (partner
             using condom and participant using diaphragm, contraceptive sponge or cervical cap,
             and spermicidal)

        Exclusion Criteria:

          -  Diagnosis of Hereditary Angioedema (HAE), Acquired Angioedema, or Ace-inhibitor
             associated angioedema, which are forms of angioedema with known mechanisms and
             alternate treatment options

          -  Chronic Urticaria (itching and/or hives) with or without Angioedema which are known
             mast cell mediated processes previously shown to be responsive to the use of
             omalizumab

          -  Previous usage of omalizumab in the last 3 months which can affect the patient-related
             outcomes and biomarker assessments if not "washed out" of the system

          -  Patients, who in the judgment of the investigator, have a history or condition that
             might compromise patient safety or compliance, interfere with evaluations, or preclude
             completion of the study