Randomized dose-finding study of anti-KIT barzolvolimab in patients with chronic spontaneous urticaria.
Martin Metz, Essack Mitha, Jeffrey Leflein et al.
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In 30 seconds
This phase 2, multicenter, double-blind, placebo-controlled randomized trial assessed barzolvolimab, an anti-KIT antibody that depletes mast cells, in adults with antihistamine-refractory chronic spontaneous urticaria (CSU). Participants received one of three dose regimens or placebo. At week 12, all barzolvolimab regimens improved UAS7 more than placebo; the mean change was −12.55 with 150 mg every 4 weeks and −13.41 with 300 mg every 8 weeks. Complete response (UAS7 = 0) occurred in 22.9%, 51.1%, and 37.5% across the three active regimens, versus 6.4% with placebo.
Key findings
- At week 12, mean UAS7 change was −6.60, −12.55, and −13.41 for the three barzolvolimab regimens, respectively, versus placebo.
- Complete response at week 12 occurred in 22.9%, 51.1%, and 37.5% with barzolvolimab 75 mg, 150 mg, and 300 mg, respectively, versus 6.4% with placebo.
- Response was similar in patients with and without prior omalizumab treatment.
- All doses were described as well tolerated; urticaria and hair color change were the most common adverse events with barzolvolimab.
Why it matters
The trial found clinical improvement with a mast cell-depleting treatment across several dose regimens, supporting mast cells as relevant to CSU manifestations. The placebo-controlled results also provide early evidence of symptom benefit in antihistamine-refractory disease, including among patients with prior omalizumab exposure. These findings inform further evaluation of barzolvolimab but do not establish its longer-term benefit or role in routine care.
What to keep in mind
The study reports outcomes through week 12, so longer-term efficacy and safety are not established by the abstract.