A Phase 3 Study of Barzolvolimab in Patients with Chronic Spontaneous Urticaria (EMBARQ – CSU1)

You may be able to join if

• 1. Read, understood, and provided written informed consent, and Health Insurance Portability and Accountability Act (HIPAA) authorization if applicable, after the nature of the study has been fully explained. Participants must be able to provide informed consent themselves.
• 2. Male or female, ≥ 18 years of age at the time of signing the informed consent.
• 3. CSU ≥ 6 months prior to Screening. Note: the investigator should establish the presence of CSU for the noted duration based on all available supporting documentation, including written medical records and communication with the participants’ previous healthcare providers, if applicable.
• CSU refractory to a stable dose and regimen containing a second-generation H1AH as defined by all of the following: • Recurrent pruritic wheals with or without angioedema for ≥ 6 weeks at any time prior to Screening (Visit 1) despite treatment with a H1AH (hives consistent with CSU should be documented and confirmed by the investigator prior to randomization) • Participants must have been on a stable dose and regimen containing a secondgeneration H1 antihistamine (H1AH) at approved or increased (up to 4x approved) dose as background therapy for the treatment of CSU for ≥ 4 weeks prior to randomization and which is expected to remain stable throughout the study. • UAS7 (range: 0 to 42) ≥ 16 and ISS7 (range: 0 to 21) ≥ 8 during the 7-day period (Day -7 to Day -1) immediately prior to randomization.
• 5. Willing and able to comply with all study requirements and procedures, including the completion of a daily symptom diary during screening and throughout the study.