Barzolvolimab Achieves 71% Complete Response in Hives Study
On March 27, 2026, Celldex presented compelling Phase 2 trial data for its chronic hives drug, barzolvolimab, at the American Academy of Dermatology Annual Meeting. In patients with Chronic Spontaneous Urticaria (CSU), treatment showed a profound clinical benefit, with up to 51% of patients achieving complete response—defined as no itch and no hives—at 12 weeks. This efficacy deepened over the course of the study, reaching a 71% complete response rate among patients who completed 52 weeks of therapy.
The results translate to a dramatic improvement in patient well-being. At the start of the study, patients reported a mean Dermatology Life Quality Index (DLQI) score of 15.6, indicating a very large negative impact on their lives. By week 52, 94% of patients with well-controlled disease reported a DLQI score of 0 or 1, signifying their condition had no effect on their quality of life.
Study Shows Durable Effect with 41% Response Post-Treatment
A key finding from the study is the drug's lasting impact. Seven months after receiving their final dose, up to 41% of patients maintained a complete response. This sustained, off-treatment efficacy suggests that barzolvolimab may offer a disease-modifying benefit, a significant differentiator in the treatment of chronic conditions. This effect was observed even after the drug had cleared from patients' systems.
The drug also demonstrated strong results in related conditions. In Phase 2 trials for Cold Urticaria (ColdU) and Symptomatic Dermographism (SD), barzolvolimab produced complete response rates of up to 66% and 58%, respectively. These outcomes strengthen the drug's profile as a potential best-in-class treatment targeting the mast cell, the root cause of these inflammatory diseases.
Phase 3 Enrollment Finishes 6 Months Early, Data Due Q4 2026
Celldex's operational execution has accelerated the drug's path to market. The company announced the completion of enrollment for its global Phase 3 CSU program, EMBARQ, six months ahead of schedule. The program includes 1,939 patients across 43 countries, making it the largest study ever conducted for this indication.
This rapid enrollment de-risks the clinical timeline and sets a clear catalyst for investors. The company expects to release topline data from the two pivotal Phase 3 studies in the fourth quarter of 2026. Positive results would position barzolvolimab for regulatory submission as a first-in-class therapy for a patient population with significant unmet needs.
