Overview of the Barzolvolimab Phase 2 Clinical Trial

EP: 1.Overview of CSU Symptoms

EP: 2.Current and Emerging CSU Therapies

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EP: 3.Overview of the Barzolvolimab Phase 2 Clinical Trial

EP: 4.Efficacy Results From the Barzolvolimab Trial

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The barzolvolimab phase 2 trial represents a landmark study in chronic spontaneous urticaria (CSU) research, featuring a randomized, double-blind, placebo-controlled design that enrolled patients with moderate to severe disease inadequately controlled by antihistamines. The study's unique 76-week duration included 52 weeks of treatment followed by 24 weeks of follow-up, making it one of the longest CSU clinical trials conducted. This extended time frame allowed researchers to assess both immediate efficacy and long-term durability of treatment effects.

The trial investigated three different dosing regimens: 75 mg every 4 weeks (lower dose), 150 mg every 4 weeks (likely commercial dose), and 300 mg every 8 weeks. The study design included a 16-week placebo-controlled treatment period, followed by a 36-week active treatment period, with the final dose administered at week 48. This comprehensive approach enabled evaluation of both short-term efficacy and sustained response after treatment discontinuation.

Patient demographics revealed a severely affected population, with UAS7 (Urticaria Activity Score over 7 days) scores indicating severe disease in 65% to 76% of participants. The UAS7 scale ranges from 1 to 42, with scores above 28 considered severe, and all enrolled patients demonstrated high baseline scores. Importantly, 16% to 22% of patients had previous omalizumab experience, representing the challenging patient population with unmet medical needs who had failed standard biologic therapy, making this study particularly relevant for real-world clinical practice.