10:40 AM EST, 12/09/2025 (MT Newswires) -- Celldex Therapeutics ( CLDX ) said Tuesday it has begun a global phase 3 trial of its experimental drug barzolvolimab in patients with cold urticaria and symptomatic dermographism, which cause intense itching and painful hives.

The EMBARQ-ColdU and SD trial will enroll about 240 adults at 75 sites in seven countries, assigning patients who remain symptomatic despite antihistamines or biologics to receive either barzolvolimab or placebo over 24 weeks, the company said.

The main goal of the study is to determine how many patients achieve a complete response at week 12 based on standardized provocation assessments, it added.

Meanwhile, Celldex expects to release results from the open-label extension of the phase 2 ColdU/SD trial in early 2026.

Shares of Celldex were down 1.7% in recent Tuesday trading.

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