Role of Immunoglobulin E (IgE) Bearing Cells in Chronic Idiopathic Urticaria (CIU)
Condition: Urticaria Chronic
MeSH terms: Urticaria; Chronic Urticaria
Intervention: Omalizumab
Intervention description: omalizumab 300 mg every 4 weeks by subcutaneous injection
Intervention MeSH terms: Omalizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Active therapy
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase IV, single-site study that will examine blood cells or tissue obtained from
      CIU ( chronic idiopathic Urticaria) patients receiving open-label treatment with omalizumab
      at the current FDA-approved dose of 300 mg/month for 12 weeks in addition to standard therapy
      with anti-histamines. Results from the 3 Phase III studies in CIU patients provide evidence
      that a meaningful change in symptoms is apparent at 1-2 wks. The Minimal Important Difference
      (MID) is achieved by 70% of patients by 2 wks on multiple background drugs for hives. The
      goal is to identity the IgE bearing cell type associated with clinical symptom change.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age >18 years old

          -  Females must be surgically sterile or postmenopausal or using a highly effective form
             of birth control throughout the duration of the study.

          -  Females must have a negative urine pregnancy test at screening and other visits
             specified in this protocol unless documented to have a hysterectomy or be
             postmenopausal.

          -  Clinical history of CIU at the time of screening, as defined by pruritus and hives for
             > 3 days in a 7-day period for > 6 consecutive weeks despite treatment with H1
             antihistamine.

          -  CIU diagnosis > 3 months (by history)

          -  No underlying etiology clearly defined for urticaria (main manifestation cannot be
             physical urticaria).

          -  Non-diary based UAS scores ≥ 2 at either the screening visit (Week -3), at the run-in
             visit (Week -2), or on Day 1.

          -  Compliance with study procedures during run-in period (e.g., completion of the study
             diary).

        Exclusion Criteria:

          -  Pregnant females, Recent history of drug or alcohol abuse (within 3 years prior to
             screening visit).Inability or unwillingness of a participant to give written informed
             consent or comply with study protocol.

          -  Use of any investigational drugs within 30 days of screening.

          -  Active atopic dermatitis or other skin disease associated with pruritus during the
             time of the study, which require treatment with topical corticosteroids.

          -  Clinically relevant major systemic disease (making interpretation of the study results
             difficult) including a history of anaphylaxis.

          -  Inability to comply with study and follow-up procedures

          -  Patients may not use oral or systemic steroids during the study or within 4 weeks
             prior to enrollment.

          -  Patients may not take H2 antihistamines and leukotriene receptor antagonists within 7
             days before screening, during the screening, run-in, or treatment phases. The
             exception will be if they are already on these medications for the treatment of
             Gastro-Esophageal Reflux Disease (GERD), asthma or allergic rhinitis.

          -  Any clinically relevant abnormal findings in clinical chemistry, hematology,
             urinalysis, physical examination, pulse, blood pressure at baseline, which, in the
             opinion of the investigator, could put the patient at risk because of his/her
             participation in the study.

          -  Past or current medical problems or findings from physical examination or laboratory
             testing that are not listed above, which, in the opinion of the investigator, may pose
             additional risks from participation in the study, may interfere with the participant's
             ability to comply with study requirements or may compromise the quality of the data
             obtained from the study.