Celldex Barzolvolimab Achieves 71% CSU Response, 66% ColdU Complete Rate
Celldex’s barzolvolimab achieved up to 71% complete response rate in chronic spontaneous urticaria patients at 52 weeks, with 41% maintaining symptom-free status seven months off therapy. Phase 2 data also showed up to 66% complete responses in cold urticaria and symptomatic dermographism by week 20.
1. Phase 2 CSU Efficacy Data
In the Phase 2 chronic spontaneous urticaria trial, barzolvolimab delivered symptom-free complete responses in up to 51% of patients at 12 weeks, increasing to 71% at 52 weeks. Remarkably, 41% of participants maintained complete response seven months after their last dose despite drug clearance, suggesting potential disease modification.
2. Inducible Urticaria Trial Outcomes
In patients with cold urticaria and symptomatic dermographism, barzolvolimab achieved complete response rates of 53% and 58% at week 12, rising to 66% and 49% at week 20 respectively. Quality-of-life improvements were evident by the first DLQI measurement at week 4, with sustained benefits through treatment.
3. Broad Quality of Life Benefits
Baseline DLQI scores indicated a very large impact on patient lives (mean 15.6). At week 52, 94% of CSU patients with well controlled disease reached DLQI scores of 0/1, and 76% maintained DLQI ≤5 at week 76, reflecting durable off-treatment improvements across all six life quality domains.