Celldex Reported Positive Barzolvolimab Trial Results

The drug candidate showed significant efficacy in treating patients with chronic spontaneous urticaria.

Updated on Sept. 28, 2026 in Allergies

Isometric editorial illustration of a sterile glass laboratory pipette positioned over a reagent beaker, representing clinical research. — Celldex Therapeutics reported that its drug candidate, barzolvolimab, showed significant efficacy in reducing symptoms for adults suffering from chronic spontaneous urticaria. AI Illustration. Upload story photo >

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Celldex Therapeutics announced positive phase 3 trial results for barzolvolimab in adults with chronic spontaneous urticaria. The drug met primary endpoints in reducing symptoms compared to a placebo.

Why it matters

The trials evaluated barzolvolimab for patients whose condition remained inadequately controlled by standard H1-antihistamines. These results offer a potential new therapeutic path for those suffering from the chronic skin condition.

In phase 3 trials involving 1,939 patients, barzolvolimab doses of 150 mg and 300 mg reduced UAS7 scores by 20.2 and 20.5 points respectively. Complete response rates reached up to 45.7%, while angioedema resolution hit as high as 74.3%.

The players

Celldex Therapeutics

This is a biopharmaceutical company focused on developing monoclonal and bispecific antibodies for patients with difficult-to-treat diseases.

Food and Drug Administration

This federal agency is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs.

The details

The randomized, double-blind trials showed barzolvolimab was well tolerated by participants throughout the 24-week initial study period. Researchers observed complete response rates at Week 12 ranging from 42.1% to 45.7% for treated patients, compared to 9.3% to 12.6% for those receiving a placebo.

Week 12 marked the primary endpoint assessment for UAS7 score changes.
Week 24 served as the conclusion of the initial placebo-controlled treatment period.
2027 is the target year for the company to submit a biologics license application to the FDA.

The Big Picture

This report marks the successful completion of the primary endpoint assessment phase for the EMBARQ-CSU clinical development program. The findings represent a key milestone in testing barzolvolimab against established therapeutic standards.

For patients suffering from chronic spontaneous urticaria that does not respond to H1-antihistamines, this drug could eventually provide a new treatment option for managing symptoms. The study suggests the medication was well tolerated, though patients should consult their doctors regarding future availability.

The takeaway

Barzolvolimab has demonstrated clear efficacy in reducing severe urticaria symptoms during clinical trials. Future regulatory submissions will determine when and how this treatment becomes an available option for the wider patient population.