Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria

Exclusion Criteria

• •1. Participation in a clinical trial involving the administration of an investigational drug or marketed drug within 30 days prior to initial dosing (90 days for biologics).
• •2. Clearly defined underlying etiology for chronic urticarias other than CIU.
• •3. Evidence of parasitic infection.
• •4. Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, or any other skin disease associated with itch.
• •5. Previous treatment with omalizumab within a year prior to screening.
• •6. Routine doses of the following medications within 10 days prior to screening: Systemic or cutaneous (topical) corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide or investigational agents such as benralizumab or dupilumab etc.
• •7. IVIG ( Intravenous immune globulin) or plasmapheresis within 90 days prior to screening.
• •8. Regular (daily/every other day) doxepin (oral) use within 14 days prior to screening.
• •9. Any H2 antihistamine use within 7 days prior to screening.
• •10. Any LTRA (Leukotriene receptor antagonists such as montelukast or zafirlukast) within 10 to 14 days prior to screening.
• •11. 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.
• •12. Hypersensitivity to omalizumab or any component of the formulation.
• •13. History of anaphylactic shock.
• •14. Presence of clinically significant cardiovascular, neurological, psychiatric, metabolic, or other pathological conditions that could interfere with the interpretation of the study results and/or compromise the safety of the patients.
• •15. Medical examination or laboratory findings that suggest the possibility of decompensation of co-existing conditions for the duration of the study.
• •16. Evidence of current drug or alcohol abuse.
• •17. Positive test for hepatitis B, hepatitis C, or HIV.
• •18. Females with positive pregnancy tests at screening or any other visit.
• •19. Females who are breastfeeding or lactating.
• •20. History of any clinically significant disease or condition that, in the opinion of the Principal Investigator (PI)/designee, would render them unsuitable for inclusion in the study.