Deep Phenotyping of CIndU

Exclusion Criteria

• •Significant, uncontrolled or unstable disease in any organ system as per judgment of the investigator (regardless of association with the immunosuppressing disorder/therapy), including but not limited to: psychiatric, neurologic, cardiovascular, pulmonary, gastrointestinal, hepatic, renal, endocrine, hematologic or respiratory disease.
• •History of immunological abnormality (e.g., immune suppression) that may interfere with study objectives, in the opinion of the investigator.
• •Loss or donation of blood over 500 mL within three months prior to screening.
• •Positive hepatitis B surface antigen (HbsAg), hepatitis C antibody (HCV ab), or human immunodeficiency virus antibody (HIB ab) at screening
• •Known infection requiring (topical or oral) antibiotic therapy within 56 days prior to Day 1.
• •The use of systemic antibiotic therapy for \>2 months the past 12 months.
• •The use of any oral/systemic medication (e.g. immunomodulatory, immunosuppressive) within 28 days prior to Day 1, if the investigator judges that it may interfere with the study objectives.
• •Treatment with omalizumab within 5 half lives (120 days) prior to Day 1
• •Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding.
• •Have any current and/or recurrent clinically significant or subject reported skin condition other than the CInDU/CSU wherefore subject is included in the study.
• •Evidence of current drug or alcohol abuse.
• •History of regular alcohol consumption within 12 months of the trial defined as an average weekly intake of \>21 alcoholic drinks/week for men or \>14 alcoholic drinks/week for women (i.e., 1 drink is equivalent to 150 mL of wine or 360 mL of beer or 45 mL of hard liquor)
• •Healthy volunteers
• •\- Participation in an investigational drug study within 3 months prior to screening or more than 4 times a year.
• •Eligible patients
• •For CIndU patients: active CSU or other forms of CIndU besides ColdU or SD that may interfere with study assessments. For CSU patients: presence of active CIndU disease that may interfere with study assessments.
• •Urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to C1 inhibitor deficiency).
• •Active, pruritic skin condition in addition to CIndU (CIndU patients) or CSU (CSU patients).
• •Routine doses of the following medications within 30 days prior to Day 1: Systemic or cutaneous (topical) corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide.
• •Intravenous (IV) immunoglobulin G (IVIG), or plasmapheresis within 30 days prior to screening.
• •Regular (daily/every other day) doxepin (oral) use within 6 weeks prior to Day 1.
• •Any H2 antihistamine use within 7 days prior to Day 1.
• •Any leukotriene receptor antagonist (LTRA) (montelukast or zafirlukast) within 7 days prior to Day 1.
• •Patients with current malignancy, history of malignancy, or currently under work-up for suspected malignancy except non-melanoma skin cancer that has been treated or excised and is considered resolved.
• •Hypersensitivity to omalizumab or any component of the formulation.
• •History of anaphylactic shock.
• •Evidence of parasitic infection.