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

Inclusion Criteria:

1. Capable of providing written informed consent, adhering to all visit schedules, andmeeting study requirements.

2. Male or female patients 18 to 75 years of age (both inclusive) at the time ofscreening.

3. Diagnosis of CIU refractory to H1 antihistamines at the time of randomization, asdefined by all of the following:

• CIU diagnosis for at least 6 months.

• Must have been on an approved H1 antihistamine for CIU for at least 3consecutive days immediately prior to the Day -14 screening visit and mustdocument current use on the day of initial screening.

• Presence of itch and hives for ≥ 8 consecutive weeks at any time prior toenrollment despite current use of H1 antihistamine treatment.

• In-clinic UAS ≥ 4 on at least 1 of the screening visit days (Day -14, Day -7,or Day 1).

• UAS7 (range 0-42) ≥ 16 and itch component of UAS7 (range 0-21) ≥ 8 during 7days prior to randomization.

4. Willing and able to complete a daily symptom diary for the duration of the study andmust not have any missing diary entries in the 7 days prior to randomization.

5. Females of childbearing potential must be willing to use acceptable contraceptivemethods throughout the study and for 6 months thereafter.

6. Females of non-childbearing potential must have undergone sterilization procedures,at least 6 months prior to the first dose or be postmenopausal with amenorrhea forat least 1 year prior to the first dose and follicle stimulating hormone serumlevels consistent with postmenopausal status.

Exclusion Criteria:

1. Participation in a clinical trial involving the administration of an investigationaldrug or marketed drug within 30 days prior to initial dosing (90 days forbiologics).

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, orany 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 orinvestigational agents such as benralizumab or dupilumab etc.

7. IVIG ( Intravenous immune globulin) or plasmapheresis within 90 days prior toscreening.

8. Regular (daily/every other day) doxepin (oral) use within 14 days prior toscreening.

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-upfor suspected malignancy except non-melanoma skin cancer that has been treated orexcised 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 theinterpretation of the study results and/or compromise the safety of the patients.

15. Medical examination or laboratory findings that suggest the possibility ofdecompensation 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 ofthe Principal Investigator (PI)/designee, would render them unsuitable for inclusionin the study.