Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, diagnosis of chronic spontaneous urticaria (CSU) for at least six months, and inadequate response to H1 antihistamine treatment.

Participants must provide e-diary entries for the last seven consecutive days before randomization and agree to continue this practice twice daily.

Participants are randomly assigned to receive either BP11 or Xolair (omalizumab) in a double-blind manner, meaning neither the participant nor the study team knows which treatment is being administered.

Baseline measurements are taken, including physical examinations, vital signs, and laboratory tests.

Participants receive subcutaneous injections of the assigned treatment every four weeks. The dosage is 150 mg per injection.

Regular assessments are conducted at Weeks 4, 8, and 12 to monitor changes in itch severity and urticaria activity scores, as well as any adverse reactions.

At Week 12, a comprehensive evaluation is performed to assess the primary endpoint, which is the change in weekly itch severity score from baseline.

Secondary endpoints, such as changes in urticaria activity and quality of life scores, are also evaluated.

Participants continue receiving their assigned treatment every four weeks, with additional assessments at Weeks 16, 20, and 24.

Monitoring includes physical examinations, vital signs, laboratory tests, and evaluation of any adverse events.

At the end of the study period, a final assessment is conducted to evaluate the overall effectiveness and safety of the treatment.

Participants’ responses to treatment, including any changes in symptoms and quality of life, are documented.